Behavioral Drug and Risk Reduction Counseling (BDRC) for HPTN058 TREATMENT MANUAL

Transcription

1 BDRC Treatment Manual for HPTN058 July 2010 Behavioral Drug and Risk Reduction Counseling (BDRC) for HPTN058 TREATMENT MANUAL Marek C. Chawarski, Ph.D. Declan T. Barry, Ph.D. Mahmud Mazlan, M.D. Richard S. Schottenfeld, M.D. Yale University School of Medicine New Haven, Connecticut Substance Abuse Center, Muar, Malaysia

2 BDRC Treatment Manual for HPTN058 July 2010 Page 2 Manual for Behavioral Drug and Risk Counseling (BDRC) for Opioid Dependent Individuals enrolled in HPTN058 study protocol Table of Contents TOPIC PAGE Introduction 3 I. Treatment Philosophy of BDRC A. Overview 3 B. Typical features of opiate dependent patients 3 C. Theory and treatment philosophy 5 II. General Aims of the Therapeutic Intervention 8 III. Therapeutic Components of BDRC 9 IV. Counselor s Specific Aims During BDRC 11 V. Sequence of BDRC sessions 12 VI. Format of BDRC 13 VII. Introduction to Counselor s Handbook 15 Phase One of BDRC 15 Phase Two of BDRC 44 BDRC Materials Appendix IA BDRC Contract Appendix IB Relapse Prevention Exercise Appendix IC PTPE Exercise

3 BDRC Treatment Manual for HPTN058 July 2010 page 3 Introduction This manual contains guidelines and recommendations for implementing Behavioral Drug and HIV Risk Counseling (BDRC) for use in the HPTN 058 Phase III randomized controlled trial to evaluate the efficacy of drug treatment in prevention of HIV infection and death among opiate dependent injectors. The purpose of HPTN 058 is to determine the efficacy of a drug treatment intervention involving administration of a buprenorphine/naloxone (BUP/NX) combination for 52 weeks plus drug and risk-reduction counseling (hereafter referred to as Long Term Medication Assisted Treatment compared with short-term Medication Assisted Treatment with BUP/NX plus drug and riskreduction counseling (hereafter referred to as Short Term Medication Assisted Treatment) for the prevention of HIV transmission and death among opiate dependent injectors by reducing drug use and associated risk behaviors. The Study Population will consist of approximately 1500 HIV-uninfected, opiate dependent injection drug users who meet the eligibility criteria. The total duration of the study will be approximately four and a half years. Participants will be followed for a minimum of 104 weeks and a maximum of 156 weeks, depending on when they are enrolled. Behavioral and serologic assessments will take place at baseline and at 26 week intervals throughout the follow-up period. Eligible, HIV-uninfected opiate dependent study volunteers will be randomized to one of two study arms in a 1:1 distribution. Counseling in both study arms will use drug and risk-reduction counseling adapted from evidence-based interventions and adapted by the sites. This counseling strategy will be delivered by trained addiction/prevention counselors and will focus on achieving and maintaining individualized goals of drug use reduction and HIV prevention. All study procedures must be consistent with the latest versions of the Protocol and the Study Specific Procedures Manual (SSP). Counseling and medication management begin together at randomization, with visits occurring at the same time and in the same facility as often as possible to reduce participant inconvenience and increase compliance. Clinicians and the counselors should consult each other regularly about the participant s overall progress in study treatment; however, each treatment modality proceeds according to its specified procedures as stated in the protocol, in the Study Specific Procedures Manual (SSP), and in the respective treatment manuals. Clinicians and counselors should become familiar with both the counseling and BUP/NX manuals so that the treatment of the participant will be coordinated. In HPTN 058, BDRC includes twelve weekly 45 minute sessions followed by ten monthly sessions through study week 52. All sessions are delivered in the individual format (i.e., oneon-one; typically, the same counselor provides all 22 BDRC sessions to the same study participant) in the appropriate clinic settings (i.e., counseling rooms affording privacy, confidentiality, and sufficient comfort to conduct minutes of uninterrupted discussions). BDRC sessions are delivered by drug counselors, nurses, medical assistants or other qualified personnel after they successfully complete a study specific BDRC training. In addition to individual sessions, the BDRC counselor should encourage the participant to engage in any available additional drug treatments or counseling services available in the community, including

4 BDRC Treatment Manual for HPTN058 July 2010 page 4 self-help or peer support groups therapy or peer counseling. Sites are encouraged to support organization/establishment of peer counseling groups if no self-help, peer support groups are available. BDRC is highly structured and prescriptive. It focuses on a limited set of immediate problem areas including treatment participation and medication adherence; becoming abstinent, maintaining abstinence, and preventing relapse; modifying or eliminating behaviors that increase the risk of contracting blood borne or infectious diseases (e.g., HIV, Hepatitis, sexually transmitted diseases); increasing engagement in non-drug-related social interactions and pleasurable activities. In BDRC, the counselor educates the patient about opiate addiction as a chronic medical condition and its optimal treatments while guiding the patient through the initial stages of the recovery process. In addition to cognitive-behavioral counseling techniques, BDRC uses explicit contracting procedures to engage the patient in a straightforward and structured recovery which involves medications (either short- or long-term depending on study arm), counseling, engagement of the participant in clean and sober activities, and promotion of lifestyle changes supportive of sustained abstinence and elimination or reduction of behavioral risks. BDRC puts strong emphasis on prevention of bloodborne and infectious diseases (HIV, Hepatitis, STDs) by increasing patient knowledge of drug and sex related transmission/infection risks and teaching effective prevention strategies. BDRC also educates the patient about effective use of all treatment components and advocates the use of other available resources (e.g., psychiatric, medical, social work, community resources) to maximize the overall effectiveness of the current treatment and to promote a sustained long-term recovery from drugs. I. Treatment Philosophy of BDRC A. Overview An opiate dependent patient is suffering from a chronic relapsing illness that affects his/her physical, emotional, and social functioning, as well as his/her relationships with family and friends, the larger community, and the society. BDRC targets multiple areas of needs for the client in a comprehensive but focused manner. BDRC incorporates the disease model of opiate dependence and is compatible with medication treatments for this disease. It utilizes behavioral change and skills-learning techniques that have proven to be highly effective in initiating and maintaining prolonged abstinence from illicit substances and in fostering a lifestyle supportive of sustained recovery from drugs and elimination of behavioral risks of bloodborne and infectious diseases (HIV, Hepatitis, STDs). In addition to the skills-learning and relapse-prevention procedures commonly utilized in cognitive-behavioral and other drug counseling approaches, BDRC makes extensive use of short-term behavioral contracting and activation procedures to address the core problems associated with opiate dependence and to supplement the counseling sessions with guided exercises aimed at practical application of the newly learned skills in the patient s natural environment. The treatment is designed to provide education about medical conceptualization of opiate addiction and available effective treatments, to increase the patient s activity levels and engagement in rewarding activities not related to drugs, to increase the patent s self-efficacy, and to counter the patient s belief that his/her actions will not lead to success in accomplishing goals. The accomplishment of simple contracts targeting short-term behavioral goals early in

5 BDRC Treatment Manual for HPTN058 July 2010 page 5 treatment promotes the patient s experience of therapeutic success and increases the likelihood of ongoing treatment adherence. In common with other drug counseling approaches, BDRC helps the patient to cope with the symptoms of drug dependence and related areas of impaired functioning, gives the patient improved coping strategies and tools for recovery, assists the patient in achieving and maintaining abstinence from drugs and risk behaviors, and guides the patient in recovery from the damage the addiction has caused in his or her life. B. Typical features of opiate dependent patients. Prolonged use of opiates inevitably leads to an increasing focus on drugs as the most important, or only, reward and reduced engagement in positive pro-social and non-drug-related activities, such as employment, education, family and other social involvement, or non-drug related pleasurable activities (e.g., hobbies, sports, or other interests). Hallmarks of drug dependence include preoccupation with obtaining and using the drug, spending increased time in drug use and drug-related activities, continuing to use drugs despite adverse consequences, and a loss of control over drug use (e.g., inability to stop or refrain from use, using more than intended and more often than intended). Individuals with opioid dependence generally experience repeated failures at achieving important life goals and at fulfilling their roles, responsibilities and obligations to family members, friends or others. Most have also failed repeated attempts to become abstinent, either on their own, or through detoxification or other treatment. Consequently, they often come to believe that they are not capable of accomplishing their own important life goals. Attempts to enter treatment are often extrinsically motivated by mounting legal, financial, health, or family problems. Treatment programs are seen as safe, temporary havens from the storm, but not as opportunities to take an active role in significantly changing lifestyle or activities. This lack of internal motivation and passivity contribute to treatment failures, which, in turn, further reduce an individual s sense of self-efficacy or perceived ability to effect change in his or her life. This combination of lifestyle dominated by opiate use and repeated failures contributes to demoralization and the belief that one s own efforts will not be effective and are not related to success or failure. Feelings of disappointment about past failures and shame are common among patients with opiate dependence. Many patients often feel down or depressed, don t have very much energy, and have difficulties sustaining work or other activities. They appear to have given up on many fronts, including the possibility of ever achieving or sustaining abstinence from illicit substances or significantly improving their lives. They feel resigned and powerless to do anything to succeed or to make things better for themselves. Extended use of illicit opiates and the development of physiologic dependence result in the need to constantly monitor immediate physiological, bodily and emotional signs of intoxication or withdrawal leading to the development of a specific cognitive/thinking style characterized by an external locus of control, extremely constricted time perspective and discounting of future rewards and overvaluation of immediate rewards. External locus of control (i.e., inability to see positive and negative consequences of his/her own actions associated with a belief that the environment, other people, or some higher power control their decisions and their life is often accompanied by unspecified or unrealistic hopes about the future. Many opiate dependent patients hope for a quick dramatic change in their lives at the onset of their current recovery

6 BDRC Treatment Manual for HPTN058 July 2010 page 6 attempt brought about by the treatment or other external circumstances. For example, the patients may believe that simply by taking study medication (Suboxone) they will rapidly become abstinent from illicit drugs or they may hope to win the lottery or obtain a very profitable job and thus solve current legal, financial, or family problems. At the same time, they often lack specific and realistic plans for achieving recovery goals, and their outlook in life is characterized by an encapsulated or constrained perspective (i.e., self-centered, with a narrow scope, and spanning a relatively short time). Typical features of opiate dependent patients, such as shame and guilt about their past actions, blaming others for current life problems; having little energy or initiative outside of obtaining and using drugs; engaging in a very restricted range of activities; believing in an external rather than internal locus of control and perceiving that success is not related to personal activity; and focusing on immediate relief of dysphoric states rather than longer term goals, make it difficult for these patients to engage actively and persistently in recovery activities and interfere with their ability to succeed in substance abuse treatment. BDRC uses cognitive-behavioral techniques to help patients overcome many of these hindrances to help them better engage in their own recovery and to succeed in achieving overall treatment goals. C. Theory and treatment philosophy BDRC uses educational, cognitive, and behavioral techniques to address the key cognitive biases, dysfunctional behaviors, and recovery misconceptions of opiate dependent patients entering a substance abuse treatment program. BDRC offers the patients a conceptualization of opioid dependence that encourages their participation in a structured treatment program; utilizes short-term behavioral contracts to help them accomplish immediate steps leading to abstinence, life style change, and recovery; fosters development of improved self-efficacy and self-esteem; and teaches patients problem solving and cognitive and behavioral skills needed to prevent relapse. To encourage participation in a treatment program offered in the HPTN 058 study, BDRC offers the patient a conceptualization of opiate addiction as a chronic medical condition with a high rate of reoccurrence (or relapse) that can be successfully treated (managed) utilizing a longterm, comprehensive treatment approach consisting of medication (agonist maintenance), expert therapy (counseling), non-expert therapy (self-help or peer support groups), lifestyle change, and active involvement of the patient in his/her own recovery. An analogy with diabetes is often used. Diabetes is a chronic medical condition treated/managed with medication (e.g., insulin injections); regular visits to medical professionals to monitor progress and alter the treatment regimen if necessary; dietary and lifestyle changes; engagement in support groups; and active patient involvement in monitoring blood glucose levels and adhering to their individual diet and exercise recommendations. A similar understanding of opiate addiction helps to attenuate patients guilt and shame about their past failures, encourages them to understand and participate actively in treatment, helps to change patients unrealistic preconceptions about treatment and to counter the belief that success in treatment is outside of the control of the patient. A common misconception among individuals entering agonist maintenance treatment is that the maintenance medication is the critical or only important ingredient of treatment. Many patients at treatment entry report that drugs have lost all of their appeal; they do not feel high or even

7 BDRC Treatment Manual for HPTN058 July 2010 page 7 good after taking the drug, and they continue to use only to prevent withdrawal symptoms. Therefore, they often view agonist medications, such as Suboxone, as a quick fix or substitute for illicit opiates that will help them to prevent relapse and overcome addiction, independent of other interventions. BDRC emphasizes that opiate addiction should be viewed as a chronic medical condition that has no quick fix. It educates the patient about all necessary treatment components and teaches patients how to best utilize all clinical contacts (e.g., counselors, therapists, doctors, social workers) and available resources (e.g., peer support groups, educational and vocational community resources) to maximize possible gains from treatment. Because of their narrow or constrained time perspective, opiate dependent patients may have particular difficulties engaging and succeeding in a long-term treatment program aimed from the outset at achieving long-range, big-picture goals. At the same time, treatments that rely on patients self-efficacy, motivation, skills, and persistence in fulfilling long-term plans to attain recovery goals may not be appropriate for such patients. For many opiate dependent patients with a long history of drug use, long-term goals may feel overwhelming and discouragingly difficult to accomplish. Thus, BDRC seeks to engage patients in a short-term, rewarding, simple and explicit treatment program with specific, limited and achievable primary objectives. These objectives include achieving an initial short period of abstinence from opiates (measured in days), initiating behavioral changes in their everyday lives and social interactions with non-drug using family and friends, and learning about addiction and how to effectively utilize available treatment options. BDRC uses the current motivational state of patients (extrinsic and short term), rather than attempting to modify it, in order to provide them with a chance to gain a firsthand experience of success in treatment and a rewarding life without drugs. D. Key therapeutic components D.1. Contracts To counter pessimism and to behaviorally activate the patient, BDRC makes use of small-step, short-term, explicit and detailed behavioral contracts between the patient and the therapist as initial steps along the way to accomplishment of longer term goals. BDRC utilizes behavioral contracts to increase the likelihood of the patient s engagement in the prescribed activities. Providing a detailed plan within each contract gives the patient a clear sequence of necessary steps leading to successful goal completion. A BDRC contract is a verbal or written agreement between the patient and the counselor describing the prescribed activity which includes an exact time frame, spanning no more than one to two days, and a clear detailed description of all intermediate steps necessary to successfully accomplish the contracted goal. Typically, during BDRC the counselor makes contracts with the patients for treatment participation (e.g., timely attendance at all scheduled counseling sessions and medication dosing appointments), cessation of drug use (e.g., to refrain from use for one day or a few days), increasing activities or social interactions unrelated to drug use (e.g., spend time with a friend or family member who is not using drugs; engage in a sport, hobby, or recreational activities; or attend a peer support group meeting, if such meetings are available), and increasing work or education related activities. Each contract must be reviewed with the patient in the subsequent session. This review follows the sequence of activities or steps outlined within the contract, starting with the activities leading to the initiation of the contract s first step and ending with an evaluation of the overall contract goal. It is

8 BDRC Treatment Manual for HPTN058 July 2010 page 8 important not to initiate the review with the end goal of the contract. In other words, the counselor should never begin the review with, So, how did it go? or similar questions. Starting with the first step of the contract gives the counselor ample opportunity to provide positive feedback or praise for partial or incremental achievement, or even just good intentions, even in a situation when the overall goal was not accomplished. The patient s failure to accomplish the overall goals of the contract, or some of the intermediate steps, are not extensively discussed or analyzed. Instead, a modified contract, often including smaller and more readily achievable goals and improved strategies to accomplish them, is devised by the counselor and negotiated with the patient. Consistent with the typical patient s expectations about treatment process, external locus of control, and difficulties problem-solving or initiating activity, BDRC is highly structured, explicit, directive and educational. The counselor selects therapeutic goals, decides on the course of actions during treatment, selects solutions to problems encountered by the patient, and makes recommendations about future directions. The therapy is not meant to be exploratory in attempts to understand the wider or deeper context of the specific addiction problems of each patient. BDRC does not require patients to generate potential solutions, or direct the course of the therapy, but it does both permit and encourage patients to become active participants in their own treatment. During the course of BDRC, the counselor and the patient follow a simple explicit plan that demonstrates to the patient how her/his actions can result in positive changes or accomplishments in life. D.2. Positive emphasis BDRC incorporates recent findings from research in cognitive and social psychology suggesting that gain-framed messages are more effective than risk-framed messages in promoting healthprevention activities. Opiate dependent patients with a long history of drug use respond better to acknowledgement of their attempts to change, even if only partially successful ( the glass is half-full ), rather than to a focus on their failures to succeed ( the glass is half-empty ). BDRC, therefore, uses positively framed messages, which emphasize positive consequences of behavioral change (e.g., benefits of not using drugs vs. dangers associated with continued use) and recognizes the importance of the patient s attempts to change. Positively framed or gainframed messages are particularly important for patients who anticipate repeated failures and loss rather than achievement of goals and who are more likely to interpret therapeutic messages in a negative way (e.g., as unhelpful criticism). Research findings also indicate that positively framed advice and recognition or praise for attempts at change generally evoke positive affect, which is often generalized and ascribed to the behavior in question, thus resulting in greater compliance with the message. Viewed from this perspective, some of the approaches often used with patients in drug treatment programs, such as an emphasis on the negative consequences that will result from continued drug use or failure to abide by program rules and expectations, may not be optimal. Consequently, BDRC counselors are trained to provide exclusively positive feedback to patients regarding even the smallest achievements. This emphasis helps patients to build self-esteem and the sense that they can change their lives for the better. D.3. Education and skills training Finally, BDRC teaches patients problem-solving and cognitive and behavioral skills that are

9 BDRC Treatment Manual for HPTN058 July 2010 page 9 helpful in achieving abstinence, preventing relapse, and reducing or eliminating risk behaviors. The focus on problem-solving skills encourages the counselor and patient to identify and harness a patient s existing strengths (rather than focus predominantly on the patient s problems, which may undermine development of self-efficacy) while learning new problemsolving techniques. Later, the focus shifts to having the patient become an increasingly autonomous effective problem-solver. A focus on cognitions and development of competence and skills may be particularly appealing for patients in cultures that do not value open disclosure of emotions (e.g., many cultures in Asia). Skill-building components include sessions focusing on identifying, avoiding and managing or coping with triggers and high risk situations for drug use (e.g., environmental, social or emotional triggers and cues), reducing HIV risk behaviors, and improving day-to-day functioning, including finding pleasurable activities that are alternatives to drug use.. Opiate dependent individuals are at heightened risk for becoming infected with the HIV virus as a result both of injection drug use (injection drug users) and sexual behaviors (both injection and non-injection drug users). Injections of illicit drugs are most often done with non-sterile equipment (needles, syringes, cookers, filters, etc., often reused without proper cleaning), frequently in non-sanitary conditions (such as public restrooms), and some drug users share both drugs and injecting equipment. Drug use may lead to, or facilitate, sexual activity and/or interfere with deciding whether or not to practice safe sex. Sexual activity may also lead to drug use or be used as a means of obtaining drugs or money to buy drugs. Improving knowledge and awareness of the negative consequences of risky behaviors (e.g., reusing or sharing of injection equipment, unprotected sex with strangers) while helping to master alternative safe behaviors promotes effective decision making and problem solving in future situations of potential risks. The goal of BDRC is incremental risk reduction with eventual elimination of these risks. BDRC accomplishes this in two steps: Individualized risk assessment and individualized behavioral modification via contracting combined with skills-learning techniques. Risk assessment involves counselor evaluation of the patient s knowledge of disease transmission, protective behaviors, and risky behaviors, and, in addition, learning about the patient s current behavioral patterns. Behavioral modification puts emphasis on prevention and protection (i.e., engaging in behaviors to protect oneself from further risk, and living a better and longer life), rather than on grave consequences of maintaining unsafe and/or risky behaviors. Patients who currently inject drugs, engage in risky sexual behaviors, or have faulty information or a dearth of information about contraction, exacerbation, and transmission of bloodborne or infectious diseases are viewed as being at-risk. However, all opiate dependent individuals regardless of their currently displayed behavioral patterns of risk or their current knowledge of HIV/Hepatitis/STD transmission are at heightened risk of contracting such diseases. There is clear epidemiological evidence demonstrating that the prevalence of such diseases is overwhelmingly higher in populations of drug users (the most common friends and peers of opiate dependent individuals) than in non-drug users or in the general population. Furthermore, current behavioral patterns of opiate dependent individuals are not indicative of their future risks as behavior and decision making skills can be adversely affected in situations of severe withdrawals or drug intoxication. BDRC equally targets all opiate dependent individuals as recipients of intensive interventions aimed at reduction of risks and improvement of preventive/protective strategies.

10 BDRC Treatment Manual for HPTN058 July 2010 page 10 II. General aims of the therapeutic intervention The stepwise goals of BDRC are to (1) increase patient treatment engagement and improve adherence with medication regimens and all therapeutic treatment components, (2) educate the patient about the disease of opiate dependence and its effective treatments (3) help the patient to reach an initial period of abstinence from drugs, (4) help the patient to reduce or eliminate risk behaviors, (5) activate the patient behaviorally and socially (by increasing interactions with nondrug-using individuals) in order to engage in rewarding or pleasurable activities that are not related to drugs (6) help the patient to master the skills needed to maintain abstinence or reinitiate abstinence after a lapse or relapse, and (7) introduce lifestyle supportive of full and sustained recovery from drug addiction. It is important to maintain the outlined order/hierarchy of the above goals during treatment progression because the accomplishment of each earlier goal is essential to achievement of the next goal. The initial sessions of BDRC seek to engage opiate dependent patients in a rewarding, simple and explicit treatment program with specific, limited and achievable primary objectives. Consequently, the process of learning about or understanding of the patient s presenting problems should focus on the present and be limited to a few content areas. These include current (e.g., within the past week) drug use, work and other everyday activities, social interactions, and immediate goals or plans. Rather than obtaining detailed lifetime history of drug use and associated problems, the counselor s initial focus should be to obtain a fairly detailed snapshot of the patient s current daily lifestyle, in order to be able to devise plans for behavioral changes that can be implemented right from the onset of the treatment. During the initial phase of treatment, which generally lasts from four to six weeks, the counselor and patient also identify longer-term treatment goals and plan specific counseling interventions for the next phase of treatment that can help the patient accomplish these goals. Although patients at treatment entry often report problems or crises in multiple domains of their lives (psychological/emotional, social, legal, economic, and medical), the BDRC therapist is encouraged to eschew extensive exploration of emotional problems (including trauma and stress associated with the patient s life situation) or attempts to resolve for the patient immediate crises (e.g., work, housing, legal, of family crises). Temporarily limiting the focus of therapy to a few, well-defined, and relatively easy to approach problem areas, and delaying attempts to deal with other important issues, may help to decrease stress and counter a typical patent s outlook that change is difficult or impossible due to the multiplicity of their problems. A short-term and restricted focus approach greatly increases the likelihood of the patient experiencing success and having a rewarding experience early in the course of therapy. This, in turn, is likely to decrease symptoms of demoralization, improve motivation, and empower the patient in his/her future attempts at solving bigger, more difficult problems. The focus of BDRC sessions should generally be confined to the following content areas: 1) Adherence with medication regimens and all other treatment components including timely participation in counseling sessions and medication dosing appointments. 2) Education about opiate addiction as a disease, its treatment, and about the role of behavioral change in recovery.

11 BDRC Treatment Manual for HPTN058 July 2010 page 11 3) Means and ways to reduce drug use and achieve abstinence, initially for a short period of time. 4) Means and ways to reduce, eliminate or modify drug- and sex-related risk behaviors associated with transmission of blood borne viruses and other infectious diseases (e.g., HIV, Hep C, STD), including education about these risks and effective prevention strategies. 5) Behavioral activation that helps the patient extricate from a state of inactivity and/or fill in the void created by the abandonment of drug related activities. 6) Development of and engagement in a drug-free network of social support (e.g., non-drugusing family members and friends or peer based recovery programs) to promote social relationships that are supportive of abstinence rather than drug use. 7) Development and strengthening of relapse prevention skills and techniques and advancement of a lifestyle supportive of prolonged recovery from drugs. BDRC should use referrals to other available resources to help the patient deal with other problem areas (e.g., trauma, anxiety, other psychiatric issues, or legal, housing or social service needs). In summary, the goal of the BDRC is to provide the patient with a snapshot of a rewarding life without drugs via patient engagement in a short-term, explicit, and rewarding counseling process. This snapshot of life without drugs is then used to build a larger picture that includes better understanding of the complexity of their substance use problem and development of long term plans for achieving long-term abstinence from drugs a major change in life. A successful course of BDRC therapy leads to the initiation of lifestyle supportive of sustained abstinence including active relapse prevention efforts and engagement in long-term recovery plan. BDRC can be conceptualized as being divided into two phases: the initial BDRC sessions put more emphasis on the patient s active engagement in treatment and achievement of initial behavioral changes; the remaining BDRC sessions (generally after the first month to six weeks of treatment) address the longer-term treatment needs and teach cognitive and behavioral skills needed to avoid relapse and sustain recovery. III. Therapeutic components of BDRC BDRC targets achievement of success early in treatment by setting small, clearly defined, and easily achievable behavioral goals with a focus on positive aspects of recovery. Instead of focusing on general hopes about major changes in life, BDRC encourages patients to focus on specific and well-defined immediate activities that produce small changes. Accomplishment of small changes illustrate to the patient that their actions can be effective and lead to positive results. When attained, small changes are rewarding, improve self-esteem and sense of achievement, help to improve emotional functioning, and reduce guilt and shame. If the patient fails at a small attempt to change, the emotional impact of a small failure is not devastating, and the problems encountered during a failed small attempt are easier to analyze,

12 BDRC Treatment Manual for HPTN058 July 2010 page 12 understand and overcome during the following attempt. The small changes achieved during the course of the therapy serve as the foundation for promoting larger change and are opportunities for the counselor to emphasize that more significant patient change is possible. BDRC is educational and prescriptive: it provides extensive education about opiate dependence and effective medical and psychosocial treatment components, as well as blood borne and infectious diseases, and effective prevention strategies. One of the BDRC counselor s roles is to educate the patient about the medical and psychosocial components of addiction and treatment and effective HIV prevention strategies. The patient s understanding of addiction as a disease that has no quick fix is paramount to success in recovery. Emphasis is also placed on educating the patient about the optimal use of all components of the study treatment (including Suboxone) and clinical contacts with counselors, doctors, or other study personnel in order to maximize the effectiveness of substance abuse treatment offered in HPTN058. BDRC utilizes short-term contracts between the counselor and the patient to increase the likelihood of the patient s engagement and successful completion of prescribed activities. The key therapeutic component of BDRC is a series of behavioral contracts in the form of written or verbal agreements between the counselor and the patient. An important feature of these contracts is the initial focus on realistic, small, and easy to obtain achievements. Examples of small and short-term contracts include timely participation in all medication dosing appointments and counseling sessions, disposing of drug use paraphernalia, not using drugs for a day or two even without a commitment to an extended drug abstinence, changing a daily routine related to the way drugs are obtained or used, or finding temporary/transient employment. At times, these initial achievements may not immediately appear to contribute substantially to the accomplishment of the greater goals (e.g., sustained abstinence and recovery). However, when patients accomplish small, well-defined goals and experience improvements in their mood and sense of efficacy, they are often motivated to engage again in similar, or even more complex, contracts. All contracts use short timeframes (1 to 2 days), target behavioral changes, and include detailed and explicit step-by-step plans. It is the counselor who suggests the most appropriate areas/activities for the contract and guides the patient through the process of developing an action plan that has a high likelihood of achieving the contracted goals. Contracting interactions end with one of two explicit patient commitments: either the patient gives a verbal commitment; or the counselor and the patient compose a written contract, signed by both. In the subsequent session, the counselor reviews the contract fulfillment with the patient, focusing on accomplishments rather than failures, administering as much of positive feedback as possible, and discussing the patient s satisfaction with attempts to meet the contract goals. It is essential to review with the patient each of the therapeutic contracts during the very next counseling session. Counselor s feedback is framed in a positive tone. Contract review follows the step-by-step order of activities that were planned in order to complete the goal of the contract. Starting with the activities leading to the initiation of the contract s first step and ending with an evaluation of the overall contract goal gives the counselor ample opportunity to provide positive feedback or praise for partial or incremental achievement, or even just good intentions,

13 BDRC Treatment Manual for HPTN058 July 2010 page 13 even in a situation when the overall goal was not accomplished. The patient s failure to accomplish the overall goals of the contract, or some of the intermediate steps, are not extensively discussed or analyzed. Instead, a modified contract, often including smaller and more readily achievable goals and improved strategies to accomplish them, is devised by the counselor and negotiated with the patient. The counselor gives the patient strong encouragement and expresses strong positive belief in the possibility of success with the newly developed alternative plan on how to achieve the goal during the next attempt. If the patient is initially unable to fulfill a contract, strong attempts should be made not to abandon the contract s original focus. The counselor should explore with the patient obstacles and potential solutions to overcoming obstacles while aiming to develop a scaled back version of the initial contract proposing simpler, smaller, and easier to accomplish steps and goals. If the goal is not achievable, common sense may suggest walking away from the unsuccessful arena and finding a different and more promising realm. However, switching from goal to goal is counterproductive in effecting behavioral change. Rather than repeatedly attempting the same goal with slightly modified plans or switching goals altogether, progress can be achieved more efficiently by stepping back (scaling down, contracting for a smaller easier to achieve activity) in order to ultimately move forward. If necessary and practical, the BDRC counselor could engage others to help the patient succeed in the initial steps. For example, if the patient agrees to go to a peer-support group meeting but has difficulties in accomplishing this goal (e.g., social anxiety, lack of transportation, planning and scheduling difficulties), a peer-support group member can often help arrange transportation or accompany the patient to the meeting. Ideally, the series of therapeutic contracts progresses from very small goals to larger, more important goals aligned with sustained abstinence from drugs. The premise is to engage the patient in rewarding activities that provide viable alternatives to drug use by using an approach that emphasizes successful completion of small steps. This approach is driven by optimism about the possibility of change, it alleviates demoralization, increases the patient s self-efficacy, and readily motivates continuation to the next, bigger step. The initial series of therapeutic contracts is viewed as providing the patient with glimpses of how continuing treatment could improve his/her psychosocial functioning and recovery. Additional description of the contracting procedures can be found in Attachment X (BDRC Contract). BDRC provides cognitive and behavioral relapse prevention and skills training and guides the patient through the early stages of a comprehensive recovery program. BDRC helps patients to learn effective, problem-solving strategies and coping skills and to make significant lifestyle changes needed to achieve and maintain abstinence and reduce the risks of blood borne viruses and other infectious diseases transmission. BDRC teaches risk reduction techniques, including both knowledge and skills to identify risks and practical abilities to cope with such risks in order to successfully maintain prolonged abstinence and full recovery from drug use. Depending on the availability of medication-friendly self-help, peer supported recovery programs, BDRC also introduces the patient to the programs and encourages

14 BDRC Treatment Manual for HPTN058 July 2010 page 14 participation. Additional description of relapse/risk prevention techniques can be found in Attachments X (Relapse Prevention Exercise) and Y (Places, Things, People, and Emotions Exercise). BDRC involves individualized risk assessment and extensive risk reduction components for all patients. All opiate dependent individuals are at increased risk of engaging in behaviors that may result in HIV infection, sexually transmitted diseases, and/or other serious medical conditions. Risk behaviors that often accompany illicit opiate use include unsafe drug preparation and use practices, sharing of needles and/or injection equipment, and engaging in unsafe/unprotected sex. Individualized assessment of behavioral risks in BDRC should systematically cover 3 (often interrelated) categories of risk associated with opiate use: a) misinformation and lack of knowledge about bloodborne and infectious diseases, including HIV, Hepatitis, and sexually transmitted diseases; b) risks associated with injection drug use; and c) risks associated with sexual behaviors. BDRC counselors should learn about specific patterns of risk behaviors for each patient before devising individualized risk reduction treatment components. Risk evaluation and risk reduction components of BDRRC involve discussing sensitive information. Both the counselor and the patient may not be initially comfortable talking about high risk behaviors. Patients may be embarrassed talking about sex in general, or about their own sexual experiences. They may also be aware that needle sharing or unsafe sex practices may be viewed with disdain by others. In addition, individuals raised in religious families may find discussion of sexual practices uncomfortable or inappropriate. Consistent with the overall BDRC approach, the counselor should make effort to put the patient at ease by providing a clear rationale for discussing a broad range of risk behaviors and be attuned to the patient s verbal and nonverbal reactions, yet all BDRC counselors should uniformly and persistently discuss such behaviors in a calm, nonjudgmental manner with all study participants. BDRRC utilizes the current motivational state of the patient. Changing the motivation of the patient and directing it toward intrinsic motivational state and achievement of big treatment goals (sustained abstinence, permanent restructuring of their social networks, and the development of an alternative lifestyle) is generally difficult, and can rarely be achieved within a short period of time. Initially the BDRC can utilize the patient s extrinsic motivation to enter treatment and the counselor can present participation in the therapy as a break from the current life storm - a safe heaven or vacation from drugs for some period of time - rather than as a long-term treatment commitment or permanent life-style change. Typically, after the patient has experienced some initial successes, accompanied by a reduction in demoralization, his/her outlook of success in the future is improved, which in turns enhances the motivation and promotes sustained effort to achieve long-term treatment goals. Urine toxicology testing in BDRRC. It is recommended that all available urine toxicology tests are utilized in BDRC treatment and their results are discussed during the counseling sessions as objective indicators of the patient progress in treatment. The counselor should introduce drug urine tests as similar to other medical laboratory testing procedures, such as monitoring blood sugar levels for patients with

15 BDRC Treatment Manual for HPTN058 July 2010 page 15 diabetes, rather than means to validate the patient s report of his or her recent drug use. In BDRC sessions, the counselor first shares all available urine test results with the patient before engaging the patient in discussing his or her reports on the current illicit drug use. Negative urine tests are presented and discussed as objective, medical confirmation of the patient progress in treatment. Positive urine tests are used as starting points to discussing ways of achieving better treatment progress, or what additional skills or behavioral changes could prevent future relapses to drug use. Involvement of family, spouses or other significant persons in BDRC. BDRC has been developed as an individual therapy and it is recommended that only one counselor and one patient participate in most, if not all, of the BDRC sessions. However, because we recognize the importance of family, spouses, significant friends and other members of the close social networks in the recovery process, BDRC includes recommendations on how such individuals could be successfully engaged in supporting the patient s recovery efforts. In general, it is recommended that family members, spouses, or other close/important individuals could be offered separate educational sessions, preferably without the participation of the patient who is in treatment. These educational session should focus on the following topics: a) medical understanding of the disease of opiate dependence and its effective treatments; b) the role of medications in effective treatments of opiate dependence (e.g., how medications differ from illicit drugs); c) the role of counseling, explaining and demystifying the counseling process and techniques: d) the role of social support in recovery, including family support, but also participation in self-help groups or organizations. IV. Counselor s specific aims during BDRC: 1. Introduce himself or herself as someone who is knowledgeable in substance abuse treatment, describe his/her role in treatment, explain the treatment components, and outline expectations and rules of conduct during the entire treatment. Establish open and honest communication with the patient. Develop a relationship with the patient where the counselor is perceived as providing expert guidance about opiate dependence/addiction and treatment for this disease. 2. Provide the patient with education regarding medical conceptualization of opiate dependence and its treatment. The counselor should also provide extensive education about health risks associated with drug use, such as unsafe drug preparation and use methods, and unsafe sex practices. Patient education should include information about the role of medications, counseling, and lifestyle changes as important components of an effective treatment and should be provided in language and format that is easily understood and accepted by the patient. 3. Establish an initial detailed case formulation of limited scope and time frame. In his/her efforts to get to know and to understand the patient drug abuse/dependence problems, the counselor should learn about typical behavioral patterns in the current daily life of the patient. 4. Devise an initial treatment plan, which includes behavioral changes in the everyday life of the patient and develop explicit contracts, or agreements, that the patient will engage in specified activities outside the therapy sessions.

16 BDRC Treatment Manual for HPTN058 July 2010 page At each session, review contract completion and administer detailed, systematic, and positively framed feedback on goals achievement. Devise modified contracts when the patient fails to fully accomplish previously contracted activities. 6. Identify the patient s existing problems in other areas and provide a summary of these problem areas, as well as recommendations on how to deal with them in the subsequent treatment programs or concurrently utilizing resources available in the community. 7. Teach the patient to recognize physiological and emotional states, social and environmental factors, as well as various life problems associated with urges to use drugs. Help the patient to develop effective, problem solving strategies and to learn effective coping skills to maintain drug abstinence and avoid health risks from relapse to drug use or other risk behaviors. 8. Over time, after initiation of drug abstinence and initial lifestyle changes, develop with the patient an explicit detailed plan on how to continue making significant lifestyle changes and how to practice newly acquired coping and problem solving skills in real-life situations, using a small step approach. V. Sequence of BDRC sessions: A. Initial Phase: Education and short-term behavioral contracting All BDRC sessions are highly structured and follow a clear therapeutic approach based on general principles of cognitive behavioral treatments that is explicitly discussed/communicated between the counselor and the patient. The first session introduces the patient and counselor, provides an overview of the treatment approach that will be used and begins the process of developing a helpful, therapeutic relationship. The session provides an opportunity to evaluate the patient s immediate circumstances and problems related to drug use as well as the patient s potential strengths and areas of success. By the end of the first session, the counselor and patient should have developed an explicit contract regarding patient s participation in the next several counseling sessions and in all other treatment components (e.g., a contract in one of the following areas: a) timely attendance at medication dosing appointments, b) timely attendance at scheduled counseling sessions, or c) timely attendance at study related medical evaluation, or other evaluation visits with study personnel if applicable) as well as rules of conduct endorsed by the treatment facility. Subsequent sessions start with a friendly greeting followed by the review of the patient s progress in completing the contracts and in achieving or maintaining drug abstinence and other relevant behavioral goals. In general, the initial sessions of BDRC focus on education and behavioral changes targeting a limited number of specific, current patient problems. The major therapeutic tasks of the initial phase of treatment involve teaching the patient about the disease of opiate dependence and effective treatments of this condition and the development, evaluation, and revision of behavioral patient contracts. Contracts comprise the patient s intentional statements to engage in therapeutic activities outside of each counseling session. In session, the counselor reviews the patient s progress with contract item completion and administers positively framed feedback regarding contract completion. Successful completion of contract items demonstrates to patients that larger goals are achievable when they are broken down into smaller, concrete, goals and when realistic, well-defined steps are specified and systematically executed.

17 BDRC Treatment Manual for HPTN058 July 2010 page 17 Detailed discussion of the patient s efforts to complete the contract provides an opportunity to acknowledge the patient s efforts and successes, as well as to help the patient become increasingly aware of their active problem solving skills. During the contract review, the counselor breaks down the steps and skills that the patient used to implement any component or the entire contract and can thus acknowledge even partial success and provide positive feedback for successive approximation of behavioral change. During the session, the counselor also works with the patient to problem solve about any difficulties encountered completing the contract or the need to modify the contract. By the end of the session the counselor and patient should develop a new, short-term contract that the patient has a high likelihood of being able to complete successfully and that the patient commits to completing prior to the next session. As patients develop greater familiarity with the contracting procedure, the time spent in a session reviewing and developing contracts may decrease, and counselors will have more time and opportunity to provide additional education and specific individualized instructions regarding cognitive and behavioral relapse prevention and HIV risk reduction skills. While working on the short-term contracts in the initial phase of BDRC, the counselor and patient can also begin to identify longer-term treatment goals and to plan specific counseling interventions that can help the patient accomplish these goals. These longer-term goals and treatment plans are then articulated in a summary session with the patient that serves as the transition to longer-term treatment. The transition to the longer-term counseling interventions generally occurs after completion of the first four to six weeks of treatment. During the second phase of treatment, the counselor and patient continue to use behavioral contracts and to focus on the lifestyle changes initiated in the first phase of treatment. Note, however, that some topics included in the second phase of treatment (usually planned for sessions 7-22) may be introduced earlier in treatment, during the first 4-6 weeks, if they are thought to be critical for the patient to achieve abstinence. Note also that the sequence of sessions and topics planned for sessions 7-22 may be varied, depending on the needs of the patient. As counselors gain greater experience with BDRC, they are able to use the BDRC manual more flexibly to address at the most appropriate time the specific treatment needs of individual patients. Session 1 (study week 1): Introduction of the counselor; reasons for seeking treatment and patient s immediate goals or plans; education about the disease of opiate dependence and components of effective treatment; evaluation of the current patient status focusing on identification of typical behaviors and activities including identification of non-drug-related activities that the patient is capable of executing; overview of the treatment components, process, and the rules of conduct; initial therapeutic contract on treatment participation and compliance (e.g., timely attendance in medication dosing appointments or timely attendance in counseling sessions); Immediately after Session 1: Complete and/or organize the session notes, review new information obtained from the patient and select potential future contract(s) or contracting areas. Before each session: Check the patient's most recent urine results and review the session notes recalling the latest contract and the major themes or issues from the previous sessions. Review the Counselor s Handbook and familiarize with the topics that are appropriate to the patient's current phase in recovery. Prepare a detailed, step-by-step plan for the upcoming session.

18 BDRC Treatment Manual for HPTN058 July 2010 page 18 Session 2 (study week 2): Detailed review and positively framed feedback on treatment compliance (initial contract); brief review of current developments or changes in patient s life since the last session; continuing education about medical conceptualization of opiate dependence/addiction and treatment including the role of medications, counseling, and lifestyle changes; contracting for a small but significant behavioral change in patient s lifestyle. Immediately after each session: Complete and/or organize the session notes, review new information obtained from the patient, select and plan for potential future behavioral contract(s) and educational topics based on the individualized treatment plan for the patient. Sessions 3 5: Detailed review of contract accomplishments; positive feedback on all successful steps; review of problems and obstacles preventing the patient from accomplishing the contract, modification of the unsuccessful contract or its unsuccessful elements. Continuing education about medical conceptualization of opiate dependence as a brain disease and effective recovery strategies, as well as education on health risks of drug use and unsafe behaviors associated with drug use and sexual practices. Session 6 (summary feedback and evaluation - typically study week 6): Detailed review of the most recent contract; overall summary review of patient accomplishments and positive changes that happened during the initial sessions of BDRC; counselor s summary feedback/evaluation of patient s remaining problems and his/her recommendations regarding the longer-term treatment plans. The exact duration of the Phase 1 of BDRC is not fixed and cannot be predetermined for each patient entering BDRC treatment. Although typically it takes about 4 to 6 sessions for the initiation of significant behavioral changes and the achievement of significant periods of abstinence from illicit drugs, the rate of progress in BDRC can vary from one study participant to another. It is recommended that counselors implement BDRC in highly individualized fashion adjusting the rate of progression through counseling components prescribed in this manual depending on the unique characteristics and/or the rate of recovery progress of each individual study participant. The summary feedback and evaluation session outlined above plays an important role in the overall sequence of BDRC treatment. B. Phase 2: Continued Contracting, Relapse Prevention, Problem Solving, Coping Skills, Lifestyle Change, HIV Risk Reduction, and Sustained Recovery Sessions 7-22: During each of the remaining weekly or monthly BDRC sessions, the counselors should continue to develop, review, and modify new short-term, small-steps behavioral contracts. Continue to provide training in problem solving, relapse prevention, lifestyle change, as well as additional education on HIV risk reduction and skills to maintain a lifestyle supportive of sustained recovery. Phase 2 sessions follow the same format and utilize the same educational and therapeutic techniques/interventions as Phase 1 sessions. Counselors should continue to emphasize the positive aspects of recovery, provide positively framed feedback on all accomplishments, and help the patient to continue improving and reengaging in incomplete or failed contracting efforts.

19 BDRC Treatment Manual for HPTN058 July 2010 page 19 VII. Introduction to Counselor s Handbook Structure of Behavioral Drug and Risk Reduction Counseling (BDRRC) This counselor s handbook contains session-by-session recommendations for implementing Behavioral Drug and Risk Reduction Counseling (BDRC). The initial phase of BDRC comprises six 45 to 60- minute weekly sessions during the initial period of a drug treatment program. The second phase of BDRC comprises an additional 16 sessions (offered weekly or monthly) focusing on cognitive and behavioral skill building, relapse prevention, additional HIV risk reduction and health education, and other specific recovery-related topics individually selected for each patient. Manual Format Description of each session includes the overall session goals, recommended content areas, examples of contracts and communication scripts, as well, as session checklists. Please note that the examples of contracts and communication scripts included in this manual are only for illustration purposes. They are based on previous experiences with providing BDRC treatment to patients in different cultural and social settings and may not accurately reflect typical problems encountered by the HPTN058 study participants in Asia. BDRC counselors working in HPTN058 study are strongly encouraged to replace the current examples with examples and scripts based on their own, actual experiences in providing BDRC or other forms of psychosocial interventions. For the purpose of ease of reading, the counselor is designated as female and the patient is designated as male. Phase One of BDRC The first six sessions BDRC Session 1 The aims of the first session are to: 1) Introduce the counselor and provide overview of all study treatment components and rules of conduct 2) Review patient s current opiate and other drug use and related symptoms 3) Review patient s behavioral risks (i.e., HIV, HCV, STD and other infectious or bloodborne diseases risks) 4) Review patient s reasons for seeking treatment, immediate goals and plans 5) Discuss patient s current daily activities 6) Develop first contract In the first session, the counselor focuses on the development of a therapeutic alliance. She introduces herself as someone who is knowledgeable in substance abuse treatment, describes her role in treatment, explains the treatment components and their sequence to the patient, and describes expectations and rules of conduct during the entire treatment. Then she encourages the patient to introduce himself, to describe his current most significant problems with drug use, and the reasons for seeking treatment. The counselor provides a strong positive feedback of patient s recent efforts to become abstinent, as indicated by his treatment participation and/or other recent changes (e.g., reported efforts to cut down on drug use, changing from injecting to

20 BDRC Treatment Manual for HPTN058 July 2010 page 20 other routes of drug use) and expresses a strong conviction that working together on such efforts would result in even greater success in the future. A common finding in psychotherapy outcome research is that the working relationship between the counselor and patient (i.e., therapeutic alliance), especially early on in treatment, is a key vehicle for positive change. Counselor Introduction The counselor begins the session by briefly introducing herself. This introduction comprises a succinct summary of her counseling experience, experience with patients with opiate problems, and the improvements that these patients have made with BDRC. The aim of this introduction is to establish the counselor as a friendly, interested, helpful and non-judgmental person and to instill or augment hope in the patient that change is possible and that BDRC can help the patient succeed. Patient s Reasons for Seeking Treatment The counselor asks the patient to outline his current most significant problems associated with drug use and his reasons for seeking treatment. For example, What brings you in here today? Why did you choose to enroll in this study? If the counselor notices any reluctance or ambivalence on the part of the patient, she addresses this in an open, nonjudgmental manner. For example, What would you like to talk about today? What would you like me to know about you? In addition to providing information about the patient s current situation and his motivation to engage in treatment, explicating the reasons for seeking treatment may inform the content of initial contracts. For example, if the patient tells the counselor that he is required to enter treatment because of legal problems, the counselor can prescribe a short-term drug abstinence contract goal, which is framed as a way of helping the patient meet externally imposed requirements. Counselor Feedback The counselor provides the patient with positive feedback regarding his decision to enter treatment. She offers positive feedback for any possible patient achievements (e.g., recent reduction in opiate use, patient s decision to seek treatment) and emphasizes that they represent very important steps toward sustained abstinence. For example, So you decided to enter treatment because your wife threatened to leave you if you didn t become clean. Your choice to follow up on your wife s comments is an important one. You could have chosen to ignore her but you did not. It is important that we also acknowledge that you have managed to decrease your use. You were using 2 bundles a day and you managed to cut down to 1 bundle a day. Making the decision to enter a treatment program and cutting down on your heroin use are important first steps on the road to achieving abstinence. In addition to providing positively framed feedback based on the patient s performance or efforts and detailing the positive consequences of the patient s actions, the counselor assesses the patient s concomitant emotional experiences. For example, How do you feel about the positive changes you have made so far?

21 BDRC Treatment Manual for HPTN058 July 2010 page 21 Treatment Overview 1. Structure and ground rules of BDRC. The counselor informs the patient that they will meet once a week during the first 12 weeks and then once every 4 weeks for the next 40 weeks, and therefore they will have an opportunity to meet for a total of minute individual sessions. The counselor should ask the patient about his/her past counseling experiences and expectations toward the counseling offered in HPTN058 study. Building on the patient s previous experiences and expectations, the counselor should explain the ground rules of counseling, including confidentiality and privacy, and the importance of timely attendance at all counseling sessions by both the patient and the counselor. The means of communication between the counselor and the patient, for example in order to reschedule appointments if necessary, should also be discussed. Additionally, the rules of conduct both during the counseling sessions (e.g., all counseling sessions will be conducted within the clinic grounds, no home visits or meetings in public spaces to conduct counseling sessions, no smoking and cigarette breaks allowed during counseling, both the counselor and the patients will not pick-up phone calls during sessions, etc.) and pertaining to the clinic premises or study participation should be explicitly discussed. 2. Rationale of Therapy. The counselor explains that the goal of the treatment is to increase the patient s chances of success initially by taking agonist medication as prescribed, participating in regularly scheduled counseling sessions, and trying to make small but important lifestyle changes. Over time, the treatment will help the patient become involved in important activities and relationships that support recovery, and the treatment will teach the patient some of the skills needed to achieve and maintain abstinence. For example, The aim of this treatment is not immediately to cure your problems with heroin. It would be unrealistic to expect that outcome right away. Instead, our focus will be to get you involved in taking smaller steps and to experience success in completing these smaller steps. Not only will these small steps be geared towards helping to reduce your opiate immediately, they will also help you to get the maximum benefits possible from the treatment over the next six months and even after you complete this program. 3. Nature of Therapy. The counselor explains to the patient that BDRC sessions will: (1) be focused on the patient s heroin and other drugs use, health and HIV risks and closely related symptoms or problem areas and will not address a wide array of issues in other areas of his life, (2) provide education/information on recent scientifically based understanding of opiate dependence as medical condition and on available effective treatments (3) provide information on effective ways of preventing HIV transmission and on AIDS treatments (4) pertain to current problems and to factors, which are maintaining those problems, and will not address etiological/historical or root factors, (5) involve the counselor assigning the patient tasks, which the patient will complete between sessions (similar to homework ) (6) involve the counselor offering feedback to the patient on his progress in task completion (7) provide specific instruction in ways to achieve and maintain abstinence, reduce health risks, and make lifestyle changes that will support long term recovery.

22 BDRC Treatment Manual for HPTN058 July 2010 page 22 For example, The counseling in this study is very focused. That means that I won t be talking to you about all the problems, which you may be experiencing; instead, we will focus on your use of heroin and one or two other issues immediately related to your heroin use. Unlike treatments that explore the past in depth or try to find out why a person has a particular problem, we will focus on the present and what is maintaining your problems. We will examine the steps that you can take to help alleviate your problems. Each time we meet, I will help you plan what tasks to work on and provide you with feedback about how you are doing on the tasks. Then between sessions, you can put these steps into practice. In a way, it will be like having homework assignments to do after each session and I will check in with you at the next session to see how you did. Your completion of these tasks outside our sessions and not just what we cover while we are together in session will be very important. 4. Contracts. The counselor informs the patient that BDRC is goal-oriented. A large part of the therapy will involve identifying small goals and the behavioral steps that the patient should follow to accomplish the goals. The counselor will define the goals and steps in simple, concrete terms so that it will be evident to them whether the patient achieved the assigned goals. Finally, these goals and steps will be written down in a contract form, which both the patient and counselor will sign. The patient will work on the contract items between sessions and will receive feedback from the counselor at the subsequent session about his performance. For example, Fighting opiate addiction is an important and difficult task. There are two basic approaches, which I could adopt with you in helping you to tackle your substance use. Using the first approach, I could set you really big goals from the very beginning, such as, After you leave the session today, I never want you to use again. Although this goal might sound good, setting up such large goals from the get-go might actually set you up for failure. Instead, I am going to take a different approach with you. I am going to assign you small but important goals. I will then help you to identity the steps that you should take to achieve the goals. This way, you have a much better chance of achieving the goals. These goals will then be written down as a contract something that you agree to work on before the next session. We will then both sign the contract with the understanding that we both agree that this is something important that you will work on between sessions. How does that sound to you? Patient Evaluation Individualized Risk Assessment and Development of Individualized Treatment Plan Although the description of all important components of patient evaluation, described below, is included within the Session 1 outline, typically it takes more time than one counseling session to gather sufficient information in all relevant areas in order to develop an individualized and comprehensive treatment plan for any given study participant. Gathering of information and treatment planning should begin during Session 1, but typically it will continue throughout several initial BDRC sessions. The suggested below order of topic areas during patient evaluation can also be altered based on individual characteristics or needs of each study participant. 1. Typical Daily Activities. The counselor informs the patient that in order to get to know the patient, to understand his unique situation, and to be able to come up with the most appropriate and useful contracts or homework, she will review with him his typical daily

23 BDRC Treatment Manual for HPTN058 July 2010 page 23 activities. A useful interviewing technique involves asking the patient to look back and review the past week in order to select one day that he would call a typical day in his current life ( a day like many other days lately, not special in any way ). After the patient identifies such a day, the counselor invites him to describe in a step-by-step fashion what happened during this day starting with the time when the patient first woke-up in the morning on that day. It is most useful to talk about an actual day, rather than a typical set of daily routines, therefore the counselor should start by asking the patient to name the day that he is describing ( It was Tuesday ) and then include additional anchoring questions ( What did you eat for breakfast on Tuesday? How was the weather on Tuesday when you were walking from home to the bus station? etc.) throughout this interview. Additionally, as the patient tells the story, the counselor should ask questions encouraging the patient to be as detailed and as specific as possible ( On Tuesday, how long did it take you to get to your friend s house? How much money did you pay your friend on Tuesday? ) and to focus the story line on actual behaviors ( What did you do on Tuesday after you finished watching the game on TV? ) rather than on typical/usual behaviors, plans, needs, opinions, etc. The goal of such interview is for the counselor to obtain detailed information about the patient s daily routine, including drug use (e.g., obtaining money to buy drugs, buying, using, and recovering from drug use, places and circumstances of drug use), social networks, family activities, work, religious/support activities, and hobbies. The counselor s should ask as many questions as necessary in order to obtain a fairly detailed snapshot of the patient s lifestyle in these areas. This knowledge will inform the counselor about potential contract items and about social supports, which either promote (e.g., opiate-using friends) or hinder (e.g., clean and sober spouse) opiate use. Other questions and/or appropriate interviewing techniques can/should also be used to obtain detailed information about drug use and associated behaviors, social relationships, work or educational activities, and other relevant areas in order for the counselor to evaluate the patient before the individualized BDRC counseling plan can be devised for each study participant. 2. Substance Use and Drug Use Behaviors. The counselor inquires about the patient s pattern of illicit drug use, including opiates and other drugs. Specifically, the counselor should ask about the time, effort, and costs incurred in the patient s procurement and use of opiates, as well as about typical circumstances of use (e.g., time of day, location, people involved when obtaining, using, and recovering from drug use), routes of drug use, and types of used paraphernalia (e.g., types of needles used). Examples include It would be helpful for me to know more about how much you have been using. What drugs do you use? How do you use drugs? What type of needles do you use? How do you usually get drugs? When and where you use? What do you do with the needle after each use? How often do you use every day? Whom do you use with? How much money are you spending on opiates each day? Where are you getting the money from? 3. Social Networks. The counselor determines the extent of the patient s substance-using and non-substance-using social networks. For example, Whom do you hang out with every day? How many of your friends use drugs? How many of your friends are clean? 4. Sexual Relationships and Behavioral Risks. The counselor inquires about the participant s sexual relationships. Specifically, the counselor should review information about the participant s regular sexual partner(s) and about sexual activities with commercial sex workers, clients or with unknown partners. With regard to each sexual partner, the counselor should review information about the circumstances of the sexual activity (planned/unplanned,

24 BDRC Treatment Manual for HPTN058 July 2010 page 24 association with drug use), whether the participant uses condoms, and about the frequency and consistency of condom use. In order to help or ease the patient to communicate openly about potentially difficult or embarrassing issues, it is often helpful to precede the discussion of sexual relationships with discussions/questions about general health concerns of the patient, his knowledge and ways of protecting himself from various health risks, or discussions/questions about sexual practices of other drug users. 5. Family Activities. The counselor inquires about the patient s involvement in family activities. For example, How do you get along with your family? Does your family know that you use? How often do you meet up with your family? Does anybody else in your family use drugs? 6. Work. The counselor asks the patient about his work history and current work and the impact of drug use on work. For example, Are you employed? Do you work? How many hours a day do you work? How has your drug use affected your work? Do people at your workplace know or suspect that you use drugs? 7. Recreational interests or hobbies. The counselor inquires about the patient s drug-free recreational activities, special interests or hobbies. For example, What do you do for fun? Do you have any hobbies? Did you have any hobbies or special interests before you started using drugs? 8. Self-help, Peer Support Activities. The counselor inquires about the patient s use of self-help self-referral support groups or activities, which promote abstinence (e.g., NA or AA type meetings, or other non-government, religious, or community based support groups or organizations). For example, Do you know of any support or self-help groups for people with substance abuse problems in your neighborhood? Have you attended any such groups? 9. Knowledge of HIV/AIDS. The counselor assesses the participant s knowledge about HIV and AIDS, including his knowledge about causes, symptoms, transmission, prevention, and treatment. Counselors should generally use open ended questions when assessing the patient s knowledge of these topics and do not introduce quizzes, false/true statements, multiple choice questions, or similar overtly evaluative components especially in the initial stages of BDRC. Similarly to other information gathering interactions with the patients, the BDRC counselors should always use non-judgmental and non-evaluative communication style which generally helps the patient to talk openly and honestly about broad range of topics and facilitates the development of strong therapeutic alliance between the counselor and the patient. Information obtained from the patient about his typical patters of drug use and other daily activities is then used by the counselor to devise strategies for altering behavioral chains leading to, or associated with drug use, risk behaviors, or problems with study protocol compliance (e.g., missing medication dosing appointments or counseling sessions) and to implement them into subsequent behavioral contracts with the patient. Assessments of the patient s knowledge (e.g., about HIV/AIDS, the role of medications in treatment of drug problems) are used by the counselors to guide their choices of educational components to be included in upcoming BDRC sessions.

25 BDRC Treatment Manual for HPTN058 July 2010 page 25 Written List of Program Regulations/Study Information Sheet. The site study team should develop a Program Regulations/Study Information Sheet (See sample sheet) which lists the major program regulations. The participant should be familiar with these guidelines because they were reviewed with him/her during enrollment and were outlined in the study enrollment consent form which the participant signed. The counselor suggests that the participant post it in some prominent place in his/her house so that she/he can remember his/her session times and other relevant study information. The counselor briefly reviews the study s guidelines concerning: Punctuality: the counselor has assigned this time especially for the participant, however s/he has other participants to counsel, therefore the appointment will be canceled if the participant is later than a certain length of time (to be determined by the sites), Rescheduling and canceling sessions: sites should communicate their specific rules for rescheduling and canceling sessions to participants, Confidentiality: the counselor briefly reviews the limits of confidentiality depending on local regulations, Program appointments: the counselor briefly reviews the importance of the participant attending all study appointments and completing the required clinical assessments according to schedule. She/he emphasizes that the participant is encouraged to ask any questions and express any concerns about the study procedure. The counselor emphasizes that although she/he and the other staff are part of the same research team, the participant should not assume that clinical information she/he shares with the other staff will be passed on to the counselor. Consequently, the participant should be sure to bring up any clinical issues in the counseling sessions so that they can be adequately addressed by the counselor. Reviewing urine toxicology results in session. The counselor explains to the participant that collecting urine samples and testing them for drug use is similar to conducting other laboratory tests in a medical treatment (e.g., monitoring blood sugar levels for participants with diabetes). The goal is to provide objective/scientific indicators of disease symptoms and the treatment progress and that the counselor will review some of the urine toxicology findings with the patient during counseling sessions. Other, applicable site/clinic specific regulations or issues should also be discussed. Developing the First Contract 1. Open Communication. The counselor reiterates that the treatment is focused and involves contract development and completion. Given that the treatment is time-limited, it is important that the counselor and patient quickly learn to work well together. A good working relationship or alliance involves open communication. The counselor informs the patient that she will do her best to develop appropriate contracts and to administer honest feedback. The patient, on the other hand, is encouraged to be as open and honest about his problems, including his drug use, as possible since it will enhance his chances of benefiting from the treatment. For example, Given that we have a limited number of sessions together, it is important for us to work well together from the get-go. I will do my best to be as open as possible with you. I will set goals for you, which will be included in your contracts. I will provide you with direct feedback about your progress. The more honest and open you can be with me, the better the position I

26 BDRC Treatment Manual for HPTN058 July 2010 page 26 will be in to help you to become abstinent. You are an expert on your life and your problems. I have expertise on helping people to change. The more we can work together as part of the same team, the greater your chances of doing well. How does that sound to you? 2. Treatment Participation. The counselor explains to the patient that active participation in treatment, including timely attendance at all medication dosing appointments and counseling sessions, and adherence to the program and study regulations are necessary ingredients for success in treatment. Rather than highlighting the negative consequences of noncompliance, the counselor points out the positive consequences of active participation (i.e., the counselor offers a positively framed message). Given that active participation and timely attendance at all treatment components offered in the study will enhance the patient s chances of making good treatment progress, the first contract focuses on these issues. The counselor briefly reviews the study guidelines, paying particular attention to any potential difficulties, which the patient might face. For example, The more you take an active role in your treatment by participating in counseling and following the study guidelines, the more likely it is that treatment will work for you. I am one member of the team which is here to help you. You will also meet with nurses, physicians and other clinic personnel. Why don t we review the schedule for your next few visits and try to figure out any potential problems that you might face in coming to the clinic as scheduled? I want you to do well, so if for example, you have transportation difficulties, that s something that I would like to know about. Simply put, the more appointments you keep with different members of the treatment team, and the more that you follow the study guidelines, the more likely it is that you will benefit from the treatment. 3. Content of First Contract. The counselor uses the information gathered when learning about the patient s daily activities and reviewing the study regulations with the patient to develop the first contract. The first contract typically focuses on promoting compliance with study treatment components, including timely attendance at BDRC sessions and at all scheduled medication dosing appointments. For example, You are scheduled to come once a week for counseling. You ve indicated that you might have some difficulty making the counseling sessions, medication dosing appointments, or appointments with the physician when your wife uses the motorbike. On those occasions, what can you do to get to the clinic on time? In this example, the counselor and patient would examine a series of options, which would facilitate the patient s attendance at the next counseling session (e.g., planning ahead and negotiating with his wife regarding the use of the motorbike, or using public transportation). The first contract should contain specific timeline and detailed plans, which if followed, will enhance the probability that the patient will attend the next counseling session. If the contract is written rather than verbal, the counselor and the patient should both sign it. The signed contract could also be photocopied; the patient is then given the original and is told that the photocopy will be placed in his chart. The counselor informs the patient that at the next session they will review how successful and how useful were all the steps specified in the contract.

27 BDRC Treatment Manual for HPTN058 July 2010 page 27 Session 1 example outline and timing Counselor Introduction, reasons for seeking treatment, counselor feedback (5 minutes) Typical daily activities (20 minutes) Patient s current opiate use, behavioral risks and other current symptoms (10 minutes) Study/program overview (10 minutes) Developing the first contract (15 minutes)

28 BDRC Treatment Manual for HPTN058 July 2010 page 28 Treatment Information Sheet (EXAMPLE) My counselor s name is My counselor s telephone number is For the next five weeks, my counseling sessions are scheduled as follows: Session 2 Session 3 Session 4 Session 5 Session 6 I will receive medication on (day/time) I will provide a supervised urine on (day/time) I will complete my scales or assessments on (day/time) Therapy sessions last minutes. If I am 15 or more minutes late for a session, the session will be canceled (and not rescheduled). To reschedule a session, I need to call my counselor at least 24 hours in advance. If I have questions about medication times, providing supervised urine samples, or doing scales, I should contact (Joanne Doe, ext 555). My counselor has reviewed the information on this sheet with me. I realize that it my responsibility to attend all of my study appointments and to follow the study regulations. Patient s Signature Counselor s Signature

29 BDRC Treatment Manual for HPTN058 July 2010 page 29 BDRC Checklist for Session 1 (EXAMPLE) Counselor : Patient ID: Date: Time started: ended: Scoring Key: Completed = 1, Partially Completed = 2, Not Covered = 3, NA = Not Applicable 1-3/NA 1. Counselor introduction 2. Reasons for seeking treatment 3. Counselor feedback 4. Patient s opiate use 5. Patient s other dug use 6. Patient s HIV risks 7. Structure and rationale of BDRC 8. Nature of BDRC and contracts 9. Typical daily activities 10. Review of Information Sheet 11. First contract developed 12. First contract co-signed 13. Contract agreed upon verbally

30 BDRC Treatment Manual for HPTN058 July 2010 page 30 BDRC Session 2 (study week 2) The aims of the second session are to: 1) Review patient s contract from session 1 2) Review medication issues 3) Review patient s view on opiate dependence 4) Discuss medical understanding of opiate dependence 5) Discuss ways of most effective utilization of treatment options 6) Review urine toxicology results (if available) and illicit opiate use since last session 7) Develop a new contract Contract Review and Positive Feedback on Completion of Contract Items After a brief greeting, the counselor begins the session by a detailed review of the contract developed in Session 1 (see also BDRC Contract in Appendix IA). The contract review begins with the first step of the contract not with the overall goal or the final steps of the contracting activity. The counselor positively (verbally) reinforces the patient s completion of each step in the contract including the completion of the final goal of the first contract (attending today s session). She informs the patient that he is attending his second session out of a total of 22 and she offers positive feedback regarding patient s attendance and punctuality, noting that the patient s efforts augment his chances of being abstinent from opiates. For example: Thank you for coming to today s session, which will be our second meeting out of a total of 22. As we discussed in the first session, abstinence from opiates is achieved through a series of small steps. Your coming here today and being on time increase your chances of becoming clean. How do you feel about having made it here on time today? Medication Issues By session 2 of BDRC in HPTN058, each patient, regardless of the study arm, has completed 1 week of Suboxone treatment. In the second BDRC session, the counselor discusses the patient s compliance with the study medication regimen, his understanding of the medication role in the overall recovery process, his level of satisfaction with and possible concerns related to study medication: (1) attendance at medication dosing visits (e.g., Are you coming for your medication dosing visits regularly? What happened yesterday that prevented you from coming to the clinic?) (2) overall evaluation of medication regimen and the patient s understanding of the role of the study medication in his recovery (e.g., What s your overall impression of the medication that you are taking, so far? What do you know about the study medication, Suboxone? Do you know how does the medication help people to overcome drug problems? ), (3) concerns or perceived side effects (e.g., Have you had any concerns so far about the medication? Does the medication help you? Have you experienced any side effects? ) The counselor determines whether the patient has been taking the medication regularly or has missed any doses. If the patient is not fully adherent with his medication dosing appointments, the counselor asks the patient for his input about potential impediments. She determines the factors that maintain his nonadherence and intervenes by developing a step-by-step contract to

31 BDRC Treatment Manual for HPTN058 July 2010 page 31 promote adherence. For example, To be honest with you, I am concerned that you are not regularly attending all your medication dosing appointments. This is an important issue to address in your contract for today. It would be useful for me to know more about why you missed some of your medication doses, so that we can develop a contract that is useful. What do you think is getting in the way of your coming to the clinic regularly? If the patient has missed medication dosing appointments to because of practical circumstances (e.g., lack of transportation, work schedule conflicts with clinic hours), or because of his own choice/decisions the counselor works with the patient to specify discrete behavioral steps, which the patient is capable of taking before the next medication dosing appointment to ameliorate the situation (e.g., talk to his boss about changing his lunch break so that he can attend all study related appointments). For example, You ve indicated that you don t come to the clinic on days when you aren t feeling withdrawal, but then afterwards you sometimes use heroin later in the day. Let s now figure out a plan for the days when you start off feeling fine and might not think about or want to take your medication. The counselor proceeds to solicit the patient s input regarding, for example, whether the patient might be more likely to go for his medication dosing appointment if he writes a note to himself as a reminder and leaves it posted in a place he is likely to see it, or the possibility of asking a family member to remind him about the importance of going regularly for his medication dosing appointments. The patient may also have concerns about medication side effects. In this circumstance, the counselor should provide the patient with education about the role of medication in drug recovery and recommend/negotiate with the patient a consult meeting with the study physician. The counselor then discusses the contract that incorporates a plan for the patient to discuss medication issues with the study physician, including discussing with the patient how he would benefit from discussing his medication regimen with the study physician rather than worrying about potential medication side effects. Patient s Views of Opiate Addiction and Optimal Treatment The counselor should extensively review/discuss the patient s own views on the nature of his problems with heroin as well as his opinions on what types of treatments he perceives as most effective for him. The counselor should also explore what does the patient know or thinks about the role of counseling in drug recovery. For example, From your point of view, what explains your problems with heroin up to now? What makes it difficult for you to stop using heroin? The counselor should also ask the patient about his views on the type of treatment, which would help alleviate his heroin use. For example, So, you ve had problems with heroin for a while, what kind of treatment would work best for you? What do you think would help you to stop using heroin? We already discussed the role of medication in recovery, how do you think counseling could help you in your recovery efforts?

32 BDRC Treatment Manual for HPTN058 July 2010 page 32 Medical Conceptualization of Opiate Addiction and Optimal Treatments After the counselor reviews the patient s views of opiate addiction and its treatment, she then presents the patient a medical conceptualization of addiction as a chronic disease that requires a comprehensive but straightforward treatment. This conceptualization serves multiple purposes. First, it offers the patient a context for the different components of his treatment, including medication, counseling, self-help or peer support recovery activities, and thus, legitimizes his current treatment regimen. Second, it informs the patient that treatment is neither a punishment nor a crutch; instead, treatment is a logical, necessary intervention to address a chronic medical condition and requires active participation of the patient in order to be successful. Third, it counters patient s ongoing negative self-attributions (e.g., I m using because I m not strong willed, If I was a better person, my wife wouldn t have left me ), by emphasizing similarities between opiate addiction and other chronic medical conditions (e.g., diabetes). Finally, it also promotes the idea that treatment compliance is the easiest most effective way to initiate a successful recovery process. The counselor emphasizes that similarly to treatments of other chronic medical conditions, if the patient is fully compliant with his treatment, some of his immediate problems will soon remit (i.e., promotes hope). For example, I appreciate that you feel embarrassed and guilty about your opiate use. You tell me that you are using because you are weak willed. I disagree with you. Opiate use is a chronic medical disease, similar to diabetes. If a friend of yours had diabetes and was not receiving the correct medical care, would you tell him that he was weak willed? [patient s response] It is important that you realize you have a medical condition similar to diabetes. Like many diabetics, you ve had symptoms for a long time. Without the right comprehensive treatment, the symptoms won t go away by themselves. Similar to diabetics who respond well to a treatment regimen that includes medication, visits with a clinician who has expertise with diabetes, support groups, and lifestyle changes, your chances of getting better increase when you actively engage in a comprehensive treatment program, like the one that you are in now. Your treatment includes a medication regimen, counseling with a clinician who has expertise in substance abuse, and you making lifestyle changes, participating in activities with non-drug using family members and friends or in peer support groups, and avoiding friends who use. Review Urine Toxicology Results The counselor explains to the patient that discussing drug use is like discussing other medical symptoms of a disease. In order for her to help the patient to overcome his disease (i.e., heroin addiction), she needs to know if he continues to experience the symptoms (i.e., heroin use). Similar to other laboratory tests (e.g., blood test for viruses, or a chest x ray), urine toxicology screen provides an objective and reliable measure of symptoms relief and is not used to verify the truthfulness of the patient s self-report. For example: If the urine results are negative, it means that the treatment is working for you and you are making a good progress. We just need to continue with our initial treatment efforts. If the urine results are positive, it means that your treatment is not yet working optimally for you, and we need to take a closer look at things that need to be adjusted or improved in order for your treatment to be more effective for you. How does it sound to you?

33 BDRC Treatment Manual for HPTN058 July 2010 page 33 If the urine results are available, the counselor reviews the findings of the most recent urine tests together with the patient. The counselor shows the patient urine test results first, before initiating the discussion about his opiate use since the previous session. If there is an inconsistency between the patient s self-report and urine result, the counselor does not challenge the patient. Instead, she reminds him that the study uses the urine toxicology findings as the gold standard or most accurate and objective method for determining recent drug use. The counselor can also discuss with the patient why urine test results are sometimes different from patients own reports (e.g., some people who use substances do not remember well all the events while they use drugs; people who want to get better often think about themselves as making bigger progress in treatment than what actually happens). Opiate Use Since Last Session. The counselor asks the patient about his opiate use since his last session and administers positive feedback concerning any decrease/reduction in use. For example, Last time you told me that you were using a bundle a day. Now you are down to 4 bags a day. That s great, you are heading in the right direction. You are exhibiting increased control. This puts you in a better position to figure out what behavioral changes you can make to support your abstinence from drugs and to decrease symptoms of depression. What have you done differently to bring about this change? If the patient attributes a reduction in use to the study medication and not to his behavior, the counselor reminds the patient that he has managed to attend his medication dosing appointments and he deserves to be congratulated for doing so. For example, You are telling me that your reduction in drug use is all due to the study medication (Suboxone). However, in reality, you also turned up for all medication dosing appointments last week. You got yourself to the clinic to get medicated. You could have stayed in bed or hang out with your friends. Instead, you organized your life better to get to the clinic on time to get your medication. This is a change in your behavior that you brought about, which has helped to reduce your heroin use. So, well done! Developing a New Contract The contract developed in this session should address opiate use, behavioral or social activation, or participation in activities unrelated to drug use or self-help support groups. The contract should specify small yet significant behavioral steps, which the patient will take before the next session. The steps should be concrete and behaviorally defined so that it will be evident to both the counselor and patient whether the patient completed the steps. Typically, the initial contracts focus on elimination or significant reduction of opiate use. However, if the patient has already demonstrated a significant reduction in substance use or achieved drug abstinence, the counselor can focus the contract on either behavioral or social activation, or participation in self-help support groups. For some patients, it could be beneficial to develop a written contract which is signed by the counselor and the patient. The signed contract is photocopied; the patient is given the original and is told that the photocopy will be placed in his chart. The counselor informs the patient that

34 BDRC Treatment Manual for HPTN058 July 2010 page 34 she will check in with him at the next session about his progress in the areas specified in the contract.

35 BDRC Treatment Manual for HPTN058 July 2010 page 35 Opiate Use Contract Rather than focusing on a large contract goal, such as abstinence from opiates for a longer period of time (e.g., 90 days), the counselor initially prescribes a time-limited (e.g., 1 day) abstinence goal and the necessary intermediate steps. The intermediate steps are outlined in a plan, which specifies patient activities during that day and which are incompatible with drug use (e.g., having lunch with a drug-free friend, taking daughter to game practice after school, attending a peer support meeting). For example, You told me that your employer gives you cash for your work every Friday, and every Friday afternoon on your way home you stop by at your drug supplier to buy enough heroin to last you for a few days. How about we try to do things differently tomorrow? Since your medication is helping you not to experience any withdrawals on the days that you do not use heroin, do you think that you are ready not to use heroin for a day or two, for example on Friday and Saturday? What follows is a discussion leading to contracting with the patient that after getting paid at work on Friday, he will take a different route from work, not buy heroin, and rather than going home directly (where he would typically take heroin in the evening and watch TV), he would go out for dinner and a movie. The contract would include explicit description of the alternate route, the restaurant that the patient would go for dinner, the location of the movie theater, what movie the patient will see, as well as timeline of all events, and a script of possible conversation between the patient and his drug dealer in case the drug dealer calls the patient inquiring about reasons why the patient did not come buy heroin. A follow up contract (during a subsequent session) could then be aimed at making more permanent arrangements around getting paid for work and changing drug buying and using behaviors For example, Last Friday worked great for you, but having money in the pocket could be a very strong trigger to buy and use drugs. Let s figure out how we can change the way you are being paid. Do you have a bank account? What follows is a discussion between the counselor and the patient on what needs to be done in order for the patient to open a bank account and to establish a direct deposit of his weekly paycheck into this account. Alternatively, for patients who have already achieved initial periods of abstinence or significant reductions in drug use, the counselor should select contracts aimed at increased behavioral or social activation of the patient. Such contracts can include any of the following areas: participation in self-help groups, or increase in non-drug related pleasurable activities. Examples of such contracts are provided below. Contracting activities with non-drug using friends or family members or participation in self-help, peer supported recovery group activities The counselor prescribes a contract goal which involves participation in activities with non-drug using friends or family members or a peer supported drug recovery group activity that promotes abstinence from illicit substances. The contract should be detailed and specify the activity location, time, and duration, and means of transportation. Description of Support Group Activity. The counselor reviews the patient s support networks and recommends that the patient engage in at least one activity (e.g., a clean and sober family activity, peer support group meeting, or religious service/activity). Possible beneficial activities

36 BDRC Treatment Manual for HPTN058 July 2010 page 36 include a broad range of formal or informal social and/or recreational activities that do not include consumption of drugs/alcohol and promote abstinence from illicit substances. Counselors may use the following approaches with patients to encourage their participation in these support groups. Some patients express initial resistance to the idea of joining a support group, typically based on their negative believes how such groups operate, whether support group participation will be effective for them, or their uncertainty regarding what to expect from a meeting and how to behave during such a meeting. The most effective way to develop a contract regarding support group participation is to change the patient s believe that in order to participate in such a meeting he needs to join the group or the organization and commit to a regularly scheduled long-term activity. Instead, the counselors presents the idea of going to one selected meeting in order to learn (or check if anything changed for patients with history of previous participation) first-hand how such meetings work and to find out whether participation in this activity would help the patient. The counselor develops with the patient a task-oriented script on what to say during the meeting, how to answer questions form group members, what to do during the meeting (e.g., actively listen for helpful hints on how other people became abstinent, observe one s emotional and physiological responses to other people s reports on their drug use, look for potential sponsors), and how to be in control (e.g., how to decide when to leave the meeting). Typically, it is easier for most patients to agree to participate in one selected meeting with the view that they may not need to go to any of such meetings again if the outcome of the first exercise suggests that such meetings are not very helpful in their treatment progression. However, when reviewing this type of contract, the counselor can educate the patient that even the negative aspects of the meeting (e.g., personal elaborate stories of drug use, excitement associated with the lifestyle, or failures and losses) can be used productively by the patient (with the counselor s assistance) in order to practice, for example, what types of triggers are particularly strong for the patient, and how to utilize newly learned coping skills in the real-life situation. For patients who have never attended peer-support meetings, the counselor provides a brief overview of foundations of peer supported recovery efforts and informs the patient that many individuals with drug problems find such meetings very useful. She elicits specific information from the patient to facilitate his attendance (e.g., Where do you live? When is the best time for you to attend a meeting? ). The counselor provides the patient with a list of available medication friendly meetings and a bus schedule (if needed). She explains to the patient that some peer support group meetings do not view medications in a positive light. However, medication friendly meetings will comprise individuals who will support his continuing participation in the study. They review these materials in session and determine how and when the patient will attend his first peer-support meeting. The counselor should set a small well-defined goal for peer-supported group attendance (e.g., attend the Tuesday 7pm medication-friendly meeting at the corner the meeting place, or, for patients who would like to go to the meeting with someone, meet a designated member of the group at 6 pm on Tuesday before the meeting at a particular coffee shop). Specifying a small time-limited goal, as well as the prerequisite steps involved (e.g., means of transportation,

37 BDRC Treatment Manual for HPTN058 July 2010 page 37 finding someone to accompany the patient to the meeting), reduces the patient s anticipatory anxiety and enhances the probability of successful goal completion. Patients currently attending peer-support meetings. If the patient is already attending such meetings, the counselor reinforces his efforts. She uses the current frequency or number of meetings per week as the goal for the coming week in order to maximize the patient s chances of successful goal completion. Patients with a negative view of peer-support meetings. If the patient reports a strong dislike for self-help support meetings (e.g., perceived religious overtones), the counselor should persuade the patient of the benefits of such meetings (e.g., a community of people with similar problems, some of whom developed very effective coping skills and a re eager to share them with others), emphasize the fact that many individuals need to shop around till they find a support groups that suits their personality or needs, assure the patient that it is OK to stay for a short period of time and leave, or recommend an alternative support group activity (e.g., clean and sober family activity). Behavioral activation contract Given that opiate dependent patients often exhibit very low activation levels, exercise can be an excellent behavioral intervention to include in a contract. The counselor explains to the patient that exercise is one proven way to increase endorphins in the brain, which help to improve mood. Exercise also improves health and a sense of well being. She recommends that the patient exercise before the next session. For example, You have already taken important steps to successfully reduce your opiate use. You are regularly attending your counseling sessions and your medication dosing appointments. You have also started spending time going fishing with your brother. These are all important steps that you have taken to feel better and succeed in recovery. You ve also indicated that you feel better about yourself when you make it to your different appointments. One additional way to improve your mood and health and help you feel better about yourself is to exercise. Not only is exercise a proven way to release endorphins, which help people to feel better, it doesn t cost anything and it s healthy for your body. Walking or jogging (depending on the patient s health status and fitness level) is inexpensive and less likely to exacerbate potential barriers to exercise. These activities do not require any special equipment and do not require a large commitment of time. The counselor asks the patient about his health status (e.g., Do you have any medical problems? How fit are you? ) and previous exercise history ( How much do you currently exercise? What types of exercise do you engage in? ). Armed with this information, the counselor recommends that the patient exercise for a certain length of time before the next session (e.g., walk 20 minutes on 2 specified days). It is important that, even if the patient is enthusiastic about exercise, the counselor not set an unreasonably high target. Exercise is a task, which the patient should succeed in and should provide him with a sense of accomplishment. Before writing the contract, the counselor should specify the type of exercise (e.g., walking, swimming), location (e.g., local park), and times when the exercise will begin and end (e.g., between 7:30 and 7:50 am on Monday and Thursday). The counselor should also discuss potential impediments (and solutions) to goal completion.

38 BDRC Treatment Manual for HPTN058 July 2010 page 38 Session 2 outline and suggested timing Review patient s contract from previous session (10 minutes) Addressing incomplete contract items (5 minutes) Patient concerns about treatment and medication issues (5 minutes) Review patient s view of opiate dependence (5 minutes) Discuss medical conceptualization of opiate dependence and effective treatments (10 minutes) Review utox results and opiate use since last session (5 minutes) Develop new patient contract (20 minutes)

39 BDRC Treatment Manual for HPTN058 July 2010 page 39 BDRC Checklist for Session 2 (EXAMPLE) Counselor : Patient ID: Date: Time started: ended: Scoring Key: Completed = 1, Partially Completed = 2, Not Covered = 3, NA = Not Applicable 1-3/NA 1. Concerns from session 1 2. Reviewed first contract 3. Positive counselor feedback 4. Medication adherence and issues 5. Patient s view of addiction/treatment 6. Medical conceptualization of addiction 7. Review urine test results 8. Patient s opiate use 9. Developed new contract 10. Contract cosigned

40 BDRC Treatment Manual for HPTN058 July 2010 page 40 BDRC Sessions 3-5 The aims of sessions 3-5 are: 1) Review patient s contract from previous session 2) Review urine toxicology results (if available) and opiate use since last session 3) Review medication and treatment compliance issues 4) Review overall progress in treatment 5) Develop new patient contract Introduction The counselor begins the session by thanking the patient for attending today s session. She informs the patient that he is attending his third, fourth, or fifth session out of a total of 22. She administers positively framed feedback regarding patient s attendance and punctuality and emphasizes that the patient s efforts augment his chances of being abstinent from opiates. For example, Thank you for coming to today s session, which will be our (third, fourth, or fifth) meeting out of a total of 22. As we discussed in the first session, abstinence from opiates is achieved through a series of small steps. Your coming here today and being on time increase your chances of becoming clean. How do you feel about having made it here on time today? Positive Feedback for Completion of Contract Items Activities contracted during the immediately preceding session must be reviewed at the beginning of each BDRC session. The contract review starts with the first step of the contract not with the overall goal or the final steps of the contracting activity. Reviewing the contract from the starting point of the contract (e.g., Do you remember, last time we discussed that on Tuesday night you will first turn off your phone before doing.. Did you turn off your phone at 8 pm last Tuesday? ) gives the counselor ample opportunities to provide positive feedback to the participants, even if the overall goals of the contract were not fully accomplished (see also Appendix!a). The counselor also administers positively framed feedback concerning completion of the overall study treatment goals and. For example, I realize that you needed to reschedule your lunch break to make it here on time today and you deserve credit for managing to do so. I also know that you attended all your medication dosing appointments since we last met, that s great. Nice job! As I ve mentioned to you before, participation in counseling and taking your medication regularly and as prescribed ehance your chances of remaining heroin free and feeling better about yourself. In addition to administering positive feedback for completion of each step and instances of positive (i.e., abstinence-supporting) changes, the counselor emphasizes the importance of each of these steps in promoting abstinence and solicts from the patient internal or emtional concomitants of step completion (e.g, pride). Sucessful completion of a contract offers the counselor an opportunity to demonstrate to the patient that the probability of successful goal completion is enhanced when the task is focused, well-defined, and when steps towards goal completion are planned in detail.

41 BDRC Treatment Manual for HPTN058 July 2010 page 41 Addressing Incomplete Contract Items If the patient did not complete all of the task items, the counselor should break down the steps even futher into smaller and more detailed steps or figure out an alternative contract item to address the situation. For example, So you managed to make all of your medication dosing appointments except for one. This tells me that you are serious about your recovery as you are now attending more of your medication dosing appointments than you did last week. That s great, keep up the good work! Regularly participating in all treatment components is an important ingredient of your success in recovery. In order for you to gain the most from your treatment, we should figure out a way to increase your chances of attending all of your appointments. Let s start by looking more closely at the day you missed your appointment. What was going on that day? After soliciting more information from the patient, the counselor should be able to prescribe the next contract item. For example, You missed the bus on Wednesday morning because you stayed up till one the night before wathcing wrestling on TV. How about next Tuesday you go to bed earlier. What would be a reasonable time for you to go to bed so that you can be confident that you be up in time next Wednesday morning to make the bus? The resulting contract should specify behavioral steps ( I will switch off the TV next Tuesday evening by 10:45pm; I will spend no more than 15 minutes preparing myself for bed; I will switch off the lights and be in bed by 11pm ). The counselor s focus on breaking down the steps of the previous contract even futher, or on figuring out alternative contract items directed toward more effective ways of addressing the situation at hand, rather than focusing on contract failures or their reasons, generally helps to reinforce the patient s effort towards task completion. Opiate Use Since Last Session. The counselor reviews the patient s urine toxicology results (if available) and asks the patient about his opiate use since the last session. The counselor positively reinforces abstinence or reduction in opiate use. She uses a positively-framed message to administer feedback (i.e., attention is focused on steps, which have been accomplished and not on what patient failed to achieve). If the patient has used since the previous session but is using less than before, the counselor emphasizes the bigger picture. For example, I realize that you are disappointed in yourself for using yesterday. However, in the bigger picture, you are exhibiting increased control by using less and this deserves to be acknowledged. You were using 2 bundles a day and now you have cut down to 2 bags a day. You are not completely abstinent but you are taking active steps toward abstinence. These steps, and not only when you manage to attain the goal of total abstinence, should be acknowledged. Continuing Opiate Use During the Study. Although prolonged drug abstinence is the most desirable outcome of effective treatment, some patients may continue their illicit drug use, either occasionally, or even persistently throughout the entire duration of their treatment. Difficulties in initiating and maintaining drug abstinence,

42 BDRC Treatment Manual for HPTN058 July 2010 page 42 as well as slips and relapses to drug use after some abstinence has been achieved are hallmarks of the disease of opiate dependence. BDRC counselors should work with study participants on setting realistic expectations regarding the pace of their drug recovery and should educate the patients about the ways of preventing treatment discontinuation due to drug relapse, in addition to helping the patients learn and build effective relapse prevention skills itself. BDRC counselors should emphasize that treatment in the HPTN058 study employs nonjudgmental and non-punitive approach to recovery and that remaining in treatment increases the patient s chances of successful long-term recovery even if he relapses to illicit opiate use or continues to use opiates despite his initial engagement and efforts toward recovery. Counselors should also ensure the patient s understanding that the counselor will continue to support and guide the patients efforts at drug recovery regardless of their opiate use during treatment. In the initial stages of the study treatment (the first 2-3 weeks while all study participants in both study arms receive medication treatment), if the patient continues to use opiates, the counselor provides the patient with psychoeducation on how medication is helpful in alleviating/reducing some of the physical aspect of opiate dependence. This education begins with the counselor discussing the patient s current experiences of reduced or eliminated withdrawal symptoms when not using illicit opiates, reduced or eliminated high when illicit opiates are used, as well as the frequency and intensity of drug cravings. In both study arms, the patients who regularly attend their medication dosing appointments in the first 2 to 3 weeks of the study will experience significant reduction or elimination of drug cravings and withdrawal symptoms when they are not using illicit drugs, as well as reduction or attenuation of the perceived high when they use illicit opiates. Such experiences, resulting from the patient s successful medication compliance efforts, offer a good opportunity to discuss with the patient the balance of the negatives and positives related to their illicit opiate use while taking the medication. For example, So you told me that yesterday you spend $20 on a couple of bags of heroin despite not really wanting to use and you ended up not getting any good high out of it. How do you feel about this experience? (patient s answer here typically, patients report feelings of shame or guilt related to the perceived waste of their initial recovery gains and disappointment from wasted money that they could have used for other needs) Let s take a closer and more detailed look at what exactly has happened yesterday. The counselor then may use techniques/exercises described in the relapse prevention exercise (see Appendix 1b) to elicit detailed sequence of events, places, things, peoples, emotions, situations, etc. that lead to drug use and result from or follow it. This exercise could be then used as a starting point to discussing how gains stack up against losses resulted from the most recent drug use, or to devising a behavioral relapse/drug use prevention contract aimed at breaking typical/common chain of events leading to illicit drug use. If the patient is not experiencing reduced drug cravings and withdrawal symptoms, or continues to experience a pleasurable high from illicit opiates, despite his full/good compliance with the medication dosing appointments, the counselor could suggest to the patient discussing his medication dose/regimen with the study physician. The conclusion of this discussion might result in the development of an explicit contract. For example, the patient will attend an appointment with the study MD at a certain time and place. The steps needed to facilitate his attendance (e.g., requesting time off work, organizing transportation) are outlined. Please note that the contract outlined above is only appropriate for study participants receiving medication: in the first 2-3 weeks of the study for the participants in both study arms, during the initial 2-3

43 BDRC Treatment Manual for HPTN058 July 2010 page 43 weeks of the second short term medication, if elected, or during the entire counseling period for the participants in the long-term medication arm of the study. Typically, the importance of discussing medication related effects will be diminished after the initial 2-3 weeks for all study participants: the participants in the short-term medication maintenance arm will no longer be receiving medication; the participants in the long-term medication-maintenance arm will be receiving stable doses of medication and their medication concerns should be minimal at most. When potential significant inadequacies in medication regimens or patient s non-compliance with his medication regimens are ruled out or resolved, the primary focus of the BDRC counselors and their patients is directed toward identifying and remediating behavioral patterns leading to illicit drug use and risk behavior episodes. The counselor may ask the patient for his input on what is maintaining his opiate using behavior and/or ask specific questions to identify triggers or antecedents to the patient s use. When the triggers have been identified, the counselor draws up a contract with the patient, which clearly states the steps that the patient will take to avoid the triggers. For example, The last three times you went to buy groceries in your favorite store, you ended buying drugs from people that you know in the store s neighborhood. What could you do differently to ensure that this doesn t happen again? If the patient is unable to identify concrete steps to rectify the situation, the counselor recommends a solution and a sequence of prerequisite steps. For example, the counselor might suggest that the patient would put a note on the fridge reminding him not to go to this particular store even for small urgent purchases (e.g., milk, bread), as well as engage the patient in planning for the next grocery shopping in a different neighborhood. This next grocery shopping contract should explicitly identify the alternative store, or a plan how to find such a store, as well as the list of costs and benefits associated with shopping in a different store (e.g., farther away but better prices, wider selection, next to a video rental). See also Appendices 1b and 1c for specific techniques or exercises. Knowledge of HIV/AIDS and Individualized Risk Assessment. Education about HIV/AIDS, Hepatitis, sexually transmitted and other infectious and blood borne diseases should begin with the counselor first evaluating the patient s current knowledge, pertinent experiences, and learning about the patient s individual pattern of risk behaviors. The counselor assesses the participant s knowledge about HIV and AIDS, including causes, symptoms, transmission, prevention, and treatment. The BDRC counselor then provides education about HIV transmission (e.g., HIV is spread through body fluids, such as blood, semen, vaginal fluids, and breast milk ), exacerbation (e.g., There are different strains of HIV so even if people are infected, they can get reinfected ), and transmission ( Once a person has HIV they will always be able to spread the virus to others, no matter how healthy they look or how low their viral load is ). Counselors should also utilize educational materials related to HIV/AIDS, but also Hepatitis, Sexually Transmitted Diseases, and other infectious and blood borne diseases that are available in their clinics/study sites. It is important to utilize educational materials that are compatible with education background and reading/comprehension level of each individual patient. If the participant speaks a different native language or distinctly different dialect than the language of the educational materials, the counselor should pay particular attention to reviewing in detail the content of such materials during the session before handing out such materials to the patient. Counselors are encouraged to put effort to collecting additional educational materials targeting individuals that speak different languages or dialects, or have limited literacy. Such materials are sometimes available from local community-based

44 BDRC Treatment Manual for HPTN058 July 2010 page 44 organizations. The counselor discusses with the patient different levels of risk for HIV associated with different injection practices (needle sharing, sharing of other injection equipment, drug splitting behaviors) and evaluates the patient s individualized risks associated with past/current injection drug use behaviors and with current/past sexual behaviors. The counselor should be aware that participant s knowledge of safe and unsafe injection or sexual behaviors may be incomplete or inaccurate and should correct any misunderstandings. Information obtained from the patient about his HIV/AIDS/infectious diseases knowledge combined with typical patters of drug use and other daily activities, learned in the context of previous BDRC sessions, is then used by the counselor to devise strategies for altering behavioral chains leading to, or associated with risk behaviors, and to implement them into subsequent appropriate behavioral contracts to promote risk reduction with the patient. Developing a New Contracts In sessions 3-5, the counselor develops contracts, which typically focus on opiate use, behavioral risks, employment or education, behavioral and social activation, engaging in pleasurable activities (such as interest or hobbies), and engagement in self-help support groups. Similar to the contracts developed in sessions 1 and 2, the contracts should specify behaviorally defined goals, which include the prerequisite behavioral steps that the patient will implement to successfully accomplish contract goals. New contracts may build on prior contracts (e.g., rectifying impediments to previous contract goal completion) or contain new goals. Contracting Engagement in Employment or Education If the patient is unemployed, an important area of behavioral change supporting sustained abstinence is becoming employed or engaging in education or skill learning activities. The counselor reviews patient s employment history, education, and skills and then selects a small step plan to obtain either part- or full time employment. For example, You have made a great progress in your drug recovery and you have been clean for the past week. I believe that finding an employment opportunity would help you become more independent financially and keeping busy will help you stay away from drugs and feel better about yourself. How do you think you can find a job for yourself? If the patient is unable to identify concrete steps identify employment opportunities and becoming employed, the counselor recommends a solution and a sequence of prerequisite steps. For example, The weekend edition of the newspapers has various jobs postings on the last two pages. How about this Saturday you buy the newspaper, read all job postings and circle or cut out all that somehow catch your interest. During our next meeting we will review them and I am sure that we will be able to find a promising job opportunity for you. Engagement in Pleasurable Activities Contract. The counselor discusses the relationship between engaging in pleasurable activities and successful recovery from drugs. People who engage in fun activities, which don t involve illicit substances or alcohol, are more likely to be abstinent from opiates and happier, in the long-

45 BDRC Treatment Manual for HPTN058 July 2010 page 45 term. The counselor conveys to the patient that prolonged substance abuse often robs the individual of learning drug-free ways to have fun. If the patient is serious about being abstinent from opiates and would like to improve his future outlook, he will benefit from engagement in drug-free hobbies or fun activities. This may require much planning on the part of the patient, as it might have been a long time since he had fun without using drugs or alcohol. The counselor asks the patient to list non-drug-related hobbies or activities, which give him pleasure. If the patient does not offer suggestions, the counselor reviews hobbies, which the patient engaged in prior to using illicit substances. The counselor can also ask the patient about his friends or family members and what they do for fun and relaxation. If the patient still does not offer suggestions, the counselor discusses the possibility that the patient might find some of the following activities fun: cooking, daytrips, exercise, fishing, fixing cars, going to the movies, having a massage/facial/manicure, listening to music, playing pool, nature watching, reading, shopping, sports, swimming, and video games. The counselor prescribes one fun activity that the patient will engage in before the next session. This activity is then listed in a contract, including steps required to prepare for the activity. For example, if the counselor were to prescribe a movie date for the patient, the contract would include the steps involved (e.g., go the store, rent a movie, buy take-out food, put children to bed). The contract would be detailed, behaviorally-defined, and should be relatively easy to implement. In the following session, as with other contracts, the counselor should follow-up on completed/incomplete tasks and intervenes appropriately. Dealing with shame or guilt. If the patient reports shame/guilt regarding his opiate use or past experiences (e.g., stealing, hurting family members), which prevents him from appropriately rewarding himself after task completion (e.g., sense of pride) or impedes him from agreeing to participate in a pleasurable activity, the counselor does not explore the past wrongdoing. Instead, she reflects the patient s concerns and reminds him in a warm, firm manner that what has happened in the past is over. The patient has elected to enter treatment, which suggests a willingness to change and to become a better person. The patient s decision to help himself, in and of itself, is worthwhile. (If the patient was mandated for treatment, the counselor reminds him that he still had the choice to attend, and that the patient made from the counselor s viewpoint the right decision). The counselor notes that many patients often use opiates to reduce their negative emotions (e.g., sadness, guilt, shame). Thus, when the patient confronts his tendency to put himself down and/or to deprive himself of the capacity to experience pleasure, he is protecting himself from relapsing (i.e., depressive symptoms and opiate use). Sessions 3-5 outline and suggested timing 1) Review patient s contract from previous session (10 minutes) 2) Develop an improved or follow up contract if previous contract not completed (10 minutes) 3) Review utox results (if available) and opiate use since last session (5 minutes) 4) Review current HIV/AIDS knowledge and behavioral patterns of risk behaviors (15 minutes)

46 BDRC Treatment Manual for HPTN058 July 2010 page 46 5) Review of treatment progress (10 minutes) 6) Develop new patient contract (10 minutes)

47 BDRC Treatment Manual for HPTN058 July 2010 page 47 BDRC Checklist for Sessions 3-5 (EXAMPLE) Counselor : Patient ID: Date: Time started: ended: Scoring Key: Completed = 1, Partially Completed = 2, Not Covered = 3, NA = Not Applicable 1-3/NA 1. Medication issues 2. Utox results 3. Patient s opiate use 4. Patient s knowledge or HIV/AIDS 5. Patient s risk behaviors 6. Patient s pleasurable, non-drug related activities 7. Reviewed previous contract 8. Developed follow-up contract 9. Positive counselor feedback 10. Developed new contract

48 BDRC Treatment Manual for HPTN058 July 2010 page 48 The aims of session 6 are to: BDRC Session 6 (Review Session) 1) Review patient s contract from last session 2) Review utox results and opiate use since last session 3) Review behavioral patterns and risks since last session 4) Review patient s accomplishments during the initial stage of BDRC 5) Planning ahead Therapeutic Goals of the Review Session BDRC is conceptualized as being divided into two phases: the initial BDRC sessions put more emphasis on the patient s active engagement in treatment and achievement of initial behavioral changes; the remaining BDRC sessions (generally after the first month to six weeks of treatment) address the longer-term treatment needs and teach cognitive and behavioral skills needed to avoid relapse and sustain recovery. During the initial phase of treatment, which generally lasts from four to six weeks, BDRC seek to engage opiate dependent patients in a rewarding, simple and explicit treatment program with specific, limited and achievable primary objectives. During this initial phase of treatment, the counselor and patient also identify longerterm treatment goals and plan specific counseling interventions for the next phase of treatment that can help the patient accomplish these goals. Session 6 of BDRC is designated in this manual as a review session, however, based on the pace of the individual treatment progress the counselors should choose the appropriate review session for each study participant. It is critical that the review session is conducted both relatively early in the course of BDRC and after some initial therapeutic progress is achieved (e.g., short period of abstinence, reduction in drug use, improvement in treatment compliance, implementation of positive behavioral changes into the patient s day-today functioning). Important goals of this session include explicitly linking BDRC intervention approaches and techniques (e.g., small steps, planned activities, contracts, educational components, the patient s engagement in his own recovery) with behavioral changes and any type of treatment progress that the patient was able to accomplish in the initial treatment phase. BDRC review session plays an important educational role ensuring the patient that progress in drug recovery can be achieved and illustrating how relatively simple but planned and structured activities are effective in implementing and sustaining recovery from the disease of opiate dependence. A successful implementation of the review session typically results in improved collaboration form the patient in his efforts to successfully engage in behavioral contracts and other treatment recommendations offered/suggested by the counselor in the later stages of the study treatment. Positive Feedback for Completion of Contract Items The counselor thanks the patient for coming to the session. She offers positive feedback regarding patient s efforts to maintain attendance at counseling session, other study related visits, his punctuality, and other behavioral changes related to his study participation and recovery efforts. She emphasizes that such positive behavioral changes augment the patient s chances of successful long-term recovery from drugs.

49 BDRC Treatment Manual for HPTN058 July 2010 page 49 The counselor administers positively framed feedback concerning completion of contract goals and/or steps that the patient completed since the previous session. In addition to administering positive feedback for completion of each step and instances of positive (i.e., abstinencesupporting) changes, the counselor underlines the importance of each of these steps in promoting abstinence and elicits fromt he patient internal or emtional concomitants of step completion (e.g., pride, accentuated perceived control). For example, You made it to all your clinic appointments this week and came regularly to all your medication dosing appointments without missing any doses. You also made it to this appointment on time. Good going! By regularly taking your medication as prescribed, you have reduced the risk of experiencing opiate cravings. You have also learned to implement important lifestyle changes. By actively taking steps to reduce your opiate cravings and to make positive lifestyle changes, you are increasing your chances of remaining abstinent from opiates and improving your mood. Let s go through your contract from last time and tell me step-by-step what you did and how you felt after you carried out each step. Opiate Use Since Last Session. The counselor reviews the patient s utox results (if available) and asks the patient about his opiate use since the last session. The counselor positively reinforces abstinence or reduction in opiate use. She uses a positively framed message to administer feedback (i.e., attention is focused on steps, which have been accomplished and not on what patient failed to achieve). For example, You managed to stay clean everyday except Saturday, so you had 6 days of being heroin free. Although I know that you wanted to be heroin free for all 7 days, you took active steps on 6 days, which promoted your abstinence and this needs to be acknowledged. You got up on time to get the bus, you made it to your medication dosing appointments on time, despite the fact that it was really cold out side. This is a positive change for you and something that you are to be congratulated on. Behavioral Patterns of Day-to-day Functioning Since Last Session The counselor inquires about the patient s overall functioning since the previous session. For example, How have you been doing since the last time we met? If the patient reports improvement in his overall day-to-day functioning, the counselor inquires about his explanation of the observed changes. For example, You re telling me that you are now more interested in meeting people and that you enjoyed going to the movies with your wife this week. That s great! As we discussed before, you are increasing your chances of remaining clean in the long-term by making small changes in your life. How do you account for the positive changes or improvements in your daily functioning and feeling happier? Review of Patient s Accomplishments During the initial phase of BDRC The counselor reviews the patient s accomplishment since he started BDRC. She links small positive changes in the patient s behavior with the overall goal of abstinence from opiate use and improving overall functioning.

50 BDRC Treatment Manual for HPTN058 July 2010 page 50 For example, When you started treatment, you told me that you often felt blue, you were using a couple of bundles of heroin daily, and you were stressed about your performance at work. Since that time you have managed to drastically reduce your opiate use. In the last week, for example, you used only 2 bags on one day. Unlike on previous occasions, when using 2 bags led to your using a lot more, you were able to stop yourself and have not used opiates since Saturday. You re experiencing less stress at work. You are no longer turning up late, you find it easier to concentrate, and your mood has brightened noticeably. Let s review what you did to bring about these changes. First, you have regularly attended your clinic appointments. Second, you made it to all of your counseling sessions. Third, you managed to successfully make a lot of small significant changes. You were able to identify step-by-step what you needed to do to reach the goals in your contracts and then you actually put the steps into practice in between sessions. You also learned that you can feel good about yourself when you attempt to implement these changes. The counselor also reviews all activities prescribed during BDRC and skills or problem solving approaches learned during BDRC and links them explicitly to patient s behaviors and accomplishments. For example, In our sessions together, you managed to identify small welldefined goals and the steps that you needed to follow to reach the goals. In the past, you had very large goals, which were not well defined. By doing this you set yourself up for failure and feeling depressed. During our sessions so far, you have demonstrated that you can accomplish your goals, especially when they are well defined and broken down into smaller steps. What you have also managed to do is build-on smaller goals to reach larger goals. For example, at the beginning of therapy, you felt isolated and did not have active support built into your lifestyle to enhance abstinence. However, you took the step of starting to go fishing with your brother. You subsequently capitalized on that step by setting up a regular time to go fishing with him every week. You also started to attend peer-support meetings and are now attending two meetings a week. At those meetings you made some friends and you now meet with them for coffee once a week. As a result you feel less isolated and have active supports built into your lifestyle that promotes abstinence. Planning Ahead for the Next Phase of Treatment The counselor reviews the plans for working with the patient in the next phase of treatment. The counselor notes that she will work with the patient to build on the successes he has experienced and the skills he has developed to help the patient achieve a secure and long-lasting recovery. The counselor lets the patient know that they will continue to work to develop and implement short-term behavioral contracts and that the counselor will also help the patient learn additional problem solving techniques and cognitive and behavioral skills that will help the patient maintain (or achieve) abstinence, reduce HIV risk, improve relationships with family and friends, and improve work functioning. For example, As we ve discussed before, the best way to tackle a chronic medical condition like heroin dependence is to engage in a comprehensive treatment. You have a comprehensive treatment plan in place. You plan to continue coming for our counseling sessions regularly, going fishing with your brother, and attending peer-support meetings, and doing drug-free fun activities, such as going to the movies with your wife. In addition, you will begin to learn the additional skills needed for long-term success.

51 BDRC Treatment Manual for HPTN058 July 2010 page 51 BDRC Checklist for Session 6 (EXAMPLE) Counselor : Patient ID: Date: Time started: ended: Scoring Key: Completed = 1, Partially Completed = 2, Not Covered = 3, NA = Not Applicable 1-3/NA 1. Medication issues 2. Utox results 3. Patient s opiate use 4. Patient s daily functioning 5. Reviewed previous contract 6. Positive counselor feedback 7. Patient s accomplishments during initial BDRC sessions 8. Discussed next phase

52 BDRC Treatment Manual for HPTN058 July 2010 page 52 Phase Two of BDRC Sessions 7-22 The format of sessions 7-22 is similar to the format for the first phase of BDRC, and includes a review of the patient s completion of the contract developed in the preceding session, review of any drug use or missed medication since the preceding session, and development of a new behavioral contract. The progression of session topics depend on the individual progress/changes accomplished in the initial phase of BDRC. Generally, the counselors should aim to provide additional specific instruction and training in problem solving and cognitive and behavioral relapse preventions skills, additional HIV risk reduction, and via detailed contracts help the patient to improve relationships with family members, to improve employment, and become more engaged in pleasurable non-drug related social and/or recreational activities in his free time. Since the structure and format of sessions is similar to those conduced in the initial phase and remains relatively constant during the second phase of BDRC, this next section of the manual only describes examples of the specific training components that could be selected by the counselor to provide in BDRC sessions. Counselors should continue to use the standard approach to reviewing the patient s progress and completion of contracts at the start of each session that are used during sessions 1-6. Topics that should be covered in the second phase of BDRC include relapse prevention and coping skills training including(teaching the patient to conduct a functional analysis of behavior leading to drug use and coping with craving or with negative emotions; drug refusal skills training; identifying, avoiding and coping with high risk situations; HIV risk reduction training; handling relationships in recovery; coping with shame, guilt and other emotional triggers; coping with social pressures to use drugs; employment (job seeking skills, coping with job pressures); managing money skills; and the role in spirituality/religion in recovery. Engagement of Family Members in BDRC In addition to individual sessions with the patient, in the second phase of BDRC, counselors may also schedule family sessions to provide education and advice to family members of the patient about the disease of opiate dependence, effective treatment and recovery methods, including the role of medications and counseling in the recovery process. During the educational family sessions, the counselors should discuss with family members ways to play a constructive role in the patient s recovery (e.g., encouragement, support of the patient s treatment adherence efforts) and increase their understanding of difficulties or even relapses that the patient may experience before a sustained recovery is achieved, as well as encourage their non-judgmental support for the patient s treatment participation and his ongoing recovery efforts. The BDRC counselors are reminded that BDRC has been designed and designated within the HPTN058 study protocol as an individual treatment model which precludes participation of family members or significant others in any of the standard BDRC counseling sessions. Typically, a small number (a few, 2 or 3 at most) additional family sessions could be scheduled in addition to the ongoing and planned 22 BDRC sessions described in this manual. In special circumstances, one or two such family sessions could replace one or two standard BDRC session (e.g., due to scheduling or other logistical difficulties of conducting additional meetings).

53 BDRC Treatment Manual for HPTN058 July 2010 page 53 Conducting therapeutic interventions with groups of people (families, couples) often invokes greater challenges than working with individuals, and overcoming such challenges requires expertise and experience that goes beyond the scope of the BDRC treatment manual. Most of BDRC trained counselors are also not expected to have extensive expertise or experience in provision of family or couples counseling. The BDRC counselors are reminded that their most important therapeutic relationship (therapeutic alliance) is with their individual patients, not with his family members. In most cases, families or couples identified as those who could clearly benefit from counseling should be referred to appropriate services outside of the study protocol The family sessions conducted within the context of the BDRC treatment should be explicitly structured with an educational format in mind. The goals of such sessions should be to increase the family members knowledge about the disease of opiate dependence, their understanding of the treatment process and other recovery activities recommended within the study protocol, and to discuss with them effective ways of supporting the patient s recovery efforts. The counselor should offer the family member ample opportunities to ask questions and she should give them as complete as possible answers. The counselors must resist the family requests for information pertaining to the details of the patient s treatment progress ( How often do you think does he use drugs now? ) or sharing of any information obtained from the patient during the therapy sessions. The patient himself, on the other hand, has the choice to share or not such information with his family. If appropriate, the counselors could work with the patient during regular BDRC session on ways of improving his family relationships or communication skills. Often, it is more beneficial to conduct family sessions without the BDRC patient s participation. However, obtaining explicit permission/request from the patient, discussing with him ahead of time the potential structure and the content of the planned family session, as well as counselor s full disclosure of what has happened during the family session(s) to the patient after the session are required to maintain the high level of therapeutic alliance between the patient and the BDRC counselor. Outline for Sessions 7-21 and suggested timing Review contract from preceding session (10 minutes) Review patient s functioning, opiate use, behavioral risks since last session (10 minutes) Complete planned/required educational, skills building, relapse prevention, or other BDRC prescribed exercises (15 minutes) Complete individual patient specific intervention(s) (e.g., Coping with craving) (15 minutes) Review other recovery activities (5 minutes) Develop a new contract (5 minutes)

54 BDRC Treatment Manual for HPTN058 July 2010 page 54 Checklist for BDRC Sessions 7-21 (EXAMPLE) Counselor : Date: Patient ID: Scoring Key: Completed = 1, Partially Completed = 2, Not Covered = 3, NA = Not Applicable 1-3/NA 1. Review previous Contract completion 2. Review patient s functioning 3. Review patient s opiate use 4. Review patient s behavioral risks 5. Educational, skills building techniques/exercises 6. Relapse prevention techniques/exercises 7. Patient specific intervention (specify: ) 8. Review supplemental recovery activities 9. Positive counselor feedback 10. Develop new contract

55 BDRC Treatment Manual for HPTN058 July 2010 page 55 Final BDRC Session (session 22) Treatment Termination The counselor reviews the patient s accomplishments during treatment, his current functioning and strengths, and his continuing treatment needs. The counselor also reviews the patient s plans for continuing drug recovery efforts following completion of BDRC. The counselor inquires about the patient s thoughts/feelings about termination, including possible fears and concerns. For example, What are your thoughts about coming to the end of your study treatment? If the patient raises any concerns about the follow-up treatment, the counselor addresses them in a warm, nonjudgmental fashion. She normalizes his concerns, expresses her confidence in the competence of the follow-up treatment and reminds the patient that the strategies, which he has learned in BDRC, will serve him well in the next stage of his treatment, if the patient plans to continue with another drug treatment program, or his other ongoing recovery efforts. For example, I realize that you are somewhat anxious about ending your current treatment and starting again in a new setting soon. That s normal and to be expected. However, you will be in excellent hands; you will receive care from a very competent and experienced treatment team. In addition, I ve been very impressed by the amount of work that you have done in therapy. Not only have you learned new strategies, such as breaking down goals into manageable smaller steps, but you have also shown that you are a fighter. These qualities will not only serve you well in your follow-up treatment to reduce your opiate use, but also in life in general. Take Home Message. At the end of the last session, the counselor wishes the patient well in his future endeavors and encourages him to continue utilizing skills learned during BDRC in the future. For example, You have accomplished a lot in the past year, and have made a great progress toward complete recovery from drugs. You also know that you need to continue what we started together. By staying in treatment, taking medication, continuing with counseling, selfhelp groups, and by being proactive yourself - meaning that you stay away from drugs and your drug use triggers and maintain a healthy and active lifestyle you have a very good chance of living a fulfilling life without drugs and all these bad things that are associated with them. Good luck!

56 BDRC Treatment Manual for HPTN058 July 2010 page 56 Checklist for BDRC Session 22 (EXAMPLE) Counselor : Date: Patient ID: Scoring Key: Completed = 1, Partially Completed = 2, Not Covered = 3, NA = Not Applicable 1-3/NA 1. Review previous contract completion 2. Review patient s overall functioning 3. Review patient s achievements in treatment 4. Review patient s future treatment plans 5. Review patient s plans for ongoing recovery efforts 6. Positive counselor feedback 7. Take home message

57 Appendix Ia BDRC Contract Category Study protocol related (e.g. counseling attendance; medication attendance; etc) Drug use Risk behaviors Work/education Pleasurable activities Family Non-drug using friends Alcohol and other drugs use Self-help, peer supported activities Other: A. Timeframe (day and time contract activities to begin, and their duration): 1. B. Detailed steps of the contract: REVIEW Optional (contract can be either verbal or written and signed): Date: Counselor Signature Participant Signature

58 Appendix Ia Description of the BDRRC contracting procedure The goal of the BDRRC contract is to engage the participant in a series of easily accomplished small, incremental behavioral changes. Do not try to rapidly replace all existing dysfunctional or risky behaviors, and do not develop extensive plans for all daily activities during the week. The easiest starting point for the BDRRC contracting technique is an idle time in the participant schedule (e.g., 2-3 hours) that provides an anchor for developing and building the BDRRC contract (e.g., From what I understand about your schedule, on Tuesday nights there is nothing interesting for you to do. ). Consequently, the BDRRC contracting procedure begins with finding the most appropriate time to engage in the contracted activity. This is accomplished by exploring the pattern of daily activities of the study participant conducted immediately before the current contracting procedure, or it can be based on the counselor s prior knowledge of the specific patterns of daily activities acquired during earlier counseling sessions. The important goal is to find a window of idle time, time that is not occupied with other activities. In the first contracting step, the counselor identifies a window of idle time in the participants schedule and obtains an explicit confirmation from the participant that he/she is interested in doing something during this idle time. After the time and duration of the contracting activities have been identified and agreed upon (e.g., Next Tuesday night, the day after tomorrow, between 8 and 10 pm, you will ), the counselor proceeds with developing a step-by-step, detailed plan of things to do in order to complete the contract. Typically, the sequence of activities begins with planning for all necessary preparatory steps (e.g., Because you do not want to be disrupted during while doing. on Tuesday night, we decided that it would be a good idea for you to turn off your phone at 8 pm on Tuesday. ), followed by the initial steps of the activity. Counselors are reminded that an interactive style of communication that actively engages the participant in expressing his/her confirmation of each contract step, using his/her own words, paraphrases, and reflections of how he/she understands what the counselor is proposing is the most effective way of building the contract. The BDRRC contract is built one step at a time, and an explicit agreement is obtained for each step, before the overall agreement/contract for the entire sequence of events is attained. Each contract is reviewed in the very next counseling session. The contract review begins with the first step of the contract not with the overall goal or the final steps of the contracting activity. Reviewing the contract from the beginning (e.g., Do you remember, last time we discussed that on Tuesday night you will first turn off your phone before doing.. Did you turn off your phone at 8 pm last Tuesday? ) gives the counselor ample opportunities to provide positive feedback to the participants, even if the overall goals of the contract were not fully accomplished.

59 Appendix Ia All accomplished steps of the BDRRC contract are praised. For steps that were not accomplished, alternative plans are developed and incorporated to into an improved/modified BDRRC contract. If the study participant is able to fully complete/accomplish BDRRC contracts, at each following session, the counselor continues to develop contracts that either build on the accomplishments of the earlier contracts (e.g., extending the time and frequency of newly developed activities, adding new similar activities, or setting larger more important goals for such activities) or move from one domain of change (e.g., hobbies or interests) to another (e.g., vocational or educational activities). If the study participant is unable to fully complete/accomplish BDRRC contracts, during the following session, the counselor develops BDRRC contracts that are smaller and easier to accomplish modifications of the original contract, rather than changing the domain of behavioral change or switching from one activity to another.

60 Appendix Ib Relapse prevention exercise (a.k.a. Relapse Prevention Worksheet) DO NOT USE THIS FORM START WITH A BLANK PAGE Drug craving (thinking about drug use or desiring to use drugs) Drug use Risk behavior Other: 8. C - REVIEW B B) Starting at 1. (above) and going up the page line by line, describe in reverse order the sequence of events that immediately preceded the event described here. START HERE in the middle of the page. Describe briefly/concisely, in one sentence, the event and the exact time when this event happened. A) Going down this page, line by line, describe the sequence of events that followed the event described above A

61 Appendix Ib Description of the exercise Ask the participant when was the most recent time that the behavior targeted by this exercise (e.g., drug use, drug craving, unsafe sexual contact) happened. Begin your question with When was the last time that you.? A desired answer should be in the form of an exact time (e.g., Last Wednesday at 4 pm) rather than in a vague length of time (e.g., three days ago). Place a blank page and a pen/pencil in front of the participant and ask him/her to write down briefly/concisely, in one sentence, when and what happened (e.g., Last Wednesday at 4 pm I injected 5 bags/$50 of heroin ). If the participant refuses to write down the steps of this exercise, the counselor does the writing. Using the description of the event as a starting point, ask the participant a series of detailed questions to determine the step-by-step sequence of events, emotions, interactions, etc. that immediately followed the event. Ask the participant to write each of the sequence steps in separate sentences, one by one, going down the page. Do not ask him/her to write down several lines/events at one time. It is important to break what followed the targeted event into clearly defined/described components. There is no prescribed number of lines or timeframe that should follow the event they should be directly related to the event. A typical timeframe spans hours, not days. After the events following the targeted event have been explored sufficiently and written down, explore, starting with the location of the targeted event (e.g., Where were you when you injected the drug last Wednesday afternoon? ), and moving back in time, step by step, the sequence of events, interactions, emotions, etc. immediately preceding the targeted event (e.g., How did you get to (location/place of drug use)? ). After all sequences/steps of the story line have been completed, the counselor asks the participant to read it, this time from the beginning to the end (hand him/her the page if you were writing the story line). It is a starting point for the counselor and the participant to discuss what could have been done differently to avoid the event (e.g., using drugs, not thinking about using, not engaging in unsafe sex), and what the participant can do (using things learned and practiced during counseling) to change his/her behavior in the future. The relapse prevention exercise should be used whenever participants experience cravings, relapse or slip to drug use, or continue with unsafe/risky behaviors. This same exercise can, and should, also be repeated for successfully avoided events (e.g., feeling cravings but not using drugs, etc). The exercise identifies triggers, places, things, peoples, emotions, situations, etc. that lead to drug use, cravings or risky behaviors and to identify the participants strengths and weaknesses in handling such situations, emotions, people, etc. The identified weaknesses and deficiencies (including the lack of knowledge and/or experience) are

62 Appendix Ib then addressed in counseling sessions using behavioral contracting and other BDRRC specific techniques or interventions. The page with the story line is given to the participant so he/she can keep it as a reminder to him/herself. However, the participant is free to do whatever he/she wants to do with the page, including destroying it. The page is not copied or retained in any way with the clinical or study related records. The participant is also informed/encouraged about the possibility of continuing with this exercise on his/her own outside of the counseling sessions. It is important to assure him/her that the page will not be retained or copied to ensure the participant s willingness to provide detailed/accurate descriptions of events, places, etc. Otherwise a vague story line is typically created (a story line that uses generalizations or fictional/hypothetical descriptors) that greatly diminishes the effectiveness of BDRC counseling and behavioral change efforts. Counselors are reminded to use open ended questions, interactive style of communication (paraphrasing and reflecting), frequent verbal reinforcement ( Thank you for telling me that ), and encouragement to provide detailed and open/honest information about the event and the components of the story line.

63 Appendix Ic Places, Things, People, or Emotions replacement exercise DO NOT USE THIS FORM - START WITH A BLANK PAGE Places Things People Emotions Other: AVOID: SEEK: Why: Why: Why: Why: Why: Why: Why: Why: Why: Why: Why: Why:

64 Appendix Ic Description of the exercise The goal of this exercise is to increase the patient s explicit awareness of places, things, people, and/or emotions to avoid in order to reduce the likelihood of drug relapse. In combination with the contracting components of BDRRC, this exercise helps the patient/participant to identify and replace the potential triggers associated with high risk of drug relapse with places, things, people, or emotions that are supportive of drug abstinence. The exercise should be conducted separately for places, things, people, and emotions (preferably in the listed order replacing places or things is easier than replacing people or emotions, and the patient is more likely to experience some degree of success with places and things, which in turn would facilitate his/her future pursuit and engagement in similar exercises targeting to replace people and emotions). Each of these topics (i.e., places, things, people, and emotions) should be explored in two steps (the AVOID part in one session and the SEEK part during the next session) and combined with a behavioral contract in between these two sessions. After providing an educational introduction about what we know about common drug use/relapse triggers, the counselor should invite the patient/participant to list several places (or, things, people, emotions) that are associated with the past instances of drug use or high risk behaviors (e.g., unsafe sex practices) and list them (write them down) under the AVOID sign on the left half side of the page (use a blank page with a line drawn in the middle as illustrated do not use the illustrated form itself). Place the page and a pen/pencil in front of the patient/participant and ask him/her to write down the name(s) of the place(s) and briefly/concisely, in one sentence, provide descriptive reasons to avoid each place. If the participant refuses to write down the steps of this exercise, the counselor does the writing. The counselor s role in this step is to help the patient/participant to identify places of high risk by recalling instances of drug use or risk behaviors discussed in earlier BDRRC sessions (e.g., I remember from our earlier discussions that your often used drugs in. What do you think would happen if you visited today? ), or inviting the patient/participant to recall and describe the most recent drug use or risk behaviors and asking the patient/participant a series of detailed questions concerning the place(s) where such events happened (or, people who were present, or emotions felt immediately before such events please also refer to the relapse prevention exercise described earlier in the BDRRC manual). The completion of the AVOID portion of the exercise should be followed by the BDRRC contract (during the same session) aimed at helping the patient/participant to discover, familiarize him/herself, and practically incorporate into daily life these new and safer places (or things, people, emotions).

65 Appendix Ic For example, a simple behavioral contract concerning going for a walk that follows a new, never or rarely taken route trough the city or the neighborhood in order to discover places that do not have any association with drug use or other risk behaviors should be developed. In the next session, after reviewing the contract, the newly discovered places are listed in the SEEK portion of the exercise, along with the descriptive reasons for their role in supporting drug abstinence (e.g., When I went on my walk, I discovered a newly opened small public library in my neighborhood that has some computer stations. I think I can use them to search for part-time or help wanted offers. ). The counselor s role in the SEEK portion of the exercise is to help the patient/participant to discover, get familiar, and develop daily life routines that incorporate the new and safe places and therefore practically and effectively replace the old, familiar, but risky places. The exercise can be extended beyond the two outlined sessions as necessary or useful. Additional contracting and other BDRRC counseling techniques can be incorporated into a larger sequence of relapse prevention sessions aimed at replacing potential triggers (places, things, people, or emotions) with alternatives that are supportive of sustained drug abstinence and safe behavioral patterns. The page listing the places to AVOID and the places to SEEK is given to the patient/participant so he/she can keep it as a reminder to him/herself. However, the participant is free to do whatever he/she wants to do with the page, including destroying it. The participant is also informed/encouraged about the possibility of continuing with this exercise on his/her own outside of the counseling sessions. Counselors are reminded to use open ended questions, interactive style of communication (paraphrasing and reflecting), frequent verbal reinforcement and encouragement of the patient/participant efforts and/or accomplishments.