HPTN 067 Qualitative Manual

Transcription

1 HPTN 067 Qualitative Manual Qualitative Manual Version 2.0 April 11, 2012

2 TABLE OF CONTENTS 1 Overview Study Timeline Recruitment Informed Consent Procedures and Documentation (All Participants) Interviews with Participants Focus Groups Interviews with Staff Interview and Focus Group Procedures Interview and Focus Group Guides Focus-Group and Interview Set-Up and Materials Documentation Requirements for Interviews and Focus Groups Data Collection Interviewer and Facilitator Interviewer and Facilitator Codes (for participant interviewers and facilitators) Recording Transcription Transcript File Format Focus Group Speaker Codes Final Submission of Staff Transcripts Confidentiality and Privacy Data Management and Analysis ADAPT Study Qualitative Core Team (AQCT) DISCUSSION GROUPS GUIDE Introduction script FOCUS GROUP GUIDE CONTENT AREAS AND QUESTIONS KEY INFORMANT INTERVIEW (PARTICIPANT) GUIDE Introduction script IN DEPTH INTERVIEWS WITH KEY INFORMANTS GUIDE CONTENT AREAS AND QUESTIONS IN DEPTH INTERVIEWS WITH COUNSELING STAFF INTERVIEW GUIDE MATERIALS CHECKLIST Participant Interview Checklist Focus Group Checklist

3 1 Overview The purpose of this manual is to provide guidance on the implementation of the qualitative components of the HPTN 067/ADAPT Study, as described in Section of the study protocol. This manual describes the procedures for a given site. All procedures should be repeated at each of the two participating ADAPT study sites. The ADAPT study includes a distinctive qualitative component for selected participants who have completed their participation in the on drug phase of the study (Week 34) and selected site staff who implemented the counseling or interacted with participants consistently around study medication use, to be conducted within 3 months of the conclusion of the last participant study visit. Select participants (2 per study arm to be selected by the site team) and staff providing adherence counseling/support are offered participation in key informant interviews; participation in a focus group (2 groups per study arm consisting of 6 8 participants each) is offered to participants completing their on drug phase of the study. These groups and interviews will occur in two general phases one series of participant groups and interviews will occur as the first half of participants enrolled approach their week 34 visit; and the remaining groups and interviews with participants will occur as the second half of participants enrolled complete their participation (week 34 visits). Sites will need to determine the exact timing for the first and second series of focus groups based on their participant sample and distribution of timing of termination of the on drug phase for their sample. Site staff in depth (also referred to as key informant interviews in the HPTN protocol) are conducted after all participants at a site have completed the ondrug phase of the study, within 3 months of the close of the on drug phase. Please note that a participant may not take part in both the focus group and a key informant interview. A participant may only participate in one. Please note: This manual is not intended to be a comprehensive explanation of qualitative methods, as sites participating in the qualitative component have been selected based on prior, proven experience in conducting qualitative research. Staff involved in this component of the study are expected to have the knowledge and skills necessary to successfully implement qualitative research and should follow the HPTN 067 protocol, Study Specific Procedures (SSP) manual, this manual and site study operating procedures (SOPs) as needed. If at any time any of these materials conflict with the protocol, the protocol should be followed. Any questions regarding the qualitative component of the study should be directed to the ADAPT Qualitative Core Team (AQCT) (see Section 6.0 of this manual). Table 1: ADAPT Qualitative Components (per site) PARTICIPANTS Participants completing on drug phase (week 34) on DAILY arm Semi structured behavioral interviews (offered early and late in clinic s sample of participants completing the on drug phase) 2 Individuals 2 Focus groups Focus Group discussion (6 8 participants per FG) (offered early and late in clinic s sample of participants completing the on drug phase) 3

4 Participants completing on drug phase (week 34) on TIME DRIVEN arm Participants completing on drug phase (week 34) on EVENT DRIVEN arm Study staff providing adherence support during the study 2 Individuals 2 Focus groups 2 Individuals 2 Focus groups 3 4 Staff members Semi structured, recorded interviews with participants in each arm will be conducted with 2 individuals identified by study sites as being able to provide insights into experiences with the study medication and the regimen assigned. Sites should give preference for at least one KII in each arm to come from an individual with reported or otherwise clear trouble (e.g., discontinuation of study drug) with the study medication and the other to come from an individual who remained on study drug through the conclusion of the study. Topics covered in the interview may include, but are not limited to: perceptions of feasibility, acceptability and ease of uptake for the assigned regimen if he or she altered the regimen to better fit his/her daily life or risk behavior whether he/she would switch to a different regimen if available what the ideal regimen would be common barriers and facilitators to following the regimen perceptions of potential impact of regimen/study drug on sexual health promotion practices and risk taking behavior whether important others knew the participant was enrolled in the study feelings towards the project, project staff, and how pill taking and condom use was supported perceptions of the support provided for pill taking and for condom use, how he/she would change it, and what frequency or type of support would be most acceptable to them if he/she was taking PrEP outside of the context of research. self perceived attributes defining PrEP participant, consistent PrEP user and consistent condom user perceptions of prevention synergy, prevention advocate, and risk compensation experiences with wise pills and/or weekly calls Interview should be conducted within 3 months of the participants week 34 visit; although recruiting the individual may take place up to 6 weeks prior to this time. 4

5 Interviews may take place at a location identified by study staff that assures adequate privacy and confidentiality. All interviews must be conducted by a staff member who does not have an established relationship with the participant and will be recorded and transcribed by qualified personnel and identifying information removed. Focus groups with participants (2 groups per study arm) will take place in two general phases one series (1 group per arm) offered among the first group of participants (e.g., the first half of the sample) completing the on drug portion of the study (week 34) and another series of groups (1 per arm) offered among participants completing week 34 later in the study (e.g., after three fourths of the sample has completed their on drug participation). Clinics are encouraged to determine the most appropriate timing for the offering of each series. Recruitment of the groups can occur 6 weeks prior to the designated focus group dates. Enrollment is rolling such that participants are enrolled for the groups on a first come first serve basis and groups are closed once enrollment maximum is reached (8 individual per group). Focus group topics may include, but are not limited to: perceptions of feasibility, acceptability and ease of uptake for the assigned regimen if he or she altered the regimen to better fit his/her daily life or risk behavior whether he/she would switch to a different regimen if available what the ideal regimen would be common barriers and facilitators to following the regimen perceptions of potential impact of regimen/study drug on sexual health promotion practices and risk taking behavior whether important others knew the participant was enrolled in the study feelings towards the project, project staff, and how pill taking and condom use was supported perceptions of the support provided for pill taking and for condom use, how he/she would change it, and what frequency or type of support would be most acceptable to them if he/she was taking PrEP outside of the context of research. self perceived attributes defining PrEP participant, consistent PrEP user and consistent condom user perceptions of prevention synergy, prevention advocate, and risk compensation experiences with wise pill and/or weekly calls The focus groups may take place at locations identified by study staff that assure adequate privacy and confidentiality. All FGs will be facilitated by a staff member that does not have standing relationships with the participants in the focus group, and will be recorded and transcribed by qualified personnel and identifying information removed. Semi structured, recorded interviews with study staff supporting adherence will be conducted with staff who volunteer to be a part of this aspect of the study. 3 to 4 staff conducting participant adherence counseling will be offered participation in the KIIs after all participants at the site have finished their week 34 visit. Topics covered in the interview may include, but are not limited to: Whether you think these regimens (pill taking schedules) will work for and are accepted by participants 5

6 What helps or prevents how well participants follow their regimens overall and in relation to specific regimens Preferred regimen Best strategies to support pill taking Perceptions of factors related to regimen migration Risk compensation and prevention synergy (continued condom use in the context of PrEP trials) Best strategies to support staff and counselors working with PrEP users Perceptions of wise pill device The KIIs with staff will be conducted by an interviewer who does not have supervisory or other influential roles in relation to the staff. Interviews may take place at locations identified by study staff that assures adequate privacy and confidentiality. All interviews will be recorded and transcribed by qualified personnel and identifying information removed. Data collected from the interviews and FGs will be used to characterize participant experiences with the study drug and various regimens, as well as experiences with the counseling approach and other support provided for individuals on study drug. Additionally, perceptions of how study drug was integrated into or competed with other sexual health promotion strategies will be examined. Data analytic methods are fully described in section of the protocol. OVERVIEW OF PROCESS 6

7 2 Study Timeline Participant focus groups and KII should be completed at two time periods. The first set will be completed after approximately half (90) of participants targeted for each site have reached their final on study visit (34 weeks). Each qualitative component participant should participate in a KII or focus group no more than 3 months after their final study visit (week 34). Recruitment may begin up to 6 weeks prior to the scheduled focus group or interview. Sites may find it necessary to over recruit for the focus group in order to ensure a full group. Participants should provide informed consent for this component directly prior to participation. The second set of participant focus groups and KIIs should be completed closer to the completion of enrollment at each site. Each site will transcribe, code and analyze all interviews and groups at this time according to the methods described in Section of the protocol. Staff KII will be completed within 3 months of the last participant completing their 34 week on study visit. No staff interviews should be completed prior to all participants completing follow up. 3 Recruitment As referenced above, the qualitative component of ADAPT includes interviews and focus groups with participants and study staff. The following section outlines the process for identifying participants for the qualitative component. 3.1 Informed Consent Procedures and Documentation (All Participants) Once study staff have determined whether or not a participant is eligible for the qualitative component, he or she should be approached and scheduled for an interview or focus group. Upon attendance for an interview or focus group, staff should complete the qualitative informed consent procedure using the appropriate language IRB approved consent forms.. Written consent must be obtained prior to participation in the interview/focus group. The informed consent process should be documented at the site according to source documentation procedures outlined in Section 3 of the HPTN 067 SSP and site SOPs. 3.2 Interviews with Participants For HPTN 067, eligible interview participants for the key informant interviews are enrolled active participants in the study although they do not need to be on drug. In fact, sites are encouraged to select one person from each arm who may have discontinued study drug, not due to an AE, HIV seroconversion or pregnancy, to gather relevant information about difficulties with the assigned regimen. As noted in Section 2 above, the first set of interviews should be completed when the site has enrolled approximately half of their total targeted participants, the second set of interviews should be completed towards the end of enrollment. All interviews should occur after participants have reached their on study participation (34 week visits). Ideal participants for interview are characterized not by their use (or non use) of study product but their abilities to articulate experiences, attitudes, and beliefs. A total of 6 interviews (2 per arm) are to be completed. Methods or criteria used to identify participants to approach for participation in an interview should be clearly documented and shared between sites, to coordinate a consistent strategy, prior to approaching the first participant. The number of participants approached and outcome (agreement to participate/ refusal, etc.) should be document at the site. At 7

8 completion of the interviews, sites can begin transcription. For participant interviews, all analyses will be completed by the site qualitative team. The ADAPT qualitative core team (AQCT) will coordinate collaboration between the sites working with their qualitative data from the interviews. 3.3 Focus Groups Before beginning recruitment for focus groups, sites should review their recruitment materials with the AQCT in order to better coordinate and standardize efforts between sites. While some efforts may be made to provide good representation of age of participants, sites may identify additional characteristics (e.g., transgendered, partnership status). All participants will have completed a demographics CRF which can be reviewed for key characteristics of participants. Note: actual or estimated product nonuse should not be used as exclusion criteria for participation in any group. Recruitment for focus groups can take place up to 6 weeks prior to the scheduled date of the group in the two phases previously described. Strategies for recruitment are anticipated to be site specific with efforts to coordinate/standardize the main strategies adopted across sites. All recruitment strategies must comply with local IRB requirements. Prior to recruiting focus group participants, the sites will agree on a strategy for scheduling that maximizes participation and minimizes staff scheduling burden. In order to facilitate timely scheduling of the focus groups, sites may select dates and times in advance, which will then be populated as participants are recruited. Care should be taken to select a variety of dates and times for the focus groups so that certain groups of women or men are not excluded based on availability (e.g. participants who work 9 am to 5 pm or on weekends). In addition, when selecting future dates for focus groups, sites should balance decisions regarding the amount of time needed to populate a focus group, overall study timelines and retention. If a woman or man is eligible and interested in participating in the focus group, but either is not available at a pre scheduled time and/or does not fit the demographics of the recruitment guidelines, site staff should keep a list of these participants and possibly explore conducting additional focus groups. To ensure adequate participation, sites should recruit up to 10 women or men for each focus group. Each focus group should include a minimum of four participants. Sites are asked to reschedule focus groups that have 3 or fewer individuals physically present at the scheduled focus group time. Sites should keep a log of the focus group number and the PTIDs of each individual who was recruited (and participated) in the focus group. The site s qualitative recruitment log should be submitted to the AQCT. At completion of the interviews, sites can begin transcription. For focus groups, all analyses will be completed by the site qualitative team. The adapt qualitative core team (AQCT) will coordinate collaboration between the sites working with their qualitative data from the groups. 3.4 Interviews with Staff For HPTN 067, selected staff conducting adherence support through the course of the trial will be invited to participate in a semi structured interview prior to 3 months post completion of all Week 34 visits at the site. Participation is voluntary. Template informed consent forms are available in the appendix of the HPTN 067 protocol. These should be adapted for local use and submitted for IRB review and approval. The interviewer should not be in supervisory position to the interviewee. Interviews should be transcribed, translated and sent to the AQCT for analysis. Unlike the participant interviews and focus groups, the AQCT will be responsible for the analyses of the staff interviews from each site. 8

9 4 Interview and Focus Group Procedures 4.1 Interview and Focus Group Guides Interview and Focus Group Guides can be found in Appendix A of this manual. Sites are responsible for making sure that all appropriate IRB approvals have been obtained prior to use of these guides. As interview and focus groups should be consistent across sites, site teams will work closely with AQCT in finalizing their guides prior to submitting for Institutional Review Board (IRB) review and approval. All interviews and focus groups should take place in a location identified by staff that assures adequate privacy and confidentiality. 4.2 Focus-Group and Interview Set-Up and Materials In an effort to streamline study procedures on the day of the actual interview or focus group, sites should consider at a minimum the following in advance: Staffing requirements o focus groups will require a minimum of 1 co facilitator or note taker, 1 facilitator and potentially additional staff for check in and informed consent procedures; o key informant interviews should have at least one interviewer; Space considerations; Set up and materials; Prior to the interview or focus group, staff should make sure that they have all necessary materials. A suggested materials list can be found in Appendix B and should be modified for site specific needs. 4.3 Documentation Requirements for Interviews and Focus Groups As with other study visits, the qualitative component should follow the guidelines for source and essential documentation as outlined in Section 3 of the HPTN 067 SSP and in site specific SOPs. Source documentation for interviews and focus groups may consist of chart notes, checklists, recruitment logs and transcripts. 4.4 Data Collection Interviewer and Facilitator All interviews and groups should be led by someone who has training and/or experience in qualitative methods. All staff conducting or attending the interviews or groups should not have a role of influence with a participant (study participant or staff member being interviewed) Interviewer and Facilitator Codes (for participant interviewers and facilitators) Each site will assign a letter code first starting with F for facilitator or I for interviewer, followed then by an A, B, C, or D depending on the number of unique facilitators or interviewers used at each site. 9

10 Facilitator or interviewer code will be included on the file name of the transcripts. Each site will keep a record of the staff members and their assigned codes. The interviewer and/or facilitator will identify themselves by their code in the introduction to the interview or focus group. Each site will keep track of participant with a number in the focus group and identify verbiage from that participant in text transcripts with their number. Note that participants also have their own code (see section 4.4.6) but these are not used to demarcate the file Recording All interviews and focus groups will be audio recorded using digital recorders which provide very detailed, high fidelity reproduction of the interview/focus group for transcription and analysis. Study staff are encouraged to always have extra batteries, and when possible, an extra digital recorder on hand. Site teams are highly encouraged to use two tape recorders for every focus group or interview, as a back up. Using two tape recorders during a focus group which are placed at a distance from each other assist with transcription in the case of poor sound acoustics, large rooms or quiet participants. Staff should test the recording device and external microphone (if applicable) prior to the beginning of each focus group or interview. Prior to initiating the interview or group, staff should record at the beginning of the digital file the date, location and study PTID (for interviews) or code (focus groups), and the interviewer or facilitator ID code. This information should also be documented on recruitment logs, checklists, participant chart notes and other forms. Template study forms which may be used can be found in Appendix C of this manual. Once the interview or focus group has been completed, the digital recordings should be reviewed and backed up by the local qualitative team within 48 hours of the interview or focus group. Backup to a secure computer should use the following labeling approach the participant s ID number (interview) or focus group code, the assigned arm of the individual or group, the date of the interview or group, and the interviewer or facilitator ID code. No other identifying information, such as participant or staff name, should be included in the file name. All audio files should be maintained until after analysis is complete Transcription For staff in depth/key informant interviews sites are responsible for transcription and translation of digital files externally in order to protect staff confidentiality. For the participant interviews and groups, sites are responsible for transcription, but not translation to English. Sites may elect to use a commercial service for this and/or use of internal resources. If using internal team to transcript and/or translate, staff interviews should be compiled only by those who do not have a role of influence with the staff member interviewed as voice in the audio recording will likely disclose the identity of the staff member; participant data collected during the first phase of qualitative work should be compiled by internal team members that are not providing risk reduction or next step counseling. Electronic recordings, transcriptions, and translation (staff interviews only) files should be transferred using secure methods. Once transcripts have been completed, they should be reviewed and corrected as needed by the appropriate staff person for accuracy against the source documentation (recordings, notes) within 2 working days of receipt. During the transcription process, transcribers should be asked to highlight or mark all names used in the session(s). This will facilitate de identification of text. Translated transcripts should not include numbering for each line, as the numbering does not convert properly with the software used during the coding and analysis process. Time line for transcription is determined by the 10

11 sites. However, all discussions (interviews and groups) conducted should be transcribed within two weeks of the final interview/group conducted at the end of the study. Transcription and cross checked translation of the staff interviewers should be received by the AQCT within 3 weeks of the last interview conducted Deidentification of Transcripts Any identifying information should be removed at the time of transcription. Identifying information should be replaced with a description holder indicating what type of information was removed. Examples of text with identifying information, as well as the deidentified version are included below. The identifiable information, as well as the corresponding deidentified description holder are indicated in bold. a) Identifiers Participant: I don t use the tablets with Sean, my boyfriend. Participant: I ve been living at the corner of Park and Vine for 5 years. b) De identified Participant: I don t use the condoms with [name of boyfriend], my boyfriend. Participant: I ve been living at the corner of [name of intersection] for 5 years Transcript File Format Save transcript file names in the following format: a) Interview Transcript files: PTID_Interviewer Code_Date For example: IA_ 15 July.2011 b) Focus Group Transcript files: Abbreviated Site Name_FG Code [arm D (daily), T (time driven), E (event driven)] _Facilitator(s) Code(s)_date For example: A focus group in Bangkok with Daily arm participants facilitated by A BK_D_FA_23 Aug

12 4.4.6 Focus Group Speaker Codes In order to create a unique identifier that will distinguish participants during data analysis, sites will assign speaker codes to each focus group participant. When finalizing the transcripts any names, nicknames, or numbers assigned to participants during the focus group will be replaced with a speaker code. As indicated in 4.2, facilitator or interviewers are identified by a unique letter (A, B, C) and participants or interviewee are identified by a number (P1, P2, P3). Note that for interviews, only one participant is interviewed and can have their segments of text identified just with the letter P. Any segment of text that cannot be identified in terms of who said it should be marked with P0 if from a participant; F0 if from a facilitator; or UNKNOWN if cannot be determined. For example: IDENTIFIED: Facilitator: What are the main reasons Shana: I really think that Anna: Definitely, when I Shana: That is what I meant as well DE IDENTIFIED: FA: What are the main reasons P1: I really think that P2: Definitely, when I P1: That is what I meant as well IDENTIFIED: Interviewer: What are the main reasons Shana: I really think that Interviewer: If I am hearing you correctly, you are saying that Shana: Not really, what I meant is DE IDENTIFIED: IA: What are the main reasons P: I really think that IA: If I am hearing you correctly, you are saying that P: Not really, what I meant is Final Submission of Staff Transcripts Sites should select one contact person who will be responsible for submitting all final translated staff interview transcripts to the AQCT. In addition the steps outlined above, prior to submission to the AQCT sites should also check for spelling and grammar errors and remove any editing mark up in the document. The corrected, deidentified transcripts should be sent to the AQCT within 3 weeks (12 working days) of completion of staff interviews for coding and analysis Confidentiality and Privacy Audio files will be saved on a password protected, access limited computer and any physical copies of the file (e.g. burned onto compact disc for transcription) will be kept in a locked, limited access storage 12

13 location like a file cabinet when not in use. Any other files related to the qualitative component, including, but not limited to, hard copies of transcriptions, written consent forms, link and recruitment logs will be handled and stored according to the study protocol and SSP. 5 Data Management and Analysis Data Management and Analysis will be lead by local qualitative teams for the participant data and the AQCT for staff data, with coordination of methodologies and backbone coding structure between sites provided by the AQCT in collaboration with the input from the full HPTN 067 protocol team and will follow strategies outlined in section of the HPTN 067/ADAPT Study Protocol. The coordination of the qualitative component of ADAP is further detailed below (section 6.0) 6 ADAPT Study Qualitative Core Team (AQCT) The composition of the AQCT will include members of the HPTN Protocol Team and site specific team members. Each site must identify a minimum of one team member who will serve as the site specific contact for all procedures related to the qualitative components of this aspect of the study. Preferably, sites will identify additional team members who can contribute to the development of qualitative code books that are representative of issues best conveyed by review of the transcripts in their local languages. The composition of the AQCT is flexible, but throughout the study a designated individual must maintain primary responsibility for monitoring the progress of this aspect of the study. The role of the AQCT is to monitor qualitative activities at each site, collaborate with the site local qualitative teams, coordinate with sites on the methodologies to be used in analyzing the collected participant data between sites, assist in the identification of a backbone of codes that can be used across sites, collaborate with each site on their tailoring/building on the backbone coding structure, conduct all staff data analyses, and facilitate movement from analyses to outcomes and presentations of outcomes within each site. The AQCT also has the responsibility of keeping the full HPTN team abreast of developments in this area. 13

14 Introduction script Appendix A I DISCUSSION GROUPS GUIDE Thank you for participating in this activity. The ideas and comments that you provide can help a lot in trying to get a good understanding of what it is like for people to try to use PrEP as part of their HIV prevention strategy. You are the world experts on this and I am really looking forward to learning from you! Anything that will be said in this group will be kept as confidential as possible. I can assure you confidentiality on my part. I can only ask that you also provide your colleagues here with you the same assurance that what they say will not be shared with others outside this group. There are no wrong or right opinions; all points of view are valid. Some requests or ground rules are that you (1) Turn off you cell phones during the discussion. (2) Please try to protect each other s confidentiality (feel free to share what you heard here but don t link it back to someone here specifically). Some of you may know each other. Even if you do, please respect each other s privacy and confidentiality by not mentioning each other s presence in the group to other people. (3) Please respect each other and each other s opinions. There is no correct way to feel or think here and we want to encourage everyone to have the opportunity to share. (4) Finally, please try to speak one at a time, so we can listen what other colleagues have to say. This will also make it easier to transcribe our discussions accurately. You have all signed an informed consent form in which you consented to tape record this discussion. I [and/or co facilitator name] will also be taking notes on the things you are saying to help me follow the discussion. We are recording this discussion so that the things we say can be written out, de indentified (meaning, we take out any names used or any identifying information shared), and reviewed by the research team. No names are written down in the transcriptions. Please recall that when these tapes are not in use, they will be stored in a locked location and destroyed after analysis has been completed. You all have note cards in front of you. You can pick what name we will use for you today by writing it down now on the card and facing that card out for us to be able to see. I would like to start recording. Before we do this, let s take a moment and have each person give the name they are using. Thank you. Ready to begin? *FACILITATOR TURNS ON THE TAPE RECORDER TO START THE DISCUSSION*

15 FOCUS GROUP GUIDE CONTENT AREAS AND QUESTIONS UNDERSTANDING OF REGIMEN 1. What is your understanding of the recommended regimen specifically? What is your understanding of what you were being asked to do? [provide definition of regimen after discussion] REGIMEN FIT TO DAILY LIFE (FACILITATORS/CHALLENGES) 2. What would you say were the main things that made this recommended regimen work well for you or fit into your life? 3. What would you say were the main things that made this recommended regimen not work so well or really fit well into your life? Were there times it was particularly hard to try to take the pills as recommended (prescribed)? [write facilitators and challenges on flip chart as discussion progresses and ask if lists are complete before moving on] FEASIBILITY/ACCEPTABILITY OF ASSIGNED REGIMEN 4. For your recommended regimen [define this for the group] what would you say about how acceptable it would be to people in general? Who would it be good for? Who would it not fit well with? 5. How reasonable is it to ask people to follow a regimen that tells people to [use regimen definition]? REGIMEN ALTERATIONS 6. Did you find yourself changing the [specify regimen assigned for this group] regimen to something a little or a lot different to better fit your life or situation? How? [explore intentional changes to the regimen and any indications that people started and stopped study drug in relation to sexual activity] IDEAL REGIMEN 7. What would your ideal schedule for taking these pills be for you? PREFERENCES FOR OTHER REGIMENS 8. Other schedules being studied include [provide details on regimens not assigned to this group and write each potential regimen on the flip chart: Daily (one tablet each day); Twice Weekly Plus (take a tablet on two separate days of the week plus a tablet after each time you have sex); Before and After sex (take one tablet a day or so before sex and shortly after sex)]. Which of these would you choose if you could? PERCEPTIONS OF ADHERENCE SUPPORT OFFERED/PROVIDED 9. Each visit that you were dispensed study drug, a counselor asked you about your experiences with trying to take the study tablets. What were those discussions like? 10. Where those discussions helpful? 15

16 11. Would you recommend a similar kind of approach to supporting PrEP use outside of a clinical trial setting? 12. Would you recommend changes to those discussions? PREP AS PART OF/OR IN CONFLICT WITH OTHER PREVENTION STRATEGIES 13. When you started taking these tablets, did you notice a change in any of the other things you used to do to help to protect you from HIV? [probe for (1) strengthening of other prevention practices and/or (2) weakening of non PrEP prevention practices and what the group perceived the reasons for these changes were] RISK COMPENSATION 14. When you started taking these tablets, did you notice a change in your sexual behaviors? [probe for potential changes in number or types of partners, frequency of sex or engaging in different kinds of sex] 15. Did you ever find yourself thinking or believing that you were immune to HIV because of the pills? [probe for preventive misconception that use of the study medication provided greater benefits than reasonably expected] CHARACTERIZING ROLES IN STUDY AND IN RELATION TO PRACTICE OF PREVENTION STRATEGIES [I am going to put some labels of different kinds of people up on the sheet [use flip chart]. You have here PrEP user, Condom user, Prevention Advocate and Good Participant.] 16. Let s take each label here and fill out what you think would describe or characterize each one. There are no true or correct characteristics here. We are just trying to explore what these different things mean to different people. Let s start with PrEP user when you hear this term, what kinds of characteristics or features come to mind what does the PrEP user look like to you? [repeat for all terms providing clarification as needed; e.g., If I call myself a PrEP user, what does that mean?]. SOCIAL MOTIVATION/STUDY CONNECTIONS [Just a couple of questions left.] 17. Did anyone close to you know about your participation in this trial? What kinds of things influenced your decision to tell people or not to tell people that you were in this study and/or that you were taking the study medication? 18. What would you say about the kind of social support you got from people important to you, the study team members you worked with during your clinic visits, or other participants you met during visits or as a part of your involvement in the study? Did you get any support from others? For what? FEASIBILITY/ACCEPTABILITY OF WISE PILL DEVICE/WEEKLY INTERVIEWS 19. How did you feel about using the wise pill device? And, how about the weekly interviews? What did you think about them? RECOMMENDATIONS 16

17 20. Last question Are there any observations or recommendations for the research team that you would like to offer that have not been discussed? 17

18 Appendix A II KEY INFORMANT INTERVIEW (PARTICIPANT) GUIDE Introduction script Thank you for participating in this interview. My name is. [INTRODUCE SELF AND ROLE]. The goal of the interview is to gain an understanding of what it was like for you to try to use the study medication in the way it was prescribed or recommended to be taken. You are an expert on this PrEP schedule and your experiences are really valuable to getting a real sense of the benefits and difficulties involve in this. Anything that you say to me will be kept confidential. What we discuss is tape recorded and then written out into words on paper. When it is written out, all information that could identify you to someone reading the words (anything said with names or locations or that kind of thing) are completely removed. The text from this interview will be reviewed so that we can better plan for Truvada for prevention approaches in the future. The material from our interview (file) is saved with your participant number but not your name. The research team members reviewing this text will not link who you are to that ID and will not tell anyone on site about your specific feedback. There are other people doing interviews as well, and we will put all those documents together and look at main topics people talked about. That kind of information will get shared with the site down the road. We do not and will not share something you say as comments linked to your name or ID number. There are no wrong or right answers to any of the questions here. Also, please don t feel like you have to stick with answering the questions I ask anything that comes up for you is really welcome. You have signed the informed consent form in which you consented to tape record this discussion. I may also be taking notes on the things you are saying to help me follow the discussion. Please recall that when these tapes are not being reviewed, they will be stored in a locked location and will be destroyed after analyses are completed. I would like to start recording. Before we do this, do you have any questions or concerns? Are you ready to begin? *INTERVIEWER TURNS ON THE TAPE RECORDER TO START THE DISCUSSION* *FACILITATOR TURNS ON THE TAPE RECORDER TO START THE DISCUSSION* 18

19 IN DEPTH INTERVIEWS WITH KEY INFORMANTS GUIDE CONTENT AREAS AND QUESTIONS UNDERSTANDING OF REGIMEN 21. What is your understanding of the recommended regimen specifically? What is your understanding of what you were being asked to do? [provide definition of regimen after discussion] REGIMEN FIT TO DAILY LIFE (FACILITATORS/CHALLENGES) 22. What would you say were the main things that made this recommended regimen work well for you or fit into your life? 23. What would you say were the main things that made this recommended regimen not work so well or really fit well into your life? Were there times it was particularly hard to try to take the pills as recommended (prescribed)? [write facilitators and challenges on flip chart as discussion progresses and ask if lists are complete before moving on] FEASIBILITY/ACCEPTABILITY OF ASSIGNED REGIMEN 24. For your recommended regimen [define this for the group] what would you say about how acceptable it would be to people in general? Who would it be good for? Who would it not fit well with? 25. How reasonable is it to ask people to follow a regimen that tells people to [use regimen definition]? REGIMEN ALTERATIONS 26. Did you find yourself changing the [specify regimen assigned for this group] regimen to something a little or a lot different to better fit your life or situation? How? [explore intentional changes to the regimen and any indications that people started and stopped study drug in relation to sexual activity] IDEAL REGIMEN 27. What would your ideal schedule for taking these pills be for you? PREFERENCES FOR OTHER REGIMENS 28. Other schedules being studied include [provide details on regimens not assigned to this group and write each potential regimen on the flip chart: Daily (one tablet each day); Twice Weekly Plus (take a tablet on two separate days of the week plus a tablet after each time you have sex); Before and After sex (take one tablet a day or so before sex and shortly after sex)]. Which of these would you choose if you could? PERCEPTIONS OF ADHERENCE SUPPORT OFFERED/PROVIDED 29. Each visit that you were dispensed study drug, a counselor asked you about your experiences with trying to take the study tablets. What were those discussions like? 30. Where those discussions helpful? 19

20 31. Would you recommend a similar kind of approach to supporting PrEP use outside of a clinical trial setting? 32. Would you recommend changes to those discussions? PREP AS PART OF/OR IN CONFLICT WITH OTHER PREVENTION STRATEGIES 33. When you started taking these tablets, did you notice a change in any of the other things you used to do to help to protect you from HIV? [probe for (1) strengthening of other prevention practices and/or (2) weakening of non PrEP prevention practices and what the group perceived the reasons for these changes were] RISK COMPENSATION 34. When you started taking these tablets, did you notice a change in your sexual behaviors? [probe for potential changes in number or types of partners, frequency of sex or engaging in different kinds of sex] 35. Did you ever find yourself thinking or believing that you were immune to HIV because of the pills? [probe for preventive misconception that use of the study medication provided greater benefits than reasonably expected] CHARACTERIZING ROLES IN STUDY AND IN RELATION TO PRACTICE OF PREVENTION STRATEGIES [I am going to put some labels of different kinds of people up on the sheet [use flip chart]. You have here PrEP user, Condom user, Prevention Advocate and Good Participant.] 36. Let s take each label here and fill out what you think would describe or characterize each one. There are no true or correct characteristics here. We are just trying to explore what these different things mean to different people. Let s start with PrEP user when you hear this term, what kinds of characteristics or features come to mind what does the PrEP user look like to you? [repeat for all terms providing clarification as needed; e.g., If I call myself a PrEP user, what does that mean?]. SOCIAL MOTIVATION/STUDY CONNECTIONS [Just a couple of questions left.] 37. Did anyone close to you know about your participation in this trial? What kinds of things influenced your decision to tell people or not to tell people that you were in this study and/or that you were taking the study medication? 38. What would you say about the kind of social support you got from people important to you, the study team members you worked with during your clinic visits, or other participants you met during visits or as a part of your involvement in the study? Did you get any support from others? For what? FEASIBILITY/ACCEPTABILITY OF WISE PILL DEVICE/WEEKLY INTERVIEWS 39. How did you feel about using the wise pill device? And, how about the weekly interviews? What did you think about them? 20

21 RECOMMENDATIONS 40. Last question Are there any observations or recommendations for the research team that you would like to offer that have not been discussed? 21

22 Introduction script Appendix A III IN DEPTH INTERVIEWS WITH COUNSELING STAFF INTERVIEW GUIDE Thank you for participating in this interview. My name is. [INTRODUCE SELF AND ROLE AND AFFILIATION]. The goal of the interview is to gain an understanding of what it was like for participants to try to use the recommended PrEP regimens and your experiences and thoughts about how to support participants in adherence. Your experiences are really valuable because you have met with many participants over time and have expertise in all these areas. Anything that you say will be kept as confidential. What we discuss is tape recorded, transcribed, translated and then sent to the ADAPT core qualitative analysis team. To help people to feel comfortable sharing openly, we do not have an internal team at the clinic doing the review of these transcripts. Even the transcription is done by professionals who do not have a relationship with you. When our discussion is transcribed, all identifying information (anything said with names or locations or that kind of thing) are completely removed. The text for the interview is analyzed for themes and content and that file is identified with what site it is from, but not your name. There are no wrong or right answers to any of the questions here. Also, please don t feel like you have to stick to answering the questions I ask anything that comes up for you is really welcome. Please recall that when these tapes are not being reviewed, they will be stored in a secure location and will be destroyed after all analyses are completed. I would like to start recording. Before we do this, do you have any questions or concerns? Ready to begin? *INTERVIEWER TURNS ON THE TAPE RECORDER TO START THE DISCUSSION* 22

23 IN DEPTH INTERVIEWS WITH COUNSELING STAFF GUIDE CONTENT AREAS AND QUESTIONS UNDERSTANDING OF REGIMEN 41. What was your sense of the participant s understanding of the regimens they were assigned? Was this similar across regimens or different? Did you find anything about this regimen which was hard for the participant to understand? FEASIBILITY/ACCEPTABILITY OF ASSIGNED REGIMEN 42. How feasible (manageable) do you think the different regimens were for participants? Was this different by regimen? 43. How attractive (well liked) do you think the different regimens were for participants? Was this different by regimen? FEASIBILITY/ACCEPTABILITY OF WISE PILL DEVICE/WEEKLY INTERVIEWS 44. Did participants share any feelings they had about the wise pill device or the weekly interviews? What did they think about those? What did you think about them? REGIMEN FIT TO DAILY LIFE (FACILITATORS/CHALLENGES) 45. What would you say were the main things that made taking the different regimens easy for participants, or well matched with their lives? [ask about DAILY, TIME, and EVENT DRIVEN] 46. What would you say were the main things that made taking the different regimens hard for participants, or poorly matched with their lives? [ask about DAILY, TIME, and EVENT DRIVEN] 47. In your next step counseling discussions with participants in the different arms of the study, what would you say were the main needs (step 5) that people had? What were the things people tended to mention that they needed for their regimens to feel easy or most manageable? [ask about DAILY, TIME, and EVENT DRIVEN] 48. Similarly, what would you say were the main strategies people used (step 6/7) to try to work the regimen into their lives? Were there things that were similar across regimens or specific to certain regimens? REGIMEN MIGRATION 49. In your perception, how often do you think participants changed their regimen like from daily to event driven or some other switch. Was that intentional, like deciding to try to follow something different than recommended, or unintentional? What factors do you think led to changing on purpose? IDEAL REGIMEN 50. What would you say the ideal regimen would be for participants you worked with? Is there one regimen that is ideal or does it depend on the person? PREFERENCES FOR OTHER REGIMENS 23

24 51. Of the three regimens in this study, do you have a preference for one? Do you think the participants would have a preference for one? PERCEPTIONS OF ADHERENCE SUPPORT STRATEGY 52. You engaged participants in a discussion concerning their experiences with the study medication, their needs, and strategies the next step counseling discussions. How did you feel about those discussions? How do you think the participants felt about these discussions? 53. Would you recommend this kind of discussion be part of providing PrEP to people outside of the context of a research trial? [probe in terms of what would be recommended] 54. Would you recommend changes to those discussions? PREP AS PART OF/OR IN CONFLICT WITH OTHER PREVENTION STRATEGIES 55. Do you feel that participants may have changed their risk behaviors or prevention practices while on PrEP? [probe for prevention synergy, risk compensation, and preventive misconception] 56. If your opinion, did condom use change at all for participants over the course of their participation in the trial? CHARACTERIZING IDEAL PREP RECEPIENT 57. How would you describe the ideal PrEP recipient? Does PrEP regimen type matter for that? RECOMMENDATIONS 58. Last question Are there any observations or recommendations for the research team that you would like to offer that have not been discussed? 24