UNIVERSITY OF MALAWI. College of Medicine

Transcription

1 UNIVERSITY OF MALAWI College of Medicine Factors Affecting Adherence To Antiretroviral Therapy (ART) Among Children Aged 7-15 Years Attending Queen Elizabeth Central Hospital (QECH) ART Clinic In Blantyre By Lucy Guluka Gawa BSC in Nursing Education and Administration, Diploma in Nursing (MPH/007/008) Dissertation Submitted in Partial Fulfillment of the Requirements of the Master of Public Health Degree June 2011

2 CERTIFICATE OF APPROVAL The Thesis of Lucy Guluka is approved by the Thesis Examination Committee (Chairman, Postgraduate Committee) (Supervisor) (Internal Examiner) (Head of Department) i

3 DECLARATION I, Lucy Guluka hereby declare that this thesis is my original work and has not been presented for any other awards at the University of Malawi or any other University. Name of Candidate: Lucy Guluka Signature: Date: 27th June 2011 ii

4 ACKNOWLEDGEMENTS I wish to express my special thanks to the department of Community Health at College of Medicine for awarding me a scholarship to study MPH at their institution. Secondly, my heartfelt gratitude is due to Professor Cameroon Bowie, Dr Peter Moons for continuously guiding me through the development of research proposal and Professor Victor Mwapasa for valuable contributions, guidance and support throughout the production of this thesis. I am very grateful to my family for being there to encourage and support me during the period of study. I thank Nurse Madalitso Daza for assisting me with data collection, and not forgetting Egnat Katengeza and Emmanuel Singogo for your assistance during data analysis. Your input contributed to the success of this project. I also appreciate the management at Queen Elizabeth Central Hospital for allowing me conduct this research in their institution Above all, I am very grateful to God, the Almighty for keeping me in good health to enable me carryout this research project, to Him be the Glory and Honor for ever and ever. iii

5 ABSTRACT BACKGROUND: The introduction of antiretroviral therapy (ART) has given hope to many people living with HIV/AIDS including children. ART is effective in suppressing HIV replication, decreasing morbidity, and mortality and improving quality of life, therefore adherence to this medication is very crucial [1]. Sustaining adherence represents a significant challenge for children getting treatment at Queen Elizabeth Central Hospital (QECH). STUDY OBJECTIVE: The purpose of this study was to investigate the factors that affect adherence to ART among children attending QECH ART clinic in Blantyre. STUDY METHODS: This was a cross-sectional descriptive study combining quantitative and qualitative methods. An interviewer administered questionnaire was used to collect data in children. Focus group discussions (FGDs) were conducted with caregivers. A systematic sample of HIV-infected children was drawn on daily basis. Quantitative data was analyzed using StataSE 10 whilst qualitative data was coded using Non-Numerical Unstructured Data Indexing, Searching and Theorizing (NVIVO) software (QSR, 2001). Adherence was ascertained by asking patients whether they missed any medication from the previous visit to the current visit, therefore in this study adherence is defined as not missing any dose from the previous visit to the current visit (which is usually two months), according to self reports. RESULTS: Ninety eight children were enrolled in the study, of which 62.3% (61/98) were 100% adherent. Among children who missed doses, the common reason for missing doses was forgetfulness. Adherence to ART was significantly associated with perceived health status (P=0.03, OR=2.1, 95% CI: ) while guardian of child having an occupation or not was marginally associated (P=0.1, OR=2.3, 95% CI: ). The most common strategy used in ensuring an effective ART adherence was a reminder to take the drug by caregivers to their children to take the pill. CONCLUSION: The results for this study showed that over one third of the children in this clinic are not 100% adhering to ART. An adherence programme that will adequately prepare patients and guardians prior to initiating treatment and provision of an ongoing ART adherence support should be developed in the ART clinic. iv

6 TABLE OF CONTENTS Certificate of approval... i Declaration... ii Acknowledgements... iii Abstract... iv Table of Contents... v List of Abbreviation... x List of Tables... ix CHAPTER 1: Background to Study HIV/AIDS Situation in the World HIV/AIDS and ART in Malawi Statement of the Problem Literature Review Definition of Adherence Importance of Adherence Measurement of Adherence Adherence Levels In Africa and Malawi Factors Affecting Adherence Justification of the Study... 7 CHAPTER 2: Study Objectives Broad Objective Specific Objectives... 8 CHAPTER 3: Methodology Study Design Study Setting Study Population Study Period Sample Size Data Collection Data Management and Analysis v

7 3.8 Definitions of Terms Ethical Consideration CHAPTER 4: Study Results Characteristics of Participants Knowledge of Treatment Type and Reason for Treatment Medication Adherence Factors associated with ART Belief in efficacy of Medication Disclosure of Status Adherence Strategies Medication Support Medication Instructions Communication Problems CHAPTER 5: Discussion Study Limitations CHAPTER 6: Conclusion Recommendations Further Research REFERENCES APPENDICES Appendix 1: English Version Informed Consent Appendix 2: Chichewa Version Informed Consent Appendix 3 : English Version Study Questionnaire Appendix 4: Chichewa Version Study Questionnaire Appendix 5: English Version Focus Group Guide Appendix 6: Chichewa Version Focus Group Guide Appendix 7: Approval Letter by Hospital Director (QECH) vi

8 List of Tables Table 1: Characteristics of Participants Table 2: Treatment Type and/or Name Table 3: Reasons for Missed Doses Table 4: Factors Associated with ART Adherence (Univariate analysis) Table 5: Factors Associated with ART Adherence (Multivariate analysis) Table 6: Reasons Why Medication is Helpful Table 7: Reasons for Disclosure and Non-Disclosure of HIV Status Table 8: Adherence Strategies Table 9: Kind of Medication Support Table 10: Medication Instructions vii

9 List of Figures Figure1: Association between Education Level and Adherence viii

10 List of Acronyms AIDS ART ARV COM COMREC FGD HAART HCW HIV MTCT MOH MPH QECH WHO Acquired Immune Deficiency Syndrome Antiretroviral Therapy Antiretroviral College of Medicine College of Medicine Research and Ethics Committee Focus Group Discussion Highly Active Antiretroviral Therapy Health Care Worker Human Immune Deficiency Virus Mother to Child Transmission of HIV Ministry of Health Masters of Public Health Queen Elizabeth Central Hospital World Health Organization ix

11 CHAPTER 1: BACKGROUND 1.1 HIV/AIDS in Sub-Saharan Africa HIV/AIDS is one of the public health challenges in the world. In 2009, it was estimated that over 33.3 million people were living with HIV/AIDS worldwide, with 2.5 million of these being children under 15 years of age. The epidemic is worse in developing countries, particularly in Sub-Saharan Africa, with 22.5 million people living with HIV/AIDS by the end of 2009[2]. Unprotected heterosexual contact is by far the primary mode of transmission of HIV virus in adults while Mother to Child Transmission (MTCT) is the largest source of infection in children below the age of 15 years. Without treatment, 15-30% of babies born to HIV positive women become infected with HIV during pregnancy and delivery. Furthermore, an additional 5-20% becomes infected through breastfeeding [3]. The introduction of antiretroviral therapy (ART) has given hope to many people living with HIV/AIDS, including children. ART is effective in suppressing the replication of HIV, decreasing morbidity and mortality associated with HIV and improving quality of life in adults as well as children [1]. 1.2 HIV/AIDS and ART in Malawi While Sub-Saharan Africa is highly rated on HIV/AIDS prevalence, Malawi through a recent survey conducted in 2007, contributed about people living with HIV/AIDS to the Sub-Saharan African figure., with about , of these being children under 15 years of age [4]. Like other countries in Sub-Saharan Africa, the primary mode of HIV transmission in Malawi is unprotected heterosexual sex, while mother-to-child transmission is the second major mode of HIV transmission. In response to the WHO three by five initiative which aimed to have three million people in developing countries on ART by the end of 2005, Malawi developed a two-year ( ) antiretroviral expansion plan with the goal of delivering free ART to eligible patients throughout the country by the end of 2005[5]. By December 2005, Malawians were ever started on ART 4]. At the end of March 2006 the HIV Unit of the Ministry of Health (MOH) reported 2,718 children (younger than 15 years old) on ART, with the majority of the children (70%) from the southern region, 26.6% from the central 1

12 region and 3.4% from the north[6][7]. Malawi aimed to have started 245,000 patients on ART by the end of 2010[3]. As of 2010, a fixed-dose combination of Stavudine, Lamivudine and Nevirapine (Triomune) was the first-line and standard ART regimen for both adults and children in Malawi [4]. Alternative first line are available for all the patients who develop side effects both for adults and children in all facilities while second line ART are available for patients who have developed treatment failure on first line regimen and are found in referral hospitals and selected district hospital where there is specialized care. 1.3 Statement of the Problem For ART to work effectively, adherence is very crucial. The recommended optimal adherence level for ART to be effective is above 95 percent [8]. Any patient who misses more than 3 dosages in a one month treatment course is considered to have achieved suboptimal adherence which is less than 95% [9]. A level of adherence which is greater than 95% (optimal adherence) suppresses viral replication and prevents the development of resistance and treatment failure. Sustaining adherence presents a significant challenge for children receiving ART treatment at QECH pediatric clinic in Malawi. A preliminary assessment using self report of children aged 7-15 years who were attending the QECH clinic and were prescribed ARVs for a period of two months found that only 56% of children were 100% adherent. The assessment attempted to verify self report with pill count but it was observed that pill count was not very accurate because the nurses were sometimes administering more or less tablets than expected. The assessment also revealed that some children did not adhere because they did not know why they were taking ARV drugs. These findings lend support to the recommendations made by Muula in his study Assessment of equity in the uptake of Anti-retroviral in Malawi to further assess factors affecting adherence since different adherence rates in different areas were revealed from his study in Malawi] [10]. 2

13 1.4 Literature Review Definition of adherence Adherence is defined as the extent to which a person s behavior - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider [11]. Adherence to medication is also known as compliance with medication. The term adherence has become preferred to the term compliance because compliance implies the patient is passively following orders, while adherence implies a treatment plan agreed by both patient and physician.[12]. In the case of pediatric patients this can be applied to both the caregiver s and the child s behavior hence agreement on treatment recommendations is required from both of them 1.42 Importance of Adherence to ART Medication adherence is fundamental to successful antiretroviral therapy. Adherence is a major factor in determining the degree of viral suppression achieved in response to antiretroviral therapy[13].the goals of ARV therapy for children are to increase survival, improve quality of life and decrease HIV-related morbidity and mortality[14]. Some scholars have argued that adherence greater than 95% will ensure a good virologic response and prevent the emergence of viral resistance, therefore impeding the success of the ART program [1] [6] [14]. Thus, there is evidence that failure to adhere to the prescribed treatment regimen is associated with adverse clinical outcomes. Therefore, efforts to improve adherence rates are likely to result in improved health outcomes Measurements of Adherence There are numerous methods that are applied to assess ART adherence. Among the most common are face-to-face interviews or self report and pill count. In face-to-face interviews, the patient is asked about the number of doses missed during a specific period and it is translated quantitatively into a percentage adherence. However, this method has its limitations because patients tend to overestimate adherence [15]. In a study by Liu, adherence as measured by patient interview was found to be considerably higher than adherence as measured by other means, for example pill count [16]. However, self-report is most useful for those patients who admit to poor adherence because such patients truly are non-adherent [15] 3

14 Pill count is done at the clinic, after the patient has brought the pill bottle with him. A healthcare provider counts the number of pills remaining in the bottle and computes the number of missed doses by comparing the difference between the actual and expected number of pills remaining in the bottle. Drawbacks of pill counts include pill dumping, whereby patients dispose off pills to make their adherence appear better than it may actually be [16] Adherence levels in Africa and Malawi Different adherence rates have been reported in various studies in both Africa and Malawi. The rates of adherence varied with study characteristics and method of ascertainment of adherence i.e. individual reports, pharmacy records and pill counting [13] [17]. Some studies have reported that fewer than 50% of children and/or caretakers report 100% adherence to their clinically prescribed regimens [13]. However, others have reported adherence interms of mean adherence rates of greater than 90% [18]. A systematic review and meta-analysis of studies in adults evaluating adherence to ART in sub-saharan Africa and North America reported a combined continent estimate of adherence rates of 64%. The pooled estimate for the North American studies was 55% and for the African studies was 77%, indicating a higher level of ART adherence in Africa [19]. However this review did not state the proportions of people associated with the reported adherence rates. In Malawi, two studies conducted by Medicines San Frontiers (MSF) to assess levels of adherence in Chiradzulu and Thyolo districts also revealed varied levels of adherence. In Chiradzulu they measured the pill count for 367 patients of which (64%) of patients were highly adherent (implying they took medication in the previous four days 100% of their time), 27% were moderately adherent (implying they took medication at least 80% and less than 100% of their time) and 9% were non-adherent (meaning they took medication less than 80% of their time). Using patient self-reporting, 383 (96%) were found to be highly adherent, 8 (2%) were moderately adherent and 16 (4%) were non-adherent. In Thyolo district, out of 151 patients, 99% had at least 95% adherence, using pill count [10]. Another study conducted in Blantyre at QECH ART clinic (before the clinic started providing free ART) assessed 176 patients and found that 52% reported to have 100% adherence never 4

15 having missed a dose. Of those that missed a dose, 43% reported that they had missed medications because of unavailability of medications at the hospital pharmacy, 32% because of lack of money and 27% had forgotten to take medications [20]. Another study conducted by Bell in adult patients, at the same hospital showed complexities of measuring adherence and probable overestimation of adherence by pill count (98.6%) and self report (86.2%) compared to medication event monitoring system (88.1)[21]. In 2004 to 2005, Ellis and Molyneux in their study Experience of Anti-retroviral treatment for HIV infected children in Malawi found that adherence using self report was excellent, better than 95% in >90% of the children[22]. However, this was the only study that looked at adherence in children Factors affecting Adherence Studies conducted in developed countries have revealed various factors affecting ART adherence in children. There are very few studies conducted in Africa and none have been published from Malawi. However, from all these studies, the following factors are revealed Drug Formulation and Complexity When treating HIV infected pediatric patients, fewer options are available, because of the small number of ARV drugs registered worldwide for pediatric use and/or inadequate formulations [23]. This significantly limits the possibility of prescribing drugs that are easy to administer to children. In addition, regimen complexity is another important contributor to poor adherence [24]. This includes the need for daily administration, dietary requirements, dosage and consequently pill burden, and pill taste [13] [25] [26] [27]. However, some studies discovered that adherence was not associated with the complexity or burden of medication regimens despite the fact that most providers often believe this to be a critical barrier to adherence [28] Side effects Studies have revealed that ARV drugs are often discontinued when side effects occur or when they are perceived. Adverse drug events influence willingness to take medication and are consistently associated with poor adherence [24] [28]. In another study by Heyer, patients with adverse events such as dermatological and gastrointestinal symptoms were 12.8 times 5

16 less likely to be % adherent [24] compared with those who did not present with symptoms Beliefs and attitude Parents beliefs and attitudes are among the predictors of ART adherence. Parents beliefs about the seriousness of their childs illness and the medication or treatment, will influence adherence[29]. In addition, the child s attitude towards the drug, his perceptions about the HIV the perceived benefits of the drug play a very important role in adherence. Greater adherence is observed in patients who believe HAART is effective, while negative beliefs reduced adherence [30] Clinical status The current experiences with symptoms and severity of such symptoms in HIV patients are associated with adherence. Studies have revealed that patients who have symptomatic disease or who feel debilitating pain and symptoms are less adherent [28] compared with patients who did not present with any symptom and pain. However, in one study an increasing adherence rate was observed in children with more advanced AIDS [31] Age Age has been identified as a relevant factor to consider when looking at adherence to HAART among HIV patients. Some studies have reported better adherence among older patients whilst others have reported no relationship [28] [30]. However, since children are dependent on their caregivers for the administration of medication, adherence is thus only as good as the caregivers are able to achieve. Other studies have revealed that special issues relating to adherence exist for HIV-infected children and adolescents. It is observed that adherence concerns intensify as children enter into adolescence because of premature responsibility for taking medication, and the developmental and social challenges faced [27] Disclosure of HIV status Disclosure of HIV status is another factor which is believed to have an influence on ART adherence. Some studies have revealed that complete parental disclosure to children helps to motivate HIV-infected children to adhere to their daily medical regimen. It enables children 6

17 to understand HIV infection and to make sense of disease-related experiences and the importance of adherence [32]. However, many caregivers decide not to tell their children that they have HIV disease until adolescence, potentially impeding their cooperation with treatment [27] Costs Studies conducted in Africa revealed that the cost of drugs and related health service are the most significant barriers to adherence. Adherence difficulties related to the financial demands of therapy and inability to afford medicines for varying periods were reported in Botswana and Uganda by both patients receiving subsidized and non subsidized ART[33][34] Provider support A supportive patient-provider relationship is another important factor in improving ART adherence. Studies have reported a positive relationship between provider support and adherence. This involves supporting the patient throughout his treatment, by providing motivation, routine adherence counseling, involving the patient in treatment decisions, open communication, compassion and taking regimen inconveniences into account to improve adherence [29]. 1.5 Justification for the Study In order to facilitate adherence to ART in HIV-infected children, it is necessary to know factors that affect adherence and to explore the possible interventions to improve adherence. In view of this, it was vital that a study be conducted to assess levels of adherence among children on ART and factors associated with adherence at QECH ART clinic. This study would help inform the hospital, MoH and other policy makers in Malawi on ways of improving and/or maintaining adherence to ART in children as access to ARV medicines is being scaled up nationwide. 7

18 CHAPTER 2: STUDY OBJECTIVES The study was designed to achieve the following objectives: 2.1 Broad Objective To explore the factors associated with ART adherence in HIV infected children aged between 7 and 15 years attending QECH ART Clinic. 2.2 Specific Objective a. To estimate the proportion of patients who have adherence 100% to ART over a period of two months b. To ascertain the children s knowledge of their HIV diagnosis and treatment c. To correlate the relationship between diagnostic disclosure and ART adherence. d. To identify the main factors that affect ART adherence including caregivers/children perceptions, beliefs and practices e. To establish the kind of support currently given to infected children under ART 8

19 CHAPTER 3: METHODOLOGY 3.1 Study Design This study used a cross-sectional descriptive study design using both quantitative and qualitative methods. 3.2 Study Setting The study took place at Queen Elizabeth Central Hospital (QECH) which is the largest central hospital in the southern region of Malawi. QECH serves as both a primary contact hospital and a regional referral hospital. The hospital started providing free ART services to HIV infected people in accordance with the national ART guidelines in Currently, the ART clinic provides HIV related services for both adults and children. The pediatric clinic opens twice a week (Mondays and Tuesdays afternoon) whilst the adult clinic opens daily. 3.3 Study Population The study target population was children aged between 7-15 years that were attending QECH ARV Clinic in Blantyre, Malawi. The inclusion criteria for the study were: o Known HIV Positive children o Age between 7 to 15 years old (This age category was chosen because of their capacity to reasonably express their views hence able to participate in this study) o On ART Treatment for not less than 2 months excluding initiation period o Guardian may be biological parent, relative or adoptive caregiver o Willing to provide Consent 3.4 Study Period The study was conducted between March and May The activities that took place during this period include, briefing of research assistant, data collection and data analysis. 3.5 Sample size At the time of the study, the pediatric ART clinic at QECH had 360 patients in the age range of 7 to 15 years registered for ART. To calculate sample size we estimated that only 56% of the patients were adhering 100%, based on a preliminary adherence assessment conducted in 9

20 the clinic. Using this as a point estimate and allowing for a 10% margin of error with 95% confidence, we calculated the sample size to be 98. Since it was difficult for the clinic to come up with a list of HIV infected children expected to come in a particular day from the clinic registry, the researchers attempted to select participants each clinic day through systematic sampling of every second child coming to the clinic. However, due to the clinic set up, patient flow and the turn up of children at their own time, it was difficult to adhere to the sampling method; as a result children who were meeting the criteria were purposively selected and interviewed as they reported to the clinic 3.6 Data Collection Each clinic day during data collection, the researchers with the help from the clinic staff (who were registering and weighing the children) were identifying the potential eligible clients who have reported for the clinic, before they were reviewed by the clinicians. Each child and her guardian were referred to the researchers to be informed about the study and were asked to give an oral consent upon understanding of the specifics of the study. A direct face-to-face interviewer administered questionnaire was used to collect data. The questionnaire had structured and semi structured questions to collect both quantitative and qualitative data. The interview included items on social demographic data, perceived functional health status using a Lansky Performance Scale for children. This scale comprises of indices for the clinical estimate of a person s physical state, performance and prognosis after therapy and for determining patient s suitability for therapy [35]. Other information that was collected during the interviews include; Childs awareness of HIV status, perceptions towards the prescribed ART, missed doses since the previous visit and in the past week, the kind of support a child receives from her/his guardian and what they do to ensure ART adherence. Upon completion of the individual interviews, data was also collected through focus group discussions (FGD) of guardians to triangulate the information obtained from face-to-face interviews. Each clinic day during registration, guardians meeting the inclusion criteria were informed of the FGD and asked to come to the playroom before weighing and reviewing 10

21 their children. When a minimum of 6 guardians was achieved, the FGD was initiated. A total of four FGD (with between 6 and 8 guardians in each group) were done. The discussions were tape recorded to capture all information provided by the participants. Health passport books were reviewed to confirm the patient report on treatment type, dosage and last date of visit. Other clinic records were reviewed to abstract the number of pills given in the last visit for each child to help calculating the number of missed doses during analysis. A nurse from another department was trained to assist in data collection hence the researcher and the trained nurse interviewed a minimum of 12 children each day until the sample size was met. 3.7 Data Management and Analysis The study completed questionnaires and signed consent forms were collected on daily basis. The researcher checked for completeness and accuracy of the forms and put them in order of numbers to be entered into a data base that was created in Microsoft Access. Quantitative data was later imported into STATA for analysis. Descriptive statistics were computed. We examined any association between various variables and ART Adherence amongst participants using a two-sided chi-square test. We first conducted univariate analysis and variables with a p-value <0.20 were later included in the multivariate regression model [36]. We used an interactive backwards elimination approach to come up with final variables as predictor factors of whether a child will miss a dose or not. Variables were included in the predictor model if they were statistically significant at p<0.10 considering that the sample size was small. Qualitative data was managed by transcribing each audio taped FGD into word document. Verbatim transcripts were produced and coded using the Non-Numerical Unstructured Data Indexing, Searching and Theorizing (NVIVO) software (QSR, 2001). After all the transcripts were coded, the codes were examined in detail for sub-themes and patterns across the FGDs to categorize frequently expressed ideas and to highlight factors affecting adherence. 11

22 3.8 Definition of Terms Adherence In this study, adherence was defined as not missing any doses from the previous visit to the current visit (which is usually two months), according to self reports by children and/or guardians. In this view, any person who has not missed the drug since the previous visit is deemed to have adhered 100% as assessed by self report. Non-adherence is therefore defined in this study as missing any dose from the previous visit to the current visit. Any person who has missed any dose will be regarded as having adhered less than 100% while any person missing more than 3 doses in a month will be regarded as having adhered less than 95% Perceived Health Status One of the things on the factors determining adherence that the study looked at is Perceived Health Status. This is defined as an overall perception of child s own health with children reporting to be fully active and normal having a 100% score, while those who reported having minor restrictions in strenuous activity having a score of 90% and 80% score to children reporting being active but tiring more quickly. 3.9 Ethical consideration The research was reviewed and approved by College of Medicine (COMREC). Permission to conduct the study was also sought through the Hospital Director from QECH. Caregivers and their children received information about the study and later an oral consent form was signed by the interviewer indicating that guardians have understood the nature of the study. Oral consent was opted for to accommodate guardians who were not adequately literate to comprehend written consent. To ensure confidentiality of all study participants, no direct identifiers were used in the data collection, storage or report writing. All electronic documents were password protected and all paper documents and tapes were stored in a locked cabinet. We identified three main potential risks associated with this study. First, guardians might have felt uncomfortable discussing the HIV status of their children. Second, there was also a 12

23 potential for distress among some children answering HIV related questions. Third, there could be accidental disclosure of HIV status to the child. However, these were dealt with by training the interviewer on the study protocol. Furthermore, participants responses were made completely anonymous, their identity remained confidential and responses were not linked to their names and address in any way. 13

24 CHAPTER 4: RESULTS 4.1 Characteristics of Participants Table 1 describes the socio-demographic characteristics of the study participants. A total of 98 children were interviewed in the study with almost an equal proportion of both sexes. Almost all the respondents were in school, with the majority in junior primary school. Nearly 90% were on first line treatment. A majority had a score of 100 on perceived health status. About two thirds were under the care of their biological parents with over half of the guardians having an occupation of some kind.. Table1. Characteristics of the Participants Characteristics Frequency Percent (%)* Sex Male Female Weight Mean Weight (SD) 28.2kg (7.5), Age Median age (range) 10.9 (7-15) Education Junior primary Senior primary Junior secondary None Religion Christianity Moslem Other None Perceived Health Status Score 100(Fully active, normal)

25 90(Minor restrictions in strenuous activity) (Active but tires more quickly) Treatment Type First line regimen (Triomune) First line alternative Second line regimen Type of Guardian Biological Mother / Father or Both Granny Brother Sister Auntie Uncle Other Occupation of Guardian Paid Employment Small Scale Business No occupation * For continuous variables, a measure of central tendency and spread was provided instead of percentage. 4.2 Knowledge of Treatment Type and Reason for Treatment All the children (100%) admitted they were taking medication. A majority (92.7%, [90/98]) generally knew the dosage and frequency of the medication. When asked whether they knew the name of the medication they receive, 36.7% (36/98) admitted to knowing the medication while the rest said they did not know the medication. The children who admitted knowing the medication were further asked to mention the name of medication. Impressively, most of the children were able to mention the drug by its name with 69.4%, (25/36) mentioning they receive ARVs. The mean age of children who mentioned the name of the medication was 12.3 SD (2.1) and were mostly from senior primary school. Table 2 gives further details of the names of the medication as reported by children who admitted to knowing their medication 15

26 Table 2: Treatment type and/or Name as mentioned by children Name of medication Frequency Percent ART ARV Alluvia, Abacavir, Didanosine Alluvia, Tenofavir, Duovir Alluvia, Videx, Abicavir Alternative first line Efanvirez Medication for HIV Mphamvu TB Drugs When asked reasons for taking the medication, only 20/36(55.5%) of the children who knew the name of their medication explained that they were taking the drugs because they have HIV/AIDS implying that they knew the reason for taking the medication. Fourteen 14/36 (38.8%) children only knew the name of medication but did not know the reason for taking it, while 2(5.5%) children admitted to know the medication but, surprisingly, they neither knew the medication nor the reasons for the medication. The study also established knowledge of purpose of using antiretroviral from guardians attending focus group discussions (FGD). The most common theme reported was that ARVs are drugs that restore immunity, for example one client reported, ARVs are drugs that are taken to boost immunity if a person who has HIV/AIDS has low immunity. Another common theme that emerged was that ARVs are drugs that prolong life. On this theme one client reported, ARVs are given to people with HIV to prolong their lives... The other themes mentioned were; ARVs are drugs that do not kill the virus and also drugs taken by people with HIV/AIDS. 16

27 4.3 Medication Adherence Based on self reports, 62.3% (61/98) were 100% adherent since the last visit. Of the patients who were not 100% adherent, only 8.6% (2/37) had adherence levels of < 95%. Using a pill count, the findings showed that only 33% (29/88) of the children who were on triomune were 100% adherent. Children admitting missing doses were further asked reasons for missing doses. Qualitative analysis from the children showed that the most common reported reason was forgetfulness. Table 3 below presents other reasons for missing medication as reported by the children. Table 3 Reasons for Missed Doses as Reported by Children Frequency (%) Forgetfulness 21(58.3%) Came late from play 4 (11.1%) Guardian not in the home to give medication 4 (11.1%) Guardian was busy 3 (8.3%) Slept early 2 (5.5%) Rushing to school 2 (5.5%) In order to determine adherence problems, guardians were asked during FGD what their experiences were like when trying to get their children take medication. The most common theme that emerged from the participants was the need for a reminder to take drugs, for example one participant reported, I have to remind my child to take the medication, apart from that I don t have problems. While other children need to be reminded, others remind their guardians to give them medication as stated by one participant, my child reminds me to give her medication. The other common theme reported as adherence problem was forgetfulness. One participant reported, If I am not in good mood I forget to give my child medication The other adherence problems that were rarely reported were; refusing to take drugs, getting sick because of medication, throwing medication away and stigma in the home 17

28 4. 4 Factors Associated with ART adherence Univariate Analysis Showing Factors Associated with ART adherence Table 9 below provides details of factors that were examined for association with adherence among children. Out of 98 children that were interviewed, 61 (62.2%) children reported adherence. In univariate analysis, the only factor that was associated with adherence was perceived health status. Children who perceived their health status as good were 1.8 times more likely to adhere to their medication than those children who perceived their health status as not good. The factors that were marginally associated with adherence were guardian having an occupation P= 0.07) and knowledge of reason for medication 0.08) Table 1: Factors associated with ART Adherence among children from Univariate Analysis Characteristic Adherence level Odds ratio (95% CI) P-value Child age /42(66.6%) Reference /43(58.1%) 1.4(0.6, 3.3) 14+ 8/13(61.5%) 1.3(0.3, 4.5) 0.59 Child Education Junior primary 30/54(55.5%) Reference Senior primary 28/39(71.7%) 0.5(0.8, 3.7) Junior secondary 3/4 (75.0%) 1.2(0.2, 7.8) 0.18 Religion Christian 55/87(63.2%) Reference Non Christians 5/8(62.5%) 1.1(0.2, 4.6) 0.95 Guardian Type Biological mother/father 36/61(59.0%) Reference Granny 11/14(78.5%) 0.4(0.1, 2.4) Other 14/23(60.8%) 0.9(0.2, 3.8) 0.71 Guardian occupation Yes 31/56(55.4%) Reference 18

29 No 30/42(71.4%) 2.2(0.9, 5.2) 0.07** Perceived Health status Not good 13/27(48.1%) Reference Good 47/67(70.1%) 1.9(0.9, 3.5) 0.05 Knowledge of medication name Yes 24/36(66.6%) Reference No 37/62(59.6%) 0.8(0.4, 1.8) 0.56 Knowledge of medication reason Yes 16/20(80.0%) Reference No 45/78(57.6%) 0.4(0.1, 1.2) 0.08** Understanding medication instruction Yes 53/83(63.8%) Reference No 8/14(57.1%) 0.8(0.2, 2.4) 0.63 Communication problems Yes 2/4(50.0%) Reference No 59/93(63.4%) 1.7(0.2, 12.9) 0.59 ** Marginal Significance Perceived Health Status =Overall perception of child s own health With regard to education level, though not significant using univariate analysis, there appeared to be a positive trend between increasing level of education and adherence. Figure 1 below shows the association between education level and adherence. 19

30 Figure 1: Association between Education level and Adherence The figure above shows that as education level was increasing, the proportion of children adhering was also increasing Multivariate Analysis of Factors associated with adherence Basing on univariate analysis in table 4 above, the following variables, with a p-value of <0.20, were considered for multivariable logistic regression models using backward elimination: child education, perceived health status, guardian on occupation and knowledge of medication reason. Table 5, shows that perceived health status was strongly associated with adherence. Thus, after adjusting for guardian on occupation, children who perceived their health status as good were 2 times more likely to adhere to their medication than children who perceive their health status as not good. Table 5: Factors associated with ART Adherence from Multivariate Analysis Characteristic Odds Ratio (95% CI) P Value Guardian on Occupation Guardian with an Occupation Reference Guardian without an Occupation 2.3 (0.9, 5.8) 0.07 Perceived health Status Perceived as not good Reference Perceived as good 2.1 (1.1, 4.1)

31 4.5 Belief in Efficacy of Medication When children were asked if the medication is helpful, the majority 96.9% (95/98) reported that the medication was helpful. These children were further asked to report the reason why they think the medication was helpful.. The reasons given were; not getting sick often 34.1 (29/85), followed by got healed from the illness I had 25.8% (22/85), medication has improved my health 16.4% (14/85), and medication make me strong 9.4% (8/85). However, 13.6% (13/95) did not give the reason why they think the medication was helpful. Table 6 below shows further reasons why children thought the medication was helpful. Table 6: Reason Why Children Think Medication is Helpful Reason Frequency (%) I don t get sick often 29(34.1) Got healed from the illness I had 22(25.8) My health has improved 14(16.4) It makes me strong 8(9.4) It heals me once I have taken it 7(8.2) It prolongs my life 4(4.7) It kills the virus 1(1.2) 4.6 Disclosure of Status With regard to disclosure of HIV status, participants were asked whether they disclosed the child s HIV status. A minority of guardians in the FGD disclosed to their children their HIV status while the rest did not disclose. The most common reason for disclosure was for child to understand reason for medication. Of the guardians who did not disclose, the most common reason for not disclosing was that the child was young and cannot understand reason for medication. Table 7 below shows further reasons for non disclosure as presented by guardians 21

32 Table 7: Reasons for Non-disclosure Reason Frequency (%) Reason for not disclosing Child young/ cannot understand 9(45) Fear of child frustration 5(25) Child may reveal to others 4(20) She is not my biological child 2(10) Guardians were also asked if they had ever experienced accidental disclosure of their children s HIV status; thus disclosure without consent and unintentional as clinician review the child. Only 4 out of 20 of the guardians who did not disclose reported to having experienced an accidental disclosure by the HCW when they have come with the child for treatment. Of these, three understood and accepted the situation together with their children, while one of the guardians was concerned because her child was not happy when she got the news. 4.7 Adherence Strategies Children were asked to explain what they do to ensure that they are taking the drugs according to health providers prescription. Qualitative analysis revealed that a reminder was the most common strategy that is used to take medication.. Further strategies are provided in table 8 below as narrated by children. 22

33 Table 8: Strategies done to ensure ART adherence. Adherence strategy Frequency (%) Guardian reminds me 21(21.4) Remind self 14(14.2) I remind guardian 10(10.2) We remind each other 2(2.0) Look at the time 6(6.1) Follow instruction from HCW 5(5.1) Medication follow breakfast 3(3.1) Medication left near 3(3.1) Medication before everything 2(2.0) Comes home early from play 2(2.0) Take medication together with guardian 1(1.0) Put alarm 1(1.0) Similarly, when participants in the FDG were asked a similar question, a majority of the participants reported that a reminder to the child to take medication as the common strategy to ensure adherence. Other strategies that were rarely reported included; medication first thing in the morning, guardian and child taking medication together, seeking adherence counseling at the hospital when child is refusing drugs, an incentive given to the child and forcing the child to take medication 4.8 Medication Support When children were asked who helped them most in taking medication the past month. The majority of children reported to have been helped by their mothers (45.9%) followed by sister (11.2%), granny (11.2%), auntie (10.2%), father (9.1), self (4.1%), brother (3.1%), uncle (2.0%), foster mother (2.0%) and boarding master (1.0%) 23

34 The study further established the kind of support children receive in the home from these persons. The responses given by children were almost similar to the strategies they use. Table below gives details of type of support children receive from their guardians. Table 9: Kind of Support children receive from Guardians Kind of Support Frequency Guardian reminds me 40 Guardian provides medication 29 Guardian observes me taking medication 4 Guardian counsels and/or advise me 10 She keeps medication for me 4 She calls me to take drugs 3 She breaks medication for me 4 I support myself 4 When guardians were asked during FGD what other kinds of support they give to the children to ensure an effective ART, four major themes emerged from their reports with the most common one being nutritional support and, showing love to the child. Other type of support reported include; providing time for rest and visiting hospital with the child when sick. 4.9 Medication Instruction Understanding of the medication instructions was assessed by asking children to recall the instruction they received from the health care worker (HCW) in the clinic. Of the 97 children who responded, 85.5% (83/97) admitted to understanding the instructions they receive from the HCW. The most common instruction children recalled was not to miss drugs 40.1% (34/83), followed by specifications of their dosage and frequency 27.7% (23/83). Table 10 below presents other medication instructions as recalled by the children. 24

35 Table 10: Medication Instructions as Reported by Children Frequency Not to miss drugs 34 To take the specified dosage and frequency) 23 Missing drugs causes resistant 13 To report of side effects 6 Not to miss follow-up visits 4 To keep drugs safe 4 To eat balanced meals 3 Medication builds immunity 2 To visit the clinic when sick 5 When the same question was asked to guardians, a majority admitted to understanding the medication instructions. Similar responses were reported as follows; to take the specified dosage and frequency, not to miss drugs missing leads to resistance, to report side effects, to give child nutritious food, to visit hospital if child gets sick and that medication is for life. 5.0 Communication Problems When asked if there are any communication problems with their HCW, a minority of the children, 4.1%(4/98) mentioned they have communication problems as follows; the nurses shout at us 1.0% (1/98), the toys given for play disturbs me from listening to instructions 1.0% (1/98) and that the clinic is always full and we go home late 2.0% (2/98). When the similar question was asked to guardians from the FDG, a majority indicated that there were communication problems, with the most common one being shouted at, while a few reported that the clinic is congested. 25

36 CHAPTER 5: DISCUSSION In this study using self reports we found that two thirds 62.3% (61/98) were 100% adherent of their ART since their last visit. Of great concern was that 2(8.6%) of the 37 children who did not adhere were less than 95% adherent and prone to ART resistance. However, the level of non-adherence found in this study is relatively low compared to findings from other studies in children [37] [[38], but it must be noted that the tendency to overestimate adherence using the self-reporting method is well established [17] [15] [25]. As outlined in the background, selfreporting is however, most useful for those patients who admit to poor adherence because such patients truly are not adherent. While the higher levels of adherence to ART were encouraging using self report, a pill count in this study revealed lower levels of adherence. Similar discrepancies were observed in a study in Kampala where lower levels of adherence (72%) were also revealed using pill counts compared with levels (89%) from self report [39]. A pill count method was employed in this study to validate self report. However, it is worth noting that pill count was not possible for 11% (11/98) of the children who were on alternative first line and second line regimen due to the complexity of their regimen and missing records on number of pills dispensed on the last visit. Another weakness of pill count is the inaccuracies in dispensing pills by nurses during the visit for medication refill. This could be one possible factor contributing to the lower levels of adherence using pill count in this study. Coupled to this is a well known drawback of pill count method of pill damage and pill dumping as revealed from literature, in which patients dispose some pills to make their adherence appear better than it may actually be [40][16][25]. However, this study did not include anything on pill dumping hence it is difficult to report the impact this had on the study. More objective measures of adherence such as blood levels of HAART were not possible in this study due to high costs and unavailability of technology to perform such tests in public hospitals, in this case QECH. The most reported reason for missed doses among children who missed their doses found in this study was forgetfulness. This finding is consistent with several studies that have 26

37 documented that forgetfulness is among the most frequently cited reason for missed doses [30] [41] [25] [42]. In this study the multiple reasons for missing doses provide a vivid illustration of the complexity of adherence in the clinic. This has implications not only for our understanding of the etiology of non-adherence, but also for interventions aimed at optimizing adherence. Therefore, health care workers in the clinic should not target at a single cause of non-adherence because they may fail other multiple causes as reported by children. In an adult study by Golin et al an association was found between education level and adherence- where lower educational level was independently associated with having lower adherence [43]. This study similarly showed a relationship between increasing adherence with increasing education level, although not statistically significant this finding suggest that higher education level increases understanding of need for treatment therefore this can be used by the clinic staff as a recipe for adherence education. In this study, perceived health status showed an association with adherence, with children who perceived their health status as good to be more adhering than those who perceived their health status to be not good. This finding is consistent with other studies that documented that patients who did not present with any symptoms or pain were more adhering than those with symptoms [28.] Furthermore, guardian of the child having an occupation showed a marginal association with parents who had an occupation having lower adherence levels compared with those whose parents did not have an occupation ( P=0.07). These results suggest that parents who have an occupation may not have adequate time to look after their children taking medication. While other research found that knowledge of reason for taking ART enables children to understand HIV infection and consequently the importance of ART adherence [32], this study showed similar finding although the association was of marginal significance. This finding suggests the need to inform children the reason for taking ART. Although over one third of the children admitted to know the medication they receive, not all of them correctly mentioned the name or regimen. This implies that children may admit knowing their medication when actually they do not know the medication they receive. When further asked to give reasons for the medication, not all children who mentioned the medication, were able to give a valid reason for taking the medication. About half reported a 27