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  1. Factors that facilitate and constrain adherence to ARV drugs among adults at four public health facilities in Botswana – A pre-intervention study FEEDBACK H Madaki

  2. RESEARCHERS • Kgatlwane, J.1, Ogenyi, R. B.2, Cosmas, E.3, Madaki, H. N.4, Moyo, S.5, Modie, T.M.6 • 1Botswana Essential Drugs Action Program, Gaborone Republic of Botswana; 2Mahalapye District Hospital Mahalapye, Republic of Botswana; 3Sekgoma Memorial Hospital, Republic of Botswana; 4Scottish Livingstone Hospital, Molepolole Republic of Botswana; 5Botswana-Harvard School of Public Health AIDS Initiative PartnershipRepublic of Botswana; 6Social Work Department University of Botswana Republic of Botswana

  3. DATA COLLECTORS • Dikeleko Nchadi - Serowe • Austin Motsamai – Molepolole • Moremi Dodo- Maun • Late Samuel Khubile - Mahalapye

  4. AIM OF THE FEEDBACK • To inform the study site about the research findings • To clarify issues raised during the research • To create opportunity for discussions on the research findings and gather suggestions on possible interventions

  5. BRIEF INTRODUCTION • This study is an outcome of a WHO organized workshop on Promoting Rational Drug Use in the Community (PRDUC), conducted in Pretoria, South Africa, in September 2004 • Participating Countries during the PRDUC workshop were asked to submit research proposals on any health issue in their setting • Among countries that submitted proposals, Botswana, Tanzania and Uganda were eventually selected • This study is therefore a three-country research on ARV adherence that included Botswana, Tanzania and Uganda. • In Botswana, the study sites selected were Maun, Serowe, Mahalapye and Molepolole • These sites were purposely selected to include two sites from the first phase of the ARV treatment program roll-out and the other two from the second phase of program roll-out.

  6. TECHNICAL AND FINANCIAL SUPPORT • Through out the duration of this study technical support was provided by the WHO and Department of Medical Anthropology, University of Amsterdam • Financial assistance was also provided by WHO, with some logistic support from the Ministry of Health, Botswana • The proposals were appraised using a collaborative peer review process, following which research tools were designed at a workshop involving all three countries in Bagamoyo, Tanzania, in February 2005. • Field work took place in May and June 2005, and an analysis workshop for the Botswana team was held in Gaborone in July, 2005. • Peer review of the three country reports took place in a workshop held at Jinja, Uganda in October, 2005

  7. RATIONALE FOR THE RESEARCH • In 2002, Botswana became the first country in Sub Saharan Africa to launch a free national antiretroviral therapy (ART) program in the public health sector. • While ART has improved the lives of many worldwide, lack of adherence to HAART is still a major challenge to AIDS care and has serious public health consequences. • Failure to adhere to HAART often leads to treatment failure, development of viral mutations and may lead to the emergence of drug resistant strains. • In the presence of sub optimal therapy HIV selects for resistance rapidly (Papella et al., 1998), in part due to rapid and error prone replication (Perelson et al., 1996) but often aided by the low genetic barrier of several antiretroviral agents to resistance (Kuritzes et al., 1996). • Adherence concerns have been one of the reasons expressed by opponents of using antiviral in developing countries or resource poor settings (Stevens et al., 2004; Gill et al., 2005).

  8. RATIONALE FOR THE RESEARCH Cont’ • Harries et al., (2001) argued that adherence problems would constitute a perceived significant barrier to the delivery of ARV therapy in Sub-Saharan Africa. • Levels of adherence below 95 percent have been associated with poor virological and immunological response (Paterson et al., 2000; Orrell et al., 2003). • Studies conducted in Botswana have reported adherence levels of 83% (Nwokike, 2004) in public sector and 54% (Weiser et al., 2003) in private sector. This portends a problem for public health because adherence levels ≥95% are required for treatment success and to prevent the emergence of resistant strains. • As Botswana scales up access to HAART in all health facilities, it is critical to estimate and monitor the rates of adherence. • It is also important to understand factors that influence adherence in order to design appropriate interventions.

  9. RESEARCH OBJECTIVES • To quantify ARV treatment adherence rates • To determine what motivates and sustain good adherence • To determine barriers to good adherence  • To determine factors at the community, the health institution and national levels that influence adherence. • To identify and recommend possible intervention(s) to improve adherence from lessons learnt.

  10. DEFINITIONS • Adherence is defined as the “extent to which a client’s behaviour coincides with the prescribed health care regimen as agreed through a shared decision making process between the client and the health care provider” (KITSO Manual., 2000; Carter, 2004). • For the purpose of this study, adherence is defined as the use of antiretroviral at the right dose, at the right frequency of dosing and at agreed times. Ability to keep to this pattern of utilization is defined as 100% adherence, while adherence including ≥ 95% is accepted as optimal adherence. A level of adherence below 95% is considered sub-optimal. • A composite adherence measure is the mean of the optimal adherence rates of all the methods used to measure adherence.

  11. CONCEPTUAL FRAMEWORK • A number of factors have been associated with adherence to HAART and are commonly divided into five intersecting categories (Reiter et al., 2003) namely: patient variables, treatment regiments, disease characteristics, patient provider relationship and clinical setting. • In this study a four dimensional conceptual framework of factors affecting adherence is considered. The factors were divided into individual, health facility, community and national levels

  12. CONCEPTUAL FRAMEWORK Cont’ a. Individual level • Forgetfulness • Educational level • Travels/Migration • Stigma • Access to treatment site • Religious/health belief • Side effect • Patient expectation • Financial constraints • Poverty and Hunger • Lack of privacy • Discrimination

  13. CONCEPTUAL FRAMEWORK Cont’ b. Health Facility level • Human resource • Training • Knowledge and Skills • STG/SOP • Drug availability • Monitoring and evaluation

  14. CONCEPTUAL FRAMEWORK Cont’ c. Community level • Belief and culture • Community participation • Discrimination d. National Level • Political commitment • Policy Framework • Regulatory issues • Monitoring and evaluation

  15. STUDY POPULATION • The population consisted of the policy makers, patients on HAART (above 18 years) who receive their treatment at the study sites, health workers and the community members at the selected sites.

  16. DATA COLLECTION METHODS • The study used cross sectional survey method, with both quantitative and qualitative research methods of enquiry. • Adherence rates were measured using patient self report methods (two-day recall, one month visual analogue using a 10cm line) and the one month pharmacy pill count. • Information on how certain factors influenced adherence was collected using in-depth interviews, semi structured interviews and focused group discussion with ARV users, policy makers, health care providers and the community.

  17. RESULTS: QUANTITATIVE DATA • A total number of 514 patients were interviewed using a structured questionnaire. • The mean adherence rates were: two day re-call 98% (N=508), one month self recall (10cm line visual analogue) 92% (N=496) and one month pharmacy pill count 93% (N=443). • We had defined optimal adherence rate as a proportion of those who take their medication ≥95% of the time.

  18. RESULTS: QUANTITATIVE DATA Cont’ • This study found optimal adherence rates to be 60% with pill count and 75% with one month self-report using a 10cm line visual analogue. • This shows that 4 out of every 10 people are not adhering optimally to their medication, when the pill count method is considered. • The two-day recall found optimal adherence rate of 96%. • The composite optimal adherence measure was estimated at 77%.


  20. SUMMARY OF ADHERENCE RATES Cont’ • *Serowe composite mean optimal adherence rate calculated without pill counts data because of data quality (pill count records) problems found at the site during data collection. • All three of these measures have both strengths and weaknesses. The pill count is in some ways the most ‘objective’, since it measures the number of pills left over from the previous refill, and can act as a very good proxy (surrogate) indicator for actual pill intake

  21. QUANTITATIVE DATA: REASONS FOR SKIPPING MEDICATION • The most common reasons mentioned for missing medication were: forgetfulness (18%), logistics (13%), work and home duties (12%), stigma (7%), lack of support (4%), food (2%) and alcohol use (2%). • This shows that 2 out of every 10 patients miss taking their medication because of forgetfulness.

  22. QUANTITATIVE DATA: SIDE EFFECTS • Fifty-eighty percent (58%) of the participants reported having experienced side effects, 8% of them had skipped the medication because of side effects. • With regard to side effects, this might be an indication that counselling is working very well as supported by fact that 99% of the respondents reported receiving counselling before HAART initiation. • It is however important to note that the 8% of the people who cited side effect as a reason for missed doses is significant.

  23. QUANTITATIVE DATA: WAITING TIME • The major issue that came strongly from the participants was the amount of time they spend waiting for service. • About 60% of the respondents reported spending 4 hours and above at the clinic with some cases where participants spent the whole day after coming 2 hours earlier than opening time

  24. Satisfaction level for the total amount of time spent at the clinic (N=133)

  25. QUANTITATIVE DATA: OTHER ISSUES • In terms of costs, 44% reported an increase in their expenditure and 37% reported loss of income due to clinic visits. • Respondents were generally satisfied with the quality of care they received. • Generally the participants felt: being listened to (99%), being given a chance to state their problems and ask questions (99%), being treated with respect (98%), having a sense of trust for the health workers (94%) and having privacy during consultation hours (89%).

  26. PREDICTORS OF ADHERENCE • Multivariate logistic regression analysis was performed on the measures of adherence using selected explanatory variables age, gender, occurrence of side effects, education, occupation, cost of transport, other costs, income given up, months on treatment, missed appointments and knowledge of HIV and ART. The variable missed appointments had a significant ability to predict adherence (Wald statistic 2 = 4.851; p=0.028) and was associated with level of adherence to ARV treatment (2=5.86; P=0.016). • This highlights the need to discuss adherence issues with patients who miss appointments

  27. RESULTS: QUALITATIVE DATA Factors that constrain adherence to ARVs • Non acceptance of positive HIV status • Non-disclosure • Perceived lack of social support, fears about stigma and privacy concerns • Logistics and cost consideration • Mis-understood information • Alcohol/substance abuse

  28. RESULTS: QUALITATIVE DATA Cont’ Facilitators of Adherence to HAART • Acceptance of one’s status and disclosure • Self-efficacy and the ability to take and adhere to ART • Belief in the efficacy of pills in treatment/pre-treatment health state • The need to care for others • Social support

  29. SEROWE SITE SPECIFIC ISSUES • ADHERENCE RATES FOR SEROWE- At optimal level (≥95%) by one month self report through a 10cm visual line = 55%, two day recall = 98%. No data to compute adherence rates due to the pill count, but composite rate = 75.5% • PILL COUNTS – During data collection, pill count records were not easily accessible. This could be problematic since this is a tool required to monitor patience adherence on every pharmacy refill visit. • WAITING TIME – HAART patients receiving treatment from the local clinics complain of long waiting hours before being attended to by doctors. This was seen more as ‘inconveniences’ and not necessarily linked to non-adherence.

  30. SEROWE SITE SPECIFIC ISSUES Cont’ • WOMEN ARV USERS • Encourage support groups for PLWA • People who are adherence counselors should be well versed with counselling. They should be taken for refresher courses • Alcohol abuse-related counselling (treatment?) • There should be assertive community treatment ( following patients to their homes where necessary, there should be a system of tracing patients who do not turn up for appointments)

  31. SEROWE SITE SPECIFIC ISSUES Cont’ MEN ARV USERS • Legislation to deal with private companies that discriminate against ARV users (especially Chinese construction companies and shop-owners, Murray and Roberts, etc). Ba gatelwe dikgato tse di gagametseng • They should be advocacy on the job. Most of our supervisors are afraid to lose their jobs as well • Men should be targeted for alcohol abuse treatment • Reduce waiting time in the IDCC • Employees should work on Saturdays and Sunday to reduce overcrowding and to cater for ARV users who are not allowed to come during the week • Provision of transportation for hard-to-reach populations

  32. SEROWE SITE SPECIFIC ISSUES Cont’ • COMMUNITY WOMEN • Provision of transportation for hard-to-reach populations • Tracking and monitoring system for defaulting ARV users • Proper and speedy referral system/transfer system • A system should be designed to closely monitor alcohol abusing ARV users • The food basket should be re-visited and clear guidelines/criterion for inclusion should be made • Hiring/recruitment of FWEs for Sekgoma IDCC • Transportation for CHBC volunteers • Payment of volunteers should be increased • Adherence counselling should be ongoing, and not a one-time event • More training is needed for lay counselors

  33. SEROWE SITE SPECIFIC ISSUES Cont’ • COMMUNITY MEN • Men-centered counselling programs • Target male for peer counseling • Targeting bars, and churches and provide information on Substance abuse/ARV interaction


  35. RECOMMENDATIONS • Practical guidelines for implementing adherence management strategies- issue of continuous adherence counselling; bringing treatment closer to the people; family care model approach to HAART, etc. Practical reminders, Adherence case management, Medication organiser. • Consideration of transport vouchers to people who genuinely cannot afford the cost of transport to collect their medications. • Adherence should be monitored uniformly across all facilities in Botswana with simple practical tools like pill count register and patient recall. Data generated should be reviewed periodically in order to know the rate and trend of adherence to HAART.

  36. RECOMMENDATIONS Cont’ • Development of practical guide lines for ARV adherence management. • Community mobilization aimed at mitigating stigma and discrimination should be sustained as this will help create an environment in which people can disclose and take medicines without fear. • Rights of people in employment to access treatment without fear of discrimination must be protected by enforcement of appropriate legislations. Workplace sensitization should be done; toll free lines should be created for people to complain in case of violation.

  37. RECOMMENDATIONS Cont’ • Program targeting men on HIV/AIDS issues should be emphasised. This will help increase the enrolment of men, help them understand the gender issues around HIV/AIDS and finally mobilize them to protectors and supporters of women in fight against HIV/AIDS treatment and prevention. • In order to deal with the issue of forgetfulness radio stations, TV stations and mobile operators could send periodic signals with jingles reminding people to take their medications. • Continuous operational research on adherence since adherence is dynamic.

  38. CONCLUSION • The adherence rates found in this study are comparable to other studies. • This rate is low for good virologic, immunologic, and clinical outcomes. Adherence is complex and multi-dimensional approach is required to tackle the barriers and strengthen the facilitators. • Critical barriers that emerged from this study include forgetfulness, lack of transport fare to health facility, non-acceptance of status, fear of discrimination and stigma, alcohol abuse, and non supportive home and work environments.

  39. CONCLUSION Cont’ Though side effects occur in a significant proportion of users, it was not perceived as a barrier to adherence. Facilitators found include self efficacy, social support, perceived benefits of the medication, and desire to say alive for the sake of others. Improving adherence requires a collaborative approach with the patient the community and health workers as well as dealing with and improving the environmental and structural constraints.


  41. Reference: • Gill CJ, Davidson HH, Jonathon LS et al. No Complacency about adherence to antiretroviral therapy in sub-saharan Africa. AIDS 2005; 19:1243-1249 • Harries AD, Nyangulu DS, Hargreaves NJ et al. Preventing antiretroviral anarchy in sub-Saharan Africa. Lancet 2001; 358:410–414. • Kitso. Harvard institute HIV/AIDS KITSO training manual for health workers in Botswana, 2004 • Nwokike J. Baseline data and predictors of adherence in patients on antiretroviral therapy in Maun General Hospital, Botswana. ICIUM. Bangkok, Abstract HI012, 2004. • Palella FJ Jr, Delaney KM, Moorman AC et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med 1998;338:853–860. • Perelson A.S, Neumann A.U, Markowitz M. HIV-1 Dynamics in viro; viron clearance rate, infected cell life span, and viral generation time. Science 1996:271 (5255): 1582-6. • Reiter GS SE, Wojtusik L, Hewitt R, Segal-Maurer S, Johnson M, Fisher A, Zackin R, Masters H, Bangsberg DR.2000. Elements of success in HIV clinical care. Topics in HIV Medicine 8:67. • Stevens W, Kaye S and Corrah T. Education and debate: Antiretroviral therapy in Africa. British Medical Journal 2004;328:280-2 • Weiser S, Wolfe W, Bangsberg D et al. Barriers to Antiretroviral Adherence for Patients Living with HIV Infection and AIDS in Botswana. J Acquir Immune Defic Syndr 2003;34:281–288.