Evaluating support interventions for adolescents living with HIV (ALHIV) in Malawi
Lead Research Organisation:
Dignitas International
Department Name: Operations Research
Abstract
An estimated 2.1 million adolescents are living with HIV and despite remarkable progress in life-saving antiretroviral therapy (ART) scale up they remain a key underserved population in the global response. Adolescent deaths from HIV have tripled since 2000, and HIV is the leading cause of death in southern Africa in youth and the second most common cause of death in this age group globally.
This study aims to evaluate the best and most cost-effective way to support HIV positive adolescents in Malawi, where there are over 500,000 people living with HIV on life-saving ART. Young adults between the ages of 15-24 face particular challenges with remaining on treatment and keeping their virus suppressed, because it can be a particularly tumultuous period as teens are coming to terms with their diagnosis and its implications, even as they are going through rapid changes physically, psychologically and socially.
Our group has worked with the Malawi government to scale-up HIV services in over 170 health facilities over the last decade. In addition to supporting over 150,000 HIV patients, we have also had success implementing the Teen Club, a health facility based adolescent ART clinic, in over 40 facilities.
There are very few rigorous studies on the effectiveness of psychosocial support interventions for adolescents living with HIV in high prevalence, low resource settings where the need is greatest.
In this study, we plan to randomize clinics providing ART services to adolescents to one of three arms: 1) standard of care as per the Malawi Ministry of Health (the control arm); 2) Teen Club clinics and 3) Teen Club PLUS a novel individualized peer support program for teens with HIV called Teen Health Advocates. We plan to compare how well adolescents in each arm stay on treatment and in care, keep taking their medications, and suppress their HIV virus. We will also look at social outcomes of these interventions including how they may facilitate the formation of peer networks and social ties, as well as development of an individual's personal responsibility for their health. Finally, because the findings of this study will be important in informing policy makers around the best package of interventions in high HIV prevalence, low-resource settings, a cost-effective analysis will also be conducted to ensure we take into account feasibility of scaling up our results.
Our team is international and multi-disciplinary. In addition to providing clinical care and programmatic support, we have developed a strong research platform, including experience in conducting pragmatic and context specific trials in this setting. The team assembled includes clinicians, epidemiologists, program implementers, social scientists, knowledge translation specialists and knowledge users. We are uniquely positioned, having worked in Malawi for more than a decade, to conduct HIV implementation research and translate the findings rapidly into change within Malawi, regionally and to stakeholders with interest in HIV programs in low resource settings. The findings of this study will inform the Malawi Ministry of Health of how best to support chronic HIV care for adolescents living with HIV as they transition into positive adulthood.
This study aims to evaluate the best and most cost-effective way to support HIV positive adolescents in Malawi, where there are over 500,000 people living with HIV on life-saving ART. Young adults between the ages of 15-24 face particular challenges with remaining on treatment and keeping their virus suppressed, because it can be a particularly tumultuous period as teens are coming to terms with their diagnosis and its implications, even as they are going through rapid changes physically, psychologically and socially.
Our group has worked with the Malawi government to scale-up HIV services in over 170 health facilities over the last decade. In addition to supporting over 150,000 HIV patients, we have also had success implementing the Teen Club, a health facility based adolescent ART clinic, in over 40 facilities.
There are very few rigorous studies on the effectiveness of psychosocial support interventions for adolescents living with HIV in high prevalence, low resource settings where the need is greatest.
In this study, we plan to randomize clinics providing ART services to adolescents to one of three arms: 1) standard of care as per the Malawi Ministry of Health (the control arm); 2) Teen Club clinics and 3) Teen Club PLUS a novel individualized peer support program for teens with HIV called Teen Health Advocates. We plan to compare how well adolescents in each arm stay on treatment and in care, keep taking their medications, and suppress their HIV virus. We will also look at social outcomes of these interventions including how they may facilitate the formation of peer networks and social ties, as well as development of an individual's personal responsibility for their health. Finally, because the findings of this study will be important in informing policy makers around the best package of interventions in high HIV prevalence, low-resource settings, a cost-effective analysis will also be conducted to ensure we take into account feasibility of scaling up our results.
Our team is international and multi-disciplinary. In addition to providing clinical care and programmatic support, we have developed a strong research platform, including experience in conducting pragmatic and context specific trials in this setting. The team assembled includes clinicians, epidemiologists, program implementers, social scientists, knowledge translation specialists and knowledge users. We are uniquely positioned, having worked in Malawi for more than a decade, to conduct HIV implementation research and translate the findings rapidly into change within Malawi, regionally and to stakeholders with interest in HIV programs in low resource settings. The findings of this study will inform the Malawi Ministry of Health of how best to support chronic HIV care for adolescents living with HIV as they transition into positive adulthood.
Technical Summary
Goal: This 3-year mixed methods study will evaluate psychosocial support models to strengthen retention in care and adherence to antiretroviral therapy (ART) for adolescents living with HIV (ALHIV). We hypothesize that an individualized peer support intervention (Teen Health Advocates - THAs) in addition to a group psychosocial support intervention (Teen Club) may further improve retention in care and viral suppression compared to Teen Club alone.
Objectives: The primary objective is to compare the effect of Teen Club and THAs on viral suppression in ALHIV on ART in Malawi, Africa. Secondary objectives are to: compare the effect of Teen Club and THAs on retention in care; evaluate social outcomes of the interventions including burden of care at facilities, levels of acceptability and impact on individual health seeking behaviours; evaluate health economics outcomes such as cost of care, quality of life and cost-effectiveness;
Methodology:
Design: Mixed-methods approach: 1) a cluster randomized trial (CRT) with randomization 1:1:1 at the health facility level to: Arm 1: Control - Standard of Care (HIV Care Clinic); Arm 2: Teen Club; Arm 3: Teen Club PLUS THAs. 2) Qualitative and 3) health economics sub-studies will evaluate social outcomes and cost-effectiveness. Outcomes: Primary: alive and retained on ART AND viral load suppressed at 24 months; Secondary: alive and retained on ART at 6, 12, and 24 months; social: explore biosocialities created by peer networks and how they may encourage retention on ART; health economics: cost-effectiveness.
Sample Size: 1656 patients (18 clusters with 92 patients per cluster); all ALHIV on ART, or initiating ART, who have completed the disclosure process at the study sites will be included.
Primary Analysis: Descriptive analysis of baseline characteristics and logistic generalized estimating equation model to estimate the impact of the intervention groups relative to control on the odds of viral suppression.
Objectives: The primary objective is to compare the effect of Teen Club and THAs on viral suppression in ALHIV on ART in Malawi, Africa. Secondary objectives are to: compare the effect of Teen Club and THAs on retention in care; evaluate social outcomes of the interventions including burden of care at facilities, levels of acceptability and impact on individual health seeking behaviours; evaluate health economics outcomes such as cost of care, quality of life and cost-effectiveness;
Methodology:
Design: Mixed-methods approach: 1) a cluster randomized trial (CRT) with randomization 1:1:1 at the health facility level to: Arm 1: Control - Standard of Care (HIV Care Clinic); Arm 2: Teen Club; Arm 3: Teen Club PLUS THAs. 2) Qualitative and 3) health economics sub-studies will evaluate social outcomes and cost-effectiveness. Outcomes: Primary: alive and retained on ART AND viral load suppressed at 24 months; Secondary: alive and retained on ART at 6, 12, and 24 months; social: explore biosocialities created by peer networks and how they may encourage retention on ART; health economics: cost-effectiveness.
Sample Size: 1656 patients (18 clusters with 92 patients per cluster); all ALHIV on ART, or initiating ART, who have completed the disclosure process at the study sites will be included.
Primary Analysis: Descriptive analysis of baseline characteristics and logistic generalized estimating equation model to estimate the impact of the intervention groups relative to control on the odds of viral suppression.
Planned Impact
Immediate beneficiaries of the interventions include: study participants, their families/guardians, and communities; frontline health care works of the Malawi MOH involved in the intervention sites; district health management teams whose study sites are involved in the study; the Southern region zonal health office in Malawi. A description of local impact on immediate beneficiaries of the interventions is outlined in the Pathways to Impact document: 5.2 Local Impact. We anticipate that study participants will experience an immediate impact on aspects of personal health as well as psychosocial well being. Pilot work on retrospective data as well as operational audits as part of programmatic evaluations have suggested a benefit to ALHIV receiving these programs as the interventions provide a safe and positive space for open disclosure of their HIV status through peer social interaction. Frontline health workers and district health and zonal managers involved in the intervention sites will develop capacities and skill sets in ALHIV management, as well as some familiarity with involvement in health services research.
Immediate beneficiaries of the research include: study co-Investigators and collaborators; research partners within Malawi with an interest in differentiated models of HIV care, including programmatic partners under the USAID-EQUIP subgrant (Partners in Hope Malawi and Baylor College of Medicine, Children's Centre of Excellence Malawi); other programmatic partners who run adolescent programs in Malawi targeting ALHIV including those on the national HIV Treatment and Care Technical Working Group; the Malawi MOH Department of HIV and AIDS. A description of impacts on immediate beneficiaries of the research is outlined in the Pathways to Impact document: 5.3 National Impact. We anticipate that the result of this study will inform other program implementers (both non-governmental and Malawi MOH) that we work closely with on best practices and lessons learned in ALHIV management. We also anticipate that the Malawi MOH will use the results of the study to make decisions around resource allocation (or not) for scale of interventions if successful.
Long term beneficiaries of the research output include: KTP Malawi Community of Practice on Support Services for ALHIV; regional partners with an interest in services for ALHIV including the International Center for AIDS Care and Treatment Programs, Baylor International Pediatric AIDS Initiative, Paediatric AIDS Treatment Africa; international organizations with an interest in providing services for ALHIV including Médecins Sans Frontières, Treat Asia, Y+ (the global network of young people living with HIV); programmatic funders with interest in ALHIV including USAID/PEPFAR, DfID; international organizations who have set research priorities for ALHIV including WHO, CIPHER/IAS; international researchers with an interest in ALHIV or service delivery models for HIV. A description of impacts in the long term of the research is outlined in the Pathways to Impact document: 5.4 Regional and International Impact. Our research directly addresses several priority research questions on service delivery to ALHIV identified in a recent global priority setting meeting conducted by WHO with CIPHER/IAS and so we anticipate that international stakeholders with an interest in ALHIV will have rapid uptake and synthesis of the study results.
Immediate beneficiaries of the research include: study co-Investigators and collaborators; research partners within Malawi with an interest in differentiated models of HIV care, including programmatic partners under the USAID-EQUIP subgrant (Partners in Hope Malawi and Baylor College of Medicine, Children's Centre of Excellence Malawi); other programmatic partners who run adolescent programs in Malawi targeting ALHIV including those on the national HIV Treatment and Care Technical Working Group; the Malawi MOH Department of HIV and AIDS. A description of impacts on immediate beneficiaries of the research is outlined in the Pathways to Impact document: 5.3 National Impact. We anticipate that the result of this study will inform other program implementers (both non-governmental and Malawi MOH) that we work closely with on best practices and lessons learned in ALHIV management. We also anticipate that the Malawi MOH will use the results of the study to make decisions around resource allocation (or not) for scale of interventions if successful.
Long term beneficiaries of the research output include: KTP Malawi Community of Practice on Support Services for ALHIV; regional partners with an interest in services for ALHIV including the International Center for AIDS Care and Treatment Programs, Baylor International Pediatric AIDS Initiative, Paediatric AIDS Treatment Africa; international organizations with an interest in providing services for ALHIV including Médecins Sans Frontières, Treat Asia, Y+ (the global network of young people living with HIV); programmatic funders with interest in ALHIV including USAID/PEPFAR, DfID; international organizations who have set research priorities for ALHIV including WHO, CIPHER/IAS; international researchers with an interest in ALHIV or service delivery models for HIV. A description of impacts in the long term of the research is outlined in the Pathways to Impact document: 5.4 Regional and International Impact. Our research directly addresses several priority research questions on service delivery to ALHIV identified in a recent global priority setting meeting conducted by WHO with CIPHER/IAS and so we anticipate that international stakeholders with an interest in ALHIV will have rapid uptake and synthesis of the study results.
