A Cluster Randomised Trial of Community-led Distribution of HIV Self-tests in Rural Malawi (HIV Self-Testing Africa [STAR])
- Conditions
- HIV/AIDS
- Interventions
- Device: OraQuick® HIV Self-Test
- Registration Number
- NCT03541382
- Lead Sponsor
- London School of Hygiene and Tropical Medicine
- Brief Summary
The aim of this study is to determine the benefits, costs and safety of community-led delivery of HIV self-testing (HIVST) kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.
- Detailed Description
RESEARCH QUESTION
Can community-led delivery of HIV self-tests be used to maximise public health and social benefits and reduce costs without introducing social harms?
RESEARCH AIMS AND OBJECTIVES
The broad aim is to determine the benefits, costs and safety of community-led delivery of HIVST kits in rural Malawi, with a focus on testing and linkage to care and prevention services among defined population sub-groups: men, adolescents aged 15-19 years old, and adults aged 40 years or older.
The specific objectives are to conduct a cluster randomised controlled trial to:
1. Establish the effectiveness of community-led HIVST campaigns on lifetime and recent HIV testing in predefined sub-groups.
2. Investigate the impact of community-led HIVST campaigns on: (a) population-level initiation of antiretroviral therapy (ART) and uptake of voluntary medical male circumcision (VMMC), (b) knowledge of HIV prevention, (c) stigma reduction
3. Explore how differences in community-led HIVST campaigns affect uptake of HIVST and linkage to care and prevention and values, attitudes and behaviours around HIVST.
4. Estimate the costs and cost-effectiveness of community-led HIVST campaigns compared to the standard of care (SOC).
RESEARCH DESIGN
The main study consists of a cluster-randomised trial evaluating the effectiveness of community-led HIVST campaigns on coverage of HIV testing and linkage to follow-on services compared to the Ministry of Health (MoH) SOC, facility-based HIV testing services (HTS). We are also interested in understanding the cost-effectiveness of community-led HIVST campaigns, and broader social benefits on stigma reduction.
The unit of randomisation is the Group Village Head (GVH), who are traditionally-appointed leaders that oversee a group of villages, and their catchments areas. Outcomes are measured through (i) household surveys in evaluation villages selected for each study cluster, and (ii) clinic records of patients coming from the study clusters.
For the primary outcome, measured using the households surveys, we assume that lifetime testing rates for adolescents aged 15-19 years old in the SOC arm are 35-50%, based on the recent Demographic and Health Survey. With 16 clusters per arm and 50 adolescents per cluster, we will have at least 90% power to detect a 20% absolute increase in lifetime testing using a coefficient of variation of outcomes (k) of 0.25. If k=0.3, for a 20% increase in lifetime testing, we would have 90% and 80% power with SOC testing rates of 35-40% and 45-55%, respectively. If the absolute increase in lifetime testing is lower at 15%, then for k=0.25 we would have 80% power for SOC testing rates of 35-40%. With adolescents making up 20-25% of the adult population, this will require 250 adults per cluster.
SUB-STUDIES
We will also be conducting a series of sub-studies related to the trial, including:
1. Process evaluation to monitor progress of the intervention and adherence to guidelines, and understand how differences in the context-driven intervention affect HIVST uptake and linkage to care and prevention.
2. Qualitative evaluation to explore which aspects of the community-led intervention were pivotal in affecting HIV testing and linkage outcomes and values, attitudes and behaviours around HIVST.
3. Economic evaluation to estimate costs, cost-effectiveness and cost-benefit per individual tested, newly diagnosed as HIV positive, started on ART and circumcised.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7880
- Aged ≥ 15 years
- Residence in GVH catchment areas included in the intervention arm
- Aged < 15 years old
- Not resident in GVH catchment areas included in the intervention arm
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIVST campaign arm OraQuick® HIV Self-Test Community representatives will be supported to plan and administer an HIVST campaign linked to HIV care and prevention services in their communities.
- Primary Outcome Measures
Name Time Method Percentage of self-reported lifetime testing in adolescents aged 15-19 years old Measured 8-12 weeks post-intervention
- Secondary Outcome Measures
Name Time Method Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months Measured 6-months post-intervention Measure of HIV testing stigma. Measured 8-12 weeks post-intervention Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years Measured 8-12 weeks post-intervention Measure of knowledge of HIV prevention methods Measured 8-12 weeks post-intervention Percentage of self-reported testing in last 3 months in men aged ≥ 15 years Measured 8-12 weeks post-intervention
Trial Locations
- Locations (1)
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
🇲🇼Blantyre, Malawi