A Cluster Randomised Trial of Community-led Distribution of HIV Self-tests in Rural Malawi (HIV Self-Testing Africa [STAR])
Community-led Distribution of HIV Self-tests: a Cluster Randomised Trial Investigating Uptake of HIV Testing and Linkage to Treatment and Prevention, Costs and Safety in Rural Malawi (HIV Self-Testing Africa [STAR])
Study Overview
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:
- Establish the effectiveness of community-led HIVST campaigns on lifetime and recent HIV testing in predefined sub-groups.
- 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
- 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.
- 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:
- 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.
- 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.
- Economic evaluation to estimate costs, cost-effectiveness and cost-benefit per individual tested, newly diagnosed as HIV positive, started on ART and circumcised.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Blantyre, Malawi
- Malawi-Liverpool-Wellcome Trust Clinical Research Programme
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged ≥ 15 years
- Residence in GVH catchment areas included in the intervention arm
Exclusion Criteria:
- Aged < 15 years old
- Not resident in GVH catchment areas included in the intervention arm
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: HIVST campaign arm
Community representatives will be supported to plan and administer an HIVST campaign linked to HIV care and prevention services in their communities.
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Community leaders, including GVHs, Village Health Committee members, Village Development Committee members, and members of key community groups will participate in a workshop to facilitate planning of a HIVST campaign. Identified community distributors, who are unpaid volunteers from the community, will also receive a training package in HIVST promotion. Campaigns will be conducted over a short period (approximately seven days) and under a fixed budget. Community distributors will deliver HIVST kits free of charge to community members, and provide information on how to self-test and access the nearest clinic for linkage to confirmatory HTS, treatment and prevention. Distributors will also provide HIV prevention messages around serodiscordancy, treatment as prevention and VMMC. |
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No Intervention: SOC arm
Standard HTS will be provided by MoH at health facilities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Percentage of self-reported lifetime testing in adolescents aged 15-19 years old
Time Frame: Measured 8-12 weeks post-intervention
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Measured 8-12 weeks post-intervention
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Percentage of self-reported testing in last 3 months in men aged ≥ 15 years
Time Frame: Measured 8-12 weeks post-intervention
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Measured 8-12 weeks post-intervention
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Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years
Time Frame: Measured 8-12 weeks post-intervention
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Measured 8-12 weeks post-intervention
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Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months
Time Frame: Measured 6-months post-intervention
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Measured 6-months post-intervention
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Measure of knowledge of HIV prevention methods
Time Frame: Measured 8-12 weeks post-intervention
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Measured 8-12 weeks post-intervention
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Measure of HIV testing stigma.
Time Frame: Measured 8-12 weeks post-intervention
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Measured 8-12 weeks post-intervention
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Collaborators and Investigators
Publications and helpful links
General Publications
- Indravudh PP, Fielding K, Sande LA, Maheswaran H, Mphande S, Kumwenda MK, Chilongosi R, Nyirenda R, Johnson CC, Hatzold K, Corbett EL, Terris-Prestholt F. Pragmatic economic evaluation of community-led delivery of HIV self-testing in Malawi. BMJ Glob Health. 2021 Jul;6(Suppl 4):e004593. doi: 10.1136/bmjgh-2020-004593.
- Indravudh PP, Fielding K, Kumwenda MK, Nzawa R, Chilongosi R, Desmond N, Nyirenda R, Neuman M, Johnson CC, Baggaley R, Hatzold K, Terris-Prestholt F, Corbett EL. Effect of community-led delivery of HIV self-testing on HIV testing and antiretroviral therapy initiation in Malawi: A cluster-randomised trial. PLoS Med. 2021 May 11;18(5):e1003608. doi: 10.1371/journal.pmed.1003608. eCollection 2021 May.
- Indravudh PP, Fielding K, Kumwenda MK, Nzawa R, Chilongosi R, Desmond N, Nyirenda R, Johnson CC, Baggaley RC, Hatzold K, Terris-Prestholt F, Corbett EL. Community-led delivery of HIV self-testing to improve HIV testing, ART initiation and broader social outcomes in rural Malawi: study protocol for a cluster-randomised trial. BMC Infect Dis. 2019 Sep 18;19(1):814. doi: 10.1186/s12879-019-4430-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 14761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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