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])
1 other identifier
interventional
7,880
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedStudy Start
First participant enrolled
October 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedAugust 11, 2020
November 1, 2019
10 months
May 17, 2018
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of self-reported lifetime testing in adolescents aged 15-19 years old
Measured 8-12 weeks post-intervention
Secondary Outcomes (5)
Percentage of self-reported testing in last 3 months in men aged ≥ 15 years
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
Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months
Measured 6-months post-intervention
Measure of knowledge of HIV prevention methods
Measured 8-12 weeks post-intervention
Measure of HIV testing stigma.
Measured 8-12 weeks post-intervention
Study Arms (2)
HIVST campaign arm
ACTIVE COMPARATORCommunity representatives will be supported to plan and administer an HIVST campaign linked to HIV care and prevention services in their communities.
SOC arm
NO INTERVENTIONStandard HTS will be provided by MoH at health facilities.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Aged ≥ 15 years
- Residence in GVH catchment areas included in the intervention arm
You may not qualify if:
- Aged \< 15 years old
- Not resident in GVH catchment areas included in the intervention arm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- Malawi-Liverpool-Wellcome Trust Clinical Research Programmecollaborator
- Liverpool School of Tropical Medicinecollaborator
- University College, Londoncollaborator
- Population Services Internationalcollaborator
- UNITAIDcollaborator
Study Sites (1)
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, Malawi
Related Publications (3)
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.
PMID: 34275869DERIVEDIndravudh 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.
PMID: 33974621DERIVEDIndravudh 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.
PMID: 31533646DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2018
First Posted
May 30, 2018
Study Start
October 8, 2018
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
August 11, 2020
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share