A Cluster Randomised Trial of Community-led Distribution of HIV Self-tests in Rural Malawi (HIV Self-Testing Africa [STAR])
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|ClinicalTrials.gov Identifier: NCT03541382|
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Device: OraQuick® HIV Self-Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7880 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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])|
|Actual Study Start Date :||October 8, 2018|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
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.
Device: OraQuick® HIV Self-Test
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.
No Intervention: SOC arm
Standard HTS will be provided by MoH at health facilities.
- Percentage of self-reported lifetime testing in adolescents aged 15-19 years old [ Time Frame: Measured 8-12 weeks post-intervention ]
- Percentage of self-reported testing in last 3 months in men aged ≥ 15 years [ Time Frame: Measured 8-12 weeks post-intervention ]
- Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years [ Time Frame: Measured 8-12 weeks post-intervention ]
- Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months [ Time Frame: Measured 6-months post-intervention ]
- Measure of knowledge of HIV prevention methods [ Time Frame: Measured 8-12 weeks post-intervention ]
- Measure of HIV testing stigma. [ Time Frame: Measured 8-12 weeks post-intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541382
|Malawi-Liverpool-Wellcome Trust Clinical Research Programme|