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 : Recruiting
First Posted : May 30, 2018
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Device: OraQuick® HIV Self-Test||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8000 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|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 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.
Clusters in this arm will also undergo a second stage randomisation with the following arms:
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.
- First randomisation: Percentage of self-reported lifetime testing in adolescents aged 15-19 years old [ Time Frame: Measured 3-months post-intervention ]
- Second randomisation: Percentage of self-reported testing in last 12 months adults aged ≥ 15 years [ Time Frame: Measured 15-months post-intervention ]
- First randomisation: Percentage of self-reported testing in last 3 months in men aged ≥ 15 years [ Time Frame: Measured 3-months post-intervention ]
- First randomisation: Percentage of self-reported testing in last 3 months in adults aged ≥ 40 years [ Time Frame: Measured 3-months post-intervention ]
- First randomisation: Cumulative incidence of population-level ART uptake in adults aged ≥ 15 years over 6 months [ Time Frame: Measured 6-months post-intervention ]
- Secondary randomisation: Knowledge of HIV prevention score [ Time Frame: Measured 3 and 15-months post-intervention ]
- Second randomisation: HIV testing stigma score [ Time Frame: Measured 3 and 15-months post-intervention ]
- First and second randomisation: Costs per individual tested and newly diagnosed as HIV positive [ Time Frame: Measured 3 and 15-months 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
|Contact: Pitchaya Indravudh||+44 (0)20 7927 email@example.com|
|Malawi-Liverpool-Wellcome Trust Clinical Research Programme||Recruiting|
|Contact: Liz Corbett firstname.lastname@example.org|