HIV Self-Testing Africa Zambia (STAR Zambia)
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|ClinicalTrials.gov Identifier: NCT02793804|
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Device: Oraquick (made in Thailand)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5005 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Self-testing for HIV (HIVST) Amongst Urban, Peri-urban and Rural Communities in Zambia, Including a Cluster-randomised Trial of Community-based HIVST Distribution|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||February 1, 2018|
No Intervention: Control
All HIV testing and counselling services will be conducted as currently.
Experimental: HIV Self-Testing
Community-based distribution agents (CBDA), including Voluntary Male Medical Circumcision (VMMC) mobilisers, will deliver OraQuick® HIV Self-Tests (Orasure Technologies, Thailand). The kits will also be available at the health facility.
Device: Oraquick (made in Thailand)
- Comparison between randomisation arms in coverage of recent (within the last 12 months) HIV testing among older adolescents and adults (aged from 16 years) in the clinic catchment areas 12 months after the start of the intervention - by self-report [ Time Frame: 12 months ]Recent testing will be measured by self-report and analyzed at the individual level. Respondents will be asked to answer the following question: "Have you tested for HIV within the past 12 months" as part of the baseline, midline, and endline surveys.
- Comparison between randomisation arms of antiretroviral therapy (ART) initiation rates for older adolescent and adult (aged from 16 years) cluster residents, during months 1 to 12 of the intervention - measured using clinic data [ Time Frame: 12 months ]Linkage to HIV care will be measured using clinic data. Self-testers will receive self-referral forms, and will be asked to bring these to clinics where they receive confirmatory testing and care. Clinic staff will log all clients seeking confirmatory testing following HIV self-testing. Data on linkage will be aggregated to the clinic level for analysis.
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): NCT02793804