Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
NCT ID: NCT03135067
Last Updated: 2022-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2102 participants
INTERVENTIONAL
2017-06-04
2020-03-25
Brief Summary
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Detailed Description
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Data will be collected from study participants at baseline on demographic and socio-economic characteristics, self-reported sexual behavior, HIV testing history, intimate partner violence history, and mental health outcomes. Follow-up data collection will occur every 6 months. Each month, participants will be sent an invitation to participate in short mobile phone based text message surveys. HIV testing of participants will occur at baseline and at 6 monthly intervals.
Based on their reported use of the HIV self-tests, participants will be invited for qualitative interviews to learn more about their interactions with partners with regard to the distribution of self-tests and referral vouchers. Participants will also be given information to distribute to some of their male partners so that those partners can contact study staff to participate in qualitative interviews that will inquired about their perceptions of self-tests.
The study has 3 specific aims. Aim 1 will determine the intervention's effect on uptake of HIV testing and identification of HIV infection among participants' sexual partners, self-reported sexual behavior of participants with partners whose HIV status was HIV-positive or not known, and HIV incidence among participants. Aim 2 will use a mixed methods approach to assessing safety and perceptions of the intervention by participants and their sexual partners. Aim 3 will assess the cost-effectiveness of the intervention and obtain information necessary to inform scale-up of the intervention in Kenya and other countries.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Provision of multiple self-tests
Participants in intervention clusters will be given multiple HIV self-test kits, testing instructions, and advice to use their discretion when offering self-tests to selected sexual partners. Participants will be encouraged to offer self-tests primarily to current and potential partners with whom unprotected sex is likely. All participants will be encouraged to use condoms with sexual partners. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering self-tests to partners. Participants will have opportunities to obtain additional HIV self-test kits on a monthly basis.
Provision of multiple self-tests
Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.
Referral vouchers for VCT
Participants will be given a multiple referral vouchers for HIV testing to distribute to their sexual partners. All participants will be encouraged to use condoms with sexual partners. These referral vouchers will encourage the partners to seek HIV counseling \& testing services in local clinics. Participants will also be advised to assess the risk of intimate partner violence (IPV) as a result of offering referral vouchers to partners. Participants will have opportunities to obtain additional referral vouchers on a monthly basis.
No interventions assigned to this group
Interventions
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Provision of multiple self-tests
Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.
Eligibility Criteria
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Inclusion Criteria
* Currently resides in the study area
* Has resided in the study area for at least 6 months in the year prior to enrollment
* Intends to stay in the study area for at least 24 months
* Reports two or more sexual partners within the past 4 weeks at time of screening
* HIV negative
* Ownership or access to a mobile phone
* Willing and able to provide informed consent
Exclusion Criteria
* Does not currently live in the study area or has not for 6 of the last 12 months, or does not plan to for at least the next 24 months
* Fewer than two sexual partners in the last four weeks at time of screening
* HIV positive
* Has no access to a mobile phone
* Enrolled in another HIV prevention study
* Cannot or will not provide informed consent
18 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Impact Research & Development Organization
OTHER
RTI International
OTHER
University of North Carolina
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Harsha Thirumurthy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Impact Research and Development Organization
Kisumu, , Kenya
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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828100
Identifier Type: -
Identifier Source: org_study_id