Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03135067|
Recruitment Status : Active, not recruiting
First Posted : May 1, 2017
Last Update Posted : May 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Behavioral: Provision of multiple self-tests||Not Applicable|
The study will recruit HIV-negative adult women who had two or more sexual partners within the past four weeks in the Nyanza region of Kenya. Beach communities and female sex worker hotspots will be randomized to an intervention group or a control group. In intervention clusters, participants will receive multiple oral fluid-based HIV test kits over a period of up to 24 months, training on how to use the tests, and encouragement to offer tests to current and potential sexual partners with whom sex without condoms is likely. In the comparison clusters, participants will be given referral vouchers for clinic-based HIV testing over a period of up to 24-months and encouraged to distribute these vouchers to sexual partners.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2102 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Female sex worker hotspots and beach communities in the Nyanza region of Kenya will be grouped into clusters that will be randomly assigned to receive the intervention (provision of multiple HIV self-test kits over time) or control (provision of clinic-based HIV testing referral vouchers over time). About 66 clusters, with an average of 30 participants per cluster, will be selected for the study.|
|Masking:||None (Open Label)|
|Official Title:||Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk|
|Actual Study Start Date :||May 24, 2017|
|Actual Primary Completion Date :||March 25, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: 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.
Behavioral: 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.
No Intervention: 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.
- 18-month HIV incidence [ Time Frame: up to 24 months ]Proportion of participants who become HIV infected over an average follow-up period of 18 months
- Identification of HIV-positive male partners [ Time Frame: up to 24 months ]Number of reported partners per participant who tested for HIV and obtained a reactive result
- Unprotected sexual encounters with partners whose HIV status is either HIV-positive or not known [ Time Frame: up to 24 months ]Proportion of unprotected sexual encounters that were with partners who were either HIV-positive or whose HIV status was unknown
- Cost-effectiveness [ Time Frame: up to 24 months ]Cost per disability-adjusted life year (DALY) averted. Calculation will be based on a) increased identification of HIV-positive men and the associated increase in antiretroviral therapy and b) fewer new HIV infections among women
- Couples testing [ Time Frame: up to 24 months ]Proportion of participants who report testing together with their primary partner
- Partner testing [ Time Frame: up to 24 months ]Proportion of participants who report that their primary partner tested for HIV since enrollment
- Intimate Partner Violence (IPV) [ Time Frame: up to 24 months of follow-up ]Proportion of participants in each study group who experience IPV due to partner testing
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): NCT03135067
|Impact Research and Development Organization|
|Principal Investigator:||Harsha Thirumurthy, PhD||University of North Carolina, Chapel Hill|