Clinical trial NCT03135067: Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
Official title: Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV self-testing
female sex workers
partner testing
couples testing
transactional sex
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Impact Research & Development Organization
name: RTI International
name: University of North Carolina
First posted: 2017-05-01
Enrollment: 2102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief summary: This cluster randomized trial will assess whether the provision of multiple oral-fluid based HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an approach that promotes HIV testing among women's sexual partners, facilitates better sexual decision making, and reduces women's risk of acquiring HIV.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* 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:

* Younger than 18 years old
* 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

  * Males will self-select to participate by contacting the study staff using the information provided by willing index participants. There are no inclusion or exclusion criteria for the men who select to participate.

Primary outcomes:
measure: HIV Incidence Per 100 Person Years
timeFrame: up to 24 months
Secondary outcomes:
measure: Identification of HIV-positive Male Partners
timeFrame: up to 24 months
measure: Used Condom With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive
timeFrame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
measure: Couples Testing With Primary Partner
timeFrame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
measure: Primary Partner Tested for HIV
timeFrame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
measure: Declined Sex With at Least One Partner After Partner Refused Self-test or HIV Testing Services Referral Card, or Tested HIV-positive
timeFrame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
Other outcomes:
measure: Intimate Partner Violence (IPV)
timeFrame: Data was measured longitudinally up to 24 months for some subjects; all participants were measured through 18 months. Measures reported are from 18 month follow-up for behavior occurring in the past 6 months.
Locations:
city: Kisumu
country: Kenya
facility: Impact Research and Development Organization
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Harsha Thirumurthy, PhD
role: PRINCIPAL_INVESTIGATOR
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