Clinical trial NCT02386215: The Use of HIV Self-tests to Promote Partner and Couples Testing: a Randomized Trial
Official title: The Use of HIV Self-tests to Promote Partner and Couples Testing: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV self-testing
randomized controlled trial
Kenya
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Impact Research & Development Organization
First posted: 2015-03-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This randomized controlled trial will explore whether the provision of oral HIV self-test kits to women can increase HIV testing among their male partners. The study will recruit adult women from antenatal care and post-partum clinics in Kisumu. Each participant will be randomized to either receive two HIV self-tests or to receive counseling referring their partner to HIV testing (standard of care). Over a 3 month period, we will obtain information from study participants on how many sexual partners they offered the tests to, the receptivity of their sexual partners to using self-tests, and the incidence of any adverse events. We will compare partner testing rates in intervention and control groups.

Detailed description: This randomized controlled trial will enroll women, ages 18-39, attending antenatal care (ANC) and post-partum care (PPC) at 3 sites in Kisumu, Kenya. The study's purpose is to investigate whether offering multiple HIV self-tests to women can increase the likelihood that either partner or couples HIV testing takes place.

Women who are randomized to the intervention group will be provided with multiple oral self-tests as well as information about how to use the tests and where to seek care if necessary. These women will be encouraged to give the self-tests to their sexual partners and encourage those partners to take a self-test. Women who are randomized to the control group will be offered the standard counseling to refer their partners for clinic-based HIV counseling and testing. Our hypothesis is that the intervention group will have higher uptake of HIV testing by women's partners within 3 months of enrollment in the study than the control group. Participants in the study will complete a baseline interview and a follow-up interview at 3 months post-enrollment. Qualitative in-depth interviews will be conducted with a subset of participants in the intervention group.

Eligibility criteria: Inclusion Criteria:

* Primarily resides in or near Kisumu
* Reports having a current, primary partner (someone that the woman has been in a relationship with for at least 6 months and is identified as her primary partner)
* Reports that primary partner has not tested for HIV in past 6 months
* Have undergone the opt-out HIV testing at the ANC or PPC clinic
* Intends to continue living in or around Kisumu for the next 3 months (follow-up period).

Exclusion Criteria:

* Believes that her partner will hurt her if she gives him an HIV self-test and encourages him to use it
* Reports having an HIV+ partner
* Intends to relocate from Kisumu area within the next 3 months

Primary outcomes:
measure: Proportion of partners that uptake HIV testing (questionnaire)
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of participants who discussed HIV testing with partner (questionnaire)
timeFrame: 3 months
measure: Proportion of participants whose partners undergo HIV testing individually (questionnaire)
timeFrame: 3 months
measure: Proportion of participants who undergo Couples HIV testing with their partners (questionnaire)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Harsha Thirumurthy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Masters SH, Agot K, Obonyo B, Napierala Mavedzenge S, Maman S, Thirumurthy H. Promoting Partner Testing and Couples Testing through Secondary Distribution of HIV Self-Tests: A Randomized Clinical Trial. PLoS Med. 2016 Nov 8;13(11):e1002166. doi: 10.1371/journal.pmed.1002166. eCollection 2016 Nov.