The Use of HIV Self-tests to Promote Partner and Couples Testing: a Randomized Trial

NCT02386215 | Completed

• 1 other identifier: 14-3040
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV

Keywords

HIV self-testing; randomized controlled trial; Kenya

Outcome Measures

Primary Outcomes (1)

• Proportion of partners that uptake HIV testing (questionnaire)

  The primary outcome for the study will be uptake of HIV testing by women's partners within 3 months of enrollment in the study. For each participant, the investigators will record whether the participant's partner underwent HIV testing. The investigators will test for differences in the primary outcome variable between the intervention and control group.

  3 months

Secondary Outcomes (3)

• Proportion of participants who discussed HIV testing with partner (questionnaire)

  3 months

• Proportion of participants whose partners undergo HIV testing individually (questionnaire)

  3 months

• Proportion of participants who undergo Couples HIV testing with their partners (questionnaire)

  3 months

Study Arms (2)

HIV Self-test

EXPERIMENTAL

Following a baseline interview, participants in the intervention group will be shown how to correctly use the self-tests and given two HIV self-tests. Subsequently, we will contact participants periodically over a 3 month period to see if they have used the test(s) with their sexual partners and conduct a follow-up interview.

Behavioral: HIV self-test

Control

NO INTERVENTION

Following the baseline interview, participants in the control group will be given referral vouchers for themselves and their partners to obtain HIV testing at Voluntary Counseling \& Testing (VCT) centers. We will contact the participants at the end of 3 months to see if they and/or their partner(s) have sought HIV testing.

Interventions

HIV self-test BEHAVIORAL

Two self-test kits will be distributed to women, each containing the following: * One standard OraQuick ADVANCE I/II test kit * Written pre-test information including test instructions in written and pictorial form * A phone number that participants can call to obtain additional information * Two vouchers with unique identifying numbers which can be redeemed at confirmatory testing

Also known as: Oraquick

HIV Self-test

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Impact Research & Development Organization: collaborator

Related Publications (1)

• 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.

  PMID: 27824882 DERIVED

Study Officials

• Harsha Thirumurthy, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 6, 2016

Record last verified: 2016-06