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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386215
• Other study ID #: 14-3040
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: June 3, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• HIV self-test
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Impact Research & Development Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of participants who discussed HIV testing with partner (questionnaire)	Proportion of participants who report that they discussed HIV testing with their partner	3 months	No
Secondary	Proportion of participants whose partners undergo HIV testing individually (questionnaire)	Proportion of participants whose partners undergo HIV testing individually (partner testing)	3 months	No
Secondary	Proportion of participants who undergo Couples HIV testing with their partners (questionnaire)	Proportion of participants who undergo HIV testing with their partners (Couples testing)	3 months	No