An interventional study of HIV self-test in HIV, sponsored by University of North Carolina, Chapel Hill. Completed. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-06.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Screening
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.
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.
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Exclusion Criteria:
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
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.
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
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.
Time frame: 3 months
Proportion of participants who discussed HIV testing with partner (questionnaire)
Proportion of participants who report that they discussed HIV testing with their partner
Time frame: 3 months
Proportion of participants whose partners undergo HIV testing individually (questionnaire)
Proportion of participants whose partners undergo HIV testing individually (partner testing)
Time frame: 3 months
Proportion of participants who undergo Couples HIV testing with their partners (questionnaire)
Proportion of participants who undergo HIV testing with their partners (Couples testing)
Time frame: 3 months
No study locations are listed for this record.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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