The Use of HIV Self-tests to Promote Partner and Couples Testing: a Randomized Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02386215|
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: HIV self-test||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of HIV Self-tests to Promote Partner and Couples Testing: a Randomized Trial|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: HIV Self-test
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
Two self-test kits will be distributed to women, each containing the following:
Other Name: Oraquick
No Intervention: Control
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.
- Proportion of partners that uptake HIV testing (questionnaire) [ Time Frame: 3 months ]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.
- Proportion of participants who discussed HIV testing with partner (questionnaire) [ Time Frame: 3 months ]Proportion of participants who report that they discussed HIV testing with their partner
- Proportion of participants whose partners undergo HIV testing individually (questionnaire) [ Time Frame: 3 months ]Proportion of participants whose partners undergo HIV testing individually (partner testing)
- Proportion of participants who undergo Couples HIV testing with their partners (questionnaire) [ Time Frame: 3 months ]Proportion of participants who undergo HIV testing with their partners (Couples testing)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386215
|Principal Investigator:||Harsha Thirumurthy, PhD||University of North Carolina, Chapel Hill|