Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 84055 for:    testing

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
Sponsor:
Collaborator:
Impact Research & Development Organization
Information provided by (Responsible Party):
Harsha Thirumurthy, PhD, University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: HIV self-test Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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:

  • 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
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of North Carolina, Chapel Hill
Impact Research & Development Organization
Investigators
Layout table for investigator information
Principal Investigator: Harsha Thirumurthy, PhD University of North Carolina, Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Harsha Thirumurthy, PhD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02386215     History of Changes
Other Study ID Numbers: 14-3040
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016

Keywords provided by Harsha Thirumurthy, PhD, University of North Carolina, Chapel Hill:
HIV self-testing
randomized controlled trial
Kenya