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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03484533
Other study ID # STUDY00002257
Secondary ID R01MH113434
Status Completed
Phase N/A
First received
Last updated
Start date May 17, 2018
Est. completion date November 22, 2021

Study information

Verified date May 2022
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits (HIVST) to HIV-positive pregnant women to provide to their male partner, increases the proportion of male partners who test and link to HIV care or prevention, compared to invitation letters for fast track testing. Pregnant women who are randomized to the arm with secondary distribution of HIVST to their male partners will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. The investigators will offer men confirmatory testing regardless of their HIVST result, counseling, and if negative, pre-exposure prophylaxis (PrEP) and if positive, antiretroviral therapy (ART). The investigators will provide counseling to minimize social harms of HIV self-testing, and additional counseling and referral to social support services when social harms occur. This project will address key challenges in PMTCT B+ programs, by evaluating innovative strategies to increase male partner's knowledge of their HIV status, disclosure, and involvement coupled with offering PrEP to HIV-negative men, ART to HIV-positive men, and encouraging post-partum ART continuation and adherence among HIV-positive women.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
HIV self-test kit
We will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women overcomes their male partners' reluctance to be tested in PMTCT clinics. Pregnant women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.
Standard of Care
In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.

Locations

Country Name City State
Uganda Infectious Disease Institute Kampala

Sponsors (4)

Lead Sponsor Collaborator
University of Washington Harvard University, National Institute of Mental Health (NIMH), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with effective post-partum ART continuation. The outcome measure is:
ART continuation at 12 months post-partum as measured by self-reported ART usage and adherence
Up to 12 months post-partum
Primary Evaluation whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with effective post-partum viral suppression The outcome measure is:
Viral suppression at 12 months post-partum as measured by viral load testing
Up to 12 months post-partum
Primary Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ increases the proportion of male partners who test for HIV The outcome measure is the proportion of men who test for HIV in the self-test arm to men who test for HIV in the standard of care arm Up to 12 months post-partum
Primary Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of ART if they test HIV-positive The outcome measure is:
The proportion of HIV-positive men who initiate ART in the self-test arm to the standard of care arm
Up to 12 months post-partum
Primary Evaluate whether the secondary distribution of HIV self-tests to male partners of HIV-infected Ugandan women in PMTCT B+ is associated with male partners uptake of PrEP if they test HIV-negative The outcome measure is:
The proportion of HIV-negative men who initiate PrEP in the self-test arm to the standard of care arm
Up to 12 months post-partum
Primary To evaluate the acceptability of HIV self-testing among pregnant women taking part in PMTCT B+, their male partners, and their providers The outcome measure is:
HIV-infected pregnant women, their male partners, and their providers perspectives and views on HIV self-testing evaluated by an inductive content analytic approach conducted through qualitative interviews
Up to 12 months post-partum
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