N/A
N=736
HIV Self Testing of Male Partners of Women in PMTCT
ART Adherence · PMTCT · Linkage to Care · HIV · PrEP
Bottom Line
View on ClinicalTrials.gov: NCT03484533 ↗Enrolled (actual)
736
Serious AEs
1.2%
Results posted
Mar 2025
Primary outcome: Primary: Proportion of Men Who Test for HIV in the Self-test Arm to Men Who Test for HIV in the Standard of Care Arm — 161; 75 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIV self-test kit (Behavioral); Standard of Care (invitation letters for fast-track HIV testing in the clinic) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Men Who Test for HIV in the Self-test Arm to Men Who Test for HIV in the Standard of Care Arm |
161; 75 | — |
| PRIMARY The Proportion of HIV-positive Men Who Initiate ART in the Self-test Arm to the Standard of Care Arm |
33; 12 | — |
| PRIMARY The Proportion of HIV-negative Men Who Initiate PrEP in the Self-test Arm to the Standard of Care Arm |
72; 41 | — |
| SECONDARY Viral Suppression at 12 Months Post-partum in HIV-infected Ugandan Women as Measured by Viral Load Testing |
239; 110 | — |
| SECONDARY The Acceptability of HIV Self-testing Among Pregnant Women Taking Part in PMTCT B+, and Their Male Partners |
29; 30 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Eligibility
For all participants
- Able and willing to provide written informed consent
- Able and willing to provide adequate locator information for study retention purposes
For women
- Age ≥18
- Currently pregnant
- HIV-positive based on positive rapid HIV tests, according to national algorithm
- Not currently enrolled in an HIV treatment study
- Male partner not known to be HIV-positive or has not tested in the past 3 months
For men - In partnership with an HIV-positive pregnant woman in PMTCT B+
Exclusion criteria
- None
Data sourced from ClinicalTrials.gov (NCT03484533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.