HIV Self Testing of Male Partners of Women in PMTCT

NCT03484533 | Completed Results DMC

• 2 other identifiers: STUDY00002257R01MH113434
• Study Type: interventional
• Target: 736
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ART Adherence; PMTCT; Linkage to Care; HIV; PrEP

Outcome Measures

Primary Outcomes (3)

• Proportion of Men Who Test for HIV in the Self-test Arm to Men Who Test for HIV in the Standard of Care Arm

  Evaluate whether the secondary distribution of HIV self-tests to enrolled male partners of HIV-infected Ugandan women in PMTCT B+ increases the proportion of male partners who test for HIV

  Up to 12 months post-partum

• The Proportion of HIV-positive Men Who Initiate ART in the Self-test Arm to the Standard of Care Arm

  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.

  Up to 12 months post-partum

• The Proportion of HIV-negative Men Who Initiate PrEP in the Self-test Arm to the Standard of Care Arm

  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

  Up to 12 months post-partum

Secondary Outcomes (2)

• Viral Suppression at 12 Months Post-partum in HIV-infected Ugandan Women as Measured by Viral Load Testing

  Up to 12 months post-partum

• The Acceptability of HIV Self-testing Among Pregnant Women Taking Part in PMTCT B+, and Their Male Partners

  Up to 12 months post-partum

Study Arms (4)

Women provided HIV Self-test kit

ACTIVE COMPARATOR

Women will be given HIV self-test kits that they can then deliver to their male partners.

Behavioral: HIV self-test kit

Women provided invitation letter-standard of care

ACTIVE COMPARATOR

Women will be given an invitation letter for fast track HIV testing in the clinic that they will deliver to their male partners.

Behavioral: Standard of Care (invitation letters for fast-track HIV testing in the clinic)

Male partners of women provided HIV self-test kit

OTHER

Male partners of women who were randomized to receive HIV self-test kits that could be delivered to their partner.

Behavioral: HIV self-test kit

Male partners of women provided invitation letter

OTHER

Male partners of women who were randomized to receive an invitation letter - standard of care.

Behavioral: Standard of Care (invitation letters for fast-track HIV testing in the clinic)

Interventions

HIV self-test kit BEHAVIORAL

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.

Male partners of women provided HIV self-test kit; Women provided HIV Self-test kit

Standard of Care (invitation letters for fast-track HIV testing in the clinic) BEHAVIORAL

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.

Male partners of women provided invitation letter; Women provided invitation letter-standard of care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: See eligibility criteria below
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator
• Harvard University: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Infectious Disease Institute

Kampala, Uganda

Location

Related Publications (3)

• Mujugira A, Nakyanzi A, Donnell D, Boyer J, Stein G, Bulterys M, Naddunga F, Kyomugisha J, Birungi JE, Ssendiwala P, Nsubuga R, Muwonge TR, Musinguzi J, Sharma M, Celum CL. Partner testing with HIV self-test distribution by Ugandan pregnant women living with HIV: a randomized trial. J Int AIDS Soc. 2023 Sep;26(9):e26156. doi: 10.1002/jia2.26156.

  PMID: 37675834 DERIVED

• Bulterys MA, Mujugira A, Nakyanzi A, Wyatt MA, Kamusiime B, Kasiita V, Kakoola GN, Nalumansi A, Twesigye C, Pisarski EE, Sharma M, Boyer J, Naddunga F, Ware NC, Celum CL. "Him Leaving Me - That is My Fear Now": A Mixed Methods Analysis of Relationship Dissolution Between Ugandan Pregnant and Postpartum Women Living with HIV and Their Male Partners. AIDS Behav. 2023 Jun;27(6):1776-1792. doi: 10.1007/s10461-022-03910-3. Epub 2022 Nov 8.

  PMID: 36348192 DERIVED

• Bulterys MA, Sharma M, Mugwanya K, Stein G, Mujugira A, Nakyanzi A, Twohey-Jacobs L, Ware NC, Heffron R, Celum C. Correlates of HIV Status Nondisclosure by Pregnant Women Living With HIV to Their Male Partners in Uganda: A Cross-Sectional Study. J Acquir Immune Defic Syndr. 2021 Apr 1;86(4):389-395. doi: 10.1097/QAI.0000000000002566.

  PMID: 33148995 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Pregnant women living with HIV (PWLHIV) were excluded if they reported intimate partner violence (IPV) in the prior year, results may not be generalizable. The HIV self-test (HIVST) arm allowed men to test at home, the proportion tested may be underestimated by the number who came to the clinic for confirmatory HIV testing and enrolment. Phone outreach may have biased the outcome of male partner testing to the null by increasing testing in the standard of care (SOC) arm.

Results Point of Contact

• Title: Andrew Mujugira
• Organization: Makerere University Infectious Diseases Institute

mujugira@uw.edu

206 520 3800

Study Officials

• Connie Celum, MD MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: April 2, 2018
• Study Start: May 17, 2018
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)