HIV Self Testing of Male Partners of Women in PMTCT

HIV Self-testing of Men to Increase Testing and Prevention Uptake Among Male Partners and Improve Postpartum ART Use in PMTCT B+ Programs in Uganda

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.

Study Overview

• Status: Completed
• Conditions: PrEP; HIV; PMTCT; Linkage to Care; ART Adherence
• Intervention / Treatment: Behavioral: HIV self-test kit; Behavioral: Standard of Care

Detailed Description

Uganda has the fifth highest HIV burden globally and one of the highest fertility rates in Africa. Prevention of mother-to-child HIV transmission Option B+ (PMTCT B+) is national policy in Uganda. To maximize the prevention and clinical benefits of PMTCT B+, the challenges of low HIV testing by male partners and high rates of post-partum discontinuation of ART, insufficient adherence, and incomplete viral suppression need to be addressed. Women may be more likely to continue ART long-term and have higher adherence post-partum if their partner is tested, there is mutual disclosure of HIV status, and their partner takes ART or PrEP, depending on his status. Innovative approaches are needed to allow men to test in settings other than busy antenatal clinics, preferably where they have privacy, are comfortable and do not miss work. Innovative HIV testing technology -HIVST- could increase male partner's uptake of HIV testing, and prevention (PrEP) or ART (for all HIV-positive men). This study has been designed to address this gap through an enhanced PMTCT B+ program with HIV self-testing, and linkage to PrEP or ART, for male partners.

In a demonstration project the investigators recently completed among mutually disclosed East African HIV serodiscordant couples (the Partners Demonstration Project), integrated ART and PrEP delivery with time-limited PrEP for the HIV-negative partner as a 'bridge' until the HIV-positive partner was on ART for six months, and achieved viral suppression, was very acceptable, achieved very high uptake and adherence to ART and PrEP, and nearly eliminated HIV transmission. This protocol builds on that demonstration project by evaluating whether PMTCT outcomes are improved by increasing uptake of HIV testing and PrEP among HIV-negative men whose pregnant partner is HIV-positive. PrEP for HIV-negative male partners of HIV-positive pregnant women provides highly effective prevention benefits during an important 'season of risk' when men may have higher HIV acquisition risk from their partner if she is viremic (during the first few months after ART initiation, post-partum ART discontinuation or due to viral resistance), or from outside partners.

The investigators will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women who are randomized to the HIVST arm, achieves higher uptake of their male partner's testing and linkages to HIV care and prevention among male partners, compared to invitation letters for fast track testing in the clinic (the standard of care). The investigators will recruit HIV-positive women ≥18 years accessing PMTCT B+ programs in Kampala, who have a male partner of unknown HIV status. Women will be randomized to the intervention (HIVST) or the control arm (invitation letters to deliver to partners to come for fast-track testing at the Antenatal Care (ANC) clinic where she receives care.

• Study Type: Interventional
• Enrollment (Actual): 734
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Infectious Disease Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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+

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HIV Self-test kit	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.
Active Comparator: Invitation letter-standard of care	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); University of North Carolina, Chapel Hill; Harvard University
• Investigators: Principal Investigator: Connie Celum, MD MPH, University of Washington

Publications and helpful links

General Publications

• 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. 2022 Nov 8. doi: 10.1007/s10461-022-03910-3. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2018
• Primary Completion (Actual): November 22, 2021
• Study Completion (Actual): November 22, 2021

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00002257; R01MH113434 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No