HIV Self Testing of Male Partners of Women in PMTCT

University of Washington

Status: Completed

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

Treatments: Behavioral: Standard of Care (invitation letters for fast-track HIV testing in the clinic); Behavioral: HIV self-test kit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03484533

STUDY00002257

R01MH113434 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 736 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

736 participants in 4 patient groups

Women provided HIV Self-test kit

Active Comparator group

Description:

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

Treatment:

Behavioral: HIV self-test kit

Women provided invitation letter-standard of care

Active Comparator group

Description:

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

Treatment:

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

Male partners of women provided HIV self-test kit

Other group

Description:

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

Treatment:

Behavioral: HIV self-test kit

Male partners of women provided invitation letter

Other group

Description:

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

Treatment:

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