HIV Self Testing of Male Partners of Women in PMTCT

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

736 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-17

Study Completion Date

2021-11-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of HIV Self-tests to Promote Partner and Couples Testing: a Randomized Trial

NCT02386215

HIV

COMPLETED NA

HIV Self-testing for Partners of HIV-uninfected Postpartum Women

NCT07194902

HIV Self-testing Male Partners of HIV-negative Postpartum Women PrEP Uptake +3 more

NOT_YET_RECRUITING NA

Impact of Male Provider Phone Calls to Increase Men's Clinic Linkage After HIVST

NCT05194085

HIV Linkage to Care PMTCT +2 more

UNKNOWN NA

Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study)

NCT05388084

Engagement, Patient Male Peer Recruitment HIV Testing +1 more

COMPLETED NA

Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women

NCT04124536

HIV

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ART Adherence PMTCT Linkage to Care HIV PrEP

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women provided HIV Self-test kit

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

Group Type ACTIVE_COMPARATOR

HIV self-test kit

Intervention Type 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.

Women provided invitation letter-standard of care

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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 HIV self-test kit

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

Group Type OTHER

HIV self-test kit

Intervention Type 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 invitation letter

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

Group Type OTHER

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HIV self-test kit

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.

Intervention Type BEHAVIORAL

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

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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+