HIV Self Testing of Male Partners of Women in PMTCT

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Harvard University

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Connie Celum, MD MPH · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-05-17

Primary Completion

2021-11-22

Completion

2021-11-22

Countries

• Uganda

Study Locations