Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07194902

HIV Self-testing for Partners of HIV-uninfected Postpartum Women to Facilitate PrEP and Antiretroviral Therapy Uptake to Promote HIV Treatment and Prevention

Led by Massachusetts General Hospital · Updated on 2026-03-23

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate a combination intervention called H4P to support HIV self-testing for partners and promote PrEP uptake among HIV-uninfected postpartum women who have partners with unknown HIV status. The study focuses on postpartum women and their male partners in KwaZulu-Natal, South Africa, using evidence-based cognitive behavioral therapy strategies like communication skills training, motivational interviewing, and problem-solving. This pilot trial will assess how feasible and acceptable the intervention is and explore its early effects on PrEP use and HIV prevention. Participants include postpartum women between 30 and 40 weeks' gestation and their male partners. Women in the control group receive up to three HIV self-test kits with standard information and demonstrations for their partners. Those in the intervention group receive additional 30-45 minute counseling covering PrEP information and skills to support HIVST kit distribution and linkage to care. Male partners in the intervention group watch a video about HIV treatment resources and the importance of HIV care in their relationship. Both groups receive HIV self-test kits and instructions for use. Participants will be followed at baseline and three months, completing assessments on feasibility, acceptability, safety concerns from HIVST distribution, and preliminary effectiveness of the intervention. Measures include PrEP uptake, HIV and pregnancy characteristics, physical and mental health, substance use, relationship dynamics, partner violence, stigma, and barriers to care. Women and men must provide consent and participate in repeated assessments. The total participation duration is at least three months after enrollment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Woman aged 18 years or older
  • Between 30 and 40 weeks pregnant based on medical records
  • Negative HIV test in the third trimester verified by antenatal care chart
  • Has at least one sexual partner with unknown HIV status
  • Fluent in English or isiZulu
  • Willing to allow researchers to contact for repeated assessments
  • Able to provide informed consent
  • Male partners of enrolled women, aged 18 years or older
  • Male partners confirmed via couples verification tool
  • Male partners fluent in English or isiZulu
  • Male partners willing to allow researchers to contact them
  • Male partners able to provide informed consent
Not Eligible

You will not qualify if you...

  • Individuals with significant psychiatric illness that may interfere with participation or ability to consent, as determined by the study team

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Baseline visit plus follow-up through 3 months

Participants receive counseling and HIV self-testing kits to facilitate PrEP and antiretroviral therapy uptake. Female participants engage in a 30-45 minute counseling session covering HIVST kit distribution and PrEP uptake. Male partners receive an informational video and materials to support linkage to HIV care.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Wits MatCH Research Unit

Durban, KwaZulu-Natal, South Africa

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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