Evaluating the Healthy Families PrEP Program for Women at Risk for HIV

Sponsor
Yale University
Study ID
NCT06746675
Status
Not Yet Recruiting

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Conditions

  • HIV
  • Pre-Exposure Prophylaxis of HIV Infection
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Healthy Families PrEP Counselling Intervention — DRUG
    Healthy Families-PrEP intervention with HIV-uninfected women with plans for pregnancy in the next year and concerns about or exposure to HIV. Session 1 focuses on providing information about HIV prevention in the context of reproductive goals (using tools with locally developed images), increasing motivation for behavior change, and developing a safer conception plan (e.g., PrEP uptake, PrEP adherence, couples-based counselling and testing, delaying condomless sex until partner serostatus known and, if living with HIV, virally suppressed). Sessions 2 and 3 (conducted at 1 and 3 months) review the safer conception plan and revise as needed (e.g., changes in readiness to initiate PrEP, partner serostatus knowledge) and engaging in problem-solving barriers (including structural) to plan execution, communication skills training, and motivational strategies for successful plan execution. Participants receive quarterly adherence counseling using tools developed by this team.

Study Details

Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy. They will now adapt the intervention to community clinics and postpartum women and test the intervention. The goal is to reduce HIV incidence among women and children.

Key Dates

First listed
Dec 24, 2024
Start date
Aug 31, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2032

Study Design

Enrollment
660 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Healthy Families PrEP Counselling Intervention
    Intervention Health Care Centers will offer the guideline-based PrEP standard of care plus trained staff will conduct the 3-session Healthy Families-PrEP intervention with HIV-uninfected women with plans for pregnancy in the next year and concerns about or exposure to HIV.
  • No Intervention: Standard of care PrEP services for perinatal women

Primary Outcome Measure

PrEP initiation - Women who start to use PrEP [ Time Frame: Enrolment to 6 months ]

Central Contacts

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