NCT06746675

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

Evaluating Healthy Families PrEP: an Intervention to Promote PrEP Use During Periconception, Pregnancy and Postpartum Periods for Women in Rural Uganda

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Women in Uganda who are planning for pregnancy, pregnant, or postpartum and have a partner living with HIV are vulnerable to acquiring HIV. Adapting this intervention to community clinics and testing effectiveness aligns with global and Ugandan Ministry of Health goals to reduce HIV incidence among women of reproductive age and eliminate perinatal transmission. Additionally, costing analyses will be conducted to determine the cost of implementing HF-PrEP from both payer and societal perspectives. This work will inform future intervention implementation.

Conditions

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

Interventions

Type	Name	Description
DRUG	Healthy Families PrEP Counselling Intervention	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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2031-01-01
• Completion: 2032-01-01
• First posted: 2024-12-24
• Last updated: 2026-03-25

Locations

1 site across 1 country: Uganda