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

Not Applicable

Not yet recruiting

• Conditions: HIV; Pregnancy; Pre-Exposure Prophylaxis of HIV Infection
• Interventions: Drug: Healthy Families PrEP Counselling Intervention

• Registration Number: NCT06746675
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-24
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-19
• Last Update Posted: 2025-09-24
• Study Start: 2026-08-01
• Primary Completion: 2031-01
• Study Completion: 2032-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 660

Inclusion Criteria

• Age ≥18 years and ≤45 years
• Willing and able to participate in the informed consent process
• HIV-uninfected by self-report, but have indications for HIV prevention strategies, such as having a partner living with HIV or who they think may be living with HIV
• Reporting pregnancy in the past 2 years, and/or desire to have a child in the next year, and/or have a partner who desires to a child in the next year
• Fluent in English or local language
• Living within 60km of a healthcare center included in the trial
• HIV Negative (onsite rapid testing)

Exclusion Criteria

• Not reporting pregnancy in the past 2 years
• Does not report personal or partner desire to have a child in the next year
• Not willing to provide informed consent
• Not able to communicate in English or local language
• Does not report pregnancy in the past 2 years and/or does not report personal or partner desire to have a child in the next year
• Not able to communicate in English or local language
• Living beyond 60km of the trial healthcare center
• HIV-positive (onsite rapid testing)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Families PrEP Counselling Intervention	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.

Primary Outcome Measures

Name	Time	Method
PrEP initiation - Women who start to use PrEP	Enrolment to 6 months	The primary effectiveness outcome will be proportion of women at 6 months with intracellular TFV-DP concentration consistent with taking at least 4 doses per week.

Secondary Outcome Measures

Name	Time	Method
Women who continue to use PrEP when they become pregnant	Enrolment to 18 months	Investigators will explore secondary outcomes of PrEP adherence patterns over perinatal periods with quarterly blood draws for TFV measurements

Trial Locations

Locations (1)

Mbarara University of Science and Technology; 🇺🇬 Mbarara, Uganda