Evaluating the Healthy Families PrEP Program for Women at Risk for HIV (HFPT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; HIV; Pre-Exposure Prophylaxis of HIV Infection
• Intervention / Treatment: Drug: Healthy Families PrEP Counselling Intervention

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 Type: Interventional
• Enrollment (Estimated): 660
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia M Smith, MSc; Phone Number: 9024395214; Email: pmsmith@uabmc.edu
• Study Contact Backup: Name: Lynn T Matthews, MD, MPH; Phone Number: 617-650-5257; Email: lynn.matthews@yale.edu

Study Locations

• Uganda
  • Mbarara, Uganda
    • Mbarara University of Science and Technology
    • Contact: Esther C Atukunda, PhD; Phone Number: 256 702 949832; Email: estheratukunda@gmail.com
    • Sub-Investigator: Esther C Atukunda, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: Standard of care PrEP services for perinatal women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP initiation - Women who start to use PrEP	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.	Enrolment to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Lynn T Matthews, MD, MPH, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HIV; pregnancy; Pre-exposure prophylaxis
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 2000041445; IRB-300013932 (Other Identifier: UAB); R01MH134680 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No