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

NCT ID: NCT06746675

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-31
• Study Completion Date: 2032-01-31

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.

Conditions

HIV; Pregnancy; Pre-Exposure Prophylaxis of HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Healthy Families PrEP Counselling Intervention

Intervention Type: 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.

Standard of care PrEP services for perinatal women

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Lynn T. Matthews

Professor of Medicine Medicine, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynn T Matthews, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Mbarara University of Science and Technology

Mbarara, , Uganda

Countries

Uganda

Central Contacts

Lynn T Matthews, MD, MPH

Role: CONTACT

lynnmatthews@uabmc.edu

617-650-5257

Patricia M Smith, MSc

Role: CONTACT

pmsmith@uabmc.edu

9024395214

Facility Contacts

Esther C Atukunda, PhD

Role: primary

estheratukunda@gmail.com

256 702 949832

Other Identifiers

R01MH134680

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300013932

Identifier Type: -

Identifier Source: org_study_id