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

NCT06746675 | Not Yet Recruiting DMC

• 3 other identifiers: 2000041445R01MH134680IRB-300013932
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Pregnancy; Pre-Exposure Prophylaxis of HIV Infection

Keywords

HIV; pregnancy; Pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Women who continue to use PrEP when they become pregnant

  Enrolment to 18 months

Study Arms (2)

Healthy Families PrEP Counselling Intervention

ACTIVE COMPARATOR

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

Standard of care PrEP services for perinatal women

NO INTERVENTION

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.

Healthy Families PrEP Counselling Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women with pregnancy intentions
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Study Officials

• Lynn T Matthews, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn T Matthews, MD, MPH

CONTACT

617-650-5257; lynn.matthews@yale.edu

Patricia M Smith, MSc

CONTACT

9024395214; pmsmith@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)