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Evaluating the Healthy Families PrEP Program for Women at Risk for HIV | Clinical Trials | Clareo Health

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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

NCT06746675•University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

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)

Locations (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Key Dates

Start Date

August 1, 2026

Primary Completion Date

January 1, 2031

Completion Date

January 1, 2032

Last Updated

September 24, 2025

Enrollment

660

ESTIMATED participants

Conditions

HIVPregnancyPre-Exposure Prophylaxis of HIV Infection

Interventions

Healthy Families PrEP Counselling Intervention

DRUG

Contacts

Lynn T Matthews, MD, MPH

CONTACT

617-650-5257 lynnmatthews@uabmc.edu

Patricia M Smith, MSc

CONTACT

9024395214 pmsmith@uabmc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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