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NCT Number: NCT06746675

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

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.

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Key information

Conditions

HIV Pre-Exposure Prophylaxis of HIV Infection Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mbarara University of Science and Technology

Mbarara, Uganda

Location contact

Esther C Atukunda, PhD

CONTACT

[email protected]

256 702 949832

Esther C Atukunda, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. PrEP initiation - Women who start to use PrEP

    Time frame: 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 outcomes

  1. Women who continue to use PrEP when they become pregnant

    Time frame: Enrolment to 18 months

    Investigators will explore secondary outcomes of PrEP adherence patterns over perinatal periods with quarterly blood draws for TFV measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Lynn T Matthews, MD, MPH

CONTACT

[email protected]

617-650-5257

Patricia M Smith, MSc

CONTACT

[email protected]

9024395214

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: HFPT

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Dec 24, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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