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

N/ANot Yet RecruitingNCT06746675

University of Alabama at Birmingham660 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

660

Conditions

HIV Pregnancy Pre-Exposure Prophylaxis of HIV Infection

Interventions

Healthy Families PrEP Counselling InterventionDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Enrolment to 6 months

Secondary Outcomes

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

Time frame: Enrolment to 18 months

Central Contacts

Lynn T Matthews, MD, MPH

CONTACT

617-650-5257 lynnmatthews@uabmc.edu

Patricia M Smith, MSc

CONTACT

9024395214 pmsmith@uabmc.edu

Data from ClinicalTrials.gov

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