Evaluating the Healthy Families PrEP Program for Women at Risk for HIV (HFPT)

The University of Alabama at Birmingham

Status: Begins enrollment in 5 months

Conditions: Pre-Exposure Prophylaxis of HIV Infection; HIV; Pregnancy

Treatments: Drug: Healthy Families PrEP Counselling Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06746675

R01MH134680 (U.S. NIH Grant/Contract)

IRB-300013932

Details and patient eligibility

About

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.

Full 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.

Enrollment: 660 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

660 participants in 2 patient groups

Healthy Families PrEP Counselling Intervention

Active Comparator group

Description:

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.

Treatment:

Drug: Healthy Families PrEP Counselling Intervention

Standard of care PrEP services for perinatal women

No Intervention group