Clinical trial NCT06746675: Evaluating the Healthy Families PrEP Program for Women At Risk for HIV
Official title: Evaluating Healthy Families PrEP: an Intervention to Promote PrEP Use During Periconception, Pregnancy and Postpartum Periods for Women in Rural Uganda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Pregnancy
Pre-Exposure Prophylaxis of HIV Infection
Keywords: HIV
pregnancy
Pre-exposure prophylaxis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-12-24
Enrollment: 660
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 criteria: 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)

Primary outcomes:
measure: Measuring PrEP adherence among number of participants in study who choose PrEP
timeFrame: 6 months
Secondary outcomes:
measure: Measuring PrEP adherence among the number of participants who become pregnant
timeFrame: 3 months, 6 months, 9 months, 12 months, 15 months, 18 months
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: University of Alabama at Birmingham
name: Lynn T Matthews, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: