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Not yet recruiting NCT06746675

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

No phase Interventional HIV Pregnancy Pre-Exposure Prophylaxis of HIV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy Families PrEP Counselling Intervention.
Who it may be relevant to
Registry conditions: HIV, Pregnancy, Pre-Exposure Prophylaxis of HIV Infection. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Uganda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

  • Drug Healthy Families PrEP Counselling Intervention
    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

Primary outcome measures

  • PrEP initiation - Women who start to use PrEP [Time frame: Enrolment to 6 months]
Secondary outcome measures (1)
  • Women who continue to use PrEP when they become pregnant [Time frame: Enrolment to 18 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Uganda · 1 center
  • Mbarara University of Science and Technology — Mbarara

Identifiers

NCT: NCT06746675 · 2000041445 · R01MH134680 · IRB-300013932

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗