HIV, Pre-Exposure Prophylaxis of HIV Infection, Pregnancy
Conditions
Keywords
HIV, pregnancy, Pre-exposure prophylaxis
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.
Interventions
DRUGHealthy 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 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.
Sponsors
Yale University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation - Women who start to use PrEP | 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
| Measure | Time frame | Description |
|---|---|---|
| Women who continue to use PrEP when they become pregnant | Enrolment to 18 months | Investigators will explore secondary outcomes of PrEP adherence patterns over perinatal periods with quarterly blood draws for TFV measurements |
Countries
Uganda
Contacts
CONTACTLynn T Matthews, MD, MPH
CONTACTPatricia M Smith, MSc
PRINCIPAL_INVESTIGATORLynn T Matthews, MD, MPH
Yale University
Outcome results
None listed