PrEP Implementation for Mothers in Antenatal Care

• Status: Recruiting
• Trial end date: 2021-04-01
• Target enrollment: 4000
• Participant gender: Female

Summary

In a region with 15-20% HIV prevalence, an estimated 20% of HIV-uninfected women could have HIV exposures in pregnancy. In a theoretical scenario of perfect PrEP coverage, all women at risk receive PrEP while no women not at HIV risk receive PrEP (Figure 4). With mandatory PrEP given to all women (similar to the approaches used for malaria prophylaxis), all women at risk would be covered but many women not at risk receive unnecessary PrEP. Our premise is that a targeted PrEP model may be closer to perfect coverage than a universal offer/self-select model. Implementing targeted PrEP through strategies that include facilitation of partner testing with self-tests could add HIV prevention benefit by increasing partner HIV diagnosis and treatment similar to the initiation of PrEP among pregnant women. By implementing these strategies and measuring uptake, process, and HIV incidence, we can inform the best health systems model for PrEP delivery in pregnancy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: Kenyatta National Hospital; National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

• Eligibility for enrollment will include age ≥15 years

• Pregnant at any gestational age

• Tuberculosis negative

• Plans to reside in area for at least one year postpartum

• Plans to receive postnatal and infant care at the study facility

• Not currently enrolled in any other studies.

Exclusion Criteria:

• HIV+ at time of enrollment