NCT03902418

Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women

Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,195 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: —

Summary

The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain subdistrict of the Metro Region (to be identified in conjunction with provincial and local health authorities) Midwife Obstetric Units in Cape Town (n=600 pregnant women per site). The enrolled women will be followed through 12-months post-delivery.

Detailed description

The objectives of the study are to: 1\. Determine the distribution of women across the PrEP cascade: 1. Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP out of all women offered PrEP 2. Evaluate the proportion of pregnant and breastfeeding women who are retained in the PrEP cohort 3. Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP who adhere to PrEP using objective dried blood spot measures and subjective measures of self-reported pill count and adherence 4. Evaluate the proportion of pregnant and breastfeeding women on PrEP (and not on PrEP) who acquire HIV, who transmit HIV to their infant, and who report adverse events 2. Evaluate patient and provider-level factors associated with the PrEP cascade using quantitative and qualitative approaches (including in-depth interviews) 3. Apply an established mathematical model to simulate the impact of improvement in the PrEP cascade on HIV infections averted (maternal and perinatal)

Conditions

• HIV-I Infection

Interventions

Type	Name	Description
DRUG	emtricitabine/tenofovir	Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2019-04-04
• Last updated: 2024-10-23
• Results posted: 2024-03-19

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study