Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study) (PrEP-PP)

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 4

Conditions: Hiv

Treatments: Behavioral: Counselling on PrEP in antenatal and postnatal care; Drug: TDF-FTC

Study type: Interventional

Funder types: Other

Identifiers

NCT03826199

K01TW011187

Details and patient eligibility

About

The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade.

Enrollment: 200 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal care protocol in this setting), confirmed with a 4th generation antigen HIV test at study enrollment
2. No previous exposure triple-drug antiretroviral therapy
3. Age 18 years or older
4. Lives within 20 kilometers of a clinic
5. Without psychiatric or medical contraindications to PrEP use
6. Able to provide informed consent for research

Exclusion criteria

Failure to meet any of the inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)