Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hiv
- Sponsor
- University of California, Los Angeles
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- PrEP Retention
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Dvora Joseph Davey, PhD, MPH
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •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
- •No previous exposure triple-drug antiretroviral therapy
- •Age 18 years or older
- •Lives within 20 kilometers of a clinic
- •Without psychiatric or medical contraindications to PrEP use
- •Able to provide informed consent for research
Exclusion Criteria
- •Failure to meet any of the inclusion criteria
Outcomes
Primary Outcomes
PrEP Retention
Time Frame: 18 months
number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP
PrEP Adherence
Time Frame: 3 months
number of women taking PrEP who have \>80 percent levels at \>40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)
Secondary Outcomes
- PrEP Initiation(18 months)
- PrEP Adherence (Peri-sexual)(3 months)
- PrEP Adherence (Subjective, Self-reported)(3 months)