Phase 4
N=200
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
Hiv
Bottom Line
View on ClinicalTrials.gov: NCT03826199 ↗Enrolled (actual)
200
Serious AEs
5.0%
Results posted
Mar 2023
Primary outcome: Primary: PrEP Retention — 100 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- TDF-FTC (Drug); Counselling on PrEP in antenatal and postnatal care (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of California, Los Angeles
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PrEP Retention |
100 | — |
| PRIMARY PrEP Adherence |
25 | — |
| SECONDARY PrEP Initiation |
180 | — |
| SECONDARY PrEP Adherence (Peri-sexual) |
25 | — |
| SECONDARY PrEP Adherence (Subjective, Self-reported) |
118 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03826199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.