Phase 4
Completed N=200
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
Source: ClinicalTrials.gov NCT03826199 ↗Enrolled (actual)
200
Serious AEs
5.0%
Results posted
Mar 2023
Primary outcomePrimary: PrEP Retention — 100 participants
◆ Published Evidence
Established
77citations · ~19 / year
Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa.
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.
Linked Publications (5)
-
Early pre-exposure prophylaxis (PrEP) initiation and continuation among pregnant and postpartum women in antenatal care in Cape Town, South Africa.
-
Maternal PrEP Use in HIV-Uninfected Pregnant Women in South Africa: Role of Stigma in PrEP Initiation, Retention and Adherence.
-
"I had Made the Decision, and No One was Going to Stop Me" -Facilitators of PrEP Adherence During Pregnancy and Postpartum in Cape Town, South Africa.
-
Evaluating the use of oral pre-exposure prophylaxis among pregnant and postpartum adolescent girls and young women in Cape Town, South Africa.
-
Psychosocial determinants of pre-exposure prophylaxis use among pregnant adolescent girls and young women in Cape Town, South Africa: A qualitative study.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.