N/A
N=1,195
Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
HIV-I Infection
Bottom Line
View on ClinicalTrials.gov: NCT03902418 ↗Enrolled (actual)
1,195
Serious AEs
5.6%
Results posted
Mar 2024
Primary outcome: Primary: Participants Initiating Pre-exposure Prophylaxis During Pregnancy — 1089 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- emtricitabine/tenofovir (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of California, Los Angeles
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Initiating Pre-exposure Prophylaxis During Pregnancy |
1089 | — |
| PRIMARY Adherence to TDF at 3-months on PrEP |
256 | — |
| PRIMARY Women Initiating Pre-exposure Prophylaxis Post-partum |
1009 | — |
| PRIMARY Adherence to TDF at 6 Months Post-partum |
51 | — |
| PRIMARY Number of Participants With Adherence to TFV-DP at 6-month Visit |
86 | — |
| SECONDARY PrEP Initiation Among Those With STI POC Testing vs Syndromic Management |
89; 84 | — |
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.
Eligibility Criteria
Inclusion Criteria
- >16 years of age,
- confirmed HIV-negative (using 2 rapid tests,
- confirmed with a 4th generation antigen HIV test;
- lives within 20 km. of the clinic;
- confirmed to be pregnant;
- without psychiatric or medical contraindications to PrEP
Exclusion Criteria
- Concurrent enrollment in another HIV-1 vaccine or prevention trial;
- medical hospitalization in the past year for any reason;
- receipt of TB treatment in the past 30 days; history of renal disease;
- exhibiting psychotic symptoms (including hallucinations, suicidal or homicidal ideation, or violent behavior),
- currently or history of taking anti-psychotic medications;
- positive Hepatitis B surface antigen test on screening;
- history of bone fracture not related to trauma;
- any other medical, psychiatric, or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study.
Data sourced from ClinicalTrials.gov (NCT03902418). 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.