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Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women

NCT03902418 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1195

Last updated 2024-10-23

Study results available
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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.

Conditions

  • HIV-I Infection

Interventions

DRUG

emtricitabine/tenofovir

Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired

Sponsors & Collaborators

Principal Investigators

  • Landon Myer, MD PhD · University of Cape Town

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2024-06-30
Completion
2024-09-30
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03902418 on ClinicalTrials.gov