CompletedNot Applicable

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

South Africa1,195 participantsStarted 2019-07-01

Plain-language 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.

Who can participate

Age range16 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Participants Initiating Pre-exposure Prophylaxis During Pregnancy

Timeframe: Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant

Adherence to TDF at 3-months on PrEP

Timeframe: Measured at 3 month follow up visit

Women Initiating Pre-exposure Prophylaxis Post-partum

Timeframe: Percentage of participants initiating pre-exposure prophylaxis at first post-partum to final post-partum visit 12 months after birth

Adherence to TDF at 6 Months Post-partum

Timeframe: Measured at 6-month post-partum visit

Number of Participants With Adherence to TFV-DP at 6-month Visit

Timeframe: Measured at 6-month study visit

Trial details

NCT IDNCT03902418

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

Results submitted2023-12-22

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