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 range

16 Years

Sex

FEMALE

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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