NCT03902418Completed
Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women
Source: ClinicalTrials.gov · Last updated 23 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1195 (actual)
- First submitted
- 10 Jan 2019
- Start date
- 1 Jul 2019
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- University of California, Los Angeles
- NCT number
- NCT03902418
What you commit to
- Study type: Observational
- Participants enrolled: 1195
- From 1 Jul 2019 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent enrollment in another HIV-1 vaccine or prevention trial;
Other illness
- receipt of TB treatment in the past 30 days; history of renal disease;
- 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.
Other
- medical hospitalization in the past year for any reason;
- exhibiting psychotic symptoms (including hallucinations, suicidal or homicidal ideation, or violent behavior),
Who the study is looking for
- \>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
Age in the registry: 16 years to - · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cape Town Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.