NCT05322629Active, not recruiting
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women (SCOPE-PP) in South Africa
Source: ClinicalTrials.gov · Last updated 3 Nov 2025
Brief summary (registry, in English)
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily antiretroviral pill that is both safe and effective for preventing HIV in pregnant and breastfeeding mothers and 2)) enhanced adherence counseling combined with differentiated deliver of community PrEP delivery for women who have difficulties with regular PrEP use. Our study will be among the first ever to evaluate the efficacy and cost-effectiveness of a PrEP intervention among pregnant and postpartum women and will play a key role in informing maternal PrEP interventions to eliminate HIV acquisition and transmission to partners and their infants.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 650 (estimated)
- First submitted
- 24 Mar 2022
- Start date
- 7 Sept 2022
- Primary completion date
- 30 May 2025
- Lead sponsor
- University of California, Los Angeles
- Diseases
- HIV
- NCT number
- NCT05322629
What you commit to
- Study type: Interventional
- Planned participants: 650
- From 7 Sept 2022 to the primary completion date, 30 May 2025
- 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.
Other
- Individuals not meeting the above criteria will be excluded.
- \-
Who the study is looking for
- Age ≥ 16 years
- Plans to deliver at the study facility
- Documented HIV-negative according to two finger prick rapid tests (per national protocol for routine antenatal care) and confirmed with a 4th generation antigen HIV test
- Lives within 20 kilometers of the study facility
- Without psychiatric or medical contraindications to PrEP use
- \>20 weeks pregnant
- Able and willing to consent to study participation.
Age in the registry: 16 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gugulethu Midwife Obstetric Unit 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.