Optimizing HIV prevention for pregnant and postpartum women in South Africa
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women (SCOPE-PP) in South Africa
This study is testing a new approach to help pregnant and breastfeeding women in South Africa use HIV prevention methods better, to see if it can lower the risk of them getting HIV and passing it to their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 650 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Cape Town) |
| Trial ID | NCT05322629 on ClinicalTrials.gov |
What this trial studies
This study aims to improve HIV prevention among pregnant and breastfeeding women in South Africa by testing a new intervention package that includes pre-exposure prophylaxis (PrEP) and enhanced adherence counseling. The randomized control trial will evaluate the effectiveness and cost-effectiveness of these interventions in addressing barriers to PrEP use. By focusing on high-risk women, the study seeks to reduce maternal HIV acquisition and prevent transmission to infants. The research builds on previous findings regarding the acceptability and feasibility of PrEP in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-negative pregnant women aged 16 years and older who plan to deliver at the study facility and live within 20 kilometers of it.
Not a fit: Patients who are HIV-positive, under 16 years of age, or have psychiatric or medical contraindications to PrEP use will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of HIV among pregnant and postpartum women, thereby preventing mother-to-child transmission.
How similar studies have performed: Other studies have shown promise in using PrEP for HIV prevention in various populations, but this specific approach targeting pregnant and postpartum women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 16 years 2. Plans to deliver at the study facility 3. 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 4. Lives within 20 kilometers of the study facility 5. Without psychiatric or medical contraindications to PrEP use 6. \>20 weeks pregnant 7. Able and willing to consent to study participation. Exclusion Criteria: Individuals not meeting the above criteria will be excluded. -
Where this trial is running
Cape Town
- Gugulethu Midwife Obstetric Unit — Cape Town, South Africa (Recruiting)
Study contacts
- Study coordinator: Dvora L Joseph Davey, PhD
- Email: dvoradavey@ucla.edu
- Phone: 310-701-1526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.