Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women (SCOPE-PP) in South Africa

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Healthy Volunteers: t
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• 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.

Locations
Other Locations
South Africa
Gugulethu Midwife Obstetric Unit
RECRUITING
Cape Town
Contact Information
Primary
Dvora L Joseph Davey, PhD
dvoradavey@ucla.edu
310-701-1526
Time Frame
Start Date: 2022-09-07
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 650
Treatments
Experimental: Intervention (enhanced PrEP HIV biofeedback)
Women in the intervention arm (n=375) will receive enhanced PrEP bio-feedback adherence counseling:~* Real-time novel immunoassay using urine that measures tenofovir and enhanced bio-feedback counseling. The novel urine assay shows tenofovir concentrations if PrEP is taken in the past 48 hours thereby enabling counselors to provide feedback on adherence levels, immediately.~* Enhanced counseling on recent adherence levels~* Rapid PrEP collection~In second randomization at 6m, women on PrEP with poor adherence or continuation, will be offered differentiated PrEP delivery in the community or in the clinic. The study will follow these participants for 15m to assess longer term PrEP continuation and adherence.
Active_comparator: Standard of care
Women in the standard of care arm (n=375) will receive facility-based PrEP and monthly HIV testing in pregnancy and quarterly in postpartum. PrEP prescriptions and HIV testing will be provided according to the national PrEP guidelines. The women will be followed through 6m postpartum for the first randomization and through 15m with the standard of care for the second randomization.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Cape Town

This content was sourced from clinicaltrials.gov