Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women

NCT ID: NCT05322629

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

HIV incidence doubles during pregnancy and postpartum period compared with non-pregnant women, underscoring the urgent need for prevention interventions tailored to high-risk pregnant and breastfeeding women. Incident maternal HIV infections lead to an estimated one-third of all infant HIV infections. South Africa expects over 90,000 infant HIV cases in the next decade; one-third of those can be prevented by eliminating maternal HIV acquisition. Pre-exposure prophylaxis (PrEP) in pregnancy and breastfeeding is safe and effective at preventing HIV. However, PrEP use remains low in pregnancy, and drop precipitously in the postpartum period.

Researchers will test a novel strategy to optimize PrEP in pregnant and postpartum women in South Africa. Our randomized control trial (RCT) is designed to address key barriers to maternal PrEP use and evaluate cost-effectiveness to inform national policy. This trial builds on our earlier work demonstrating the acceptability, feasibility, safety and potential efficacy of a package of interventions including PrEP, enhanced adherence counseling combined with community, differentiated delivery of PrEP for women who want to take PrEP but have difficulties with adherence.

Our team developed and piloted a novel intervention entitled, Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP) that addresses barriers to taking daily PrEP by reducing clinic visit frequency and empowering women to adhere to PrEP. Our team will evaluate SCOPE-PP in a pragmatic RCT of pregnant and postpartum women at risk of HIV acquisition. The study will enroll 750 pregnant women in antenatal care and follow them through 12-months' postpartum. Women in the intervention will be offered rapid PrEP collection with enhanced adherence counseling. Women with poor PrEP continuation and/or adherence who want to continue on PrEP will be offered a differentiated care model of PrEP delivery to de-link PrEP from clinical visits. The primary outcome is PrEP continuation and adherence in postpartum women, measured through drug levels of tenofovir diphosphate. The study aims to: 1) Evaluate the efficacy of the SCOPE-PP intervention on PrEP adherence in pregnant and postpartum women in a RCT; 2) Assess the acceptability and feasibility of integrating SCOPE-PP into ante- and postnatal care using a consolidated framework for implementation research (CFIR); and 3) Estimate the incremental cost effectiveness of SCOPE-PP vs. standard of care per HIV infection and disability-adjusted life-year averted. This research is critical to inform maternal PrEP interventions to eliminate HIV acquisition and transmission.

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PrEP adherence biofeedback

Intervention Type: BEHAVIORAL

Services for women in the intervention arm includes bio-feedback adherence counseling based on urine lateral flow assays of tenofovir to measure adherence with rapid PrEP delivery .

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.

Group Type: ACTIVE_COMPARATOR

Standard of care counseling

Intervention Type: BEHAVIORAL

Adherence counseling based on self report and following national guidelines

Interventions

PrEP adherence biofeedback

Services for women in the intervention arm includes bio-feedback adherence counseling based on urine lateral flow assays of tenofovir to measure adherence with rapid PrEP delivery .

Intervention Type: BEHAVIORAL

Standard of care counseling

Adherence counseling based on self report and following national guidelines

Intervention Type: BEHAVIORAL

Eligibility 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.

-

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Dvora Joseph Davey, PhD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gugulethu Midwife Obstetric Unit

Cape Town, South Africa, South Africa

Countries

South Africa

References

Joseph Davey DL, Dovel K, Cleary S, Khadka N, Mashele N, Silliman M, Mvududu R, Nyemba DC, Coates TJ, Myer L. Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial. BMC Public Health. 2022 Jul 7;22(1):1306. doi: 10.1186/s12889-022-13652-5.

Reference Type: DERIVED

PMID: 35799121 (View on PubMed)

Other Identifiers

3R01HD106862-04S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-21-1770

Identifier Type: -

Identifier Source: org_study_id