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

October 30, 2025 updated by: Dvora Joseph Davey, PhD, MPH, University of California, Los Angeles

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • South Africa
      • Cape Town, South Africa, South Africa
        • Gugulethu Midwife Obstetric Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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 .
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.
Behavioral: Standard of care counseling
Adherence counseling based on self report and following national guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to PrEP at 6 months after PrEP initiation
Time Frame: 6 months following study enrollment
Number and proportion of participants who have objective levels of PrEP adherence after 6 months using urine tenofovir test (rapid test of tenofovir, a metabolite of PrEP; yes/no) and blood test (dried blood spots measuring tenofovir diphosphate; categorical measure) comparing the intervention to standard of care arms.
6 months following study enrollment
Adherence to PrEP at 15 months after PrEP initiation
Time Frame: 15 months following study enrollment
Number and proportion of participants who have objective levels of PrEP adherence after 15 months using urine tenofovir test (rapid test of tenofovir, a metabolite of PrEP; yes/no) and blood test (dried blood spots measuring tenofovir diphosphate; categorical measure) comparing the intervention to standard of care arms.
15 months following study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV incidence (maternal and infant)
Time Frame: Any time during study follow up (through 15 months after enrollment)
Number of new HIV infections in women and infants by study arm (diagnosed in study or found in participant medical records)
Any time during study follow up (through 15 months after enrollment)
Adverse events
Time Frame: Any time during study follow up (through 15 months after enrollment)
Number of participants with adverse events as assessed by CTCAE v4.0, by study arm and treatment exposure
Any time during study follow up (through 15 months after enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Actual)

May 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-21-1770
  • 3R01HD106862-04S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study team will share de-identified data upon request

IPD Sharing Time Frame

1 year following study start through 1 year following study end

IPD Sharing Access Criteria

Email PI with full request: dvoradavey@ucla.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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