Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women

Hiv Clinical Trial

— SCOPE-PP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322629
• Other study ID #: R01HD106862
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: Dvora L Joseph Davey, PhD
• Phone: 310-701-1526
• Email: dvoradavey[@]ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: July 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Hiv

Intervention

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 .
• Standard of care counseling
Adherence counseling based on self report and following national guidelines

Locations

Country	Name	City	State
South Africa	Gugulethu Midwife Obstetric Unit	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to PrEP at 6 months after PrEP initiation	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
Primary	Adherence to PrEP at 15 months after PrEP initiation	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	HIV incidence (maternal and infant)	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)
Secondary	Adverse events	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)