Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women

NCT05322629 | Active Not Recruiting DMC

• 2 other identifiers: IRB-21-17703R01HD106862-04S1
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv

Keywords

pregnant; postpartum; prevention of mother to child transmission; PrEP; pre-exposure prophylaxis; HIV prevention; breastfeeding

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• HIV incidence (maternal and infant)

  Any time during study follow up (through 15 months after enrollment)

• Adverse events

  Any time during study follow up (through 15 months after enrollment)

Study Arms (2)

Intervention (enhanced PrEP HIV biofeedback)

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

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

Interventions

PrEP adherence biofeedback 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 .

Intervention (enhanced PrEP HIV biofeedback)

Standard of care counseling BEHAVIORAL

Adherence counseling based on self report and following national guidelines

Standard of care

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Individuals not meeting the above criteria will be excluded.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Cape Town: collaborator

Study Sites (1)

Gugulethu Midwife Obstetric Unit

Cape Town, South Africa, South Africa

Location

Related Publications (1)

• 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.

  PMID: 35799121 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Breast Feeding

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In a randomized control trial of 750 women, the study team will evaluate: (1) PrEP continuation (missing \<1 PrEP collections) and (2) PrEP adherence per drug levels of TFV-DP at 6m follow up. Pregnant women who are on PrEP or initiate PrEP at baseline visit will be recruited and screened for eligibility during their routine antenatal services at gestational \>25 weeks using a set script for screening and a brief description of the study. Study staff will obtain written informed consent immediately following screening.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 12, 2022
• Study Start: September 7, 2022
• Primary Completion: May 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year following study start through 1 year following study end
• Access Criteria: Email PI with full request: dvoradavey@ucla.edu

Locations

ZA (1)