NCT06526507

PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics

PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics for Pregnant and Postpartum Women

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17,000 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This project aims to develop a community of practice; then test a combination of community of practice, quality improvement, and a training toolkit, to enhance implementation and clinical outcomes; and identify patterns attributes associated with successful implementation.

Detailed description

Aim 1: To develop and determine the impact of a Community of Practice (CoP) on stakeholder and healthcare worker engagement and knowledge of integrated pre-exposure prophylaxis (PrEP) delivery. Aim 2: To determine the impact of a 3-component scale-up package on implementation outcomes and PrEP patient outcomes among pregnant and postpartum populations. Aim 2a: To determine the impact of the scale-up package on PrEP implementation outcomes, including reach, service penetration, adoption (primary outcomes), and PrEP fidelity and maintenance (secondary outcomes). Aim 2b: To determine the impact of the scale-up package on PrEP patient outcomes, including PrEP initiation and continuation. Aim 3: To identify difference-making bundles of facility- and regional-level attributes and implementation processes that influence reach, fidelity implementation, and maintenance.

Conditions

• Hiv

Interventions

Type	Name	Description
OTHER	Implementation strategy package	Package includes a Community of Practice, a quality improvement (QI) practice, and a training \& delivery toolkit.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2024-07-29
• Last updated: 2026-01-30

Locations

5 sites across 1 country: Kenya