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

University of Washington

Status and phase: Invitation-only; Phase 4

Conditions: Hiv

Treatments: Other: Implementation strategy package

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06526507

R01MH135730 (U.S. NIH Grant/Contract)

STUDY00019007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17,000 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Health Care Workers:

• work at a facility involved in study
• involved in PrEP service delivery
• >=18 years

Clients:

• female clients seeking health services at study facilities
• pregnant or postpartum
• >15 years (includes emancipated minors)

Exclusion criteria

• N/A

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17,000 participants in 2 patient groups

Implementation strategy package

Experimental group

Description:

Package includes a Community of Practice, a quality improvement (QI) practice, and a training \& delivery toolkit.

Treatment:

Other: Implementation strategy package

Comparison

No Intervention group