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

Phase 4Enrolling By InvitationNCT06526507

University of Washington17,000 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

17,000

Conditions

Hiv

Interventions

Implementation strategy packageOTHER

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

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (5)

Kapsabet County Referral Hospital

Kapsabet, Nandi, Kenya

Kitale County Referral Hospital

Kitale, Trans Nzoia, Kenya

Uasin Gishu District Hospital

Eldoret, Uasin Gishu County, Kenya

Busia County Referral Hospital

Busia, Kenya

Outcomes

Primary Outcomes

Service penetration

Number and proportion of pregnant and postpartum maternal child health clinic (MCH) clients who are screened for PrEP

Time frame: 1 year

Reach

Number of pregnant and postpartum MCH clients initiated on PrEP each month

Time frame: 1 year

Adoption (provider)

Number, proportion, and representativeness of nurses and HIV testing services (HTS) providers who have begun offering or counseling on PrEP in MCH

Time frame: 1 year

Adoption (facility)

Proportion of facilities per county that have begun offering PrEP in MCH

Time frame: 1 year

Data from ClinicalTrials.gov

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