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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06526507
Enrollment
17000
Registered
2024-07-29
Start date
2025-01-01
Completion date
2028-12-31
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Brief 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.

Interventions

OTHERImplementation strategy package

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

Sponsors

University of Washington
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Difference in differences design, also known as a controlled pre-post design

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Service penetration1 yearNumber and proportion of pregnant and postpartum maternal child health clinic (MCH) clients who are screened for PrEP
Reach1 yearNumber of pregnant and postpartum MCH clients initiated on PrEP each month
Adoption (provider)1 yearNumber, proportion, and representativeness of nurses and HIV testing services (HTS) providers who have begun offering or counseling on PrEP in MCH
Adoption (facility)1 yearProportion of facilities per county that have begun offering PrEP in MCH

Countries

Kenya

Contacts

PRINCIPAL_INVESTIGATORAnjuli Wagner, PhD

University of Washington

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026