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

January 28, 2026 updated by: Anjuli Wagner, University of Washington

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

17000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Busia, Kenya
        • Busia County Referral Hospital
      • Nairobi, Kenya, MRX5 + 53
        • Kenyatta National Hospital
    • Nandi
      • Kapsabet, Nandi, Kenya
        • Kapsabet County Referral Hospital
    • Trans Nzoia
      • Kitale, Trans Nzoia, Kenya
        • Kitale County Referral Hospital
    • Uasin Gishu County
      • Eldoret, Uasin Gishu County, Kenya
        • Uasin Gishu District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Comparison
Experimental: Implementation strategy package
Package includes a Community of Practice, a quality improvement (QI) practice, and a training & delivery toolkit.
Other: Implementation strategy package
Package includes a Community of Practice, a quality improvement (QI) practice, and a training & delivery toolkit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach
Time Frame: 1 year
Number of pregnant and postpartum MCH clients initiated on PrEP each month
1 year
Adoption (facility)
Time Frame: 1 year
Proportion of facilities per county that have begun offering PrEP in MCH
1 year
Service penetration
Time Frame: 1 year
Number and proportion of pregnant and postpartum maternal child health clinic (MCH) clients who are screened for PrEP
1 year
Adoption (provider)
Time Frame: 1 year
Number, proportion, and representativeness of nurses and HIV testing services (HTS) providers who have begun offering or counseling on PrEP in MCH
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Anjuli Wagner, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00019007
  • R01MH135730 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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