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

NCT06526507 | Enrolling By Invitation Phase 4

• 2 other identifiers: STUDY00019007R01MH135730
• Study Type: interventional
• Target: 17,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Hiv

Outcome Measures

Primary Outcomes (4)

• Service penetration

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

  1 year

• Reach

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

  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

  1 year

• Adoption (facility)

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

  1 year

Study Arms (2)

Implementation strategy package

EXPERIMENTAL

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

Other: Implementation strategy package

Comparison

NO INTERVENTION

Interventions

Implementation strategy package OTHER

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

Implementation strategy package

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

Kapsabet County Referral Hospital

Kapsabet, Nandi, Kenya

Location

Kitale County Referral Hospital

Kitale, Trans Nzoia, Kenya

Location

Uasin Gishu District Hospital

Eldoret, Uasin Gishu County, Kenya

Location

Busia County Referral Hospital

Busia, Kenya

Location

Kenyatta National Hospital

Nairobi, MRX5 + 53, Kenya

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Anjuli Wagner, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Global Health

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

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

KE (5)