PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics
- Conditions
- Hiv
- Interventions
- Other: Implementation strategy package
- Registration Number
- NCT06526507
- Lead Sponsor
- University of Washington
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 17000
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)
- N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Implementation strategy package Implementation strategy package Package includes a Community of Practice, a quality improvement (QI) practice, and a training \& delivery toolkit.
- Primary Outcome Measures
Name Time Method Reach 1 year Number of pregnant and postpartum MCH clients initiated on PrEP each month
Adoption (facility) 1 year Proportion of facilities per county that have begun offering PrEP in MCH
Service penetration 1 year Number and proportion of pregnant and postpartum maternal child health clinic (MCH) clients who are screened for PrEP
Adoption (provider) 1 year Number, proportion, and representativeness of nurses and HIV testing services (HTS) providers who have begun offering or counseling on PrEP in MCH
- Secondary Outcome Measures
Name Time Method