PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implementation strategy package.
- Who it may be relevant to
- Registry conditions: Hiv. Basic parameters: 15 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics for Pregnant and Postpartum Women
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.
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
- Other Implementation strategy package
Package includes a Community of Practice, a quality improvement (QI) practice, and a training \& delivery toolkit.
Primary outcome measures
- Service penetration [Time frame: 1 year]
- Reach [Time frame: 1 year]
- Adoption (provider) [Time frame: 1 year]
- Adoption (facility) [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Kenya · 5 centers
- Kapsabet County Referral Hospital — Kapsabet
- Kitale County Referral Hospital — Kitale
- Uasin Gishu District Hospital — Eldoret
- Busia County Referral Hospital — Busia
- Kenyatta National Hospital — Nairobi
Identifiers
NCT: NCT06526507 · STUDY00019007 · R01MH135730