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Enrolling by Invitation

NCT Number: NCT06526507

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

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.

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Key information

Conditions

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

Age range

15 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kapsabet County Referral Hospital, Kapsabet, Nandi, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implementation strategy package

Other

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

Primary outcomes

  1. Service penetration

    Time frame: 1 year

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

  2. Reach

    Time frame: 1 year

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

  3. 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

  4. Adoption (facility)

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 29, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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