Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya

Summary

This study aims to test the use of a multi-component care strategy (DADA LINK) designed to improve cervical cancer screening and linkage to treatment. The duration of the trial is 12 months, with a 6-month follow-up period to evaluate intervention costs and measure maintenance of the care strategies. Study staff at each clinic will abstract data on cervical cancer screening and triage/treatment. Clinics randomized to the intervention arm will have care coordinators who motivate clinic staff to adhere to cervical cancer care guidelines, conduct patient exit surveys to assess intervention fidelity, and support care coordination through use of the mHealth platform (WEMA).

Conditions

• Cervical Cancer
• Cervical Cancer Screening
• HPV DNA

Interventions

BEHAVIORAL

DADA LINK

Intervention facilities will receive the DADA-LINK intervention, comprised of: 1. HPV self-sampling: We will provide clinics with HPV self-sampling kits to administer to eligible patients. 2. Care Navigation: One study-supported non-physician care navigator will be assigned to each clinic to support the clinic staff. These trained individuals will be responsible for managing data collection through the mHealth platform to aid the coordination of services and for motivating the clinic staff to adhere to cervical cancer care guidelines. 3. mHealth support for cervical cancer screening and treatment linkage: The WEMA application is a low-cost and highly adaptable open-source application designed for cervical cancer data monitoring and evaluation. Relevant patient information and data on uptake of cervical cancer screening and triage/treatment will be entered in the WEMA platform. The platform will additionally be used to send text messages to patients to facilitate clinic attendance.

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Kenya Ministry of Health

  collaborator OTHER_GOV

• Queen's University

  collaborator OTHER

• University of Nairobi

  collaborator OTHER

• Kenyatta National Hospital

  lead OTHER_GOV

Principal Investigators

• Rose J Kosgei, MBChB,MMed,MSc,Fell.GynOnc,PhD · University of Nairobi

• Leslie Johnson, MPH, MLitt, PhD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Kenya

Study Locations