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

Sponsor
Kenyatta National Hospital
Study ID
NCT07050745
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • DADA LINK — BEHAVIORAL
    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.

Study Details

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).

Key Dates

First listed
Jul 3, 2025
Start date
Dec 1, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,980 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: DADA-LINK Integrated Care Package: HPV Self-Sampling, Care Navigation, and mHealth support
    Intervention facilities will receive the DADA-LINK multi-component integrated care package comprised of HPV self-sampling, care navigation, and mHealth support.
  • No Intervention: Routine standard of care for cervical cancer screening, linkage and treatment
    Clinics randomized to the control arm will continue with usual care practices for cervical cancer screening, triage, and treatment

Primary Outcome Measure

Primary implementation outcome: Cervical cancer screening uptake [ Time Frame: 1 day (on the day of clinic visit) ]

Central Contacts

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