Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya
DADA-LINK
2 other identifiers
interventional
1,980
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2025
CompletedFirst Posted
Study publicly available on registry
July 3, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 12, 2026
January 1, 2026
1 year
June 25, 2025
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary implementation outcome: Cervical cancer screening uptake
Binary endpoint (Yes/No) based on completion of the HPV self-sampling (return of the self-collected HPV swab) or having conducted VIA
1 day (on the day of clinic visit)
Primary effectiveness outcome: Receipt of triage and/or treatment
Binary endpoint (Yes/No) based on receipt of triage and/or treatment
within 12 months
Secondary Outcomes (4)
Secondary effectiveness outcomes: Form of triage and/or treatment received
within 12 months
Secondary effectiveness outcomes: Form of triage and/or treatment received
within 12 months
Secondary effectiveness outcomes: Form of triage and/or treatment received
within 12 months
Communication of HPV test result to patients via mHealth messages
Within 10 days of results being made available
Study Arms (2)
DADA-LINK Integrated Care Package: HPV Self-Sampling, Care Navigation, and mHealth support
EXPERIMENTALIntervention facilities will receive the DADA-LINK multi-component integrated care package comprised of HPV self-sampling, care navigation, and mHealth support.
Routine standard of care for cervical cancer screening, linkage and treatment
NO INTERVENTIONClinics randomized to the control arm will continue with usual care practices for cervical cancer screening, triage, and treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- \- Women ages 25-49 years
You may not qualify if:
- Pregnant women
- Women ≤6 weeks postpartum
- Women already confirmed to have cervical cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kenyatta National Hospitallead
- Emory Universitycollaborator
- University of Washingtoncollaborator
- National Cancer Institute (NCI)collaborator
- Kenya Ministry of Healthcollaborator
- Queen's Universitycollaborator
- University of Nairobicollaborator
Study Sites (1)
Kenyatta National Hospital
Nairobi, Kenya
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rose J Kosgei, MBChB,MMed,MSc,Fell.GynOnc,PhD
University of Nairobi
- PRINCIPAL INVESTIGATOR
Leslie Johnson, MPH, MLitt, PhD
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2025
First Posted
July 3, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- At the end of the project
- Access Criteria
- All IPD submitted as part of the trial publication will be accessible
All IPD that underlie results in a publication