Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya (DADA-LINK)

January 8, 2026 updated by: Kenyatta National Hospital
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The highest global incidence of cervical cancer is in sub-Saharan Africa, and it is the leading cause of cancer mortality among women in Kenya. Barriers to cervical cancer screening and treatment have been identified at the patient-, provider-, and facility-level, demonstrating the need for a multi-strategy approach to enhance cervical cancer control. In this research study, formative qualitative research and clinic mapping processes were conducted with primary care clinics in Nairobi County to select contextually appropriate strategies targeting the primary barriers to cervical cancer screening and linkage to treatment in Nairobi, Kenya. This study seeks to evaluate the implementation and effectiveness of a care package designed to enhance the early detection and treatment of precancerous cervical lesions among women aged 25-49 years in Kenya.

Trained study staff will abstract patient data from existing clinic records to monitor and assess rates of cervical cancer screening and linkage to treatment.

Study staff at the intervention clinics (i.e., care coordinators) will motivate and support clinic staff to adhere to cervical cancer care guidelines. Care coordinators will use a mHealth platform (i.e., WEMA) tailored for use in primary care clinics in Kenya to track patient exit interview responses regarding uptake of HPV self-sampling kits and to support clinic staff by tracking cervical cancer screening, follow-up, and linkage to treatment, when appropriate. WEMA will serve as an information management system in the intervention clinics, providing a data dashboard to track patient follow-up and enable text communication with patients.

Study Type

Interventional

Enrollment (Estimated)

1980

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Millicent Masinde, MBChB, MMed, Fell.Gyn Oncology
  • Phone Number: +254721243740
  • Email: dr.msmillies@gmail.com

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Recruiting
        • Kenyatta National Hospital
        • Contact:
        • Contact:
          • Millicent Masinde, MBChB, MMed, Fell.Gyn Oncology
          • Phone Number: +254721243740
          • Email: masinde@uw.edu
        • Principal Investigator:
          • Rose Kosgei, MBChB,MMed,MSc,Fell.GynOnc,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Women ages 25-49 years

Exclusion Criteria:

  • Pregnant women
  • Women ≤6 weeks postpartum
  • Women already confirmed to have cervical cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary implementation outcome: Cervical cancer screening uptake
Time Frame: 1 day (on the day of clinic visit)
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
Time Frame: within 12 months
Binary endpoint (Yes/No) based on receipt of triage and/or treatment
within 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Communication of HPV test result to patients via mHealth messages
Time Frame: Within 10 days of results being made available
Binary endpoint (Yes/No) based on confirmation of HPV test results being sent to the participant's phone via mhealth application (WEMA).
Within 10 days of results being made available
Secondary effectiveness outcomes: Form of triage and/or treatment received
Time Frame: within 12 months

Receipt of:

a) Triage (any next step not exclusively counseling or receipt of results) (yes/no);
within 12 months
Secondary effectiveness outcomes: Form of triage and/or treatment received
Time Frame: within 12 months
Description: Receipt of: b) Treatment (must be some sort of therapeutic procedure) (yes/no)
within 12 months
Secondary effectiveness outcomes: Form of triage and/or treatment received
Time Frame: within 12 months
Description: Receipt of: c) Triage and treatment (any next step not exclusively counseling or receipt of results; must be some sort of triage or therapeutic procedure) (yes/no)
within 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenyatta National Hospital

Collaborators

National Cancer Institute (NCI)
Emory University
University of Washington
Queen's University
University of Nairobi
Kenya Ministry of Health

Investigators

  • Principal Investigator: Rose J Kosgei, MBChB,MMed,MSc,Fell.GynOnc,PhD, University of Nairobi
  • Principal Investigator: Leslie Johnson, MPH, MLitt, PhD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 25, 2025

First Submitted That Met QC Criteria

June 25, 2025

First Posted (Actual)

July 3, 2025

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P864/11/2023
  • U54CA284036 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

At the end of the project

IPD Sharing Access Criteria

All IPD submitted as part of the trial publication will be accessible

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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