Official Title
Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya
Brief Summary

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

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.

Not yet recruiting
Cervical Cancer
Cervical Cancer Screening
Cervical Cancer Follow up and Linkage to Treatment

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.

Eligibility Criteria

Inclusion Criteria:

- Women ages 25-49 years

Exclusion Criteria:

- Pregnant women

- Women ≤6 weeks postpartum

- Women already confirmed to have cervical cancer

Eligibility Gender
Female
Eligibility Age
Minimum: 25 Years ~ Maximum: 49 Years
Countries
Kenya
Locations

Kenyatta National Hospital
Nairobi, Kenya

Investigator: Agnes K Karume, MBChB, MBA, MPH
Contact: +254715181283
karumeagnes@gmail.com

Investigator: Rose Kosgei, MBChB,MMed,MSc,Fell.GynOnc,PhD

Contacts

Agnes K Karume, MBChB, MBA, MPH
+254715181283
karumeagnes@gmail.com

Millicent Masinde, MBChB, MMed, Fell.Gyn Oncology
+254721243740
dr.msmillies@gmail.com

Kenyatta National Hospital
NCT Number
Keywords
Cervical Cancer
Screening
M-health
linkage to treatment
VIA
HPV
HPV self-sampling
MeSH Terms
Uterine Cervical Neoplasms