Accelerating Adoption of Patient-centered Cervical Cancer Screening and Treatment Linkage in Kenya
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-49
SponsorKenyatta National Hospital
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Pregnant women
Women ≤6 weeks postpartum
Women already confirmed to have cervical cancer
Trial design
Design model
Parallel
Treatments tested in this trial
DADA LINK
BehavioralIntervention 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.
Treatment groups
1,980 Participants
are divided into 2 treatment groupsGroup A: DADA-LINK Integrated Care Package: HPV Self-Sampling, Care Navigation, and mHealth supportExperimental treatment 1 intervention
Group B: Routine standard of care for cervical cancer screening, linkage and treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
1 day (on the day of clinic visit)2
Primary effectiveness outcome: Receipt of triage and/or treatment
Binary endpoint (Yes/No) based on receipt of triage and/or treatment
Time frame
within 12 monthsSecondary outcomes
1
Secondary effectiveness outcomes: Form of triage and/or treatment received
Receipt of: a) Triage (any next step not exclusively counseling or receipt of results) (yes/no);
Time frame
within 12 months2
Secondary effectiveness outcomes: Form of triage and/or treatment received
Description: Receipt of: b) Treatment (must be some sort of therapeutic procedure) (yes/no)
Time frame
within 12 months3
Secondary effectiveness outcomes: Form of triage and/or treatment received
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)
Time frame
within 12 months4
Communication of HPV test result to patients via mHealth messages
Binary endpoint (Yes/No) based on confirmation of HPV test results being sent to the participant's phone via mhealth application (WEMA).
Time frame
Within 10 days of results being made availableSponsors and contacts
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Kenyatta National Hospital
Lead sponsor
Emory University
Collaborator
University of Washington
Collaborator
National Cancer Institute (NCI)
Collaborator
Kenya Ministry of Health
Collaborator
Queen's University
Collaborator
University of Nairobi
Collaborator
Source ClinicalTrials.gov