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

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancer; Cervical Cancer Screening; HPV DNA

• Registration Number: NCT07050745
• Lead Sponsor: Kenyatta National Hospital

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).

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 Timeline

• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Status Verified: 2025-07
• Study First Posted: 2025-07-03
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-14
• Study Start: 2025-09-01
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1980

Inclusion Criteria

• Women ages 25-49 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary implementation outcome: Cervical cancer screening uptake	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
Primary effectiveness outcome: Receipt of triage and/or treatment	within 12 months	Binary endpoint (Yes/No) based on receipt of triage and/or treatment

Secondary Outcome Measures

Name	Time	Method
Secondary effectiveness outcomes: Form of triage and/or treatment received	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)
Communication of HPV test result to patients via mHealth messages	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).

Trial Locations

Locations (1)

Kenyatta National Hospital; 🇰🇪 Nairobi, Kenya