Evaluation of the Cancer Tracking System (CATSystem)

Not Applicable

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT06286462
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care).

Detailed Description

To help address system level barriers to cervical cancer screening, treatment, and follow-up in Kenya, investigators worked with end-users (providers and patients) to develop the Cancer Tracking System (CATSystem), a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care). Specific aims (SA) of the study are to (1) Implement and evaluate the efficacy of CATSystem to improve guideline adherent cervical cancer screening, treatment, referral and follow up, (2) Assess feasibility and acceptability of implementation of CATSystem in government run facilities using a human centered design approach, and (3) Calculate the costs and cost-effectiveness of the CATSystem to increase quality adjusted life years gained. Cervical cancer deaths can be prevented with early detection and treatment. This study will evaluate the public health impact of the CATSystem in improving cervical cancer screening, treatment, referral, follow-up, and the feasibility of scale up to other low resource settings.

Study Timeline

• Study Start: 2024-02-05
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 6600

Inclusion Criteria

• women above 16 years of age
• access to a cell phone,
• presenting for cervical cancer screening at a study hospital.

Exclusion Criteria

• greater than 20 weeks gestation,
• incarcerated patients,
• women who study staff feel are unable to provide written informed consent due to impaired capacity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cost-effectiveness of the CATSystem Intervention on screening and treatment outcomes	Years 2 and 3	The cost and cost-effectiveness of the CATSystem to improve Quality-Adjusted Life-Years (QALYs).
Guideline adherent treatment for a positive screen	0-12 months [from screening result to treatment completion]	Provide guideline adherent treatment and rescreening for the range of possible positive screen results: cervicitis, precancerous lesions (mild, moderate, severe), invasive cervical cancer. Participants who receive the guideline adherent treatment for their positive screen result will be coded as 1 or "yes". Participants who do not receive the guideline adherent treatment for their positive screen will be coded as 0 or "no".

Secondary Outcome Measures

Name	Time	Method
Cervical cancer screening	0-24 months	Compare the number of women screened for cervical cancer pre (12 month retrospective review of screening rates) and throughout the two-year enrollment period at all intervention and control sites.

Trial Locations

Locations (10)

Akala Health Center; 🇰🇪 Akala, Kenya

Bondo Referral Hospital; 🇰🇪 Bondo, Kenya

Alupe Sub-County Hospital; 🇰🇪 Busia, Kenya

Busia County Referral Hospital; 🇰🇪 Busia, Kenya

Khunyangu Sub-County Hospital; 🇰🇪 Busia, Kenya

Matayos Health Center; 🇰🇪 Busia, Kenya

Port Victoria Sub-County Hospital; 🇰🇪 Busia, Kenya

Nambale Sub-County Hospital; 🇰🇪 Siaya, Kenya

Yala Sub-County Hospital; 🇰🇪 Siaya, Kenya

Ukwala Sub-County Hospital; 🇰🇪 Ukwala, Kenya