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Active, Not Recruiting

NCT Number: NCT06286462

Evaluation of the Cancer Tracking System (CATSystem)

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Akala Health Center, Akala, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cancer Tracking System (CATSystem)

Other

The CATSystem provider dashboard highlights patients with overdue services or those in need of outreach and sends automated, customized texts to support screening and treatment follow-up per national guidelines. Points of intervention and alerts include: cervical cancer screening and treatment counseling, initial and follow up cervical cancer screening per national guidelines, treatment for precancer and cancer, referral tracking and follow up. In addition, the CATSystem can securely store images of the cervix taken with colposcopes to allow for remote expert consultation if needed to correctly diagnose a patient or can be reviewed at clinical team meetings for input. Primary goals of the CATSystem are to increase rates of guideline-adherent cervical cancer screening/ rescreening and improve guideline-adherent treatment, referral, and follow-up rates of women with positive screens.

Primary outcomes

  1. Guideline adherent treatment for a positive screen

    Time frame: 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 outcomes

  1. Cervical cancer screening

    Time frame: 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.

Other outcomes

  1. Cost-effectiveness of the CATSystem Intervention on screening and treatment outcomes

    Time frame: Years 2 and 3

    The cost and cost-effectiveness of the CATSystem to improve Quality-Adjusted Life-Years (QALYs).

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • DARTNet Institute
  • Global Health Innovations
  • San Diego State University
  • University of Michigan

Registry information

Official study title

Implementing and Evaluating the Cancer Tracking System (CATSystem): A Systems Level Intervention to Improve Cervical Cancer Screening, Treatment Referral and Follow up in Kenya

Acronym: CATSystem

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Feb 29, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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