Evaluation of the Cancer Tracking System (CATSystem) (CATSystem)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Other: Cancer Tracking System (CATSystem)

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 Type: Interventional
• Enrollment (Estimated): 6600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Akala, Kenya
    • Akala Health Center
  • Bondo, Kenya
    • Bondo Referral Hospital
  • Busia, Kenya
    • Busia County Referral Hospital
  • Busia, Kenya
    • Alupe Sub-County Hospital
  • Busia, Kenya
    • Khunyangu Sub-County Hospital
  • Busia, Kenya
    • Matayos Health Center
  • Busia, Kenya
    • Port Victoria Sub-County Hospital
  • Siaya, Kenya
    • Nambale Sub-County Hospital
  • Siaya, Kenya
    • Yala Sub-County Hospital
  • Ukwala, Kenya
    • Ukwala Sub-County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CATSystem Intervention; Participants enrolled at intervention sites will receive CATSytem-supported cervical cancer screening and treatment services. Interventions received will include: text messages to patients and algorithm-driven alerts to providers when guideline-adherent cervical cancer screening and treatment services are required including: initial and follow up cervical cancer screening, on site treatment, and referral tracking.	Other: Cancer Tracking System (CATSystem); 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.
No Intervention: Standard of care; Participants enrolled at control sites will receive standard of care PMTCT services, with no CATSystem tracking or follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Guideline adherent treatment for a positive screen	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".	0-12 months [from screening result to treatment completion]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical cancer screening	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.	0-24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of the CATSystem Intervention on screening and treatment outcomes	The cost and cost-effectiveness of the CATSystem to improve Quality-Adjusted Life-Years (QALYs).	Years 2 and 3

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: San Diego State University; University of Michigan; DARTNet Institute; Global Health Innovations
• Investigators: Principal Investigator: Sarah Finocchario-Kessler, PhD, Univer; Principal Investigator: Natabhona Mabachi, PhD, DARTNet Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Kenya; cervical cancer screening; eHealth intervention; treatment of precancerous lesions; treatment of invasive cervical cancer; referral and retention; system level intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: R01CA278617 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators will make data collected for aims 1 & 2 available only upon request from users who meet eligibility. Data from aim 3 includes costing data for PMTCT services. These data will be shared openly at the dissemination meetings planned at the end of the study, which will include county and national health personnel. Furthermore, these data will be placed in a readily accessible public database.
• IPD Sharing Time Frame: After participant follow up is complete, data are cleaned, and the data set is locked.
• IPD Sharing Access Criteria: Eligible requesters are those who can show proof of human subject's training and only under a data-sharing agreement that provides for: (1) use of the data only for research purposes, (2) exclusion of any identifying or potentially identifying information in shared analyses, publications, reports, etc., (3) appropriate storage and securing of the data to prevent authorized persons from accessing it, (4) a commitment to destroy or return the data after analyses are completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No