NCT06286462

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,600

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Feb 2024Aug 2028

Study Start

First participant enrolled

February 5, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

February 6, 2024

Last Update Submit

March 12, 2026

Conditions

Cervical Cancer

Keywords

cervical cancer screeningtreatment of precancerous lesionstreatment of invasive cervical cancerreferral and retentionsystem level interventioneHealth interventionKenya

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cervical cancer screening

    0-24 months

Other Outcomes (1)

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

    Years 2 and 3

Study Arms (2)

CATSystem Intervention

EXPERIMENTAL

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)

Standard of care

NO INTERVENTION

Participants enrolled at control sites will receive standard of care PMTCT services, with no CATSystem tracking or follow up

Interventions

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.

CATSystem Intervention

Eligibility Criteria

Age16 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Akala Health Center

Akala, Kenya

Location

Bondo Referral Hospital

Bondo, Kenya

Location

Alupe Sub-County Hospital

Busia, Kenya

Location

Busia County Referral Hospital

Busia, Kenya

Location

Khunyangu Sub-County Hospital

Busia, Kenya

Location

Matayos Health Center

Busia, Kenya

Location

Port Victoria Sub-County Hospital

Busia, Kenya

Location

Nambale Sub-County Hospital

Siaya, Kenya

Location

Yala Sub-County Hospital

Siaya, Kenya

Location

Ukwala Sub-County Hospital

Ukwala, Kenya

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Sarah Finocchario-Kessler, PhD

    Univer

    PRINCIPAL INVESTIGATOR

  • Natabhona Mabachi, PhD

    DARTNet Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Matched, cluster randomized controlled design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 29, 2024

Study Start

February 5, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After participant follow up is complete, data are cleaned, and the data set is locked.
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.

Locations

KE(10)