Clinical trial NCT06286462: Evaluation of the Cancer Tracking System (CATSystem)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer screening
treatment of precancerous lesions
treatment of invasive cervical cancer
referral and retention
system level intervention
eHealth intervention
Kenya
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Global Health Innovations
name: DARTNet Institute
name: San Diego State University
name: University of Michigan
First posted: 2024-02-29
Enrollment: 6600
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Matched, cluster randomized controlled design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Guideline adherent treatment for a positive screen
timeFrame: 0-12 months [from screening result to treatment completion]
measure: Cost-effectiveness of the CATSystem Intervention on screening and treatment outcomes
timeFrame: Years 2 and 3
Secondary outcomes:
measure: Cervical cancer screening
timeFrame: 0-24 months
Other outcomes:
Locations:
city: Akala
country: Kenya
facility: Akala Health Center
city: Bondo
country: Kenya
facility: Bondo Referral Hospital
city: Busia
country: Kenya
facility: Alupe Sub-County Hospital
city: Busia
country: Kenya
facility: Busia County Referral Hospital
city: Busia
country: Kenya
facility: Khunyangu Sub-County Hospital
city: Busia
country: Kenya
facility: Matayos Health Center
city: Busia
country: Kenya
facility: Port Victoria Sub-County Hospital
city: Siaya
country: Kenya
facility: Nambale Sub-County Hospital
city: Siaya
country: Kenya
facility: Yala Sub-County Hospital
city: Ukwala
country: Kenya
facility: Ukwala Sub-County Hospital
Study officials:
affiliation: Univer
name: Sarah Finocchario-Kessler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: DARTNet Institute
name: Natabhona Mabachi, PhD
role: PRINCIPAL_INVESTIGATOR
References: