Trial Title:
Evaluation of the Cancer Tracking System (CATSystem)
NCT ID:
NCT06286462
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer screening
treatment of precancerous lesions
treatment of invasive cervical cancer
referral and retention
system level intervention
eHealth intervention
Kenya
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Matched, cluster randomized controlled design
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cancer Tracking System (CATSystem)
Description:
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.
Arm group label:
CATSystem Intervention
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
female
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Akala Health Center
Address:
City:
Akala
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba, MCH
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng, BA
Phone:
+254735870242
Email:
johnchng5@gmail.com
Facility:
Name:
Bondo Referral Hospital
Address:
City:
Bondo
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba, MCH
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng, BA
Phone:
+254735870242
Email:
johnchng5@gmail.com
Facility:
Name:
Alupe Sub-County Hospital
Address:
City:
Busia
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng
Phone:
+254735870242
Email:
johnchng5@gmail.com
Facility:
Name:
Busia County Referral Hospital
Address:
City:
Busia
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba, MCH
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng, BA
Phone:
+254735870242
Email:
johnchng5@gmail.com
Facility:
Name:
Khunyangu Sub-County Hospital
Address:
City:
Busia
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng
Phone:
+254735870242
Email:
johnchng5@gmail.com
Facility:
Name:
Matayos Health Center
Address:
City:
Busia
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng
Phone:
+254735870242
Email:
johnchng5@gmail.com
Facility:
Name:
Port Victoria Sub-County Hospital
Address:
City:
Busia
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba, MCH
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng, BA
Phone:
+254735870242
Email:
johnchng5@gmail.com
Facility:
Name:
Nambale Sub-County Hospital
Address:
City:
Siaya
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng
Phone:
+254735870242
Email:
johnchng5@gmail.com
Facility:
Name:
Yala Sub-County Hospital
Address:
City:
Siaya
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng
Phone:
+254735870242
Email:
johnchng5@gmail.com
Facility:
Name:
Ukwala Sub-County Hospital
Address:
City:
Ukwala
Country:
Kenya
Status:
Recruiting
Contact:
Last name:
May H Maloba
Phone:
+254720254069
Email:
maymcurtis@gmail.com
Contact backup:
Last name:
John Ochieng
Phone:
+254735870242
Email:
johnchng5@gmail.com
Start date:
February 5, 2024
Completion date:
August 31, 2028
Lead sponsor:
Agency:
University of Kansas Medical Center
Agency class:
Other
Collaborator:
Agency:
Global Health Innovations
Agency class:
Other
Collaborator:
Agency:
DARTNet Institute
Agency class:
Other
Collaborator:
Agency:
San Diego State University
Agency class:
Other
Collaborator:
Agency:
University of Michigan
Agency class:
Other
Source:
University of Kansas Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06286462
