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).
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
6,600
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.
Akala Health Center
Akala, Kenya
RECRUITINGBondo Referral Hospital
Bondo, Kenya
RECRUITINGAlupe Sub-County Hospital
Busia, Kenya
RECRUITINGBusia County Referral Hospital
Busia, Kenya
RECRUITINGKhunyangu Sub-County Hospital
Busia, Kenya
RECRUITINGMatayos Health Center
Busia, Kenya
RECRUITINGPort Victoria Sub-County Hospital
Busia, Kenya
RECRUITINGNambale Sub-County Hospital
Siaya, Kenya
RECRUITINGYala Sub-County Hospital
Siaya, Kenya
RECRUITINGUkwala Sub-County Hospital
Ukwala, Kenya
RECRUITINGGuideline 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".
Time frame: 0-12 months [from screening result to treatment completion]
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).
Time frame: Years 2 and 3
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.
Time frame: 0-24 months
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