Cervical CancerCATSystemNCT06286462
Evaluation of the Cancer Tracking System (CATSystem)
A study testing Cancer Tracking System (CATSystem) in people with Cervical Cancer, run by University of Kansas Medical Center at 10 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Cancer Tracking System (CATSystem)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,600 participants
- Where
- 10 sitesKenya
- Study dates
- 5 Feb 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- women above 16 years of age
- access to a cell phone,
- presenting for cervical cancer screening at a study hospital.
Who cannot join
- greater than 20 weeks gestation,
- incarcerated patients,
- women who study staff feel are unable to provide written informed consent due to impaired capacity.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Kenya10 sites
Akala Health Center
Akala
Bondo Referral Hospital
Bondo
Alupe Sub-County Hospital
Busia
Busia County Referral Hospital
Busia
Khunyangu Sub-County Hospital
Busia
Matayos Health Center
Busia
Port Victoria Sub-County Hospital
Busia
Nambale Sub-County Hospital
Siaya
Yala Sub-County Hospital
Siaya
Ukwala Sub-County Hospital
Ukwala
About this study
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
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).
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Cancer Tracking System (CATSystem)
- Keywords
- cervical cancer screening, treatment of precancerous lesions, treatment of invasive cervical cancer, referral and retention, system level intervention, eHealth intervention, Kenya
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 0-12 months [from screening result to treatment completion]
Secondary outcomes (1)
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.
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start5 Feb 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Matched, cluster randomized controlled design
- Masking
- None (open label)
- Enrolment
- 6,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Global Health Innovations, DARTNet Institute, San Diego State University, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Sarah Finocchario-Kessler, PhD, Principal investigator, UniverNatabhona Mabachi, PhD, Principal investigator, DARTNet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286462
- Sponsor's protocol ID
- R01CA278617
- Acronym
- CATSystem
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06286462
- Acronym / sponsor ID
- CATSystem / R01CA278617
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,600 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Global Health Innovations, DARTNet Institute, San Diego State University, University of Michigan
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Matched, cluster randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| CATSystem Intervention | Experimental | Other: Cancer Tracking System (CATSystem)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. |
| Standard of care | No intervention | –Participants enrolled at control sites will receive standard of care PMTCT services, with no CATSystem tracking or follow up |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- women above 16 years of age
- access to a cell phone,
- presenting for cervical cancer screening at a study hospital.
Key exclusion criteria (3 listed)
- greater than 20 weeks gestation,
- incarcerated patients,
- women who study staff feel are unable to provide written informed consent due to impaired capacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | CATSystem Intervention |
Primary outcome
Guideline adherent treatment for a positive screen
Time frame: 0-12 months [from screening result to treatment completion]
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".
1 secondary outcome
Cervical cancer screening
Time frame: 0-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Finocchario-Kessler, PhD principal investigator
Univer
Natabhona Mabachi, PhD principal investigator
DARTNet Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Tracking System (CATSystem) in people with Cervical Cancer, run by University of Kansas Medical Center at 10 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline adherent treatment for a positive screen (time frame: 0-12 months [from screening result to treatment completion]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.