Embodied Conversational Agents for CervicalCancer Screening Abnormalities
ECA-CCSA
2 other identifiers
interventional
750
0 countries
N/A
Brief Summary
Many people who receive abnormal results from cervical cancer screening do not follow up with appointments that would allow treatment of precancer and would prevent cancer. In this project, we will develop an animated health coach that works on a smartphone to guide them through the cervical cancer screening and care process to ensure they receive the follow up and treatment they need to prevent cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2029
September 16, 2026
September 1, 2026
1.9 years
August 26, 2026
September 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of participants who receive recommended follow-up testing and treatment.
18 months
Study Arms (3)
Control
NO INTERVENTIONStandard of care only
Conversational agent only
EXPERIMENTALReceives conversational agent to provide personalized education
conversational agent and advocacy
EXPERIMENTALReceives conversational agent to provide personalized education and also guidance on talking to family and friends about cancer screening
Interventions
People receiving the intervention will receive an animated health coach that works on a smartphone to guide them through the cervical cancer screening and care process to ensure they receive the follow up and treatment they need to prevent cancer.
Eligibility Criteria
You may qualify if:
- age 21-65
- has an abnormal cervical cancer screening test result
- able to read in English or Spanish
You may not qualify if:
- planning to move out of the study area during the follow up period
- pregnant
- incarcerated
- dose not have adequate vision or hearing to use the app
- diagnosed with cervical cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Officials
- PRINCIPAL INVESTIGATOR
Perkins
Tufts Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2026
First Posted
August 31, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
August 15, 2028
Study Completion (Estimated)
August 15, 2029
Last Updated
September 16, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- As developed and for the amount of time stipulated by our IRB after study completion.
- Access Criteria
- see above
ACCESS, DISTRIBUTION, OR REUSE CONSIDERATIONS Data will be shared under a two-tier distribution system. All data that can be de-identified will be publicly shared. Data with specific confidentially risks, such as transcripts of interviews will not be shared publicly because of the difficulty masking the identity of participants. Data with increased risk of reidentification will be shared under a data-use agreement that clearly establish use rules to facilitate respondent confidentiality WHETHER ACCESS TO SCIENTIFIC DATA WILL BE CONTROLLED De-identified data will be freely available on the repository website. Restricted data (I.e., de-identified transcripts of interviews) will be available through a data use agreement. Data use agreements providing access to sensitive data will be managed by the repository of record. PROTECTIONS FOR PRIVACY, RIGHTS, AND CONFIDENTIALITY OF HUMAN RESEARCH PARTICIPANTS In order to ensure participant consent for data sharing, IRB paperwork and informed