Cervical Cancer ScreeningECA-CCSANCT07795385
Embodied Conversational Agents for CervicalCancer Screening Abnormalities
A study testing embodied conversational agents for cervical cancer prevention in people with Cervical Cancer Screening, run by Tufts Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- embodied conversational agents for cervical cancer prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 15 Aug 2029
- 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 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 21-65
- has an abnormal cervical cancer screening test result
- able to read in English or Spanish
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Embodied Conversational Agents for Cervical Cancer Screening Abnormalities
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.
- Conditions
- Cervical Cancer Screening
- Being tested
- embodied conversational agents for cervical cancer prevention
- Keywords
- cervical cancer screening, HPV testing, colposcopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embodied conversational agents for cervical cancer preventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care only |
| Conversational agent only | Experimental | Receives conversational agent to provide personalized education Receives: Behavioral: embodied conversational agents for cervical cancer prevention |
| conversational agent and advocacy | Experimental | Receives conversational agent to provide personalized education and also guidance on talking to family and friends about cancer screening Receives: Behavioral: embodied conversational agents for cervical cancer prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who receive recommended follow-up testing and treatment.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Perkins, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795385
- Sponsor's protocol ID
- 00006533
- Other IDs
- 1R01CA296021-01A1
- Acronym
- ECA-CCSA
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embodied Conversational Agents for Cervical Cancer Screening Abnormalities
- ClinicalTrials.gov ID
- NCT07795385
- Acronym / sponsor ID
- ECA-CCSA / 00006533
- Conditions
- Cervical Cancer Screening
- Keywords
- cervical cancer screening, HPV testing, colposcopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 31 Aug 2026 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care only |
| Conversational agent only | Experimental | Behavioral: embodied conversational agents for cervical cancer preventionReceives conversational agent to provide personalized education |
| conversational agent and advocacy | Experimental | Behavioral: embodied conversational agents for cervical cancer preventionReceives conversational agent to provide personalized education and also guidance on talking to family and friends about cancer screening |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 21-65
- has an abnormal cervical cancer screening test result
- able to read in English or Spanish
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| embodied conversational agents for cervical cancer preventionPeople 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. | Behavioural | Conversational agent only, conversational agent and advocacy |
Primary outcome
The proportion of participants who receive recommended follow-up testing and treatment.
Time frame: 18 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 Sep 2026.
- Individual participant dataSharing planned: Yes. 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
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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.
Perkins principal investigator
Tufts Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing embodied conversational agents for cervical cancer prevention in people with Cervical Cancer Screening, run by Tufts Medical Center.
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 5 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact ECA-CCSA Research Coordinator (617-651-9410, saramyhealthnav@tuftsmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants who receive recommended follow-up testing and treatment. (time frame: 18 months). 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 Sep 2026.