Human Papilloma VirusNCT06367699
Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care (ECA-HPV)- Clinical Trial
A study testing ECA-HPV App with Clinic Notification and Adolescent Functions Disabled, ECA-HPV App with Clinic Notification Function Enabled and ECA-HPV App with Adolescent Function Enabled in people with Human Papilloma Virus, run by Tufts Medical Center at 1 site in United States.
Trial summary
The objective of this study is to assess the use of and satisfaction with the ECA-HPV intervention over a 16-month period, its ability to increase HPV vaccination, and the comparative effectiveness of clinic notification and adolescent ECA components on these factors. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- ECA-HPV App with Clinic Notification and Adolescent Functions Disabled, ECA-HPV App with Clinic Notification Function Enabled and ECA-HPV App with Adolescent Function Enabled
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For parent/guardian participants:
- Speaks English fluently
- Able to independently consent
- Has adequate corrected vision to use the ECA-HPV system (based on their ability to go through the consent form)
- Has adequate hearing to use the ECA-HPV system (based on their ability to hear the research staff member conducting the consent process)
- Has a smartphone that is able to support the ECA-HPV app
Show all 15Show fewer
- For adolescent participants:
- Is between the ages of 9-12 at the time of the index (first) well child visit
- Has received either 1 or none of the HPV vaccine series
- Speaks English fluently
- Able to independently assent
- Has adequate corrected vision to use the ECA-HPV system
- Has adequate hearing to use the ECA-HPV system
- Has a smartphone or has access to parent/guardian's smartphone (that is able to support the ECA-HPV app)
- Has an upcoming well child visit at Boston Medical Center
Who cannot join
- Is not able to use the ECA-HPV system
- Has already participated in the study before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care
The objective of this study is to assess the use of and satisfaction with the ECA-HPV intervention over a 16-month period, its ability to increase HPV vaccination, and the comparative effectiveness of clinic notification and adolescent ECA components on these factors.
Read the detailed description
In the US, universal Human Papillomavirus (HPV) vaccination has the potential to decrease overall burdens of certain cancers. However, HPV vaccination rates for US adolescents of all races, ethnicities, and income levels remain below national targets. Embodied Conversational Agents (ECAs) are animated computer agents that simulate face-to-face conversation between a patient and a caregiver, to provide a natural and intuitive computer interface that is accessible to patients of all levels of health and computer literacy. In this project, we produced smartphone ECAs for HPV vaccination to provide vaccine recommendations and motivational interviewing to parents/guardians and vaccine-eligible adolescents and facilitate communication with clinic staff.
In this study, we will be using the ECA-HPV system to administer interactive information to parents and adolescents in the form of a smartphone app. We will obtain data from participants by asking subjects to fill out surveys on REDCap and electronically from use of the ECA system. The parent/guardian and adolescent participants will each complete 3 surveys over a 16-month period occurring at baseline, after the first well child visit, and after the second well child visit (anticipated to be ~1 year after their initial well child visit). Additionally, a randomly selected subset of adolescent and parent/guardian participant dyads who were in an intervention group where adolescents also had the ECA-HPV adolescent app will be interviewed after their first well child visit about their experience. Lastly, for healthcare providers who have interacted with at least 5 study participants in any of the intervention groups, they will be recruited to participate in qualitative interviews.
For this RCT, the participant dyads (parent/guardian and adolescent) will be randomly assigned into one of five groups (N = 875 dyads). The control group will receive usual standard care (n = 175 dyads). The other four groups are intervention groups in which all will get the ECA-HPV app for the parent/guardian. Additionally, these four groups will receive either (1) the complete ECA-HPV, including the ECA-HPV adolescent app and the clinic notification feature (on both the parent/guardian and adolescent apps) (n = 175 dyads), (2) the ECA-HPV app and adolescent ECA-HPV app with the clinic communication function disabled (n = 175 dyads), (3) the ECA-HPV app with clinic notification with no adolescent ECA-HPV app (n = 175 dyads), or (4) the ECA-HPV app with no clinic communication feature and no adolescent ECA-HPV app (n = 175 dyads).
For this study, we will evaluate whether (1) adolescents who receive the ECA-HPV intervention will have a higher rate of HPV vaccine series completion, (2) participating parents/guardians will have higher vaccine knowledge and greater intention to vaccinate, and (3) vaccine series completion rates will be higher for those receiving the full ECA-HPV intervention, compared to those who get ECA-HPV without the adolescent or clinic notification components.
- Conditions
- Human Papilloma Virus
- Being tested
- Usual Care, ECA-HPV App with Clinic Notification and Adolescent Functions Disabled, ECA-HPV App with Clinic Notification Function Enabled, ECA-HPV App with Adolescent Function Enabled, ECA-HPV App with Clinic Notification and Adolescent Functions Enabled
- Keywords
- Human Papilloma Virus, Cancer Prevention, Vaccination Promotion, Vaccination Attitudes, Vaccination Completion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Parent/guardian and adolescent participants will not receive the ECA-HPV system intervention. A survey will be given via REDCap to the parent/guardian and adolescent participants at baseline, after the first well child clinic visit, and after the second well child clinic visit to assess self-reported vaccination attitudes and behaviors. Adolescent participants will receive usual care.
ECA-HPV App with Clinic Notification and Adolescent Functions DisabledBehavioural
Parent/guardian participants will interact with the ECA-HPV smartphone-based system over a period of ~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/guardian and adolescent to assess self-reported vaccination attitudes and behaviors. Parent/guardian participants will also be asked questions about the ECA-HPV app. The clinic notification and adolescent functions of the complete ECA-HPV app are disabled. Adolescent participants will receive usual care.
ECA-HPV App with Clinic Notification Function EnabledBehavioural
Parent/guardian participants will interact with the ECA-HPV smartphone-based system over a period of ~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/guardian and adolescent to assess self-reported vaccination attitudes and behaviors. Parent/guardian participants will also be asked questions about the ECA-HPV app and the clinic notification feature. The clinic notification is enabled on the parent/guardian ECA-HPV app, however, the adolescent does not have access to the adolescent ECA-HPV app. Adolescent participants will receive usual care.
ECA-HPV App with Adolescent Function EnabledBehavioural
Parent/guardian participants will interact with the ECA-HPV smartphone-based system over a period of ~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/guardian and adolescent to assess self-reported vaccination attitudes and behaviors as well as ECA-HPV app use and satisfaction. The adolescent function is enabled, however, the clinic notification function is disabled. Thus, the ECA-HPV system app will have an adolescent-facing feature for adolescent participants to engage with the agent. Adolescent participants will receive usual care and will be able to engage with the adolescent version of the ECA-HPV app throughout the duration of the study.
ECA-HPV App with Clinic Notification and Adolescent Functions EnabledBehavioural
Parent/guardian participants will interact with the complete ECA-HPV smartphone-based system over a period of ~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given to parent/guardian participants via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/ guardian and adolescent to assess self-reported vaccination attitudes and behaviors as well as ECA-HPV app use and satisfaction and questions about the clinic notification feature. The complete ECA-HPV app includes the parent version and adolescent versions of the ECA-HPV app. Both versions have the clinic notification feature enabled. Adolescent participants will receive usual care and can engage with the adolescent version of the ECA-HPV app throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. Both parent/guardian and adolescent participants do not have access to the ECA-HPV app. Adolescent participants will receive usual standard of care. Receives: Behavioral: Usual Care |
| ECA-HPV App with Clinic Notification and Adolescent Functions Disabled | Experimental | The ECA-HPV (Embodied Conversational Agent adapted for this project) system comprises of a smartphone-based ECA parent/guardian interface, where the parent/guardian participants can receive HPV vaccine promotion and counseling from an interactive agent. The clinic notification feature is disabled on the app. Adolescent participants do not receive the adolescent version of the ECA-HPV app. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. Receives: Behavioral: ECA-HPV App with Clinic Notification and Adolescent Functions Disabled |
| ECA-HPV App with Clinic Notification Function Enabled | Experimental | The ECA-HPV (Embodied Conversational Agent adapted for this project) system comprises of a smartphone-based ECA parent/guardian interface, where the parent/guardian participants can receive HPV vaccine promotion and counseling from an interactive agent. With the clinic notification function enabled, parent/guardian participants can communicate their concerns, questions, and logistical barriers to the clinic staff. Adolescent participants do not receive the adolescent version of the ECA-HPV app. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. Receives: Behavioral: ECA-HPV App with Clinic Notification Function Enabled |
| ECA-HPV App with Adolescent Function Enabled | Experimental | The ECA-HPV (Embodied Conversational Agent adapted for this project) system comprises of a smartphone-based ECA parent/guardian interface, where the parent/guardian participants can receive HPV vaccine promotion and counseling from an interactive agent. Adolescent participants receive the adolescent version of the ECA-HPV app, which includes age-appropriate education and adolescent-focused engagement features, like games. The clinic notification feature is disabled on both the parent/guardian and adolescent apps. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. Receives: Behavioral: ECA-HPV App with Adolescent Function Enabled |
| ECA-HPV App with Clinic Notification and Adolescent Functions Enabled | Experimental | Participants will receive the full ECA-HPV (Embodied Conversational Agent adapted for this project) system on their smartphone app, which includes both the clinic notification and adolescent functions enabled. With the clinic notification function enabled, parent/guardian participants can communicate their concerns, questions, and logistical barriers to the clinic staff. Adolescent participants receive the adolescent version of the ECA-HPV app, which includes age-appropriate education and adolescent-focused engagement features, like games. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. Receives: Behavioral: ECA-HPV App with Clinic Notification and Adolescent Functions Enabled |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination series completion comparing the control group to the intervention groups
HPV vaccination series completion for the control group will be compared to the collective rate for the intervention groups. A review of medical records at the T2 timepoint will be done for vaccination series completion.
Measured: 16 months
HPV vaccination series completion comparing the intervention groups
HPV vaccination series completion will be assessed between participants randomized to the full ECA-HPV versus people randomized to the ECA-HPV with no adolescent app function and no clinic notification function. A review of medical records at the T2 timepoint will be done for vaccination series completion.
Measured: 16 months
Secondary outcomes (5)
HPV Knowledge
The parent/guardian participants will be asked questions about their HPV knowledge in all three surveys: at baseline (T0), post-first well child visit (T1), and post-second well child visit (T2). Participants will fill out the surveys in REDCap. The outcomes for this measure at T1 and T2 will be compared to the outcome at T0.
Measured: 16 months
HPV Attitudes
Both the parent/guardian and adolescent participants will be asked questions about their attitudes towards HPV in all three surveys: at baseline (T0), post-first well child visit (T1), and post-second well child visit (T2). Participants will fill out these surveys in REDCap. The outcomes for this measure at T1 and T2 will be compared to the outcome at T0.
Measured: 16 months
General Vaccine Attitudes
The parent/guardian participants will be asked questions about their attitudes towards vaccines in general in all three surveys: at baseline (T0), post-first well child visit (T1), and post-second well child visit (T2). Participants will fill out these surveys in REDCap. The outcomes for this measure at T1 and T2 will be compared to the outcome at T0.
Measured: 16 months
ECA-HPV App Satisfaction
If participants are in an intervention group with the ECA-HPV app, their post-first well child visit survey will include questions about use and satisfaction of the app. Participants will fill out these surveys in REDCap.
Measured: 16 months
Clinic Notification Feature Satisfaction
If participants are in an intervention group with the ECA-HPV app and the clinic notification function enabled, their post-first well child visit survey will include questions about use and satisfaction of this feature. Participants will fill out these surveys in REDCap
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start13 Nov 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: We were informed by the NCI that this research no longer aligns with NCI values, therefore our grant was terminated and we had received a stop work order.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, Northeastern University
- Responsible party
- Sponsor
- Investigators
- Michael Paasche-Orlow, MD, MPH, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367699
- Sponsor's protocol ID
- H-44821
- Status last verified
- Jul 2025
- First submitted
- 11 Apr 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care
- ClinicalTrials.gov ID
- NCT06367699
- Acronym / sponsor ID
- H-44821
- Conditions
- Human Papilloma Virus
- Keywords
- Human Papilloma Virus, Cancer Prevention, Vaccination Promotion, Vaccination Attitudes, Vaccination Completion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were informed by the NCI that this research no longer aligns with NCI values, therefore our grant was terminated and we had received a stop work order.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Boston Medical Center, Northeastern University
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 16 Apr 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.
The objective of this study is to assess the use of and satisfaction with the ECA-HPV intervention over a 16-month period, its ability to increase HPV vaccination, and the comparative effectiveness of clinic notification and adolescent ECA components on these factors.
Detailed description
In the US, universal Human Papillomavirus (HPV) vaccination has the potential to decrease overall burdens of certain cancers. However, HPV vaccination rates for US adolescents of all races, ethnicities, and income levels remain below national targets. Embodied Conversational Agents (ECAs) are animated computer agents that simulate face-to-face conversation between a patient and a caregiver, to provide a natural and intuitive computer interface that is accessible to patients of all levels of health and computer literacy. In this project, we produced smartphone ECAs for HPV vaccination to provide vaccine recommendations and motivational interviewing to parents/guardians and vaccine-eligible adolescents and facilitate communication with clinic staff.
In this study, we will be using the ECA-HPV system to administer interactive information to parents and adolescents in the form of a smartphone app. We will obtain data from participants by asking subjects to fill out surveys on REDCap and electronically from use of the ECA system. The parent/guardian and adolescent participants will each complete 3 surveys over a 16-month period occurring at baseline, after the first well child visit, and after the second well child visit (anticipated to be ~1 year after their initial well child visit). Additionally, a randomly selected subset of adolescent and parent/guardian participant dyads who were in an intervention group where adolescents also had the ECA-HPV adolescent app will be interviewed after their first well child visit about their experience. Lastly, for healthcare providers who have interacted with at least 5 study participants in any of the intervention groups, they will be recruited to participate in qualitative interviews.
For this RCT, the participant dyads (parent/guardian and adolescent) will be randomly assigned into one of five groups (N = 875 dyads). The control group will receive usual standard care (n = 175 dyads). The other four groups are intervention groups in which all will get the ECA-HPV app for the parent/guardian. Additionally, these four groups will receive either (1) the complete ECA-HPV, including the ECA-HPV adolescent app and the clinic notification feature (on both the parent/guardian and adolescent apps) (n = 175 dyads), (2) the ECA-HPV app and adolescent ECA-HPV app with the clinic communication function disabled (n = 175 dyads), (3) the ECA-HPV app with clinic notification with no adolescent ECA-HPV app (n = 175 dyads), or (4) the ECA-HPV app with no clinic communication feature and no adolescent ECA-HPV app (n = 175 dyads).
For this study, we will evaluate whether (1) adolescents who receive the ECA-HPV intervention will have a higher rate of HPV vaccine series completion, (2) participating parents/guardians will have higher vaccine knowledge and greater intention to vaccinate, and (3) vaccine series completion rates will be higher for those receiving the full ECA-HPV intervention, compared to those who get ECA-HPV without the adolescent or clinic notification components.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareAn internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. Both parent/guardian and adolescent participants do not have access to the ECA-HPV app. Adolescent participants will receive usual standard of care. |
| ECA-HPV App with Clinic Notification and Adolescent Functions Disabled | Experimental | Behavioral: ECA-HPV App with Clinic Notification and Adolescent Functions DisabledThe ECA-HPV (Embodied Conversational Agent adapted for this project) system comprises of a smartphone-based ECA parent/guardian interface, where the parent/guardian participants can receive HPV vaccine promotion and counseling from an interactive agent. The clinic notification feature is disabled on the app. Adolescent participants do not receive the adolescent version of the ECA-HPV app. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. |
| ECA-HPV App with Clinic Notification Function Enabled | Experimental | Behavioral: ECA-HPV App with Clinic Notification Function EnabledThe ECA-HPV (Embodied Conversational Agent adapted for this project) system comprises of a smartphone-based ECA parent/guardian interface, where the parent/guardian participants can receive HPV vaccine promotion and counseling from an interactive agent. With the clinic notification function enabled, parent/guardian participants can communicate their concerns, questions, and logistical barriers to the clinic staff. Adolescent participants do not receive the adolescent version of the ECA-HPV app. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. |
| ECA-HPV App with Adolescent Function Enabled | Experimental | Behavioral: ECA-HPV App with Adolescent Function EnabledThe ECA-HPV (Embodied Conversational Agent adapted for this project) system comprises of a smartphone-based ECA parent/guardian interface, where the parent/guardian participants can receive HPV vaccine promotion and counseling from an interactive agent. Adolescent participants receive the adolescent version of the ECA-HPV app, which includes age-appropriate education and adolescent-focused engagement features, like games. The clinic notification feature is disabled on both the parent/guardian and adolescent apps. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. |
| ECA-HPV App with Clinic Notification and Adolescent Functions Enabled | Experimental | Behavioral: ECA-HPV App with Clinic Notification and Adolescent Functions EnabledParticipants will receive the full ECA-HPV (Embodied Conversational Agent adapted for this project) system on their smartphone app, which includes both the clinic notification and adolescent functions enabled. With the clinic notification function enabled, parent/guardian participants can communicate their concerns, questions, and logistical barriers to the clinic staff. Adolescent participants receive the adolescent version of the ECA-HPV app, which includes age-appropriate education and adolescent-focused engagement features, like games. An internet-based measure, REDCap, will be used for parent/guardian and adolescent participants to complete surveys at baseline, after the index well child visit, and after the second well child visit. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Speaks English fluently
- Able to independently consent
- Has adequate corrected vision to use the ECA-HPV system (based on their ability to go through the consent form)
- Has adequate hearing to use the ECA-HPV system (based on their ability to hear the research staff member conducting the consent process)
- Has a smartphone that is able to support the ECA-HPV app
Key exclusion criteria (2 listed)
- Is not able to use the ECA-HPV system
- Has already participated in the study before
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 |
|---|---|---|
| Usual CareParent/guardian and adolescent participants will not receive the ECA-HPV system intervention. A survey will be given via REDCap to the parent/guardian and adolescent participants at baseline, after the first well child clinic visit, and after the second well child clinic visit to assess self-reported vaccination attitudes and behaviors. Adolescent participants will receive usual care. | Behavioural | Usual Care |
| ECA-HPV App with Clinic Notification and Adolescent Functions DisabledParent/guardian participants will interact with the ECA-HPV smartphone-based system over a period of ~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/guardian and adolescent to assess self-reported vaccination attitudes and behaviors. Parent/guardian participants will also be asked questions about the ECA-HPV app. The clinic notification and adolescent functions of the complete ECA-HPV app are disabled. Adolescent participants will receive usual care. | Behavioural | ECA-HPV App with Clinic Notification and Adolescent Functions Disabled |
| ECA-HPV App with Clinic Notification Function EnabledParent/guardian participants will interact with the ECA-HPV smartphone-based system over a period of ~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/guardian and adolescent to assess self-reported vaccination attitudes and behaviors. Parent/guardian participants will also be asked questions about the ECA-HPV app and the clinic notification feature. The clinic notification is enabled on the parent/guardian ECA-HPV app, however, the adolescent does not have access to the adolescent ECA-HPV app. Adolescent participants will receive usual care. | Behavioural | ECA-HPV App with Clinic Notification Function Enabled |
| ECA-HPV App with Adolescent Function EnabledParent/guardian participants will interact with the ECA-HPV smartphone-based system over a period of ~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/guardian and adolescent to assess self-reported vaccination attitudes and behaviors as well as ECA-HPV app use and satisfaction. The adolescent function is enabled, however, the clinic notification function is disabled. Thus, the ECA-HPV system app will have an adolescent-facing feature for adolescent participants to engage with the agent. Adolescent participants will receive usual care and will be able to engage with the adolescent version of the ECA-HPV app throughout the duration of the study. | Behavioural | ECA-HPV App with Adolescent Function Enabled |
| ECA-HPV App with Clinic Notification and Adolescent Functions EnabledParent/guardian participants will interact with the complete ECA-HPV smartphone-based system over a period of ~16 months. The ECA-HPV is designed to interact with parents/guardians to increase vaccine acceptability prior to the clinic visit. A survey will be given to parent/guardian participants via REDCap at baseline, after the first well child clinic visit, and after the second well child clinic visit to both the parent/ guardian and adolescent to assess self-reported vaccination attitudes and behaviors as well as ECA-HPV app use and satisfaction and questions about the clinic notification feature. The complete ECA-HPV app includes the parent version and adolescent versions of the ECA-HPV app. Both versions have the clinic notification feature enabled. Adolescent participants will receive usual care and can engage with the adolescent version of the ECA-HPV app throughout the study. | Behavioural | ECA-HPV App with Clinic Notification and Adolescent Functions Enabled |
Primary outcome
HPV vaccination series completion comparing the control group to the intervention groups
Time frame: 16 months
HPV vaccination series completion for the control group will be compared to the collective rate for the intervention groups. A review of medical records at the T2 timepoint will be done for vaccination series completion.
HPV vaccination series completion comparing the intervention groups
Time frame: 16 months
HPV vaccination series completion will be assessed between participants randomized to the full ECA-HPV versus people randomized to the ECA-HPV with no adolescent app function and no clinic notification function. A review of medical records at the T2 timepoint will be done for vaccination series completion.
5 secondary outcomes
HPV Knowledge
Time frame: 16 months
HPV Attitudes
Time frame: 16 months
General Vaccine Attitudes
Time frame: 16 months
ECA-HPV App Satisfaction
Time frame: 16 months
Clinic Notification Feature Satisfaction
Time frame: 16 months
Results and safety
The study was stopped early (reason given: We were informed by the NCI that this research no longer aligns with NCI values, therefore our grant was terminated and we had received a stop work order.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Michael Paasche-Orlow, MD, MPH principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECA-HPV App with Clinic Notification and Adolescent Functions Disabled, ECA-HPV App with Clinic Notification Function Enabled and ECA-HPV App with Adolescent Function Enabled in people with Human Papilloma Virus, run by Tufts Medical Center at 1 site in United States.
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 15 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was stopped early (reason given: We were informed by the NCI that this research no longer aligns with NCI values, therefore our grant was terminated and we had received a stop work order.). Results are not available in the source record.
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?
HPV vaccination series completion comparing the control group to the intervention groups (time frame: 16 months). The study lists 2 primary outcomes in all. 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 15 Jul 2025.