HPV VaccinationNCT06704308
Parents' HPV Stories
A study testing Web Application and Provider Elaborated Prompts in people with HPV Vaccination, run by Anne E Ray at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the feasibility of intervention implementation in two clinics in rural KY, and its preliminary efficacy with regards to increasing vaccine confidence in a sample of vaccine hesitant parents. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccination
- What is being tested?
- Web Application and Provider Elaborated Prompts
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Nov 2026
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- status as a mother or female guardian of an 11-17-year-old adolescent
- status as a U.S. resident
- self-reported ability to read English
- self-reported HPV vaccine hesitant using established methodology
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kentucky
Lexington, Kentucky, 40506
Anne E Ray, PhD, 859-218-4944, anne.ray@uky.edu
About this study
Official title: Development and Preliminary Evaluation of a Multilevel Intervention to Increase HPV Vaccine Confidence Among Parents of Youth in Rural KY
The goal of this clinical trial is to evaluate the feasibility of intervention implementation in two clinics in rural KY, and its preliminary efficacy with regards to increasing vaccine confidence in a sample of vaccine hesitant parents.
Hypothesis: Parents will report increased vaccine confidence scores post-intervention.
Data from this study will provide preliminary data for a larger scale evaluation of the intervention.
Participants will be asked to complete surveys, view a web-based intervention and then visit with their child's healthcare provider.
Read the detailed description
Participants will be asked to complete a brief screening assessment to establish their eligibility for participation. Eligible participants will be asked to complete a consent form and be directed to the pre-test survey. Upon completion of the survey, the participants will be directed to the tailored intervention content, including the Parents' Stories videos. This step will be completed prior to interaction with the provider. During the provider-patient visit, the provider will deliver the elaborated prompt portion of the intervention to participating mothers. Mothers will receive a link to the post-test survey two weeks following their appointment.
- Conditions
- HPV Vaccination
- Being tested
- Web Application, Provider Elaborated Prompts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web ApplicationBehavioural
A web application for vaccine-hesitant parents and their teens with brief, 90-second narrative videos and tailored, motivational content
Provider Elaborated PromptsBehavioural
A component for providers that suggests elaborated prompts to be used with parents that align with the content of the web application, are tailored to parent concerns, and are motivational in nature
| Study group | Role | What they receive |
|---|---|---|
| Parents' Stories Web Application + Provider Elaborated Prompts | Experimental | Participating parents will be asked to navigate a web application that consists of (a) brief, 90-second narrative videos that encourage parent-provider communication about the vaccine and (b) personalized feedback to parents that is tailored to provide educational content in response to their concerns and be motivational in nature. Providers will provide elaborated prompts related to the vaccine when meeting with parents tailored to their concerns. Receives: Behavioral: Web Application; Behavioral: Provider Elaborated Prompts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HPV Vaccine Hesitancy Scale score
9-item scale from Strongly Disagree (1) to Strongly Agree (5); scores range from 1-5, with higher scores indicating greater hesitancy
Measured: From pretest to posttest (up to two weeks)
Change Human Papillomavirus Knowledge Questionnaire score
13-item scale with True / False / I don't know response options; scores range from 0-13 with higher scores indicating greater vaccine knowledge
Measured: From pretest to posttest (up to two weeks)
Change in intent to discuss HPV vaccine with provider
Answers include Very likely; Somewhat likely; Not too likely; Not likely at all; Not sure / do not know
Measured: From pretest to posttest (up to two weeks)
Change in HPV vaccine intent
1 item adapted from NIS-TEEN survey. Answers include very likely; somewhat likely; not too likely; not likely at all; not sure / do not know
Measured: From pretest to posttest (up to two weeks)
Change in self-reported HPV vaccination and related provider recommendations
4 items adapted from the NIS-TEEN survey.
Measured: from screening to posttest (up to two weeks)
Change in Reasons Not to Vaccinate score
16 items adapted from NIS-TEEN survey; higher score indicates more obstacles to vaccination
Measured: Pretest only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV VaccinationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne E Ray
- Sponsor type
- University, hospital or other
- Collaborators
- Real Prevention, LLC, Merck Institute for Therapeutic Research
- Responsible party
- Sponsor-investigator, Anne E Ray, University of Kentucky
- Investigators
- Anne E Ray, PhD., Principal investigator, University of KentuckyAaron Kruse-Diehr, PhD, Study chair, University of KentuckyMichael Hecht, PhD, Study chair, Real Prevention, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704308
- Sponsor's protocol ID
- 95632
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available to qualified researchers after the main findings are published in a peer-reviewed journal upon request. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Preliminary Evaluation of a Multilevel Intervention to Increase HPV Vaccine Confidence Among Parents of Youth in Rural KY
- ClinicalTrials.gov ID
- NCT06704308
- Acronym / sponsor ID
- 95632
- Conditions
- HPV Vaccination
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Anne E RayUniversity, hospital or other
- Collaborators
- Real Prevention, LLC, Merck Institute for Therapeutic Research
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Nov 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 goal of this clinical trial is to evaluate the feasibility of intervention implementation in two clinics in rural KY, and its preliminary efficacy with regards to increasing vaccine confidence in a sample of vaccine hesitant parents.
Hypothesis: Parents will report increased vaccine confidence scores post-intervention.
Data from this study will provide preliminary data for a larger scale evaluation of the intervention.
Participants will be asked to complete surveys, view a web-based intervention and then visit with their child's healthcare provider.
Detailed description
Participants will be asked to complete a brief screening assessment to establish their eligibility for participation. Eligible participants will be asked to complete a consent form and be directed to the pre-test survey. Upon completion of the survey, the participants will be directed to the tailored intervention content, including the Parents' Stories videos. This step will be completed prior to interaction with the provider. During the provider-patient visit, the provider will deliver the elaborated prompt portion of the intervention to participating mothers. Mothers will receive a link to the post-test survey two weeks following their appointment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents' Stories Web Application + Provider Elaborated Prompts | Experimental | Behavioral: Web Application, Behavioral: Provider Elaborated PromptsParticipating parents will be asked to navigate a web application that consists of (a) brief, 90-second narrative videos that encourage parent-provider communication about the vaccine and (b) personalized feedback to parents that is tailored to provide educational content in response to their concerns and be motivational in nature. Providers will provide elaborated prompts related to the vaccine when meeting with parents tailored to their concerns. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- status as a mother or female guardian of an 11-17-year-old adolescent
- status as a U.S. resident
- self-reported ability to read English
- self-reported HPV vaccine hesitant using established methodology
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Web ApplicationA web application for vaccine-hesitant parents and their teens with brief, 90-second narrative videos and tailored, motivational content | Behavioural | Parents' Stories Web Application + Provider Elaborated Prompts |
| Provider Elaborated PromptsA component for providers that suggests elaborated prompts to be used with parents that align with the content of the web application, are tailored to parent concerns, and are motivational in nature | Behavioural | Parents' Stories Web Application + Provider Elaborated Prompts |
Primary outcome
Change in HPV Vaccine Hesitancy Scale score
Time frame: From pretest to posttest (up to two weeks)
9-item scale from Strongly Disagree (1) to Strongly Agree (5); scores range from 1-5, with higher scores indicating greater hesitancy
Change Human Papillomavirus Knowledge Questionnaire score
Time frame: From pretest to posttest (up to two weeks)
13-item scale with True / False / I don't know response options; scores range from 0-13 with higher scores indicating greater vaccine knowledge
Change in intent to discuss HPV vaccine with provider
Time frame: From pretest to posttest (up to two weeks)
Answers include Very likely; Somewhat likely; Not too likely; Not likely at all; Not sure / do not know
Change in HPV vaccine intent
Time frame: From pretest to posttest (up to two weeks)
1 item adapted from NIS-TEEN survey. Answers include very likely; somewhat likely; not too likely; not likely at all; not sure / do not know
Change in self-reported HPV vaccination and related provider recommendations
Time frame: from screening to posttest (up to two weeks)
4 items adapted from the NIS-TEEN survey.
Change in Reasons Not to Vaccinate score
Time frame: Pretest only
16 items adapted from NIS-TEEN survey; higher score indicates more obstacles to vaccination
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be available to qualified researchers after the main findings are published in a peer-reviewed journal upon request. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.
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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.
Anne E Ray, PhD. principal investigator
University of Kentucky
Aaron Kruse-Diehr, PhD study chair
University of Kentucky
Michael Hecht, PhD study chair
Real Prevention, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web Application and Provider Elaborated Prompts in people with HPV Vaccination, run by Anne E Ray 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 4 inclusion and 1 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 10 Sep 2026. 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?
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 Anne E Ray, PhD (859-218-4944, anne.ray@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HPV Vaccine Hesitancy Scale score (time frame: From pretest to posttest (up to two weeks)). The study lists 6 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 10 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.