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Stories to Prevent (StoP) HPV Cancers

NCT ID: NCT06808776

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-17

Study Completion Date

2027-01-15

Brief Summary

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This randomized controlled trial (RCT) evaluates the association of a narrative communication intervention on human papillomavirus (HPV) vaccination rates among 9- to 12-year-olds. The intervention is a brief video from local cancer survivors narrating their stories with an HPV-related cancer diagnosis and recommending the HPV vaccine for cancer prevention. RCT participants will be the parents (n=200) of children ages 9-12 who have not initiated HPV vaccination. Participants will be randomized (1:1) to our intervention or control (placebo video) one week before their child's next primary care visit. Our primary outcome is HPV vaccine initiation (first dose of the HPV vaccine series) among children ages 9-12 at the time of the wellness visit. The study also explores the effect of narratives on theory-based mediators of HPV vaccination, including parents' cognitive (e.g., risk perception) and emotional reactions (e.g., hope, anticipated regret).

Detailed Description

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Despite the availability of the human papillomavirus (HPV) vaccine that can prevent over 37,300 HPV-related cancers in the US every year, only 62.6% of girls and boys were up-to-date in 2022. Low-quality provider recommendations and time constraints during clinic visits limit parents' opportunities to discuss and make HPV vaccination decisions. Pre-visit education to parents could complement provider communication to promote HPV vaccination. There is a critical need to identify better communication strategies to increase HPV vaccine uptake, including the use of narrative messaging and existing digital technologies in clinics and at home (electronic health records, patient portal, mobile devices). The Stories to Prevent (StoP) HPV Cancers Study is a randomized controlled trial (RCT) to evaluate the association of a narrative communication intervention delivered through digital and mobile technology before clinic visits on HPV vaccine initiation rates. A sample of 200 parents of unvaccinated children ages 9-12 will be randomized to receive our intervention or control (placebo video). Participants will be recruited from general pediatric and family medicine clinics affiliated with Penn State Health. We will also examine the effect of narrative communication on theory-based psychological mediators of HPV vaccine initiation and narrative communication processes, specifically parents' cognitive and emotional reactions.

Conditions

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Human Papillomavirus Vaccination Emotions

Keywords

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Human papillomavirus vaccine Narrative communication Emotions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Cancer survivor narrative video

Parents randomly assigned to this arm will receive the video intervention using their personal devices around two weeks before their child's wellness visit. The video will be approximately 4 minutes in length with three parts: (1) Cancer experience, (2) Vaccine recommendation, and (3) Closing message.

Group Type EXPERIMENTAL

Cancer survivor narrative

Intervention Type OTHER

The narrative video intervention has three parts: (1) Cancer experience - the cancer survivor narrates his/her experience with an HPV-related cancer, including diagnosis, treatment, and how cancer affected their personal life or family; (2) Vaccine recommendation - the cancer survivor provides brief information about the safety and effectiveness of the HPV vaccine and recommend that parents get the HPV vaccine for their child to prevent cancers; and (3) Closing message - The sentence "HPV vaccine is cancer prevention. Talk to your child's healthcare provider about getting the HPV vaccine during the next clinic visit" will appear on the screen.

Placebo video

Parents randomly assigned to this arm will receive the placebo video using their personal devices around two weeks before their child's wellness visit. The placebo video is about healthy eating tips for families with children. The video will be approximately 4 minutes in length.

Group Type PLACEBO_COMPARATOR

Healthy eating tips

Intervention Type OTHER

A publicly available video about healthy eating tips for families with children.

Interventions

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Cancer survivor narrative

The narrative video intervention has three parts: (1) Cancer experience - the cancer survivor narrates his/her experience with an HPV-related cancer, including diagnosis, treatment, and how cancer affected their personal life or family; (2) Vaccine recommendation - the cancer survivor provides brief information about the safety and effectiveness of the HPV vaccine and recommend that parents get the HPV vaccine for their child to prevent cancers; and (3) Closing message - The sentence "HPV vaccine is cancer prevention. Talk to your child's healthcare provider about getting the HPV vaccine during the next clinic visit" will appear on the screen.

Intervention Type OTHER

Healthy eating tips

A publicly available video about healthy eating tips for families with children.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Parent/guardian of a 9-12 year old receiving primary care at a Penn State Health clinic
* Their child has not previously received or initiated the HPV vaccine
* Is able to read and understand spoken English or Spanish
* Has a valid email address and access to a mobile phone, table, desktop or laptop computer to engage in the intervention

Exclusion Criteria

* Parent of guardian is less than 18 years of age
* Unable to read and understand spoken English or Spanish
* Does not have access to a mobile phone, table, desktop or laptop computer
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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William Calo

Associate Professor of Public Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Penn State Health

Hershey, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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William A Calo, PhD

Role: CONTACT

Phone: 717-531-3535

Email: [email protected]

Facility Contacts

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Ben Fogel, MD

Role: primary

Other Identifiers

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STUDY00025798

Identifier Type: -

Identifier Source: org_study_id