NCT06397378

Brief Summary

HPV vaccines offer hope against HPV-associated cancers for males and females; however, the rate of vaccination has not reached projected public health goals. This study will engage key stakeholders in the research process to co-design and pilot testing a video-based intervention addressing low HPV vaccination rates among college students The intervention and its approach have the potential to reduce health disparities in HPV-associated cancers in young adults via low-cost technology and timely intervention.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress92%
Aug 2024Jun 2026

First Submitted

Initial submission to the registry

April 12, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

August 16, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

April 12, 2024

Last Update Submit

September 20, 2025

Conditions

Keywords

video interventionHPV vaccination rateHPV infectioncollege students

Outcome Measures

Primary Outcomes (6)

  • Participants' HPV vaccination intention

    The investigators will assess participants' intention to receive HPV vaccines before and after watching HPV vaccine-related videos, t

    through study completion, an average of 1 year

  • Participants' HPV vaccine uptake

    Participants will be asked if they received any HPV vaccines after watching the videos.

    through study completion, an average of 1 year

  • Participants' attitude toward receiving the HPV vaccines

    Participants' attitude toward receiving HPV vaccines will be assessed before and after watching videos.

    through study completion, an average of 1 year

  • Participants' subjective norms

    Participants' subjective norms regarding receiving HPV vaccines will be assessed before and after watching videos.

    through study completion, an average of 1 year

  • Participants' perceived behavioral controls

    Participants' perceived behavioral control regarding receiving HPV vaccines will be assessed before and after watching videos.

    through study completion, an average of 1 year

  • Participants' satisfaction

    participants' satisfaction about the interventions.

    through study completion, an average of 1 year

Study Arms (2)

Group using CDC factsheet

ACTIVE COMPARATOR

We did not develop this intervention. Instead, we will use information from the CDC website on HPV and the HPV vaccine and convert it into a narrated voiceover video to ensure the information is delivered in the same format as our video-based intervention.

Other: CDC HPV Fact Sheet

Group using videos

EXPERIMENTAL

Ninety-three college students will be randomly assigned to three groups (31 participants in each video group Vs. 30 participants in the CDC group) to watch the created videos. The videos will be presented in randomized order and distributed to participants to minimize bias.

Other: short videos related to HPV and the HPV vaccine

Interventions

Eight college students created and developed four videos on human papillomavirus (HPV) and the HPV vaccine, designed to increase their knowledge and attitude, shape subjective norms, enhance perceived behavioral control, and strengthen intentions to receive the HPV vaccine. Two months after the video intervention, we will follow up with participants to collect their self-reported vaccine uptake status. Outcomes will be compared with those of another group whose participants will watch a video presenting CDC information on HPV and the HPV vaccine, adapted into a narrated voiceover format.

Group using videos

We did not develop this intervention. Instead, we will use information from the CDC website on HPV and the HPV vaccine and convert it into a video with a narrated voiceover format. Because our student advisory board will develop four short videos, participants who are randomly assigned to the CDC fact sheet group will watch the converted CDC video four times to ensure that all groups are exposed to the same number of videos. Here is the CDC link: https://www.cdc.gov/hpv/vaccines/?CDC\_AAref\_Val=https://www.cdc.gov/hpv/parents/vaccinesafety.html

Group using CDC factsheet

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

RECRUITING

Related Publications (1)

  • Liu C, Chen AC, Rhodes N, Ewoldsen D, Arcoleo K. Evaluating the preliminary effectiveness of a video-based intervention for HPV vaccination promotion among college students aged 18-26: study protocol for a pilot randomised controlled trial. BMJ Open. 2025 Nov 16;15(11):e102235. doi: 10.1136/bmjopen-2025-102235.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

ChengChing Hiya Liu, Ph. D.

CONTACT

Angela Chia-Chen Chen, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study has been approved by the host university's Biomedical and Health Institutional Review Board (Study ID: STUDY00010264). We propose conducting a two-phase, mixed-methods research project to co-develop a culturally and developmentally appropriate video-intervention (Phase 1) with a Student Advisory Board (SAB) composed of eight college students with diverse background (sex, age, discipline). Once the videos are finalized, we will engage the SAB in the Phase 2 activities aimed to examine the feasibility, acceptability, and preliminary effectiveness of a RCT among college students aged 18-26.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2024

First Posted

May 2, 2024

Study Start

August 16, 2024

Primary Completion

September 5, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

IPD including individuals' intention to receive the HPV vaccines and developed videos can be shared upon request.

Shared Documents
STUDY PROTOCOL
Time Frame
December 2025
Access Criteria
To increase the robustness of the study design and results, the team member who handles data and analysis will be blinded to the assignment of participants in the respective study arms. Each participant will be assigned a unique ID linked to respective random group assignments. One unblinded team member will be selected to make reminder calls; this staff member will not be involved in intervention delivery or data entry, cleaning, or analysis. The PI will closely monitor the procedures to ensure high treatment fidelity.
More information

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