N/A - Healthy SubjectsHPV videosNCT06397378
Engaging College Students in Developing and Testing a Video-based Intervention for HPV Vaccination Promotion
A study testing short videos related to HPV and the HPV vaccine and CDC HPV Fact Sheet in people with N/A - Healthy Subjects, run by Michigan State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- N/A - Healthy Subjects
- What is being tested?
- short videos related to HPV and the HPV vaccine and CDC HPV Fact Sheet
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 30 Jun 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 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: college students aged 18-26 never receive HPV vaccines able to understand English.
Exclusion Criteria: not able to understand English younger than 18 or older than 26 years old have received HPV vaccines.
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, 1 recruiting
- Recruiting
Michigan State University
East Lansing, Michigan, 48824
Cheng-Ching Hiya Liu, Ph.D., 626-566-4835, chengliu@msu.edu
Cheng-Ching Liu, Ph.D., 626-566-4835, chengliu@msu.edu
About this study
Official title: Development and Pilot Testing a Video-based Intervention to Promote HPV Vaccination Among College Students
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.
Read the detailed description
Human papillomavirus (HPV) infection is the most common sexually transmitted infection in the United States (U.S.) and a significant public health issue, as almost all sexually active individuals contract it at some point in their lives. Approximately 79 million Americans are infected with HPV, most in their late teens or early 20s. HPV has been found to be associated with cancers for females (e.g., cervical cancer) and males (e.g., penile cancer). The high morbidity, mortality, and economic burden attributed to cancer-causing HPV call for researchers to address this public health concern through vigorous prevention efforts, including HPV vaccination.
HPV-associated cancers could be prevented through vaccination. HPV vaccination is recommended for individuals aged 9-26 years. Economic models have shown that HPV vaccination of adolescents and young adults is cost effective; however, HPV vaccination rates are falling dramatically short of the 80% Healthy People 2030 target recommendation. Young adults such as college students are at higher risk for HPV infection but a significant portion of them is not yet vaccinated against HPV.
Empirical evidence suggests that a lack of awareness and knowledge about HPV and the vaccine, the inconvenience of getting the vaccine, and concern about side effects are main barriers for college students. Current interventions developed to increase HPV vaccination rates are primarily focusing on adolescents as recipients. In the limited interventions developed to address low HPV vaccination rates among college students, most of them only included female college students. In one online RCT study that young adults aged 18-26 were randomized into intervention group (YouTube videos) reported significantly higher vaccination intention compared to comparison group (educational pamphlet); however, the vaccination status was not assessed. College students have advocated for educational videos featuring healthcare providers and peers and sharing videos on YouTube and Instagram.
To our knowledge, this study is the first one of a few video-based interventions co-designed with the main stakeholder-college students to address the low HPV vaccination rates in this at-risk population. This novel intervention is brief, portable, tailored to college students and feasible to fit the intervention into college student\'s busy schedules.
The investigators will develop a video-based intervention and conduct a pilot randomized trial comparing this intervention to an HPV Fact Sheet developed by CDC. The investigators will target college students aged 18-26 because of their higher risk of contracting HPV infection and low vaccination rates. Aim 1. Develop a developmentally and culturally congruent video-based intervention for college students aged 18-26. The investigators will recruit and form a student advisory board (SAB) consisting of 8-10 college students aged 18-26 to assist with developing four brief HPV education videos (each 2-3 mins long; two will be revised from Co-I's prior research). The advisory board will provide input on the study recruitment plan, assessments, and be involved in data interpretation and dissemination processes. Aim 2. Conduct a pilot randomized controlled trial (RCT) to examine the feasibility (participation rate, retention, intervention fidelity), acceptability (satisfaction) and preliminary efficacy of the intervention to promote HPV vaccination among 80 college students aged 18-26.
Once consented, participants will receive assessments at baseline (T0) using the web-based data collection tool, Qualtrics, before being assigned to one of the two study arms. Participants will be invited to fill out Time 1 (T1) assessment immediately after the intervention (video vs. Fact Sheet) and Time 2 (T2) assessment 2 months after completion of the intervention. The interventions (video and CDC Fact Sheet) and T0-T2 assessments will be administered online. A resource kit including available resources to obtain vaccines will be provided to all participants after T2 assessment. The investigators will also provide the video-based intervention to the students in the comparison arm after T2 assessment should they be interested. Videos will be sent out after participants complete T0. One video will be sent out every 3 days and the intervention (4 videos in total) will be completed in 2-week via emails. Participants in the intervention group can watch the videos at their leisure.
Feasibility will be assessed by response rate (percentage of eligible individuals agreeing to participate), retention (proportion retained through follow-up and complete T0-T2 assessments), intervention fidelity (% of participants watch all stories). Acceptability will be assessed via two Likert-type satisfaction questions. Based on our prior research, the investigators will use the following benchmarks to determine study feasibility as ≥ 80% response rate, ≥ 80% retention rate, ≥ 80% intervention fidelity, and acceptability by a mean satisfaction score ≥ 4.0. Preliminary efficacy will be determined by the % of participants completing the 1st HPV vaccine does within 2 months of completing the intervention.
- Conditions
- N/A - Healthy Subjects
- Being tested
- short videos related to HPV and the HPV vaccine, CDC HPV Fact Sheet
- Keywords
- video intervention, HPV vaccination rate, HPV infection, college students
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short videos related to HPV and the HPV vaccineOther
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.
CDC HPV Fact SheetOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: short videos related to HPV and the HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' HPV vaccination intention
The investigators will assess participants' intention to receive HPV vaccines before and after watching HPV vaccine-related videos, t
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Participants' satisfaction
participants' satisfaction about the interventions.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start16 Aug 2024
- Primary completion5 Sep 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for N/A - Healthy SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChengChing Hiya Liu, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397378
- Sponsor's protocol ID
- MSUSTUDY10264
- Other IDs
- PD66847
- Acronym
- HPV videos
- Status last verified
- Sep 2025
- First submitted
- 12 Apr 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD including individuals' intention to receive the HPV vaccines and developed videos can be shared upon request.
Publications
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.
PubMed 41248380
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing a Video-based Intervention to Promote HPV Vaccination Among College Students
- ClinicalTrials.gov ID
- NCT06397378
- Acronym / sponsor ID
- HPV videos / MSUSTUDY10264
- Conditions
- N/A - Healthy Subjects
- Keywords
- video intervention, HPV vaccination rate, HPV infection, college students
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 May 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.
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.
Detailed description
Human papillomavirus (HPV) infection is the most common sexually transmitted infection in the United States (U.S.) and a significant public health issue, as almost all sexually active individuals contract it at some point in their lives. Approximately 79 million Americans are infected with HPV, most in their late teens or early 20s. HPV has been found to be associated with cancers for females (e.g., cervical cancer) and males (e.g., penile cancer). The high morbidity, mortality, and economic burden attributed to cancer-causing HPV call for researchers to address this public health concern through vigorous prevention efforts, including HPV vaccination.
HPV-associated cancers could be prevented through vaccination. HPV vaccination is recommended for individuals aged 9-26 years. Economic models have shown that HPV vaccination of adolescents and young adults is cost effective; however, HPV vaccination rates are falling dramatically short of the 80% Healthy People 2030 target recommendation. Young adults such as college students are at higher risk for HPV infection but a significant portion of them is not yet vaccinated against HPV.
Empirical evidence suggests that a lack of awareness and knowledge about HPV and the vaccine, the inconvenience of getting the vaccine, and concern about side effects are main barriers for college students. Current interventions developed to increase HPV vaccination rates are primarily focusing on adolescents as recipients. In the limited interventions developed to address low HPV vaccination rates among college students, most of them only included female college students. In one online RCT study that young adults aged 18-26 were randomized into intervention group (YouTube videos) reported significantly higher vaccination intention compared to comparison group (educational pamphlet); however, the vaccination status was not assessed. College students have advocated for educational videos featuring healthcare providers and peers and sharing videos on YouTube and Instagram.
To our knowledge, this study is the first one of a few video-based interventions co-designed with the main stakeholder-college students to address the low HPV vaccination rates in this at-risk population. This novel intervention is brief, portable, tailored to college students and feasible to fit the intervention into college student\'s busy schedules.
The investigators will develop a video-based intervention and conduct a pilot randomized trial comparing this intervention to an HPV Fact Sheet developed by CDC. The investigators will target college students aged 18-26 because of their higher risk of contracting HPV infection and low vaccination rates. Aim 1. Develop a developmentally and culturally congruent video-based intervention for college students aged 18-26. The investigators will recruit and form a student advisory board (SAB) consisting of 8-10 college students aged 18-26 to assist with developing four brief HPV education videos (each 2-3 mins long; two will be revised from Co-I's prior research). The advisory board will provide input on the study recruitment plan, assessments, and be involved in data interpretation and dissemination processes. Aim 2. Conduct a pilot randomized controlled trial (RCT) to examine the feasibility (participation rate, retention, intervention fidelity), acceptability (satisfaction) and preliminary efficacy of the intervention to promote HPV vaccination among 80 college students aged 18-26.
Once consented, participants will receive assessments at baseline (T0) using the web-based data collection tool, Qualtrics, before being assigned to one of the two study arms. Participants will be invited to fill out Time 1 (T1) assessment immediately after the intervention (video vs. Fact Sheet) and Time 2 (T2) assessment 2 months after completion of the intervention. The interventions (video and CDC Fact Sheet) and T0-T2 assessments will be administered online. A resource kit including available resources to obtain vaccines will be provided to all participants after T2 assessment. The investigators will also provide the video-based intervention to the students in the comparison arm after T2 assessment should they be interested. Videos will be sent out after participants complete T0. One video will be sent out every 3 days and the intervention (4 videos in total) will be completed in 2-week via emails. Participants in the intervention group can watch the videos at their leisure.
Feasibility will be assessed by response rate (percentage of eligible individuals agreeing to participate), retention (proportion retained through follow-up and complete T0-T2 assessments), intervention fidelity (% of participants watch all stories). Acceptability will be assessed via two Likert-type satisfaction questions. Based on our prior research, the investigators will use the following benchmarks to determine study feasibility as ≥ 80% response rate, ≥ 80% retention rate, ≥ 80% intervention fidelity, and acceptability by a mean satisfaction score ≥ 4.0. Preliminary efficacy will be determined by the % of participants completing the 1st HPV vaccine does within 2 months of completing the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group using CDC factsheet | Active comparator | Other: CDC HPV Fact SheetWe 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. |
| Group using videos | Experimental | Other: short videos related to HPV and the HPV vaccineNinety-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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| short videos related to HPV and the HPV vaccineEight 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. | Other | Group using videos |
| CDC HPV Fact SheetWe 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 | Other | Group using CDC factsheet |
Primary outcome
Participants' HPV vaccination intention
Time frame: through study completion, an average of 1 year
The investigators will assess participants' intention to receive HPV vaccines before and after watching HPV vaccine-related videos, t
Participants' HPV vaccine uptake
Time frame: through study completion, an average of 1 year
Participants will be asked if they received any HPV vaccines after watching the videos.
Participants' attitude toward receiving the HPV vaccines
Time frame: through study completion, an average of 1 year
Participants' attitude toward receiving HPV vaccines will be assessed before and after watching videos.
Participants' subjective norms
Time frame: through study completion, an average of 1 year
Participants' subjective norms regarding receiving HPV vaccines will be assessed before and after watching videos.
Participants' perceived behavioral controls
Time frame: through study completion, an average of 1 year
Participants' perceived behavioral control regarding receiving HPV vaccines will be assessed before and after watching videos.
Participants' satisfaction
Time frame: through study completion, an average of 1 year
participants' satisfaction about the interventions.
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 25 Sep 2025.
- Derived from this study: PubMed 41248380Liu 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.
- Individual participant dataSharing planned: Yes. IPD including individuals' intention to receive the HPV vaccines and developed videos can be shared upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short videos related to HPV and the HPV vaccine and CDC HPV Fact Sheet in people with N/A - Healthy Subjects, run by Michigan State University 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?
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: looking for participants now, as of the sponsor's last update on 25 Sep 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?
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 ChengChing Hiya Liu, Ph. D. (626-566-4835, chengliu@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' HPV vaccination intention (time frame: through study completion, an average of 1 year). 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?
On the ClinicalTrials.gov record for NCT06397378, which also lists 1 linked publication.
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 25 Sep 2025.