Clinical trial NCT06397378: Engaging College Students in Developing and Testing a Video-based Intervention for HPV Vaccination Promotion
Official title: Development and Pilot Testing a Video-based Intervention to Promote HPV Vaccination Among College Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: N/A - Healthy Subjects
Keywords: video intervention
HPV vaccination rate
HPV infection
college students
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The interventions (videos and CDC Fact Sheet) and T0-T2 assessments will be administered online. 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.

A resource kit including available resources to obtain vaccines will be provided to all participants after T2 assessment. We will also provide the video-based intervention to the students in the comparison arm after T2 assessment should they be interested.
Primary purpose: OTHER

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.

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\&#39;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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participants' HPV vaccination intention
timeFrame: through study completion, an average of 1 year
measure: Participants' HPV vaccine uptake
timeFrame: through study completion, an average of 1 year
measure: Participants' attitude toward receiving the HPV vaccines
timeFrame: through study completion, an average of 1 year
measure: Participants' subjective norms
timeFrame: through study completion, an average of 1 year
measure: Participants' perceived behavioral controls
timeFrame: through study completion, an average of 1 year
measure: Participants' satisfaction
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
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