NCT07068802

Brief Summary

The goal of this clinical trial is to determine if different risk communication strategies can increase the intention to receive the HPV vaccine among male college students in China. The study focuses on male college students aged 18-25 years, who are healthy volunteers and have not previously received the HPV vaccine. The main question it aims to answer is: Can specific risk communication interventions increase the willingness to receive the HPV vaccine among male college students? Researchers will compare four different interventions to see if they have a significant effect on vaccination intention: Control group: Receiving a standard statement about HPV risks. Personal risks group: Receiving information on male-specific health risks. Partner risks group: Receiving information on risks to female partners. Combined risks group: Receiving information on both personal risks and risks to female partners. Participants will: Provide electronic informed consent. Complete pre-exposure questionnaires. Be exposed to a 120-second message based on their assigned group. Complete an immediate post-exposure assessment. This study aims to identify effective communication strategies to promote HPV vaccination among male college students, especially in light of the upcoming approval of the first male HPV vaccine in China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
612

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 10, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

27 days

First QC Date

July 7, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

HPVVACCINECOMMUNICATIONINTENTION

Outcome Measures

Primary Outcomes (3)

  • HPV vaccination intention

    The primary outcome measure is the intention to receive the HPV vaccine among male college students, assessed through a question: "If HPV vaccine were available for males in China, would you get vaccinate?". The answer was measured using a 5-point Likert scale (1= "not at all willing" to 5= "highly willing")

    Immediately after the 120-second message exposure.

  • Precaution Adoption Process Model (PAPM) adapted decisional readiness

    A single question was asked "Before today, what do your stance on HPV vaccination?" the answer was categories as "pre-decisional (never heard/knew but no consideration) vs. "decisional (active refusal/acceptance).

    Immediately after the 120-second message exposure.

  • respondents' perceived responsibility toward HPV infection prevention

    The third outcome aims to test the respondents' perceived responsibility toward HPV infection prevention with a single question "HPV infection is a shared responsibility of both genders." The answer was measured using a 5-point Likert scale on agreement (1= "strongly disagree" to 5= "strongly agree").

    Immediately after the 120-second message exposure.

Study Arms (4)

control group

ACTIVE COMPARATOR

HPV risks

Behavioral: Message framing

intervention group 1

EXPERIMENTAL

HPV risks+personal risks

Behavioral: Message framing

intervention group 2

EXPERIMENTAL

HPV risks+partner risks

Behavioral: Message framing

intervention group 3

EXPERIMENTAL

HPV risks+personal risks and partner risks

Behavioral: Message framing

Interventions

Message framingBEHAVIORAL

Participants provided electronic informed consent with voluntary withdraw options. Randomization was implemented through a 1:1:1:1 allocation ratio to four conditions: Control group (Group 1, n=154) receiving a standard statement of HPV risks (In mainland China, HPV vaccines are currently approved only for female use. However, in other countries, they are also available for males. HPV can cause cancers throughout the body, from the head to the reproductive system. Thus, HPV vaccination can protect against many cancer types. Annually, over 120,000 Chinese are diagnosed with HPV-related cancers, with about 50,000 dying from them.); Intervention 1 (Group 2, n=152) adding male-specific health risks; Intervention 2 (Group 3, n=153) adding risk to female partners; Intervention 3 (Group 4, n=153) adding both personal risk and risk to female partners. The protocol involved sequential completion of pre-exposure questionnaires, timed 120-second message exposure, and immediate post-exposure asses

control groupintervention group 1intervention group 2intervention group 3

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- aged above 18, male,college student, willing to participate

You may not qualify if:

  • \- vaccinated with one dose or more HPV vaccine or decided to get vaccinated with HPV vaccine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The study is double-blinded, meaning that both the subjects and the researchers are unaware of the group assignments. The randomization of groups is conducted using Wenjuanxing (a survey tool). However, blinding is not implemented during data analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

December 10, 2024

Primary Completion

January 6, 2025

Study Completion

January 6, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Locations