HPV Vaccination Intention Among Male College StudentsNCT07068802
Message Framing in HPV Vaccination Decision
A study testing Message framing in people with HPV Vaccination Intention Among Male College Students, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccination Intention Among Male College Students
- What is being tested?
- Message framing
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 6 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged above 18, male,college student, willing to participate
Who cannot join
- vaccinated with one dose or more HPV vaccine or decided to get vaccinated with HPV vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Message Framing in HPV Vaccination Decision: A Survey Experimental Study Among Chinese Male College Students
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?
Read more
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.
Read the detailed description
Study design We conducted a randomized survey experiment with pre-post design between December 2024 to January 6th 2025, right before the approval of the first HPV vaccine for male in the country in January 8th across three geographically dispersed Chinese universities (eastern, western, and northern regions). This study was conducted from The Institutional Review Board of Hangzhou Normal University, School of Public Health approved this study (approval no. 20240010).
Participants The proportion of male college students intending to receive the HPV vaccine was assumed to be 45% in the calculation of sample size, based on a previous report in China [28]. We assumed an increase in vaccination willingness to 55% for the personal risks group and partner risks group and 65% for the both risks group. To detect a significant intervention effect with a 2-sided α = .05, a power of 0.80, and an 80% valid response rate, we calculated that 169 participants were required (676 participants total).
From 720 initially involved in baseline evaluation, we excluded 82 due to incompleteness (>10% missing data) or invalidity (i.e., inconsistent responses to attention-check items), and 35 additional participants reporting prior HPV vaccination or definite baseline vaccination intention, yielding a final analytical sample of 612 male college students.
Randomization and interventions 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 assessment.
Measures We evaluated three primary outcomes. The first outcome is vaccination intention ("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") and then dichotomized into "willing (4-5)" vs. "unwilling (1-3)". The second outcome is 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). 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"). The final answer was dichotomized into "agree (4-5)" and "disagree (1-3)".
Statistical analysis Chi-square test and Kruskal-Wallis H test were performed to compare the frequencies and percentages of participants' demographic characteristics across groups. McNemar's test and Chi-square test were used to compare the effect within and between groups respectively. Multivariate logistic regression models, adjusting for sociodemographic factors (e.g., age and education background), were adopted to evaluate the differences between the four groups. All statistical analyses were performed using SPSS version 27.0, based on different statistical significance levels of p value after Bonferroni correction.
- Being tested
- Message framing
- Keywords
- HPV, VACCINE, COMMUNICATION, INTENTION
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Message framingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | HPV risks Receives: Behavioral: Message framing |
| intervention group 1 | Experimental | HPV risks+personal risks Receives: Behavioral: Message framing |
| intervention group 2 | Experimental | HPV risks+partner risks Receives: Behavioral: Message framing |
| intervention group 3 | Experimental | HPV risks+personal risks and partner risks Receives: Behavioral: Message framing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 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).
Measured: 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").
Measured: Immediately after the 120-second message exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start10 Dec 2024
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
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 HPV Vaccination Intention Among Male College StudentsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Yan, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068802
- Sponsor's protocol ID
- 20240010
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wang X, Yan B, Wang X. Effects of message framing on HPV Vaccination decision-making: A Survey experiment among Chinese male college students. Hum Vaccin Immunother. 2026 Dec;22(1):2606516. doi: 10.1080/21645515.2025.2606516. Epub 2026 Jan 2.
PubMed 41480936
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Message Framing in HPV Vaccination Decision: A Survey Experimental Study Among Chinese Male College Students
- ClinicalTrials.gov ID
- NCT07068802
- Acronym / sponsor ID
- 20240010
- Keywords
- HPV, VACCINE, COMMUNICATION, INTENTION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 16 Jul 2025 (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.
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.
Detailed description
Study design We conducted a randomized survey experiment with pre-post design between December 2024 to January 6th 2025, right before the approval of the first HPV vaccine for male in the country in January 8th across three geographically dispersed Chinese universities (eastern, western, and northern regions). This study was conducted from The Institutional Review Board of Hangzhou Normal University, School of Public Health approved this study (approval no. 20240010).
Participants The proportion of male college students intending to receive the HPV vaccine was assumed to be 45% in the calculation of sample size, based on a previous report in China [28]. We assumed an increase in vaccination willingness to 55% for the personal risks group and partner risks group and 65% for the both risks group. To detect a significant intervention effect with a 2-sided α = .05, a power of 0.80, and an 80% valid response rate, we calculated that 169 participants were required (676 participants total).
From 720 initially involved in baseline evaluation, we excluded 82 due to incompleteness (>10% missing data) or invalidity (i.e., inconsistent responses to attention-check items), and 35 additional participants reporting prior HPV vaccination or definite baseline vaccination intention, yielding a final analytical sample of 612 male college students.
Randomization and interventions 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 assessment.
Measures We evaluated three primary outcomes. The first outcome is vaccination intention ("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") and then dichotomized into "willing (4-5)" vs. "unwilling (1-3)". The second outcome is 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). 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"). The final answer was dichotomized into "agree (4-5)" and "disagree (1-3)".
Statistical analysis Chi-square test and Kruskal-Wallis H test were performed to compare the frequencies and percentages of participants' demographic characteristics across groups. McNemar's test and Chi-square test were used to compare the effect within and between groups respectively. Multivariate logistic regression models, adjusting for sociodemographic factors (e.g., age and education background), were adopted to evaluate the differences between the four groups. All statistical analyses were performed using SPSS version 27.0, based on different statistical significance levels of p value after Bonferroni correction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: Message framingHPV risks |
| intervention group 1 | Experimental | Behavioral: Message framingHPV risks+personal risks |
| intervention group 2 | Experimental | Behavioral: Message framingHPV risks+partner risks |
| intervention group 3 | Experimental | Behavioral: Message framingHPV risks+personal risks and partner risks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- aged above 18, male,college student, willing to participate
Key exclusion criteria (1 listed)
- vaccinated with one dose or more HPV vaccine or decided to get vaccinated with HPV vaccine.
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 |
|---|---|---|
| Message framingParticipants 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 | Behavioural | control group, intervention group 1, intervention group 2, intervention group 3 |
Primary outcome
HPV vaccination intention
Time frame: Immediately after the 120-second message exposure.
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")
Precaution Adoption Process Model (PAPM) adapted decisional readiness
Time frame: Immediately after the 120-second message exposure.
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).
respondents' perceived responsibility toward HPV infection prevention
Time frame: Immediately after the 120-second message exposure.
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").
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Derived from this study: PubMed 41480936Wang X, Yan B, Wang X. Effects of message framing on HPV Vaccination decision-making: A Survey experiment among Chinese male college students. Hum Vaccin Immunother. 2026 Dec;22(1):2606516. doi: 10.1080/21645515.2025.2606516. Epub 2026 Jan 2.
- Individual participant dataSharing planned: Yes
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Message framing in people with HPV Vaccination Intention Among Male College Students, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 16 Jul 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccination intention (time frame: Immediately after the 120-second message exposure.). The study lists 3 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 NCT07068802, 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 16 Jul 2025.