- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07856563
Vaccine Knowledge, Attitudes and Practices Among Men Who Have Sex With Men: a Global Cross-sectional Study (VAC-M)
This study aims to investigate vaccine-related knowledge, attitude, vaccine confidence and vaccine hesitancy among MSM across multiple countries and regions.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Huachun Zou
- Phone Number: +86-21-54237707
- Email: zouhuachun@fudan.edu.cn
Study Contact Backup
- Name: Feiyang Yin
- Phone Number: +86 18008631217
- Email: fyyin25@m.fudan.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Self-identify as MSM, with eligibility in certain participating countries and regions potentially extended to transgender women and non-binary individuals who have sexual relations with men, using the same questionnaire.
Description
Inclusion Criteria:
-
Participants will be eligible for the study if they meet all of the following conditions:
- Have resided in a participating country or region for at least six months.
- Are aged 18 years or older.
- Self-identify as MSM, with eligibility in certain participating countries and regions potentially extended to transgender women and non-binary individuals who have sexual relations with men, using the same questionnaire.
Exclusion Criteria:
-
Participants will be excluded if they meet any of the following conditions:
- Are aged under 18 years.
- Decline to participate in the study or fail to complete the informed consent process.
- Have not resided, or do not currently reside, in a participating country or region.
- Submit duplicate responses from the same IP address or device.
- Fail data quality checks, including automated or fraudulent submissions and failure to pass human verification procedures.
Study Plan
How is the study designed?
Design Details
- Observational Models: CASE_ONLY
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Men who have sex with men
|
No interventions because it is a observational cross-sectional study |
|
transgender women and non-binary individuals
transgender women and non-binary individuals who have sexual relations with men |
No interventions because it is a observational cross-sectional study |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccine uptake
Time Frame: Baseline, at enrollment in this cross-sectional study
|
Percentage(%) of participants who have received at least one dose of HPV vaccine, assessed by self-reported vaccination history |
Baseline, at enrollment in this cross-sectional study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccine knowledge
Time Frame: Baseline, at enrollment in this cross-sectional study
|
Vaccine knowledge will be measured based on participants' scores on the vaccine knowledge items included in the study questionnaire, which will assess general vaccine knowledge and HPV vaccine-specific knowledge. Responses to individual items will be scored according to the predefined scoring criteria and summed to generate domain-specific knowledge scores. Higher scores indicate greater knowledge in the corresponding domain. |
Baseline, at enrollment in this cross-sectional study
|
|
Vaccine attitude
Time Frame: Baseline, at enrollment in this cross-sectional study
|
Vaccine attitudes will be measured based on participants' scores on the Vaccination Attitudes Examination Scale included in the study questionnaire, which assesses four dimensions of vaccination attitudes: mistrust of vaccine benefits, worries about unforeseen future effects, concerns about commercial profiteering, and preference for natural immunity. Responses to individual items will be scored according to the predefined scoring criteria and combined to generate an overall vaccine attitude score. Higher scores indicate more negative attitudes toward vaccination. |
Baseline, at enrollment in this cross-sectional study
|
|
Vaccine confidence
Time Frame: Baseline, at enrollment in this cross-sectional study
|
Vaccine confidence will be measured based on participants' scores on the Vaccine Confidence Index included in the study questionnaire, which assesses perceptions of vaccine importance, safety, effectiveness, and compatibility with religious beliefs. Responses to individual items will be scored according to the predefined scoring criteria and combined to generate an overall vaccine confidence score. Higher scores indicate greater confidence in vaccines. |
Baseline, at enrollment in this cross-sectional study
|
|
Vaccine hesitancy
Time Frame: Baseline, at enrollment in this cross-sectional study
|
Vaccine hesitancy will be measured based on participants' scores on the Vaccine Hesitancy Scale included in the study questionnaire. The scale assesses participants' perceptions of vaccine importance and effectiveness, trust in vaccine information and recommendations, perceived benefits of vaccination, and concerns about vaccine risks and adverse effects. Responses to individual items will be scored according to the predefined scoring criteria and summed to generate a total vaccine hesitancy score. Higher total scores indicate greater vaccine hesitancy. |
Baseline, at enrollment in this cross-sectional study
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H2026163
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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