Vaccine Knowledge, Attitudes and Practices Among Men Who Have Sex With Men: a Global Cross-sectional Study (VAC-M)

September 30, 2026 updated by: Fudan University

This study aims to investigate vaccine-related knowledge, attitude, vaccine confidence and vaccine hesitancy among MSM across multiple countries and regions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

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:

    1. Have resided in a participating country or region for at least six months.
    2. Are aged 18 years or older.
    3. 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:

    1. Are aged under 18 years.
    2. Decline to participate in the study or fail to complete the informed consent process.
    3. Have not resided, or do not currently reside, in a participating country or region.
    4. Submit duplicate responses from the same IP address or device.
    5. Fail data quality checks, including automated or fraudulent submissions and failure to pass human verification procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_ONLY
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Men who have sex with men
Other: No Interventions

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
Other: No Interventions

No interventions because it is a observational cross-sectional study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Malaya
Mahidol University
University of Westminster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H2026163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings