HPV Vaccine AttitudesNCT01535794
HPV Vaccine Acceptability Among Young Men Who Have Sex With Men
An observational study of HPV Vaccine Attitudes and HPV Vaccine Intention, run by Indiana University at 1 site in United States.
Trial summary
The FDA has recently approved Gardasil for the prevention of anal cancer in people aged 9-26. Men who have sex with men (MSM) have disproportionately high rates of anal cancer and could benefit greatly from vaccination. Read more about this study
- Who is it for?
- Ages 18 to 26 years, men only
- Conditions the study is for
- HPV Vaccine Attitudes, HPV Vaccine Intention
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Mar 2012
- Phase
- Observational
- 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 26 years
- Men only
- No healthy volunteers
- Adult
Study population: This study will be an internet-based, cross-sectional study targeting all US profiles of two separate online social/sexual networking communities of YMSM. A recruitment email will be sent internally to all active US profiles for men 18-26 years old.
Who may be able to join
- 18-26 years old
- male
Who cannot join
- younger than 18 years old
- older than 26 years old
- female
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: Exploring the Potential for Social Network Site-delivered Interventions to Increase HPV Vaccine Uptake Among Men Who Have Sex With Men
The FDA has recently approved Gardasil for the prevention of anal cancer in people aged 9-26. Men who have sex with men (MSM) have disproportionately high rates of anal cancer and could benefit greatly from vaccination. Vaccine uptake among young MSM (YMSM) is poor, and little is known about factors associated with vaccine acceptance in this population. With the risk of anal cancer among MSM higher than the risk of cervical cancer among women before routine cytological screening was introduced, acceptance of a prophylactic vaccine in this subgroup is the most cost-effective and attainable strategy to greatly reduce the prevalence of anal cancer. While the investigators can assume the human papillomavirus (HPV) vaccine has many acceptable concepts among these men, there are multiple barriers which may potentially interfere with their likelihood of initiating the vaccine series. Vaccine catch-up rates among women of a similar age has been poor, and there is no reason to expect this to be higher among men. One potential strategy to increase vaccine uptake in this catch-up group is to implement a patient-driven program to promote vaccination among men.
This project will contribute to the investigators understanding of how the investigators can utilize social networks to identify barriers to HPV vaccination among YMSM, and how to potentially influence a patient-driven vaccination effort to increase uptake among men in the catch-up age group. This research will inform future interventions to targeted populations that may be incorporated into online social networking websites to encourage HPV vaccination.
- Conditions
- HPV Vaccine Attitudes, HPV Vaccine Intention
- Keywords
- HPV vaccine, acceptability, males, men who have sex with men
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 18-26 year old men who have sex with men | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccine acceptability
The primary outcome in this study is young men's intention to be vaccinated for human papillomavirus (HPV). This will be measured on a scale of 0-100, with a higher number indicating greater likelihood of future vaccination. No vaccine will be administered.
Measured: Spring 2012
Secondary outcomes (1)
Attitudes towards HPV vaccination
A secondary outcome will be young men's attitudes towards HPV vaccination, including their beliefs about vaccine safety, efficacy, and effectiveness. This outcome will also assess the presence of logistical or pragmatic barriers to their future vaccination.
Measured: Spring 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV Vaccine AttitudesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535794
- Sponsor's protocol ID
- YMSM HPV vaccine acceptability
- Status last verified
- Aug 2014
- First submitted
- 13 Feb 2012
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential for Social Network Site-delivered Interventions to Increase HPV Vaccine Uptake Among Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT01535794
- Acronym / sponsor ID
- YMSM HPV vaccine acceptability
- Conditions
- HPV Vaccine Attitudes, HPV Vaccine Intention
- Keywords
- HPV vaccine, acceptability, males, men who have sex with men
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Feb 2012 (estimated)
- 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 FDA has recently approved Gardasil for the prevention of anal cancer in people aged 9-26. Men who have sex with men (MSM) have disproportionately high rates of anal cancer and could benefit greatly from vaccination. Vaccine uptake among young MSM (YMSM) is poor, and little is known about factors associated with vaccine acceptance in this population. With the risk of anal cancer among MSM higher than the risk of cervical cancer among women before routine cytological screening was introduced, acceptance of a prophylactic vaccine in this subgroup is the most cost-effective and attainable strategy to greatly reduce the prevalence of anal cancer. While the investigators can assume the human papillomavirus (HPV) vaccine has many acceptable concepts among these men, there are multiple barriers which may potentially interfere with their likelihood of initiating the vaccine series. Vaccine catch-up rates among women of a similar age has been poor, and there is no reason to expect this to be higher among men. One potential strategy to increase vaccine uptake in this catch-up group is to implement a patient-driven program to promote vaccination among men.
This project will contribute to the investigators understanding of how the investigators can utilize social networks to identify barriers to HPV vaccination among YMSM, and how to potentially influence a patient-driven vaccination effort to increase uptake among men in the catch-up age group. This research will inform future interventions to targeted populations that may be incorporated into online social networking websites to encourage HPV vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18-26 year old men who have sex with men | – | – |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be an internet-based, cross-sectional study targeting all US profiles of two separate online social/sexual networking communities of YMSM. A recruitment email will be sent internally to all active US profiles for men 18-26 years old.
Key inclusion criteria (2 listed)
- 18-26 years old
- male
Key exclusion criteria (3 listed)
- younger than 18 years old
- older than 26 years old
- female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HPV vaccine acceptability
Time frame: Spring 2012
The primary outcome in this study is young men's intention to be vaccinated for human papillomavirus (HPV). This will be measured on a scale of 0-100, with a higher number indicating greater likelihood of future vaccination. No vaccine will be administered.
1 secondary outcome
Attitudes towards HPV vaccination
Time frame: Spring 2012
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 8 Aug 2014.
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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?
An observational study of HPV Vaccine Attitudes and HPV Vaccine Intention, run by Indiana University at 1 site in United States.
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 2 inclusion and 3 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 8 Aug 2014. 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 United States. 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 vaccine acceptability (time frame: Spring 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2014.