Human Papillomavirus (HPV)NCT01197079
Perception, Awareness, and Acceptance of Human Papillomavirus Disease and Vaccine Among Parents of Boys Aged 9 to 18 Years
An observational study of Human Papillomavirus (HPV), run by Ann & Robert H Lurie Children's Hospital of Chicago at 7 sites in United States.
Trial summary
The objectives of this study are: 1. to determine the degree of understanding and perceived risks for human papillomavirus (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and identify potential barriers to HPV vaccine access and utilization in a population of young men who have sex with… Read more about this study
- Who is it for?
- Ages 9 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus (HPV)
- What is being tested?
- Survey
- How many people
- 500 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2010to Dec 2016
- 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 9 to 26 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Young men who have sex with men (MSM) that obtain medical care from a Gay/Lesbian/Bisexual/Transgender community health clinic Parents of boys aged 9 to 18 years who obtain their medical care from several public health clinics or who obtain their medical care from private pediatrician offices in Chicago
Who may be able to join
- MSM group - under age 26 years
- Parent group - parent of boy(s) ages 9 to 18 years
Who cannot join
- MSM group - previous receipt of HPV vaccine
- Parent group - previous receipt of HPV vaccine by male child
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Pediatric Private practice
Chicago, Illinois, 60610
Children's Memorial Hospital Uptown Clinic
Chicago, Illinois, 60640
Pediatric Private Practice
Chicago, Illinois, 60657
Erie Family Health Clinic
Chicago, Illinois
Howard Brown Health Center
Chicago, Illinois
Private pediatric practice
Evanston, Illinois, 60202
Pediatric Private practice
Evanston, Illinois
About this study
The objectives of this study are:
- to determine the degree of understanding and perceived risks for human papillomavirus (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and identify potential barriers to HPV vaccine access and utilization in a population of young men who have sex with men (MSM) (under 26 years of age)and in parents of boys aged 9 to 18 years
- to determine HPV vaccine acceptance and predictors of acceptance in a population of young MSM and in patients of boys ages 9 to 18 years
- to develop strategies to overcome potential barriers to vaccination and improve vaccine access and utilization via development of targeted educational initiatives.
- Conditions
- Human Papillomavirus (HPV)
- Being tested
- Survey
- Keywords
- HPV, Vaccine, Vaccine utilization, Disease awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Self administered anonymous survey
| Study group | Role | What they receive |
|---|---|---|
| Parents - Private Pediatric Offices | Parents of Boys aged 9 to 18 years from Private Pediatric Offices Receives: Other: Survey | |
| Parents - Public Health Clinics | Parents of Boys aged 9 to 18 years from Public Health Clinics |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2013
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina Q. Tan, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197079
- Sponsor's protocol ID
- Merck IISP 37875
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2010
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception, Awareness, and Acceptance of Human Papillomavirus Disease and Vaccine Among Parents of Boys Aged 9 to 18 Years
- ClinicalTrials.gov ID
- NCT01197079
- Acronym / sponsor ID
- Merck IISP 37875
- Conditions
- Human Papillomavirus (HPV)
- Keywords
- HPV, Vaccine, Vaccine utilization, Disease awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Sep 2010 (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 objectives of this study are:
- to determine the degree of understanding and perceived risks for human papillomavirus (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and identify potential barriers to HPV vaccine access and utilization in a population of young men who have sex with men (MSM) (under 26 years of age)and in parents of boys aged 9 to 18 years
- to determine HPV vaccine acceptance and predictors of acceptance in a population of young MSM and in patients of boys ages 9 to 18 years
- to develop strategies to overcome potential barriers to vaccination and improve vaccine access and utilization via development of targeted educational initiatives.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents - Private Pediatric Offices | – | Other: SurveyParents of Boys aged 9 to 18 years from Private Pediatric Offices |
| Parents - Public Health Clinics | – | –Parents of Boys aged 9 to 18 years from Public Health Clinics |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young men who have sex with men (MSM) that obtain medical care from a Gay/Lesbian/Bisexual/Transgender community health clinic Parents of boys aged 9 to 18 years who obtain their medical care from several public health clinics or who obtain their medical care from private pediatrician offices in Chicago
Key inclusion criteria (2 listed)
- MSM group - under age 26 years
- Parent group - parent of boy(s) ages 9 to 18 years
Key exclusion criteria (2 listed)
- MSM group - previous receipt of HPV vaccine
- Parent group - previous receipt of HPV vaccine by male child
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 |
|---|---|---|
| SurveySelf administered anonymous survey | Other | Parents - Private Pediatric Offices |
Primary outcome
Not reported in the source record.
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 28 Mar 2025.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus (HPV), run by Ann & Robert H Lurie Children's Hospital of Chicago at 7 sites 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 2 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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 28 Mar 2025.