Papillomavirus InfectionsNCT02897232
Community and Physician Perspectives Regarding Male Youth Human Papillomavirus (HPV) Disease and Vaccination
An observational study of Papillomavirus Infections and Health Behavior, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
This is a minimal risk, anonymous, convenience sample, social behavioral study using qualitative descriptive survey methods. It is to ascertain community member, physician, resident and medical student perspectives regarding Human Papillomavirus (HPV) infection, associated diseases and to identify barriers which… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections, Health Behavior, Attitude of Health Personnel
- What is being tested?
- Survey
- Type of treatment
- Vaccines
- How many people
- 386 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Apr 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Northern Louisiana community members in the Ambulatory Care Clinics in University Health. Northern Louisiana, Louisiana State University Health, clinical faculty, residents and medical students.
Who may be able to join
- All visitors to the Pediatric or Internal Medicine University Health Shreveport Clinics willing to complete a survey
- Community Study Exclusion
- Those do not wish to participate in the study
- Those who English is not their first language
- Clinical Faculty, Resident, and Medical Student Study
- All Louisiana State University Shreveport Health Clinical Faculty, Resident, and Medical Student Inclusion willing to to complete the online survey.
- Clinical Faculty, Resident, and Medical Student Study
Who cannot join
- Any LSU Health Shreveport Clinical Faculty, Resident, and Medical Student which declines to take the survey or do not attempt to complete it.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health
Shreveport, Louisiana, 71103
About this study
This is a minimal risk, anonymous, convenience sample, social behavioral study using qualitative descriptive survey methods. It is to ascertain community member, physician, resident and medical student perspectives regarding Human Papillomavirus (HPV) infection, associated diseases and to identify barriers which prevent these groups from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection.
The research is focused on these questions:
Do community members understand the ease of transmission of the HPV virus in males 9-26? Do community members, physicians, residents and medical students have knowledge of the associated diseases that may occur with the HPV virus infection in males age 9-26? Do community members, physicians, residents and medical students know the ages in which males should receive the HPV vaccine three-shot series? What barriers prevent community members and physicians, residents and medical students from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection?
Read the detailed description
This is a minimal risk, anonymous, convenience sample, social behavioral study using qualitative descriptive survey methods. It is to ascertain community member, physician, resident and medical student perspectives regarding Human Papillomavirus (HPV) infection, associated diseases and to identify barriers which prevent these groups from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection.
The research is focused on these questions:
Do community members understand the ease of transmission of the HPV virus in males 9-26? Do community members, physicians, residents and medical students have knowledge of the associated diseases that may occur with the HPV virus infection in males age 9-26? Do community members, physicians, residents and medical students know the ages in which males should receive the HPV vaccine three-shot series? What barriers prevent community members and physicians, residents and medical students from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection?
- Conditions
- Papillomavirus Infections, Health Behavior, Attitude of Health Personnel, Human Papilloma Virus, Male
- Being tested
- Survey
- Keywords
- Human Papillomavirus Vaccine, HPV, Patient Acceptance, Physician Comfort, Male Vaccination, HPV Associated Cancers
- Medical subject headings
- Papillomavirus Infections, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Clinical Faculty and community will be given a survey to define issues preventing HPV Vaccination
| Study group | Role | What they receive |
|---|---|---|
| Community Group Survey | Community members coming into the University Health Shreveport Ambulatory Care Facility. Receives: Other: Survey | |
| Physician Group Survey | Physicians affiliated with LSU Health Shreveport School of Medicine Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers to HPV Vaccination
What are the barriers which prevent community members and physicians, residents and medical students from ensuring that males age 9-26 are vaccinated with the HPV three-shot vaccination.
Measured: 60 days
Secondary outcomes (3)
Knowledge pertaining to ease of Human Papillomavirus transmission.
Do community members and physicians understand the ease of HPV transmission?
Measured: 60 days
Knowledge of Associated HPV diseases
Do community member and physicians know the associated HPV diseases?
Measured: 60 days
Knowledge of age in which males should be vaccinated against HPV.
Do community member and physicians know the age in which males should be vaccinated against HPV?
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia M. Esparza, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Julia M Esparza, MLS, Principal investigator, 3186754179
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897232
- Sponsor's protocol ID
- STUDY00000618
- Status last verified
- Feb 2021
- First submitted
- 7 Sep 2016
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only aggregate data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community and Physician Perspectives Regarding Male Youth Human Papillomavirus (HPV) Disease and Vaccination
- ClinicalTrials.gov ID
- NCT02897232
- Acronym / sponsor ID
- STUDY00000618
- Conditions
- Papillomavirus Infections, Health Behavior, Attitude of Health Personnel, Human Papilloma Virus, Male
- Keywords
- Human Papillomavirus Vaccine, HPV, Patient Acceptance, Physician Comfort, Male Vaccination, HPV Associated Cancers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 13 Sep 2016 (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.
This is a minimal risk, anonymous, convenience sample, social behavioral study using qualitative descriptive survey methods. It is to ascertain community member, physician, resident and medical student perspectives regarding Human Papillomavirus (HPV) infection, associated diseases and to identify barriers which prevent these groups from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection.
The research is focused on these questions:
Do community members understand the ease of transmission of the HPV virus in males 9-26? Do community members, physicians, residents and medical students have knowledge of the associated diseases that may occur with the HPV virus infection in males age 9-26? Do community members, physicians, residents and medical students know the ages in which males should receive the HPV vaccine three-shot series? What barriers prevent community members and physicians, residents and medical students from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection?
Detailed description
This is a minimal risk, anonymous, convenience sample, social behavioral study using qualitative descriptive survey methods. It is to ascertain community member, physician, resident and medical student perspectives regarding Human Papillomavirus (HPV) infection, associated diseases and to identify barriers which prevent these groups from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection.
The research is focused on these questions:
Do community members understand the ease of transmission of the HPV virus in males 9-26? Do community members, physicians, residents and medical students have knowledge of the associated diseases that may occur with the HPV virus infection in males age 9-26? Do community members, physicians, residents and medical students know the ages in which males should receive the HPV vaccine three-shot series? What barriers prevent community members and physicians, residents and medical students from ensuring that males 9-26 receive the three-shot vaccine series to prevent HPV infection?
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Group Survey | – | Other: SurveyCommunity members coming into the University Health Shreveport Ambulatory Care Facility. |
| Physician Group Survey | – | Other: SurveyPhysicians affiliated with LSU Health Shreveport School of Medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Northern Louisiana community members in the Ambulatory Care Clinics in University Health. Northern Louisiana, Louisiana State University Health, clinical faculty, residents and medical students.
Key inclusion criteria (7 listed)
- All visitors to the Pediatric or Internal Medicine University Health Shreveport Clinics willing to complete a survey
- Community Study Exclusion
- Those do not wish to participate in the study
- Those who English is not their first language
- Clinical Faculty, Resident, and Medical Student Study
Key exclusion criteria (1 listed)
- Any LSU Health Shreveport Clinical Faculty, Resident, and Medical Student which declines to take the survey or do not attempt to complete it.
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 |
|---|---|---|
| SurveyClinical Faculty and community will be given a survey to define issues preventing HPV Vaccination | Other | Community Group Survey, Physician Group Survey |
Primary outcome
Barriers to HPV Vaccination
Time frame: 60 days
What are the barriers which prevent community members and physicians, residents and medical students from ensuring that males age 9-26 are vaccinated with the HPV three-shot vaccination.
3 secondary outcomes
Knowledge pertaining to ease of Human Papillomavirus transmission.
Time frame: 60 days
Knowledge of Associated HPV diseases
Time frame: 60 days
Knowledge of age in which males should be vaccinated against HPV.
Time frame: 60 days
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 10 Feb 2021.
- Individual participant dataSharing planned: No. Only aggregate data will be shared.
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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.
Julia M Esparza, MLS principal investigator
3186754179
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 Papillomavirus Infections and Health Behavior, run by Louisiana State University Health Sciences Center Shreveport 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 7 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 10 Feb 2021. 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?
Barriers to HPV Vaccination (time frame: 60 days). 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 10 Feb 2021.