HPV InfectionNCT01300689
Human Papillomavirus Infection and Knowledge and Attitudes About HPV Vaccines Among Men Who Have Sex With Men (MSM)
An observational study of HPV Infection and HIV Infection, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a observational study aims to assess anal and genital human papillomavirus (HPV) infection status among men who have sex with men (MSM) in China, and their knowledge and attitude about HPV vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, HIV Infection, Syphilis
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to not given
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 3,000 eligible men who have sex with men (MSM) with 300 from each city will be enrolled from ten cities (BeiJing, ShangHai, TianJin, ChongQing, GuangZhou, ZhengZhou, Harbin, ShenYang, ChengDu, and KunMing) by the local CDCs and non-government MSM organizations
Who may be able to join
- ≥ 18 years old;
- Ever had homosexual behaviors in the past 12 months;
- Willing to take tests for HIV/HPV infection;
- Physically able and willing to provide written informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Pathogen Biology (IPB)
Beijing, Beijing Municipality, 100730
Yu Yang, MD, wolfson@ipbcams.ac.cn
Lei Gao, Ph. D.
About this study
This is a observational study aims to assess anal and genital human papillomavirus (HPV) infection status among men who have sex with men (MSM) in China, and their knowledge and attitude about HPV vaccine.
- Conditions
- HPV Infection, HIV Infection, Syphilis
- Keywords
- HPV, MSM, Vaccine, China
- Medical subject headings
- Papillomavirus Infections, HIV Infections, Syphilis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies 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
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Lei Gao, Ph.D., Principal investigator, Institute of Pathogen Biology (IPB), CAMS&PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300689
- Sponsor's protocol ID
- HPV and MSM in China
- Status last verified
- Feb 2011
- First submitted
- 22 Feb 2011
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gao L, Zhou F, Li X, Yang Y, Ruan Y, Jin Q. Anal HPV infection in HIV-positive men who have sex with men from China. PLoS One. 2010 Dec 6;5(12):e15256. doi: 10.1371/journal.pone.0015256.
PubMed 21151900
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus Infection and Knowledge and Attitudes About HPV Vaccines Among Men Who Have Sex With Men (MSM)
- ClinicalTrials.gov ID
- NCT01300689
- Acronym / sponsor ID
- HPV and MSM in China
- Conditions
- HPV Infection, HIV Infection, Syphilis
- Keywords
- HPV, MSM, Vaccine, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2011
- First posted
- 23 Feb 2011 (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 observational study aims to assess anal and genital human papillomavirus (HPV) infection status among men who have sex with men (MSM) in China, and their knowledge and attitude about HPV vaccine.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 3,000 eligible men who have sex with men (MSM) with 300 from each city will be enrolled from ten cities (BeiJing, ShangHai, TianJin, ChongQing, GuangZhou, ZhengZhou, Harbin, ShenYang, ChengDu, and KunMing) by the local CDCs and non-government MSM organizations
Key inclusion criteria (4 listed)
- ≥ 18 years old;
- Ever had homosexual behaviors in the past 12 months;
- Willing to take tests for HIV/HPV infection;
- Physically able and willing to provide written informed consent.
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
- Background: PubMed 21151900Gao L, Zhou F, Li X, Yang Y, Ruan Y, Jin Q. Anal HPV infection in HIV-positive men who have sex with men from China. PLoS One. 2010 Dec 6;5(12):e15256. doi: 10.1371/journal.pone.0015256.
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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.
Lei Gao, Ph.D. principal investigator
Institute of Pathogen Biology (IPB), CAMS&PUMC
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 Infection and HIV Infection, run by Chinese Academy of Medical Sciences at 1 site in China.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 23 Feb 2011. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XiangWei Li, MD (86-10-67855012, xiangweili@ipbcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01300689, which also lists 1 linked publication.
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 23 Feb 2011.