Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01422356
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2011-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006716', 'term': 'Homosexuality'}], 'ancestors': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mchen@mshc.org.au', 'phone': '+61 3 9341 6260', 'title': 'Associate Professor Marcus Chen', 'organization': 'Melbourne Sexual Health Centre, Alfred Health'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The findings from this study may or may not extend to other populations of teenage MSM.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '12 Month Cohort', 'otherNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HPV Prevalence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Prevalence'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Prevalence of anal HPV of any type at baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of men at baseline visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '12 Month Cohort', 'description': '16-20 year old males'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}]}], 'recruitmentDetails': 'Two hundred males aged 16 to 20 years were recruited into the study. Men were seen at 0, 3, 6 and 12 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '12 Month Cohort'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '200', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Genital samples (genital swabs from anus, penis), oral rinse, and serum.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-19', 'studyFirstSubmitDate': '2011-08-16', 'resultsFirstSubmitDate': '2013-10-27', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-19', 'studyFirstPostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV Prevalence', 'timeFrame': 'Baseline', 'description': 'Prevalence of anal HPV of any type at baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cohort study', 'men who have sex with men'], 'conditions': ['Human Papillomavirus']}, 'referencesModule': {'references': [{'pmid': '34971362', 'type': 'DERIVED', 'citation': 'Chow EPF, Fairley CK, Zou H, Wigan R, Garland SM, Cornall AM, Atchison S, Tabrizi SN, Chen MY. Human Papillomavirus Antibody Levels Following Vaccination or Natural Infection Among Young Men Who Have Sex With Men. Clin Infect Dis. 2022 Aug 25;75(2):323-329. doi: 10.1093/cid/ciab1052.'}, {'pmid': '34043963', 'type': 'DERIVED', 'citation': 'Chow EPF, Tabrizi SN, Fairley CK, Wigan R, Machalek DA, Garland SM, Cornall AM, Atchison S, Hocking JS, Bradshaw CS, Balgovind P, Murray GL, Chen MY. Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study. Lancet Infect Dis. 2021 Oct;21(10):1448-1457. doi: 10.1016/S1473-3099(20)30687-3. Epub 2021 May 24.'}, {'pmid': '25435055', 'type': 'DERIVED', 'citation': 'Zou H, Tabrizi SN, Grulich AE, Hocking JS, Bradshaw CS, Cornall AM, Morrow A, Prestage G, Law MG, Garland SM, Chen MY, Fairley CK. Site-specific human papillomavirus infection in adolescent men who have sex with men (HYPER): an observational cohort study. Lancet Infect Dis. 2015 Jan;15(1):65-73. doi: 10.1016/S1473-3099(14)70994-6. Epub 2014 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'Studies indicate that men who have sex with men (MSM) have a high prevalence of anogenital Human papillomavirus (HPV) infection and increased risk for HPV related anogenital lesions including anogenital warts, anal intraepithelial neoplasia (the abnormal proliferation of cells) and anal cancer. Currently in Australia, HPV vaccine for men is not covered by programs. This study will explore the prevalence of HPV infection and sexual behaviours associated with varying prevalence of HPV infection.\n\nThe investigators will survey 200 MSM aged 16-20 years who just started their sexual life. The investigators will use a questionnaire to collect information of socio-demographic characteristics, lifetime sexual experience, recent sexual experience, the most recent sexual contact, sexually transmitted infections (STIs)/HIV history and testing history, HPV knowledge and attitude, smoking/alcohol/drug/circumcision. The investigators will also collect oral, penile and anal samples as well as blood samples to test for HPV DNA and antibody.\n\nThe study will include four visits in the 12-month period. In each visit, participants will be asked to fill a questionnaire and provide oral, penile and anal samples as well as blood samples.', 'detailedDescription': 'Study aims\n\nThe objectives of this study are to determine among younger MSM:\n\n1. The prevalence of HPV infection\n2. Sexual behaviours associated with varying prevalence of HPV infection\n\nMethods\n\nCriteria for eligibility:\n\n* Men aged 16 to 20\n* Same sex attracted\n* Able to complete all study requirements including questionnaire in English and completion of 4 visits\n\nRecruitment\n\nMen were recruited between October 2010 and September 2012 via a number of avenues focusing on gay teenage males: community organizations supporting gay teenagers with study promotion at social events such as dance parties; gay clubs at six Melbourne universities; gay community events including the MidSumma Festival; gay media including radio and magazine; the study website; and social networking websites including Facebook, Twitter and Grindr. Recruitment also took place through three sexual health services in Melbourne.\n\nMen were assessed by the study nurse at a baseline visit then 3, 6, and 12 months later. On each occasion specimens were obtained for HPV DNA testing, blood was obtained for HPV serology, and men completed a questionnaire regarding their sexual experiences.\n\nSpecimen collection Specimens were obtained from men for HPV DNA testing in the following order: first an oral rinse, second an anal canal swab, third a perianal swab, then fourth a penile swab. The oral rinse and penile swab were self-collected by men after watching a video demonstrating how to self-collect these specimens\n\nMen were screened for pharyngeal and rectal Neisseria gonorrhoeae using modified Thayer-martin media. First void urine and a rectal swab were tested for Chlamydia trachomatis by strand displacement assay (Becton Dickinson ProbeTec ET, NJ, USA). In addition, men were screened for syphilis using enzyme immunoassay (EIA) and rapid plasma reagin and tested for HIV using EIA.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young same sex attracted men 16-20 years of age from Melbourne', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 16 to 20\n* Same sex attracted\n* Able to complete all study requirements including questionnaire in English and completion of 4 visits'}, 'identificationModule': {'nctId': 'NCT01422356', 'acronym': 'HYPER', 'briefTitle': 'Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men', 'orgStudyIdInfo': {'id': 'MSHC-174/10'}}, 'contactsLocationsModule': {'locations': [{'zip': '3053', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Health (Melbourne Sexual Health Centre)', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Christopher K Fairley, MB BS, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Alfred'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Public Health Central Clinical School Monash University and Director Melbourne Sexual Health Centre Alfred Health', 'investigatorFullName': 'Christopher Fairley', 'investigatorAffiliation': 'The Alfred'}}}}