Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-04-21 @ 3:18 PM
Study NCT ID:
NCT03000933
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2016-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Oral sampling for HPV\n2. Anal sampling for HPV\\&\n3. Penile sampling for HPV\n4. Blood for HPV, HIV, Syphilis\n5. Anal swabs for rectal gonorrhoea and chlamydia\n6. Pharyngeal swabs for gonorrhoea and chlamydia\n7. Urine sample for gonorrhoea and chlamydia\n\nOral, penile, and anal specimens will be collected from each man at two visits 7 days apart. Routine HIV and STI (chlamydia, gonorrhoea, and syphilis) screening will be performed at baseline (Day 0).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-02', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2016-12-19', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of quadrivalent vaccine HPV types', 'timeFrame': 'Baseline', 'description': 'The primary outcome of interest will be the prevalence of quadrivalent vaccine types (6, 11, 16 and 18) among 16-20 year old MSM and comparison of these with non-quadrivalent vaccine HPV types which would be expected to remain high unless there is significant cross protection. Oral, penile, and anal HPV prevalence will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Persistent HPV infection', 'timeFrame': 'Day 7', 'description': 'Detection of same HPV type at the same site at both visits (day 0 and 7). The objective of repeat sampling at day 7 is to investigate whether this might distinguish transient HPV detection from infection. A brief questionnaire will be self-completed by participants at day 7 to ascertain whether there has been any sexual re-exposure between day 0 and 7 that might explain repeat HPV positivity at day 7.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Human Papillomavirus', 'Human Papillomavirus Infection']}, 'referencesModule': {'references': [{'pmid': '34043963', 'type': 'RESULT', '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': '34971362', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'Australia was one of the countries to implement a universal school-based male vaccination program - in 2013. This research project will examine the prevalence of HPV among young men who have sex with men (MSM) who have been offered school-based HPV vaccination.', 'detailedDescription': 'HYPER-2, will be a cross-section study, using the same recruitment and testing strategies used in HYPER 1, which determined the prevalence of anal, genital and oral HPV among men who have sex with men aged 16-20 years. Given the differing age groups that will have been offered vaccination over the 2 study period, men aged 16-19 will be recruited in the first year (2017) and men aged 16-20 will be recruited in the second year (2018) to ensure that the participants included in the HYPER-2 study would have been eligible for the free male HPV vaccine in Australia. A total of 200 men will be recruited over a 2-year period, and HPV vaccination status for each participant will be verified against the National HPV Vaccination Program Register.\n\nThis 2-year cross-sectional study will recruit men who report sex with men aged from 16 to 20 years.'}, '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 in Melbourne, Australia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 16 to 20 (Must be aged 16-19 years from 1 January 2017 to 31 December 2017, and aged 16-20 years from 1 January 2018 to 31 December 2018)\n* Report any previous type of sexual contact (including but not restricted to oral or anal sex) with at least one other man ever\n* Able to complete all study requirements including questionnaire in English and completion of 2 visits\n* Residing in Australia since 2013 (This is to ensure that males included in the study were present in Australia at the time HPV vaccination was offered)\n\nExclusion Criteria:\n\n* Transgender male'}, 'identificationModule': {'nctId': 'NCT03000933', 'acronym': 'HYPER2', 'briefTitle': 'Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men Following Introduction of Universal Male HPV Vaccination Program in Australia', 'orgStudyIdInfo': {'id': 'Merck-54860'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young same-sex attracted men', 'description': 'Same-sex attracted men aged 16 to 20'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3053', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Melbourne Sexual Health Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Fellow', 'investigatorFullName': 'Eric Chow', 'investigatorAffiliation': 'The Alfred'}}}}