Viewing Study NCT00743392


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Study NCT ID: NCT00743392
Status: COMPLETED
Last Update Posted: 2013-11-19
First Post: 2008-08-26
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: HPV Infections in Older Women
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': 'Vaginal swab samples for HPV DNA testing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 503}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-15', 'studyFirstSubmitDate': '2008-08-26', 'studyFirstSubmitQcDate': '2008-08-26', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High-risk HPV DNA', 'timeFrame': 'Every 4 months for 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Papillomavirus Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://depts.washington.edu/hpvstudy', 'label': 'HPV study website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year.', 'detailedDescription': "Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a longitudinal study of predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 300 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect four sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. We will identify behavioral and health predictors of type-specific HR HPV infections, predictors of repeatedly-detected HR HPV infections, and evaluate study participants' experiences with self-collecting vaginal specimens and attitudes towards HPV vaccination and cervical cancer screening. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '25 to 65 year old women who date online', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have had sex with men\n* Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or planning a pregnancy in the next 6 months\n* Hysterectomy'}, 'identificationModule': {'nctId': 'NCT00743392', 'briefTitle': 'HPV Infections in Older Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'HPV Infections in Older Women', 'orgStudyIdInfo': {'id': '34339-A'}}, 'contactsLocationsModule': {'locations': [{'zip': '98103', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Rachel L Winer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rachel Winer', 'investigatorAffiliation': 'University of Washington'}}}}