Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
Study NCT ID:
NCT04612660
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2020-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HPV Self-test to Increase Cervical Cancer Screening in Asian Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096002', 'term': 'Physician Engagement'}, {'id': 'D062526', 'term': 'Patient Navigation'}], 'ancestors': [{'id': 'D000074824', 'term': 'Work Engagement'}, {'id': 'D010559', 'term': 'Personnel Management'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D018802', 'term': 'Patient-Centered Care'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change in the rate of cervical cancer screening', 'timeFrame': 'baseline, and 6-month follow up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '35193408', 'type': 'RESULT', 'citation': 'Ma GX, Zhu L, Zhai S, Lin TR, Tan Y, Johnson C, Fang CY, Belinson JL, Wang MQ. Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention. Cancer Control. 2022 Jan-Dec;29:10732748221076813. doi: 10.1177/10732748221076813.'}]}, 'descriptionModule': {'briefSummary': 'The study was to pilot test the feability of using HPV self-sampling testing to increase cervical cancer screening among under-served Asian women through engaging community-based organizations in the greater Philadelphia and New York City area, addressing a significant global cancer burden, the preventable infection-related cervical cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. gender: female\n2. age: 30-55\n3. no current diagnosis of cervical cancer, and\n4. have not participated in cervical cancer screening within the past 3 years.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04612660', 'briefTitle': 'HPV Self-test to Increase Cervical Cancer Screening in Asian Women', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Human Papillomavirus (HPV) and Cervical Cancer Intervention to Increase Cervical Cancer Screening for Underserved Asian Women', 'orgStudyIdInfo': {'id': 'HPV Self-sampling'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Specific Education and Dynamic Group', 'description': '1. Motivational group education specifically focused on cervical cancer prevention;\n2. Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures;\n3. Engaging community bilingual physicians in cervical cancer screening and referral;\n4. Patient navigation assistance.', 'interventionNames': ['Behavioral: Education on cervical cancer prevetnion', 'Behavioral: Dynamic group interaction', 'Behavioral: Physician engagement', 'Behavioral: Patient Navigation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General Health Education', 'description': 'Comparison group participants received general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.', 'interventionNames': ['Behavioral: General Health Education']}], 'interventions': [{'name': 'Education on cervical cancer prevetnion', 'type': 'BEHAVIORAL', 'description': 'Motivational group education by trained bilingual community health educators (CHEs) on cervical cancer prevention', 'armGroupLabels': ['Specific Education and Dynamic Group']}, {'name': 'Dynamic group interaction', 'type': 'BEHAVIORAL', 'description': 'Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures;', 'armGroupLabels': ['Specific Education and Dynamic Group']}, {'name': 'Physician engagement', 'type': 'BEHAVIORAL', 'description': 'Engaging community bilingual physicians in cervical cancer screening and referral;', 'armGroupLabels': ['Specific Education and Dynamic Group']}, {'name': 'Patient Navigation', 'type': 'BEHAVIORAL', 'description': 'Patient navigation assistance will be provided to participants who tested HPV positive for further diagnostic testing and treatment.', 'armGroupLabels': ['Specific Education and Dynamic Group']}, {'name': 'General Health Education', 'type': 'BEHAVIORAL', 'description': 'general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.', 'armGroupLabels': ['General Health Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Grace Ma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}