Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05616767
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2022-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2022-10-28', 'studyFirstSubmitQcDate': '2022-11-08', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess screening practices of hrHPV-related OPCa', 'timeFrame': 'Baseline', 'description': 'Questionaire'}, {'measure': 'To assess the acceptability and feasibility of teaching SMM in Tanzania to conduct self-exams', 'timeFrame': 'baseline to 6 months', 'description': 'Questionaire to assess post-test selfie evaluations, Scores: 0= was not trained; 1= was trained; 2=took a selfie; 3= clear selfie'}, {'measure': 'To assess the acceptability and feasibility of hrHPV vaccination', 'timeFrame': 'baseline', 'description': 'percentage of individuals recruited for aim 1 who request HPV vaccination, Scores are 0=no vaccination; 1=first vaccination; 2= second vaccination; 3=third vaccination'}, {'measure': 'To assess the acceptability and feasibility of hrHPV vaccination', 'timeFrame': '1 month', 'description': 'percentage of individuals recruited for aim 1 who request HPV vaccination, Scores are 0=no vaccination; 1=first vaccination; 2= second vaccination; 3=third vaccination'}, {'measure': 'To assess the acceptability and feasibility of hrHPV vaccination', 'timeFrame': '6 months', 'description': 'percentage of individuals recruited for aim 1 who request HPV vaccination, Scores are 0=no vaccination; 1=first vaccination; 2= second vaccination; 3=third vaccination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HPV']}, 'descriptionModule': {'briefSummary': 'The long-term objective of the parent study is "to reduce the effects of OPCa through secondary prevention (i.e., early detection, diagnosis and treatment referral)." Consistent with this, this supplement will test HPV-related interventions tailored for Sexual Minority Men (SMM). Acceptability, feasibility and preliminary effectiveness of a smart-phone delivered Oropharyngeal Cancer (OPCA) self-assessment tool will be assessed. Given that homosexuality is stigmatized and criminalized in Tanzania, and that cell phone use is the key way SMM communicate in Tanzania, a self-assessment screening cell phone intervention holds particular promise for SMM in Tanzania but warrants separate evaluation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'gay or bisexual men', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18\n* gay or bisexual men\n* speak Kiswahili or English\n* resident in Dar es Salam'}, 'identificationModule': {'nctId': 'NCT05616767', 'briefTitle': 'Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Prevention and Screening for Early Detection of HPV-related Cancers in Gay and Bisexual Men in Tanzania', 'orgStudyIdInfo': {'id': '000017185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training on self-screening and HPV vaccination administration', 'description': 'teaching SMM in Tanzania to conduct self-exams for oropharyngeal hrHPV-associated cancers using cellphone-mediated oral selfies, and administering the HPV vaccination series (with 2 and 6-8 month follow-up) to those who request it', 'interventionNames': ['Other: Training on self-screening and HPV vaccination administration']}], 'interventions': [{'name': 'Training on self-screening and HPV vaccination administration', 'type': 'OTHER', 'description': 'Participants will be taught how to do self-screening for HPV-associated cancers using Training on self-screening and HPV vaccination administration. They will also be given HPV vaccination series.', 'armGroupLabels': ['Training on self-screening and HPV vaccination administration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dar es Salaam', 'country': 'Tanzania', 'facility': 'Dar es Salaam', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}