Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-02-03 @ 4:52 PM
Study NCT ID:
NCT03646032
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2018-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexually Active Adolescent Focused Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073599', 'term': 'Health Risk Behaviors'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'A total of 200 AAA males and females will be recruited from Washington, DC (n=100) and Birmingham, Alabama (n=100). At both data collection sites, participants will be randomly assigned to one of two groups i.e., intervention and control during the pilot.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge about HIV/STIs', 'timeFrame': '1 month', 'description': 'During the pilot, adolescents will be asked if they would like to download the game to play on their own mobile device and complete a pre- and post-game assessment designed to measure their knowledge on HIV/STIs by assessing the level of knowledge around risky sexual activity.'}], 'secondaryOutcomes': [{'measure': 'Perception of sexual risks', 'timeFrame': '1 month', 'description': 'During the pilot, adolescents will be asked if they would like to download the game to play on their own mobile device and complete a pre- and post-game assessment designed to measure their perceived risk'}, {'measure': 'Intention to be tested for STIs', 'timeFrame': '1 month', 'description': "We will ask participants on a scale of 1-5 their intent to get tested for HIV and most common STI's."}, {'measure': 'Intention to use a condom', 'timeFrame': '1 month', 'description': 'We will ask participants on a scale of 1-5, their intent to use a condom.'}, {'measure': 'Consent', 'timeFrame': '1 month', 'description': 'We will ask participants on a 4-point Likert scale (strongly agree to strongly disagree)'}, {'measure': 'System Usability and Acceptability Metrics', 'timeFrame': '1 month', 'description': 'We will ask participants to answer the questions based on their current impressions on the game.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile dating simulation game', 'Sexual education', 'HIV', 'STI', 'Consent'], 'conditions': ['Health Risk Behaviors']}, 'descriptionModule': {'briefSummary': 'SAAFE will be pilot tested in 2 geographically distinct areas (Washington, DC and Deep South) with 100 participants from each site to 1) primarily assess the efficacy of improved self-efficacy, knowledge about HIV/STIs and perception of sexual risks by AAAs, and (2) secondarily detect intention to be tested for STIs and to change sexual risk behavior (i.e., use a condom).', 'detailedDescription': 'A total of 200 African American adolescents (AAA) males and females will be recruited from Washington, DC (n=100) and Birmingham, Alabama (n=100). At both data collection sites, participants will be randomly assigned to one of two groups during the pilot. The two groups are:\n\n1. Intervention group (n=100) - will consist of 50 AAA males / 50 AAA females randomly selected participants who will receive a download of the SAAFE game and play for at least 30 minutes and as long as an hour, if desired.\n2. Control group (n=100) - will consist of 50 AAA males / 50 AAA females randomly selected participants. This group will receive dating sim game (called Choices). They will also receive pamphlets that provide information on the testing location and care if they have HIV/STI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American female or male\n* Between 15-21 years of age\n\nExclusion Criteria:\n\n* Pregnant women\n* The first 6 weeks post-partum\n* Adolescents younger than 15'}, 'identificationModule': {'nctId': 'NCT03646032', 'acronym': 'SAAFE', 'briefTitle': 'Sexually Active Adolescent Focused Education', 'organization': {'class': 'INDUSTRY', 'fullName': 'Benten Technologies, Inc.'}, 'officialTitle': 'An mHealth Education Intervention for Encouraging STI Testing Uptake', 'orgStudyIdInfo': {'id': 'SAAFE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intervention group (n=200) - will consist of 100 AAA males / 100 AAA females randomly selected participants who will receive a download of the SAAFE game and play for at least 30 minutes and as long as an hour, if desired.', 'interventionNames': ['Behavioral: SAAFE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Control group (n=200) - will consist of 100 AAA males / 100 AAA females randomly selected participants. This group will receive the standard of care by launching a mobile app that will play a dating sim game (called Choices). They will also receive pamphlets that provide information on the testing location and care if they have HIV/STI.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'SAAFE', 'type': 'BEHAVIORAL', 'description': 'After completing the pre-game assessment, participants will be asked to play the SAAFE game for at least 30 minutes and up to 1 hour . At the conclusion of the game, participants will be provided with a post-game assessment about their perception of risk, knowledge of specific protective behaviors, and whether they plan to change behaviors.', 'armGroupLabels': ['Intervention group']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'This group will receive dating sim game (called Choices). They will also receive pamphlets that provide information on the testing location and care if they have HIV/STI.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Tony Ma, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benten Technologies, Inc.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benten Technologies, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Tony Ma', 'investigatorAffiliation': 'Benten Technologies, Inc.'}}}}