Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT00353405
Status:
COMPLETED
Last Update Posted:
2012-01-19
First Post:
2006-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HIV and STD Prevention for High-Risk, Inner-City, African American Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1650}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2006-07-14', 'studyFirstSubmitQcDate': '2006-07-14', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'STD incidence', 'timeFrame': 'Measured at Months 6, 12, and 18 post-treatment'}], 'secondaryOutcomes': [{'measure': 'Number of unprotected sexual occasions', 'timeFrame': 'Measured at Months 6, 12, and 18 post-treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adolescents', 'Sexually Transmitted Infections', 'Gonorrhea', 'Chlamydia Infections'], 'conditions': ['HIV Infections', 'Sexually Transmitted Diseases']}, 'referencesModule': {'references': [{'pmid': '31380687', 'type': 'DERIVED', 'citation': 'Foley JD, Vanable PA, Brown LK, Carey MP, DiClemente RJ, Romer D, Valois RF. Depressive symptoms as a longitudinal predictor of sexual risk behaviors among African-American adolescents. Health Psychol. 2019 Nov;38(11):1001-1009. doi: 10.1037/hea0000780. Epub 2019 Aug 5.'}, {'pmid': '23153149', 'type': 'DERIVED', 'citation': 'Hennessy M, Romer D, Valois RF, Vanable P, Carey MP, Stanton B, Brown L, DiClemente R, Salazar LF. Safer sex media messages and adolescent sexual behavior: 3-year follow-up results from project iMPPACS. Am J Public Health. 2013 Jan;103(1):134-40. doi: 10.2105/AJPH.2012.300856. Epub 2012 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the joint and separate effectiveness of two HIV/STD prevention programs in providing protection against acquiring STDs and maintaining safer sex behavior.', 'detailedDescription': "Approximately 25% of the new HIV cases in the United States each year occur among adolescents. Although African American teens make up only 15% of the adolescent population in the U.S., they account for about two thirds of new AIDS cases among teens. An Atlanta, Georgia study involving a population composed primarily of urban African American teens demonstrated that few of the teens who tested positive for HIV were aware of the risks involved in sexual activity. Because of this population's increased risk for contracting HIV and other STDs, prevention programs that specifically target African American teens are necessary. This study will evaluate the joint and separate effectiveness of two HIV/STD prevention programs, small group training and mass media messages, in providing protection against acquiring STDs and maintaining safer sex behavior.\n\nAfrican American adolescents will be recruited for this single-blind, 18-month study through community-based organizations in four different cities. All participants will first complete a computer-administered survey to assess sexual attitudes, beliefs, and behaviors. They will also provide a urine sample for STD testing. Following these baseline assessments, participants will be randomly assigned to either the Focus on Youth (FOY) HIV prevention program or the Promoting Health Among Teens general health intervention. Both programs will involve eight 1-hour small group sessions that will occur over three Saturdays. Participants in the FOY program will learn safe sex and abstinence skills. Participants in the Promoting Health Among Teens intervention will receive general health information about diet, substance use, and appropriate screening for common health conditions other than STDs. All participants who test positive for an STD during the study will receive treatment. Follow-up assessments will occur at Months 6, 12, and 18 post-intervention to determine program effectiveness.\n\nThe second prevention program, mass media messages, will be administered among all participating African American teens in one of the two participating Northern cities and one of the two participating Southern cities. Cities that will receive the media intervention will be randomly selected. The other city in each pair will serve as a control city. Tailored HIV/STD prevention messages will be delivered through local mass media. Telephone interviews will be conducted over a 34-month period among 900 randomly selected teens from both media and non-media cities to assess community-wide effectiveness of the program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently resides in one of the test cities\n\nExclusion Criteria:\n\n* Presence of mental impairments'}, 'identificationModule': {'nctId': 'NCT00353405', 'briefTitle': 'HIV and STD Prevention for High-Risk, Inner-City, African American Youth', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Multilevel HIV Prevention Strategy for High-Risk Youth', 'orgStudyIdInfo': {'id': 'U01MH066809', 'link': 'https://reporter.nih.gov/quickSearch/U01MH066809', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01MH066809', 'link': 'https://reporter.nih.gov/quickSearch/U01MH066809', 'type': 'NIH'}, {'id': 'DAHBR 9A-ASAC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants receiving social skills training and mass media messages', 'interventionNames': ['Behavioral: Social Skills Training', 'Behavioral: Mass media']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Participants receiving social skills training and no mass media messages', 'interventionNames': ['Behavioral: Social Skills Training']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Participants receiving mass media messages and no social skills training', 'interventionNames': ['Behavioral: Mass media']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Participants receiving no social skills training and no mass media messages', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Social Skills Training', 'type': 'BEHAVIORAL', 'description': 'Social skills training includes two 8-hour sexual health skills building sessions conducted in the community.', 'armGroupLabels': ['1', '2']}, {'name': 'Mass media', 'type': 'BEHAVIORAL', 'description': 'Mass media provides messages that support sexual health skills.', 'armGroupLabels': ['1', '3']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Control group received no social skills training and no media mass media messages.', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University, Rollins School of Public Health', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '13244', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Syracuse University, Department of Psychology', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University, Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina, Arnold School of Public Health', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Daniel Romer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Ralph DiClemente, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Lawrence Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}, {'name': 'Peter Vanable, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Syracuse University'}, {'name': 'Robert Valois, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Daniel Romer, Director', 'oldOrganization': 'Adolescent Risk Communication Institute, Annenberg Public Policy Center'}}}}