Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT00146406
Status:
TERMINATED
Last Update Posted:
2012-09-11
First Post:
2005-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-level Interventions for STD Prevention Among Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}], 'ancestors': [{'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36502}}, 'statusModule': {'whyStopped': 'IRB terminated due to no continuation request.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-10', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of students who return to abstinence (measured yearly for 6 years)'}, {'measure': 'Proportion of sexually active students who have unprotected intercourse (measured yearly for 6 years)'}, {'measure': 'Proportion of sexually active students screened for chlamydia (measured yearly for 6 years)'}, {'measure': 'Prevelance of chlamydia from Baseline to Year 6'}, {'measure': 'Number of students who are sexually experienced (measured yearly for 6 years'}], 'secondaryOutcomes': [{'measure': 'Parental monitoring (measured yearly for 6 years)'}, {'measure': 'Parental communication (measured yearly for 6 years)'}, {'measure': 'Supervision (measured yearly for 6 years)'}, {'measure': 'Participation in after-school activities (measured yearly for 6 year)'}, {'measure': 'Use of reproductive health care services (measured yearly for 6 years)'}]}, 'conditionsModule': {'keywords': ['Adolescent Health', 'Sexually Transmitted Disease', 'Sexual Behavior'], 'conditions': ['Chlamydia']}, 'descriptionModule': {'briefSummary': 'Sexually active adolescents between the ages of 10 and 19 are at extremely high risk for sexually transmitted diseases (STD), including HIV, and teen pregnancy.The overall goal of this research program is to develop, implement and evaluate integrated multi-level interventions to prevent STD, including HIV, and pregnancy among adolescents. The study includes 12 high schools and 19 of their feeder middle schools in the Los Angeles Unified School District and the surrounding communities. Interventions will be implemented among parents, health care providers, and in schools in an integrated fashion with the goal of improving social context factors related to health outcomes among adolescents. The evaluation phase will include in-school surveys with adolescents at all middle schools', 'detailedDescription': 'In the current study we plan to implement interventions at four social context levels, that is, with parents, providers or in other medical institutions, schools and community venues, to improve communication between adolescents and adults, facilitate increased access and utilization of health care services, and appropriate supervision of adolescents outside of school hours. As such the goals of the specific level interventions are as follows.\n\nAmong parents: (1) to enhance communication and relationship satisfaction; (2) increase parents participation in the healthcare of their adolescents; and (3) to enhance appropriate monitoring and supervision of adolescents.\n\nAmong school-based health care providers: (1) to increase access to and utilization of services by adolescents; and (2) to increase STD screening of adolescents.\n\nIn middle schools: (1) to increase access and utilization to supervised after-school activities, either at school or in the community; (2) to address quality and fidelity of health education curriculum provision and teacher training; (3) to increase parental participation in school-related activities.\n\nIn high schools: (1) to increase access and utilization to supervised after-school activities, either at school or in the community; (3) to address quality and fidelity of health education curriculum provision and teacher training; (4) to increase parental participation in school-related activities; (5) to increase awareness and utilization of school-based condom availability programs.\n\nIn community venues: (1) increase adolescents utilization of community-based clinical services; (2) to increase adolescent utilization of non-clinic-based screening; and (3) to increase utilization of community-based supervised activities for youth.\n\nActivities will address these goals with the ultimate purpose of reducing adolescent risk for STDs, including HIV, and teen pregnancy through (1) increased age at first intercourse, (2) return to abstinence among sexually active adolescents, (3) decreased rates of unprotected sex among adolescents, (4) and increased screening and treatment of STD-infected adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Student at participating school\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00146406', 'briefTitle': 'Multi-level Interventions for STD Prevention Among Adolescents', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Integrated Multi-level Interventions to Improve Adolescent Health Through the Prevention of STD, Including HIV, and Teen Pregnancy', 'orgStudyIdInfo': {'id': 'CDC-NCHSTP-4347'}, 'secondaryIdInfos': [{'id': 'U30/CCU922283-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Project Connect', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90038', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Health Research Association', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Peter R Kerndt, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Research Association'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'Health Research Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}