HIV and STD Prevention for High-Risk, Inner-City, African American Youth
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First Received Date ICMJE | July 14, 2006 | ||||||||||||||||||||
Last Updated Date | January 18, 2012 | ||||||||||||||||||||
Start Date ICMJE | October 2006 | ||||||||||||||||||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
STD incidence [ Time Frame: Measured at Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ] | ||||||||||||||||||||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00353405 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
Number of unprotected sexual occasions [ Time Frame: Measured at Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ] | ||||||||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||
Brief Title ICMJE | HIV and STD Prevention for High-Risk, Inner-City, African American Youth | ||||||||||||||||||||
Official Title ICMJE | A Multilevel HIV Prevention Strategy for High-Risk Youth | ||||||||||||||||||||
Brief Summary | 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. |
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Detailed Description | 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. African 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. The 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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||||
Study Phase | Phase 3 | ||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||
Enrollment ICMJE | 1650 | ||||||||||||||||||||
Completion Date | December 2010 | ||||||||||||||||||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||||||||||
Ages | 14 Years to 17 Years | ||||||||||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
Location Countries ICMJE | United States | ||||||||||||||||||||
Administrative Information | |||||||||||||||||||||
NCT Number ICMJE | NCT00353405 | ||||||||||||||||||||
Other Study ID Numbers ICMJE | U01 MH66809, U01MH066809, DAHBR 9A-ASAC | ||||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||||
Responsible Party | Daniel Romer, Director, Adolescent Risk Communication Institute, Annenberg Public Policy Center | ||||||||||||||||||||
Study Sponsor ICMJE | University of Pennsylvania | ||||||||||||||||||||
Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||||||||||||||
Investigators ICMJE |
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Information Provided By | University of Pennsylvania | ||||||||||||||||||||
Verification Date | January 2012 | ||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |