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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00353405 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Sexually Transmitted Diseases |
Behavioral: Social Skills Training Behavioral: Mass media Behavioral: Control |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multilevel HIV Prevention Strategy for High-Risk Youth |
Estimated Enrollment: | 1600 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants receiving social skills training and mass media messages
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Behavioral: Social Skills Training
Social skills training includes two 8-hour sexual health skills building sessions conducted in the community.
Behavioral: Mass media
Mass media provides messages that support sexual health skills.
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2: Experimental
Participants receiving social skills training and no mass media messages
|
Behavioral: Social Skills Training
Social skills training includes two 8-hour sexual health skills building sessions conducted in the community.
|
3: Experimental
Participants receiving mass media messages and no social skills training
|
Behavioral: Mass media
Mass media provides messages that support sexual health skills.
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4: Experimental
Participants receiving no social skills training and no mass media messages
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Behavioral: Control
Control group received no social skills training and no media mass media messages.
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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.
Ages Eligible for Study: | 14 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Emory University, Rollins School of Public Health | |
Atlanta, Georgia, United States, 30322 | |
United States, New York | |
Syracuse University, Department of Psychology | |
Syracuse, New York, United States, 13244 | |
United States, Rhode Island | |
Brown University, Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 | |
United States, South Carolina | |
University of South Carolina, Arnold School of Public Health | |
Columbia, South Carolina, United States, 29208 |
Principal Investigator: | Daniel Romer, PhD | University of Pennsylvania |
Principal Investigator: | Ralph DiClemente, PhD | Emory University |
Principal Investigator: | Lawrence Brown, MD | Brown University |
Principal Investigator: | Peter Vanable, PhD | Syracuse University |
Principal Investigator: | Robert Valois, PhD | University of South Carolina |
Responsible Party: | Adolescent Risk Communication Institute, Annenberg Public Policy Center ( Daniel Romer, Director ) |
Study ID Numbers: | U01 MH66809, DAHBR 9A-ASAC |
Study First Received: | July 14, 2006 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00353405 |
Health Authority: | United States: Federal Government |
Adolescents Sexually Transmitted Infections Gonorrhea Chlamydia Infections |
Genital Diseases, Female Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases |
Chlamydia Infections Gonorrhea Genital Diseases, Male Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |