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HIV and STD Prevention for High-Risk, Inner-City, African American Youth
This study is ongoing, but not recruiting participants.
Study NCT00353405   Information provided by National Institute of Mental Health (NIMH)
First Received: July 14, 2006   Last Updated: September 19, 2008   History of Changes

July 14, 2006
September 19, 2008
October 2006
June 2009   (final data collection date for primary outcome measure)
STD incidence [ Time Frame: Measured at Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
  • Measured 6, 12, and 18 months post-intervention: STD prevalence
  • Self reports of safe sexual behavior
Complete list of historical versions of study NCT00353405 on ClinicalTrials.gov Archive Site
Number of unprotected sexual occasions [ Time Frame: Measured at Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]
Same as current
 
HIV and STD Prevention for High-Risk, Inner-City, African American Youth
A Multilevel HIV Prevention Strategy for High-Risk Youth

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.

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.

Phase III
Interventional
Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • HIV Infections
  • Sexually Transmitted Diseases
  • Behavioral: Social Skills Training
  • Behavioral: Mass media
  • Behavioral: Control
  • Experimental: Participants receiving social skills training and mass media messages
  • Experimental: Participants receiving social skills training and no mass media messages
  • Experimental: Participants receiving mass media messages and no social skills training
  • Experimental: Participants receiving no social skills training and no mass media messages
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
1600
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently resides in one of the test cities

Exclusion Criteria:

  • Presence of mental impairments
Both
14 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00353405
Daniel Romer, Director, Adolescent Risk Communication Institute, Annenberg Public Policy Center
U01 MH66809, DAHBR 9A-ASAC
National Institute of Mental Health (NIMH)
 
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
National Institute of Mental Health (NIMH)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP