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Trial record 49 of 1178 for:    Sexually Transmitted Diseases | ( Map: United States ) | NIH

HIV and STD Prevention for High-Risk, Inner-City, African American Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00353405
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : January 19, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE July 14, 2006
First Posted Date  ICMJE July 18, 2006
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE October 2006
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
STD incidence [ Time Frame: Measured at Months 6, 12, and 18 post-treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2006)
  • Measured 6, 12, and 18 months post-intervention: STD prevalence
  • Self reports of safe sexual behavior
Change History Complete list of historical versions of study NCT00353405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
Number of unprotected sexual occasions [ Time Frame: Measured at Months 6, 12, and 18 post-treatment ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Sexually Transmitted Diseases
Intervention  ICMJE
  • 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.
  • Behavioral: Control
    Control group received no social skills training and no media mass media messages.
Study Arms  ICMJE
  • Experimental: 1
    Participants receiving social skills training and mass media messages
    Interventions:
    • Behavioral: Social Skills Training
    • Behavioral: Mass media
  • Experimental: 2
    Participants receiving social skills training and no mass media messages
    Intervention: Behavioral: Social Skills Training
  • Experimental: 3
    Participants receiving mass media messages and no social skills training
    Intervention: Behavioral: Mass media
  • Experimental: 4
    Participants receiving no social skills training and no mass media messages
    Intervention: Behavioral: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2012)
1650
Original Enrollment  ICMJE
 (submitted: July 14, 2006)
1600
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Currently resides in one of the test cities

Exclusion Criteria:

  • Presence of mental impairments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00353405
Other Study ID Numbers  ICMJE U01MH066809( U.S. NIH Grant/Contract )
U01MH066809 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASAC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
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
PRS Account 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