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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00353405
First received: July 14, 2006
Last updated: January 18, 2012
Last verified: January 2012

July 14, 2006
January 18, 2012
October 2006
December 2010   (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 ]
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • HIV Infections
  • Sexually Transmitted Diseases
  • 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.
  • 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
Hennessy M, Romer D, Valois RF, Vanable P, Carey MP, Stanton B, Brown L, DiClemente R, Salazar LF. Safer sex media messages and adolescent sexual behavior: 3-year follow-up results from project iMPPACS. Am J Public Health. 2013 Jan;103(1):134-40. doi: 10.2105/AJPH.2012.300856. Epub 2012 Nov 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1650
December 2010
December 2010   (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
U01 MH66809, U01MH066809, DAHBR 9A-ASAC
Yes
Daniel Romer, Director, Adolescent Risk Communication Institute, Annenberg Public Policy Center
University of Pennsylvania
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
University of Pennsylvania
January 2012

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