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
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multilevel HIV Prevention Strategy for High-Risk Youth

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • STD incidence [ Time Frame: Measured at Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of unprotected sexual occasions [ Time Frame: Measured at Months 6, 12, and 18 post-treatment ] [ Designated as safety issue: No ]

Enrollment: 1650
Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants receiving social skills training and mass media messages
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.
Experimental: 2
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.
Experimental: 3
Participants receiving mass media messages and no social skills training
Behavioral: Mass media
Mass media provides messages that support sexual health skills.
Experimental: 4
Participants receiving no social skills training and no mass media messages
Behavioral: Control
Control group received no social skills training and no media mass media messages.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently resides in one of the test cities

Exclusion Criteria:

  • Presence of mental impairments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353405

Locations
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
Sponsors and Collaborators
University of Pennsylvania
Investigators
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
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Romer, Director, Adolescent Risk Communication Institute, Annenberg Public Policy Center
ClinicalTrials.gov Identifier: NCT00353405     History of Changes
Other Study ID Numbers: U01 MH66809, U01MH066809, DAHBR 9A-ASAC
Study First Received: July 14, 2006
Last Updated: January 18, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
Adolescents
Sexually Transmitted Infections
Gonorrhea
Chlamydia Infections

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 22, 2014