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

January 18, 2012 updated by: University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1650

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University, Rollins School of Public Health
    • New York
      • Syracuse, New York, United States, 13244
        • Syracuse University, Department of Psychology
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown University, Rhode Island Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina, Arnold School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently resides in one of the test cities

Exclusion Criteria:

  • Presence of mental impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
STD incidence
Time Frame: Measured at Months 6, 12, and 18 post-treatment
Measured at Months 6, 12, and 18 post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of unprotected sexual occasions
Time Frame: Measured at Months 6, 12, and 18 post-treatment
Measured at Months 6, 12, and 18 post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute of Mental Health (NIMH)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 14, 2006

First Submitted That Met QC Criteria

July 14, 2006

First Posted (Estimate)

July 18, 2006

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01MH066809 (U.S. NIH Grant/Contract)
  • DAHBR 9A-ASAC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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