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

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Social Skills Training
Mass media
Control
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Adolescents, Sexually Transmitted Infections, Gonorrhea, Chlamydia Infections

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Currently resides in one of the test cities Exclusion Criteria: Presence of mental impairments

Sites / Locations

  • Emory University, Rollins School of Public Health
  • Syracuse University, Department of Psychology
  • Brown University, Rhode Island Hospital
  • University of South Carolina, Arnold School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Participants receiving social skills training and mass media messages

Participants receiving social skills training and no mass media messages

Participants receiving mass media messages and no social skills training

Participants receiving no social skills training and no mass media messages

Outcomes

Primary Outcome Measures

STD incidence

Secondary Outcome Measures

Number of unprotected sexual occasions

Full Information

First Posted
July 14, 2006
Last Updated
January 18, 2012
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00353405
Brief Title
HIV and STD Prevention for High-Risk, Inner-City, African American Youth
Official Title
A Multilevel HIV Prevention Strategy for High-Risk Youth
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases
Keywords
Adolescents, Sexually Transmitted Infections, Gonorrhea, Chlamydia Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants receiving social skills training and mass media messages
Arm Title
2
Arm Type
Experimental
Arm Description
Participants receiving social skills training and no mass media messages
Arm Title
3
Arm Type
Experimental
Arm Description
Participants receiving mass media messages and no social skills training
Arm Title
4
Arm Type
Experimental
Arm Description
Participants receiving no social skills training and no mass media messages
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training
Intervention Description
Social skills training includes two 8-hour sexual health skills building sessions conducted in the community.
Intervention Type
Behavioral
Intervention Name(s)
Mass media
Intervention Description
Mass media provides messages that support sexual health skills.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Control group received no social skills training and no media mass media messages.
Primary Outcome Measure Information:
Title
STD incidence
Time Frame
Measured at Months 6, 12, and 18 post-treatment
Secondary Outcome Measure Information:
Title
Number of unprotected sexual occasions
Time Frame
Measured at Months 6, 12, and 18 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Currently resides in one of the test cities Exclusion Criteria: Presence of mental impairments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Romer, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralph DiClemente, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Brown, MD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Vanable, PhD
Organizational Affiliation
Syracuse University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Valois, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University, Rollins School of Public Health
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Syracuse University, Department of Psychology
City
Syracuse
State/Province
New York
ZIP/Postal Code
13244
Country
United States
Facility Name
Brown University, Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of South Carolina, Arnold School of Public Health
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31380687
Citation
Foley JD, Vanable PA, Brown LK, Carey MP, DiClemente RJ, Romer D, Valois RF. Depressive symptoms as a longitudinal predictor of sexual risk behaviors among African-American adolescents. Health Psychol. 2019 Nov;38(11):1001-1009. doi: 10.1037/hea0000780. Epub 2019 Aug 5.
Results Reference
derived
PubMed Identifier
23153149
Citation
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.
Results Reference
derived

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

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