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

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University of Pennsylvania

Status and phase

Completed
Phase 3

Conditions

Sexually Transmitted Diseases
HIV Infections

Treatments

Behavioral: Control
Behavioral: Social Skills Training
Behavioral: Mass media

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00353405
U01MH066809 (U.S. NIH Grant/Contract)
DAHBR 9A-ASAC

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,650 patients

Sex

All

Ages

14 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Currently resides in one of the test cities

Exclusion criteria

  • Presence of mental impairments

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,650 participants in 4 patient groups

1
Experimental group
Description:
Participants receiving social skills training and mass media messages
Treatment:
Behavioral: Mass media
Behavioral: Social Skills Training
2
Experimental group
Description:
Participants receiving social skills training and no mass media messages
Treatment:
Behavioral: Social Skills Training
3
Experimental group
Description:
Participants receiving mass media messages and no social skills training
Treatment:
Behavioral: Mass media
4
Experimental group
Description:
Participants receiving no social skills training and no mass media messages
Treatment:
Behavioral: Control

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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