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

A Multilevel HIV Prevention Strategy for High-Risk Youth

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00353405
Enrollment
1650
Registered
2006-07-18
Start date
2006-10-31
Completion date
2010-12-31
Last updated
2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexually Transmitted Diseases

Keywords

Adolescents, Sexually Transmitted Infections, Gonorrhea, Chlamydia Infections

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.

Interventions

BEHAVIORALSocial Skills Training

Social skills training includes two 8-hour sexual health skills building sessions conducted in the community.

BEHAVIORALMass media

Mass media provides messages that support sexual health skills.

BEHAVIORALControl

Control group received no social skills training and no media mass media messages.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Currently resides in one of the test cities

Exclusion criteria

* Presence of mental impairments

Design outcomes

Primary

MeasureTime frame
STD incidenceMeasured at Months 6, 12, and 18 post-treatment

Secondary

MeasureTime frame
Number of unprotected sexual occasionsMeasured at Months 6, 12, and 18 post-treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026