Clinical trial NCT00353405: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Sexually Transmitted Diseases
Keywords: Adolescents
Sexually Transmitted Infections
Gonorrhea
Chlamydia Infections
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-07-18
Enrollment: 1650
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Currently resides in one of the test cities

Exclusion Criteria:

* Presence of mental impairments

Primary outcomes:
measure: STD incidence
timeFrame: Measured at Months 6, 12, and 18 post-treatment
Secondary outcomes:
measure: Number of unprotected sexual occasions
timeFrame: Measured at Months 6, 12, and 18 post-treatment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University, Rollins School of Public Health
state: Georgia
city: Syracuse
country: United States
facility: Syracuse University, Department of Psychology
state: New York
city: Providence
country: United States
facility: Brown University, Rhode Island Hospital
state: Rhode Island
city: Columbia
country: United States
facility: University of South Carolina, Arnold School of Public Health
state: South Carolina
Study officials:
affiliation: University of Pennsylvania
name: Daniel Romer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Ralph DiClemente, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Lawrence Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Syracuse University
name: Peter Vanable, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Carolina
name: Robert Valois, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.