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Community Intervention Trial for Youth (CITY) Study

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ClinicalTrials.gov Identifier: NCT00164580
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Study Description
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Brief Summary:
The purpose of this study is to test whether a multi-component, community-level, HIV-prevention intervention is more effective than existing HIV prevention activities in reducing unprotected anal intercourse (UAI) among men ages 15-25 who have sex with men.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Community-Level Intervention Phase 2 Phase 3

Detailed Description:

In recent years, there have been increases in the rates of unprotected anal intercourse (UAI) reported by men who have sex with men (MSM) and in the numbers of newly diagnosed HIV infections among MSM. Surveys of young MSM (ages 15-29) in numerous U.S. cities from 1994-2000 found an HIV prevalence of 2.2% to 18%, however, HIV prevalence was higher among young MSM of color than among white men. In a survey of 23-29 year-old MSM,nearly 1/3 of African-American men and 15% of Hispanic/Latino men were infected with HIV.

The Community Intervention Trial for Youth (CITY) study is a 13-community randomized control trial designed to evaluate a multi-component, community-level intervention for MSM ages 15-25 (i.e., young MSM or YMSM). All 13 communities have some form of HIV-prevention activities naturally occurring in their jurisdiction, but 6 of the 13 communities were randomly assigned to also receive the multi-component intervention (1 additional city served as a case study and also received the intervention). This intervention includes 4 components: 1) community health advisor network (CHAN) consisting of YMSM who conduct outreach to their peers, including linking other YMSM to community services and conducting other parts of the intervention; 2) social marketing, to include the use media to disseminate HIV risk-reduction messages and promote positive norms for safer sex; 3) large group events with an HIV prevention theme; and 4) small group activities/workshops that focus on increasing HIV prevention skills and enhancing a positive self-identity.

The study population varies by site based on the specific racial or ethnic groups of YMSM that are targeted. African-American YMSM are the study population in Atlanta, Georgia (comparison site); Birmingham, Alabama (intervention site); and Chicago, Illinois (intervention site). Hispanic/Latino YMSM are the study population in Washington Heights/South Bronx, New York (intervention site); Jackson Heights/Queens, New York (comparison site); Orange County, California (intervention site); and San Gabriel Valley, California (comparison site). Asian and Pacific Islander YMSM are the study population in Seattle, Washington (intervention site) and San Diego, California (comparison site). YMSM regardless or race/ethnicity are the study population in Milwaukee, Wisconsin (intervention site); Detroit, Michigan (comparison site), Minneapolis, Minnesota (comparison site); and West Hollywood, California (intervention site).

The primary goals of the intervention are to 1) decrease UAI with any male partners; 2) decrease UAI with main male partners; and 3) decrease UAI with non-main (i.e., casual) male partners. Using a venue-based, time/space sampling strategy in each community, cross-sectional samples of YMSM were interviewed from May-August across 4 years (1999-2002). Data collected in 1999 and 2000 were prior to the implementation of the multi-component intervention, and data collected in 2001 and 2002 were during the implementation of the intervention.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of HIV Infection in Youth at Risk: Developing Community-Level Intervention Strategies That Work (Community Intervention Trial for Youth (CITY) Study)
Study Start Date : October 1996
Actual Primary Completion Date : August 2002
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 1) unprotected anal intercourse with a male partner in the past 3 months
  2. 2) unprotected anal intercourse at last sex with a main male partner (among participants with a male sex partner in the past 3 months and in the past year)
  3. 3) unprotected anal intercourse at last sex with the most recent non-main male partner (among participants with a male sex partner in the past 3 months and in the past year)

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 15-25 years of age
  • reports having sexual contact with another man in the past year
  • meets the race/ethnicity eligibility criteria for the particular community

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164580


Locations
United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
University of California-San Francisco, Center for AIDS Prevention Studies
San Francisco, California, United States, 94105
United States, Georgia
Georgia State University
Atlanta, Georgia, United States, 30303
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60607
United States, Massachusetts
Education Development Center
Newton, Massachusetts, United States, 02158
United States, Minnesota
University of Minnesota Youth and AIDS Projects
Minneapolis, Minnesota, United States, 55403
United States, Wisconsin
Medical College of Wisconsin, Center for AIDS Intervention Research
Milwaukee, Wisconsin, United States, 53202
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Carolyn A Guenther-Grey, M.A. Centers for Disease Control and Prevention
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Choi KH, Kumekawa E, Dang Q, Kegeles SM, Hays RB, Stall R. Risk and protective factors affecting sexual behavior among young Asian and Pacific Islander men who have sex with men: Implications for HIV prevention. Journal of Sex Education and Therapy, 24(1&2): 47-55, 1999.
Mashburn AJ, Peterson JL, Bakeman R, Miller RL, Clark LF, and the Community Intervention Trial for Youth Study Team. Influences on HIV testing among young African-American men who have sex with men and the moderating effect of the geographic setting. Journal of Community Psychology 32(1): 45-60, 2004.
Peterson JL, Bakeman R, Stokes J, and the Community Intervention Trial for Youth Study Team. Racial/ethnic patterns of HIV sexual risk behaviors among young men who have sex with men. Journal of the Gay and Lesbian Medical Association 5(4): 155-162, 2001.

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00164580     History of Changes
Other Study ID Numbers: CDC-NCHSTP-1733
U62/CCU113642
U62/CCU513631
U62/CCU513650
U62/CCU513661
U62/CCU913658
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Centers for Disease Control and Prevention:
Homosexuality, Male
Adolescents
Minority Groups
Community Participation
 Community Surveys
HIV Seronegativity
HIV

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases