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Clinical Trials/NCT00164580
NCT00164580
Completed
Phase 2

Prevention of HIV Infection in Youth at Risk: Developing Community-Level Intervention Strategies That Work (Community Intervention Trial for Youth (CITY) Study)

Centers for Disease Control and Prevention8 sites in 1 country12,000 target enrollmentOctober 1996
ConditionsHIV Infections

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Centers for Disease Control and Prevention
Enrollment
12000
Locations
8
Primary Endpoint
1) unprotected anal intercourse with a male partner in the past 3 months
Status
Completed
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 1996
End Date
August 2004
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility 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

  • Not provided

Outcomes

Primary Outcomes

1) unprotected anal intercourse with a male partner in the past 3 months

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) 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)

Study Sites (8)

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