HIV Infections Clinical Trial
Official title:
Prevention of HIV Infection in Youth at Risk: Developing Community-Level Intervention Strategies That Work (Community Intervention Trial for Youth (CITY) Study)
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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