Community Intervention Trial for Youth (CITY) Study

September 26, 2012 updated by: Centers for Disease Control and Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

12000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama - Birmingham
    • California
      • Los Angeles, California, United States, 90027
        • Childrens Hospital Los Angeles
      • San Francisco, California, United States, 94105
        • University of California-San Francisco, Center for AIDS Prevention Studies
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Georgia State University
    • Illinois
      • Chicago, Illinois, United States, 60607
        • University of Illinois at Chicago
    • Massachusetts
      • Newton, Massachusetts, United States, 02158
        • Education Development Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55403
        • University of Minnesota Youth and AIDS Projects
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • Medical College of Wisconsin, Center for AIDS Intervention Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Carolyn A Guenther-Grey, M.A., Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1996

Primary Completion (Actual)

August 1, 2002

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

September 27, 2012

Last Update Submitted That Met QC Criteria

September 26, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHSTP-1733
  • U62/CCU113642
  • U62/CCU513631
  • U62/CCU513650
  • U62/CCU513661
  • U62/CCU913658

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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