NCT00164580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,000

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Oct 1996

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

5.8 years

First QC Date

September 9, 2005

Last Update Submit

September 26, 2012

Conditions

Keywords

Homosexuality, MaleAdolescentsMinority GroupsCommunity ParticipationCommunity SurveysHIV SeronegativityHIV

Outcome Measures

Primary Outcomes (3)

  • 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)

Interventions

Eligibility Criteria

Age15 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

University of California-San Francisco, Center for AIDS Prevention Studies

San Francisco, California, 94105, United States

Location

Georgia State University

Atlanta, Georgia, 30303, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

Education Development Center

Newton, Massachusetts, 02158, United States

Location

University of Minnesota Youth and AIDS Projects

Minneapolis, Minnesota, 55403, United States

Location

Medical College of Wisconsin, Center for AIDS Intervention Research

Milwaukee, Wisconsin, 53202, United States

Location

Related Publications (16)

  • Agronick G, O'Donnell L, Stueve A, Doval AS, Duran R, Vargo S. Sexual behaviors and risks among bisexually- and gay-identified young Latino men. AIDS Behav. 2004 Jun;8(2):185-97. doi: 10.1023/B:AIBE.0000030249.11679.d0.

    PMID: 15187480BACKGROUND
  • Choi KH, Yep GA, Kumekawa E. HIV prevention among Asian and Pacific Islander American men who have sex with men: a critical review of theoretical models and directions for future research. AIDS Educ Prev. 1998 Jun;10(3 Suppl):19-30.

    PMID: 9642428BACKGROUND
  • 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.

    BACKGROUND
  • Choi KH, Han CS, Hudes ES, Kegeles S. Unprotected sex and associated risk factors among young Asian and Pacific Islander men who have sex with men. AIDS Educ Prev. 2002 Dec;14(6):472-81. doi: 10.1521/aeap.14.8.472.24114.

    PMID: 12512848BACKGROUND
  • Guenther-Grey CA, Varnell S, Weiser JI, Mathy RM, O'Donnell L, Stueve A, Remafedi G; Community Intervention Trial for Youth Study Team. Trends in sexual risk-taking among urban young men who have sex with men, 1999-2002. J Natl Med Assoc. 2005 Jul;97(7 Suppl):38S-43S.

    PMID: 16080456BACKGROUND
  • Hart T, Peterson JL; Community Intervention Trial for Youth Study Team. Predictors of risky sexual behavior among young African American men who have sex with men. Am J Public Health. 2004 Jul;94(7):1122-4. doi: 10.2105/ajph.94.7.1122.

    PMID: 15226130BACKGROUND
  • 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.

    BACKGROUND
  • Miller RL, Bedney BJ, Guenther-Grey C; CITY Project Study Team. Assessing organizational capacity to deliver HIV prevention services collaboratively: tales from the field. Health Educ Behav. 2003 Oct;30(5):582-600. doi: 10.1177/1090198103255327.

    PMID: 14582599BACKGROUND
  • Muhib FB, Lin LS, Stueve A, Miller RL, Ford WL, Johnson WD, Smith PJ; Community Intervention Trial for Youth Study Team. A venue-based method for sampling hard-to-reach populations. Public Health Rep. 2001;116 Suppl 1(Suppl 1):216-22. doi: 10.1093/phr/116.S1.216.

    PMID: 11889287BACKGROUND
  • O'Donnell L, Agronick G, San Doval A, Duran R, Myint-U A, Stueve A. Ethnic and gay community attachments and sexual risk behaviors among urban Latino young men who have sex with men. AIDS Educ Prev. 2002 Dec;14(6):457-71. doi: 10.1521/aeap.14.8.457.24109.

    PMID: 12512847BACKGROUND
  • 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.

    BACKGROUND
  • Remafedi G. Suicidality in a venue-based sample of young men who have sex with men. J Adolesc Health. 2002 Oct;31(4):305-10. doi: 10.1016/s1054-139x(02)00405-6.

    PMID: 12359375BACKGROUND
  • Seal DW, Bloom FR, Somlai AM. Dilemmas in conducting qualitative sex research in applied field settings. Health Educ Behav. 2000 Feb;27(1):10-23. doi: 10.1177/109019810002700102.

    PMID: 10709789BACKGROUND
  • Seal DW, Kelly JA, Bloom FR, Stevenson LY, Coley BI, Broyles LA. HIV prevention with young men who have sex with men: what young men themselves say is needed. Medical College of Wisconsin CITY Project Research Team. AIDS Care. 2000 Feb;12(1):5-26. doi: 10.1080/09540120047431.

    PMID: 10716014BACKGROUND
  • Stueve A, O'Donnell LN, Duran R, San Doval A, Blome J. Time-space sampling in minority communities: results with young Latino men who have sex with men. Am J Public Health. 2001 Jun;91(6):922-6. doi: 10.2105/ajph.91.6.922.

    PMID: 11392935BACKGROUND
  • Stueve A, O'Donnell L, Duran R, San Doval A, Geier J; Community Intervention Trial for Youth Study Team. Being high and taking sexual risks: findings from a multisite survey of urban young men who have sex with men. AIDS Educ Prev. 2002 Dec;14(6):482-95. doi: 10.1521/aeap.14.8.482.24108.

    PMID: 12512849BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHomosexuality, Male

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHomosexualitySexualitySexual BehaviorBehavior

Study Officials

  • Carolyn A Guenther-Grey, M.A.

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

October 1, 1996

Primary Completion

August 1, 2002

Study Completion

August 1, 2004

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations