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A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00691496

First Posted: June 5, 2008

Last Update Posted: June 13, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

New York Blood Center

The New York Academy of Medicine

Information provided by (Responsible Party):

Centers for Disease Control and Prevention

Purpose

The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk among African-American men who have sex with men (MSM).

Condition	Intervention
HIV Infections	Behavioral: Behavioral intervention to reduce sexual risk among African-American men who have sex with men


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men

Resource links provided by NLM:

MedlinePlus related topics: African American Health HIV/AIDS

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

The primary goal of the intervention is to reduce HIV transmission or acquisition by reducing the frequency of unprotected anal intercourse among African-American MSM. [ Time Frame: 3 months after completing intervention ]

Secondary Outcome Measures:

Encourage participants to engage in discussions to reduce sexual risk within their social network and with sexual partners. [ Time Frame: 3 months after completing the intervention ]


Enrollment:	326
Study Start Date:	May 2008
Study Completion Date:	November 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Receives HIV testing and counseling and 5 week intervention	Behavioral: Behavioral intervention to reduce sexual risk among African-American men who have sex with men 5 week intervention to increase skill level of participants with talking to their social networks and sexual partners about reducing high risk sexual behaviors while preparing a healthy meal
No Intervention: 2 Receives only HIV Testing and Counseling

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria: identify as African-American, Black, Caribbean Black or multiethnic Black, report sex with men

Exclusion Criteria:

Participated in pilot
Identify as transgender
Plan to move before end of study
Refuse HIV testing at baseline or identified as a newly diagnosed HIV through testing at the baseline
Under 18 years of age

Contacts and Locations

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): NCT00691496

Locations


United States, New York
New York Blood Center
New York, New York, United States, 10003

Sponsors and Collaborators

Centers for Disease Control and Prevention

New York Blood Center

The New York Academy of Medicine

Investigators


Principal Investigator:	Beryl Koblin, PhD	New York Blood Center

More Information

Publications:

Koblin BA, Bonner S, Powell B, Metralexis P, Egan JE, Patterson J, Xu G, Hoover DR, Goodman K, Chin J, Tieu HV, Spikes P. A randomized trial of a behavioral intervention for black MSM: the DiSH study. AIDS. 2012 Feb 20;26(4):483-8. doi: 10.1097/QAD.0b013e32834f9833.

Tieu HV, Spikes P, Patterson J, Bonner S, Egan JE, Goodman K, Stewart K, Frye V, Xu G, Hoover DR, Koblin BA. Sociodemographic and risk behavior characteristics associated with unprotected sex with women among black men who have sex with men and women in New York City. AIDS Care. 2012;24(9):1111-9. doi: 10.1080/09540121.2012.672723. Epub 2012 Apr 25.

Tieu HV, Xu G, Bonner S, Spikes P, Egan JE, Goodman K, Stewart K, Koblin BA. Sexual partner characteristics, serodiscordant/serostatus unknown unprotected anal intercourse and disclosure among human immunodeficiency virus-infected and uninfected black men who have sex with men in New York City. Sex Transm Dis. 2011 Jun;38(6):548-54. doi: 10.1097/OLQ.0b013e318203e2d7.


Responsible Party:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00691496 History of Changes
Other Study ID Numbers:	CDC-NCHHSTP-5157
First Submitted:	June 3, 2008
First Posted:	June 5, 2008
Last Update Posted:	June 13, 2012
Last Verified:	June 2012

Keywords provided by Centers for Disease Control and Prevention:


HIV Prevention African-American gay	bisexual intervention trial HIV Seronegativity

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

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