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

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.
ClinicalTrials.gov Identifier: NCT00691496
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : June 13, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Infections Behavioral: Behavioral intervention to reduce sexual risk among African-American men who have sex with men

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
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
Study Start Date : May 2008
Primary Completion Date : October 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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:
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00691496     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-5157
First Posted: June 5, 2008    Key Record Dates
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