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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:
Collaborators:
New York Blood Center
The New York Academy of Medicine
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00691496
First received: June 3, 2008
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 3, 2008
Last Updated: June 12, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013