Back to resultsA Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral intervention to reduce sexual risk among African-American men who have sex with men
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Prevention, African-American, gay, bisexual, intervention trial, HIV Seronegativity
Eligibility 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
Sites / Locations
- New York Blood Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Receives HIV testing and counseling and 5 week intervention
Receives only HIV Testing and Counseling
Outcomes
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.
Secondary Outcome Measures
Encourage participants to engage in discussions to reduce sexual risk within their social network and with sexual partners.
Full Information
NCT ID
NCT00691496
First Posted
June 3, 2008
Last Updated
June 12, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
New York Blood Center, The New York Academy of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00691496
Brief Title
A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men
Official Title
A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
New York Blood Center, The New York Academy of Medicine
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Prevention, African-American, gay, bisexual, intervention trial, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Receives HIV testing and counseling and 5 week intervention
Arm Title
2
Arm Type
No Intervention
Arm Description
Receives only HIV Testing and Counseling
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention to reduce sexual risk among African-American men who have sex with men
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beryl Koblin, PhD
Organizational Affiliation
New York Blood Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Blood Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22156967
Citation
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.
Results Reference
result
PubMed Identifier
22533637
Citation
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.
Results Reference
result
PubMed Identifier
21217419
Citation
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.
Results Reference
result
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A Behavioral Intervention to Reduce Sexual Risk Among African-American Men Who Have Sex With Men
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