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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691496
• Other study ID #: CDC-NCHHSTP-5157
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: June 12, 2012
• Start date: May 2008
• Est. completion date: November 2009

Study information

• Verified date: June 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

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

Locations

Country	Name	City	State
United States	New York Blood Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	New York Blood Center, The New York Academy of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.0b013e — View 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 N — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months after completing intervention	No
Secondary	Encourage participants to engage in discussions to reduce sexual risk within their social network and with sexual partners.		3 months after completing the intervention	No