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

June 12, 2012 updated by: Centers for Disease Control and Prevention
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months after completing intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months after completing the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

New York Blood Center
The New York Academy of Medicine

Investigators

  • Principal Investigator: Beryl Koblin, PhD, New York Blood Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHHSTP-5157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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