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Feasibility Study of a Multi-Component Intervention for Black Men Who Have Sex With Men

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ClinicalTrials.gov Identifier: NCT00951249
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : May 11, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
It has been estimated that black men who have sex with men (MSM) account for one quarter of all new HIV infections in the US annually, yet little prevention work has been directed towards this population. The purpose of this study is to research and potentially design a new and better way to try and slow the spread of HIV among black MSM.

Condition or disease Intervention/treatment
HIV Infections Behavioral: Referral of Partners Behavioral: Screening for STIs and counseling Behavioral: Peer health care system navigators Behavioral: Enhanced counseling

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1553 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility Study of a Community-Level, Multi-Component Intervention for Black Men Who Have Sex With Men
Study Start Date : July 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
HIV-infected and uninfected black MSM
Behavioral: Referral of Partners
Referral of up to five sexual partners by index participants for enrollment into the study
Behavioral: Screening for STIs and counseling
Identification of STIs and treatment or referral for treatment, if applicable
Behavioral: Peer health care system navigators
HIV/STI treatment and other medical and social services
Behavioral: Enhanced counseling
Counseling and referral for care offered to participants for issues such as substance use and mental health

Outcome Measures

Primary Outcome Measures :
  1. Number of participants enrolled at each city [ Time Frame: At 52 Weeks ]
  2. Proportion of participants who agree to HIV testing [ Time Frame: Throughout study ]
  3. Proportion of participants who agree to STI testing [ Time Frame: Throughout study ]
  4. Proportion of participants who use PHN [ Time Frame: Throughout study ]
  5. Proportion of participants who are newly diagnosed with HIV at enrollment [ Time Frame: At Study Entry ]
  6. Increase in condom use [ Time Frame: Study Entry to Week 52 ]
  7. Decrease in viral load among HIV-infected participants who initiate HAART during their study participation [ Time Frame: At Week 52 ]
  8. Decrease in STI [ Time Frame: At Study Entry to Week 52 ]

Secondary Outcome Measures :
  1. Number of participants with recent HIV infection [ Time Frame: At Study Entry ]
  2. Number of participants with acute HIV infection [ Time Frame: At Week 52 ]
  3. Number of seroconversions during follow-up among those who are HIV-uninfected [ Time Frame: At Follow-up ]
  4. Number of sex partners [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
  5. Number of sero-discordant or sero-unknown partners [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
  6. Type and frequency of anal intercourse [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
  7. Level of condom use [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
  8. Partner change rate [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
  9. As individually self-reported by participants: network size, composition, density, multiplexity, durability, and homogeneity [ Time Frame: Throughout study ]
  10. Overlap of participant's sexual network with his social network [ Time Frame: Throughout study ]
  11. Attitudes of black MSM toward other prevention interventions [ Time Frame: Throughout study ]

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

Inclusion Criteria:

  • Willing and able to provide informed consent
  • Black, African American, Caribbean Black, or multiethnic Black
  • At least one instance of unprotected anal intercourse (UAI) with a man in the past six months
  • Residing in the metropolitan area and do not plan to move away during the time of study participation

Exclusion Criteria:

  • Co-enrollment in any other HIV interventional research study or have been enrolled in an HIV vaccine trial in which they were either in the active arm or do not know the arm in which they were enrolled.
  • Would be enrolled as a community-recruited participant in a category that has already reached its enrollment cap
  • Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
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): NCT00951249

United States, California
UCLA Vine Street CRS
Los Angeles, California, United States, 90038
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States, 94102
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Georgia
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States, 30308
Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States, 30030
United States, Massachusetts
The Fenway Institute
Boston, Massachusetts, United States, 02115
United States, New York
NY Blood Ctr./Union Square CRS
New York, New York, United States, 10003
Harlem Hospital Center/Columbia University CRS
New York, New York, United States, 10032
Sponsors and Collaborators
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
Study Chair: Beryl Koblin, PhD New York Blood Center
Study Chair: Kenneth Mayer, MD Fenway Community Health Center
Study Chair: Darrell P. Wheeler, PhD, MPH, ACSW School of Social Work, Hunter College
More Information

Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT00951249     History of Changes
Other Study ID Numbers: HPTN 061
1U01AI068619 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: May 11, 2012
Last Verified: May 2012

Keywords provided by HIV Prevention Trials Network:
HIV infections
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