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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
HIV Prevention Trials Network
ClinicalTrials.gov Identifier:
NCT00951249
First received: July 31, 2009
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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 Intervention
HIV Infections
Behavioral: Referral of Partners
Behavioral: Screening for STIs and counseling
Behavioral: Peer health care system navigators
Behavioral: Enhanced counseling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility Study of a Community-Level, Multi-Component Intervention for Black Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by HIV Prevention Trials Network:

Primary Outcome Measures:
  • Number of participants enrolled at each city [ Time Frame: At 52 Weeks ] [ Designated as safety issue: No ]
  • Proportion of participants who agree to HIV testing [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Proportion of participants who agree to STI testing [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Proportion of participants who use PHN [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Proportion of participants who are newly diagnosed with HIV at enrollment [ Time Frame: At Study Entry ] [ Designated as safety issue: No ]
  • Increase in condom use [ Time Frame: Study Entry to Week 52 ] [ Designated as safety issue: No ]
  • Decrease in viral load among HIV-infected participants who initiate HAART during their study participation [ Time Frame: At Week 52 ] [ Designated as safety issue: No ]
  • Decrease in STI [ Time Frame: At Study Entry to Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with recent HIV infection [ Time Frame: At Study Entry ] [ Designated as safety issue: No ]
  • Number of participants with acute HIV infection [ Time Frame: At Week 52 ] [ Designated as safety issue: No ]
  • Number of seroconversions during follow-up among those who are HIV-uninfected [ Time Frame: At Follow-up ] [ Designated as safety issue: No ]
  • Number of sex partners [ Time Frame: At Study Entry, and Weeks 26 and 52 ] [ Designated as safety issue: No ]
  • Number of sero-discordant or sero-unknown partners [ Time Frame: At Study Entry, and Weeks 26 and 52 ] [ Designated as safety issue: No ]
  • Type and frequency of anal intercourse [ Time Frame: At Study Entry, and Weeks 26 and 52 ] [ Designated as safety issue: No ]
  • Level of condom use [ Time Frame: At Study Entry, and Weeks 26 and 52 ] [ Designated as safety issue: No ]
  • Partner change rate [ Time Frame: At Study Entry, and Weeks 26 and 52 ] [ Designated as safety issue: No ]
  • As individually self-reported by participants: network size, composition, density, multiplexity, durability, and homogeneity [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Overlap of participant's sexual network with his social network [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Attitudes of black MSM toward other prevention interventions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 1553
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951249

Locations
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
Harlem Hospital Center/Columbia University CRS
New York, New York, United States, 10032
NY Blood Ctr./Union Square CRS
New York, New York, United States, 10003
Sponsors and Collaborators
HIV Prevention Trials Network
Investigators
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

Publications:
Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT00951249     History of Changes
Other Study ID Numbers: HPTN 061, 1U01AI068619
Study First Received: July 31, 2009
Last Updated: May 9, 2012
Health Authority: United States: Federal Government

Keywords provided by HIV Prevention Trials Network:
MSM
HIV infections
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
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 September 18, 2014