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

Sponsor:	HIV Prevention Trials Network
Collaborators:	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)
Information provided by (Responsible Party):	HIV Prevention Trials Network
ClinicalTrials.gov Identifier:	NCT00951249

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

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

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

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)

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:

Bissessor M, Fairley CK, De Guingand D, Bradshaw CS, Chen MY. Delay in the diagnosis of early syphilis among men who have sex with men: need for greater community and health provider education. Int J STD AIDS. 2009 Jan;20(1):52-3.

Rowniak S. Safe sex fatigue, treatment optimism, and serosorting: new challenges to HIV prevention among men who have sex with men. J Assoc Nurses AIDS Care. 2009 Jan-Feb;20(1):31-8.

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
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 May 23, 2012