Feasibility Study of a Multi-Component Intervention for Black Men Who Have Sex With Men
Feasibility Study of a Community-Level, Multi-Component Intervention for Black Men Who Have Sex With Men
2 other identifiers
interventional
1,553
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Jul 2009
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 31, 2009
CompletedFirst Posted
Study publicly available on registry
August 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedAugust 26, 2022
August 1, 2022
2.4 years
July 31, 2009
August 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Number of participants enrolled at each city
At 52 Weeks
Proportion of participants who agree to HIV testing
Throughout study
Proportion of participants who agree to STI testing
Throughout study
Proportion of participants who use PHN
Throughout study
Proportion of participants who are newly diagnosed with HIV at enrollment
At Study Entry
Increase in condom use
Study Entry to Week 52
Decrease in viral load among HIV-infected participants who initiate HAART during their study participation
At Week 52
Decrease in STI
At Study Entry to Week 52
Secondary Outcomes (11)
Number of participants with recent HIV infection
At Study Entry
Number of participants with acute HIV infection
At Week 52
Number of seroconversions during follow-up among those who are HIV-uninfected
At Follow-up
Number of sex partners
At Study Entry, and Weeks 26 and 52
Number of sero-discordant or sero-unknown partners
At Study Entry, and Weeks 26 and 52
- +6 more secondary outcomes
Study Arms (1)
A
EXPERIMENTALHIV-infected and uninfected black MSM
Interventions
Referral of up to five sexual partners by index participants for enrollment into the study
Identification of STIs and treatment or referral for treatment, if applicable
HIV/STI treatment and other medical and social services
Counseling and referral for care offered to participants for issues such as substance use and mental health
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HIV Prevention Trials Networklead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- National Institute on Drug Abuse (NIDA)collaborator
- National Institute of Mental Health (NIMH)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (8)
UCLA Vine Street CRS
Los Angeles, California, 90038, United States
San Francisco Vaccine and Prevention CRS
San Francisco, California, 94102, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, 30308, United States
Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, 30030, United States
The Fenway Institute
Boston, Massachusetts, 02115, United States
NY Blood Ctr./Union Square CRS
New York, New York, 10003, United States
Harlem Hospital Center/Columbia University CRS
New York, New York, 10032, United States
Related Publications (2)
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. doi: 10.1258/ijsa.2008.008254.
PMID: 19103894BACKGROUNDRowniak 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. doi: 10.1016/j.jana.2008.09.006.
PMID: 19118769BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2009
First Posted
August 4, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 26, 2022
Record last verified: 2022-08