Feasibility Study of a Multi-Component Intervention for Black Men Who Have Sex With Men
This study has been completed.
Sponsor:
HIV Prevention Trials Network
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
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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
|
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
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 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, 2013