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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Referral of Partners Behavioral: Screening for STIs and counseling Behavioral: Peer health care system navigators Behavioral: Enhanced counseling | Not Applicable |

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 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |
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
|
- Number of participants enrolled at each city [ Time Frame: At 52 Weeks ]
- Proportion of participants who agree to HIV testing [ Time Frame: Throughout study ]
- Proportion of participants who agree to STI testing [ Time Frame: Throughout study ]
- Proportion of participants who use PHN [ Time Frame: Throughout study ]
- Proportion of participants who are newly diagnosed with HIV at enrollment [ Time Frame: At Study Entry ]
- Increase in condom use [ Time Frame: Study Entry to Week 52 ]
- Decrease in viral load among HIV-infected participants who initiate HAART during their study participation [ Time Frame: At Week 52 ]
- Decrease in STI [ Time Frame: At Study Entry to Week 52 ]
- Number of participants with recent HIV infection [ Time Frame: At Study Entry ]
- Number of participants with acute HIV infection [ Time Frame: At Week 52 ]
- Number of seroconversions during follow-up among those who are HIV-uninfected [ Time Frame: At Follow-up ]
- Number of sex partners [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- Number of sero-discordant or sero-unknown partners [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- Type and frequency of anal intercourse [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- Level of condom use [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- Partner change rate [ Time Frame: At Study Entry, and Weeks 26 and 52 ]
- As individually self-reported by participants: network size, composition, density, multiplexity, durability, and homogeneity [ Time Frame: Throughout study ]
- Overlap of participant's sexual network with his social network [ Time Frame: Throughout study ]
- Attitudes of black MSM toward other prevention interventions [ Time Frame: Throughout study ]

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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

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 |
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 |
Publications:
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:
MSM 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 |