Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM (B-ME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01722838
Recruitment Status : Unknown
Verified March 2015 by Loyola University Chicago.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2012
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):
Loyola University Chicago

Brief Summary:

B-ME is a research intervention study designed to address the needs of African American men who have sex with men (AAMSM) who are at high risk for HIV. The intent of the intervention is to decrease HIV risk behaviors among African American MSM using an intervention developed by and for African American MSM.

The hypothesis guiding this study is: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group.

Condition or disease Intervention/treatment Phase
HIV CDC Category A1 Behavioral: B-ME Intervention Phase 2

Detailed Description:
The Specific Aims of this study are 1) to further explicate and develop the intervention, 2) to evaluate its efficacy in reducing HIV risk behaviors and 3) to expand the limited body of research on HIV prevention/risk reduction practices for African American men who have sex with men(AAMSM). The study will use a randomized-controlled trial design to compare receiving B-ME intervention to receiving basic men's health and wellness messaging (standard of care), hypothesizing: hypothesizing: that participants who complete B-ME intervention will report greater reductions in sexual risk behaviors than the standard of care comparison group. The study will utilize a pre-test/post-test design with participants randomized to intervention and comparison groups; have a strategy to retain at least 80% of participants through study completion; collect data at baseline, at 3 months post-intervention, and at 6 months post-intervention; and rigorously measure outcomes that directly impact HIV risk. Data will be collected at each assessment point to assess B-ME's ability to improve behavioral outcomes that directly impact Black MSM HIV risk: (1) number of unprotected anal and vaginal sex events; (2) number of unprotected sex events with persons of unknown HIV status; (3) frequency of HIV testing, and (4) increased communication between partners about sex and strategies for reducing the risk of HIV infection.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention
Study Start Date : September 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: B-ME intervention
Men will receive behavioral HIV prevention intervention, B-ME.
Behavioral: B-ME Intervention
B-ME is a behavioral intervention of HIV prevention risk reduction administered in a group format during a 2.5 day retreat (19 hours) format.

No Intervention: Control Arm
Men in this arm will receive monthly text or telephone voice messages relaying general health messages.

Primary Outcome Measures :
  1. reductions in sexual risk behaviors [ Time Frame: baseline, 3-month, 6-month ]
    Unprotected anal or vaginal sex and condom use during

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • a) Be 18 to 55 years old b) Self identify as African American (Black national) c) Self identify as a male (because this is a study of an intervention to impact change among Black MSM, only self identified males will be included, therefore no females or transgendered identified persons will be included).

    d) Report being sexually active in the past 30 days (ie., one or more instances of vaginal or anal sex with a male or female) e) Report at least one instance of unprotected anal or oral sex with a male identified partner in the past year f) Have not previously participated in the CTCA intervention. g) Have not received an evidence-based HIV prevention intervention in the past 180 days

Exclusion Criteria:

  • Men are ineligible to participate in the trial if they:

    1. Identify as a transgender woman; OR
    2. Plan to move before the end of the study; OR
    3. Have participated in any HIV or substance use prevention studies in the last 180 days.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01722838

United States, Illinois
Loyola University Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Loyola University Chicago
Principal Investigator: Darrell P Wheeler, PHD MPH Loyola University Chicago

Responsible Party: Loyola University Chicago Identifier: NCT01722838     History of Changes
Other Study ID Numbers: 5U01PS001574 ( U.S. NIH Grant/Contract )
PS09-007 ( Other Identifier: CDC/DHAP )
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Loyola University Chicago:
Black MSM
HIV Prevention