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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Loyola University Chicago
ClinicalTrials.gov Identifier:
NCT01722838
First received: November 5, 2012
Last updated: September 8, 2014
Last verified: September 2014

November 5, 2012
September 8, 2014
September 2012
December 2014   (final data collection date for primary outcome measure)
reductions in sexual risk behaviors [ Time Frame: baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
Unprotected anal or vaginal sex and condom use during
Same as current
Complete list of historical versions of study NCT01722838 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM
An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV CDC Category A1
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.
  • Experimental: B-ME intervention
    Men will receive behavioral HIV prevention intervention, B-ME.
    Intervention: Behavioral: B-ME Intervention
  • No Intervention: Control Arm
    Men in this arm will receive monthly text or telephone voice messages relaying general health messages.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
438
April 2015
December 2014   (final data collection date for primary outcome measure)

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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01722838
5U01PS001574, PS09-007
Yes
Loyola University Chicago
Loyola University Chicago
Not Provided
Principal Investigator: Darrell P Wheeler, PHD MPH Loyola University Chicago
Loyola University Chicago
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP