Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM (B-ME)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention|
- 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
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722838
|United States, Illinois|
|Loyola University Chicago|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Darrell P Wheeler, PHD MPH||Loyola University Chicago|