Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM (B-ME)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV CDC Category A1 |
Behavioral: B-ME Intervention |
Phase 2 |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 438 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders 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:
- Identify as a transgender woman; OR
- Plan to move before the end of the study; OR
- Have participated in any HIV or substance use prevention studies in the last 180 days.
Contacts and Locations| Contact: Darrell P Wheeler, PHD, MPH | 312.915.7024 | dwheeler@luc.edu |
| Contact: Stpehen Armstead | 312.291.9427 | sarmstead@luc.edu |
| United States, Illinois | |
| Loyola University Chicago | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Stephen Armstead 312-291-9427 sarmstead@luc.edu | |
| Contact: Raymond Townes 312.291.9399 rtownes@luc.edu | |
| Principal Investigator: Darrell P Wheeler, PHD MPH | |
| Principal Investigator: | Darrell P Wheeler, PHD MPH | Loyola University Chicago |
More Information
No publications provided
| Responsible Party: | Loyola University Chicago |
| ClinicalTrials.gov Identifier: | NCT01722838 History of Changes |
| Other Study ID Numbers: | 5U01PS001574, PS09-007 |
| Study First Received: | November 5, 2012 |
| Last Updated: | November 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Loyola University Chicago:
|
Black MSM HIV Prevention |
ClinicalTrials.gov processed this record on May 19, 2013