Trial record 20 of 27 for:    " October 31, 2012":" November 30, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Loyola University Chicago
Sponsor:
Information provided by (Responsible Party):
Loyola University Chicago
ClinicalTrials.gov Identifier:
NCT01722838
First received: November 5, 2012
Last updated: December 20, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by Loyola University Chicago:

Primary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722838

Contacts
Contact: Darrell P Wheeler, PHD, MPH 312.915.7024 dwheeler@luc.edu
Contact: Anthony Johnson, MPH 312.291.9427 ajohnson34@luc.edu

Locations
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         
Sponsors and Collaborators
Loyola University Chicago
Investigators
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: December 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University Chicago:
Black MSM
HIV Prevention

ClinicalTrials.gov processed this record on August 21, 2014