Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM

NCT01722838 | Completed DMC

• 2 other identifiers: 5U01PS001574PS09-007
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV CDC Category A1

Keywords

Black MSM; HIV Prevention

Outcome Measures

Primary Outcomes (1)

• reductions in sexual risk behaviors

  Unprotected anal or vaginal sex and condom use during

  baseline, 3-month, 6-month

Study Arms (2)

B-ME intervention

EXPERIMENTAL

Men will receive behavioral HIV prevention intervention, B-ME.

Behavioral: B-ME Intervention

Control Arm

NO INTERVENTION

Men in this arm will receive monthly text or telephone voice messages relaying general health messages.

Interventions

B-ME Intervention BEHAVIORAL

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.

B-ME intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University Chicago: lead

Study Sites (1)

Loyola University Chicago

Chicago, Illinois, 60611, United States

Location

Study Officials

• Darrell P Wheeler, PHD MPH

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Assignment to behavioral intervention or comparison group

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 7, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

US (1)