This trial is active, not recruiting.

Condition hiv cdc category a1
Treatment b-me intervention
Phase phase 2
Sponsor Loyola University Chicago
Start date September 2012
End date April 2015
Trial size 438 participants
Trial identifier NCT01722838, 5U01PS001574, PS09-007


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Men will receive behavioral HIV prevention intervention, B-ME.
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)
Men in this arm will receive monthly text or telephone voice messages relaying general health messages.

Primary Outcomes

reductions in sexual risk behaviors
time frame: baseline, 3-month, 6-month

Eligibility Criteria

Male participants from 18 years up to 55 years old.

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.

Additional Information

Official title An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention
Principal investigator Darrell P Wheeler, PHD MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Loyola University Chicago.