Clinical trial NCT01722838: Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM
Official title: An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV CDC Category A1
Keywords: Black MSM
HIV Prevention
Lead sponsor: Loyola University Chicago
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 438
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment to behavioral intervention or comparison group
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: reductions in sexual risk behaviors
timeFrame: baseline, 3-month, 6-month
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Loyola University Chicago
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Darrell P Wheeler, PHD MPH
role: PRINCIPAL_INVESTIGATOR
References: