Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM

HIV CDC Category A1 Clinical Trial

— B-ME  

Official title:

An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722838
• Other study ID #: 5U01PS001574
• Secondary ID: PS09-007
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: April 2015

Study information

• Verified date: February 2019
• Source: Loyola University Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV CDC Category A1

Intervention

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.

Locations

Country	Name	City	State
United States	Loyola University Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reductions in sexual risk behaviors	Unprotected anal or vaginal sex and condom use during	baseline, 3-month, 6-month