- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722838
Black Men Evolving Behavioral HIV Prevention Intervention for Black MSM (B-ME)
An Evaluation of a Locally Developed Homegrown HIV Prevention Intervention
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Loyola University Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B-ME intervention
Men will receive behavioral HIV prevention intervention, B-ME.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reductions in sexual risk behaviors
Time Frame: baseline, 3-month, 6-month
|
Unprotected anal or vaginal sex and condom use during
|
baseline, 3-month, 6-month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Darrell P Wheeler, PHD MPH, Loyola University Chicago
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5U01PS001574 (U.S. NIH Grant/Contract)
- PS09-007 (Other Identifier: CDC/DHAP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV CDC Category A1
-
University of Illinois at ChicagoNational Institute of Nursing Research (NINR); Kamuzu College of Nursing, University...CompletedHIV CDC Category A1Malawi
-
Ministry of Health and Child Welfare, ZimbabweCompletedCircumcision Adult | HIV CDC Category B2Zimbabwe
-
University of California, San FranciscoJanssen Scientific Affairs, LLCWithdrawnHepatitis C, Chronic | HIV CDC Category A1United States
-
Ministry of Health and Child Welfare, ZimbabweCompletedHIV Infections | Circumcision Adult | HIV CDC Category B2Zimbabwe
Clinical Trials on B-ME Intervention
-
University of South FloridaTemple University; National Institute on Disability, Independent Living, and... and other collaboratorsRecruitingMental Illness | Behavior Disorders | Psychiatric Diagnosis | Psychiatric Disorders | Severe Mental Illness | Psychiatric Diseases | Psychiatric IllnessUnited States
-
Kent State UniversityGoJo Industries, Akron OH; Cuyahoga County Government CenterCompletedRespiratory Tract Infections | Gastrointestinal InfectionsUnited States
-
University of FloridaPatient-Centered Outcomes Research Institute; National Cancer Institute (NCI)Not yet recruitingHuman Papillomavirus (HPV) VaccinesUnited States
-
San Diego State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Unknown
-
University of OxfordEuropean and Developing Countries Clinical Trials Partnership (EDCTP)Completed
-
University of OxfordCompleted
-
Shanghai Jiao Tong University School of MedicineCompleted
-
University of ChileFondo Nacional de Desarrollo Científico y Tecnológico, ChileCompleted
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)CompletedHIV | Medication AdherenceIndia
-
London School of Hygiene and Tropical MedicineUniversity of Oxford; Wellcome Trust; Medical Research Council Unit, The GambiaCompleted