- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00691041
A Network Intervention for Reducing Sexual Risk for HIV With African American Men Who Have Sex With Men (AA MSM) (UDP)
June 12, 2012 updated by: Centers for Disease Control and Prevention
The purpose of the study is to examine the efficacy of a network-oriented "outreach intervention" to reduce HIV and sexually transmitted infection (STI) related risk behaviors among African American men who have sex with men (AA MSM)and their social network.
The hypothesis is to determine whether the new intervention is more efficacious at reducing high risk sexual behaviors than the standard normal of care provided to the public (a single session of individual HIV counseling and testing.
Study Overview
Detailed Description
The intervention increases participants' personal level of knowledge and skills concerning HIV prevention and inspires participants to diffuse the information to their social network.
Study Type
Interventional
Enrollment (Actual)
233
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Lighthouse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Identify as a black / African American male
- Report sex with at least 2 people in past 3 months/ 1 being male
- Willingness to take HIV test or provide documentation if HIV+
- Willingness to identify and recruit friend/relative to study
Exclusion Criteria:
- Under age 18
- Identify as female or transgender
- Not identify as Black / African American
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: 1
HIV/STI counseling and testing and a 7 session intervention to increase participants' level of knowledge and skills concerning HIV prevention (to decrease HIV acquisition or transmission) and to diffuse the information to their social network
|
HIV/STI counseling and testing and a 7 session intervention to increase participants' level of knowledge and skills concerning HIV prevention (to decrease HIV acquisition or transmission) and to diffuse the information to their social network
|
|
No Intervention: 2
HIV/STI counseling and testing and a single 15 minute session of resources available in the community
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To increase participants knowledge of HIV/STI risks to assist with decreasing high risk sex/drug behaviors
Time Frame: 3 months after completing intervention
|
3 months after completing intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To increase participants' level of knowledge and skills concerning HIV/STI prevention and diffusing the information to their social network)
Time Frame: 3 months after completing the intervention
|
3 months after completing the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carl Latkin, PhD, Johns Hopkins University -Bloomberg School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tobin KE, German D, Spikes P, Patterson J, Latkin C. A comparison of the social and sexual networks of crack-using and non-crack using African American men who have sex with men. J Urban Health. 2011 Dec;88(6):1052-62. doi: 10.1007/s11524-011-9611-4.
- Latkin C, Yang C, Tobin K, Penniman T, Patterson J, Spikes P. Differences in the social networks of African American men who have sex with men only and those who have sex with men and women. Am J Public Health. 2011 Oct;101(10):e18-23. doi: 10.2105/AJPH.2011.300281. Epub 2011 Aug 18.
- Latkin C, Yang C, Tobin K, Roebuck G, Spikes P, Patterson J. Social network predictors of disclosure of MSM behavior and HIV-positive serostatus among African American MSM in Baltimore, Maryland. AIDS Behav. 2012 Apr;16(3):535-42. doi: 10.1007/s10461-011-0014-z.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
June 3, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (Estimate)
June 5, 2008
Study Record Updates
Last Update Posted (Estimate)
June 13, 2012
Last Update Submitted That Met QC Criteria
June 12, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCHHSTP-5221
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.