Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men
NCT ID: NCT00231972
Last Updated: 2011-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
201 participants
INTERVENTIONAL
2003-12-31
2008-07-31
Brief Summary
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Detailed Description
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Participants in this 1-year open-label study will be randomly assigned to receive either PCM alone or a behavioral intervention called Project Enhance, in addition to PCM. The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. PCM will entail standard case management, as well as referrals to specific services that each individual may need. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Project Enhance
Participants will receive the risk reduction program, Project Enhance
Project Enhance
The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
Active Comparison Condition
Participants will receive standard prevention case management
Standard prevention case management (PCM)
Participants will receive standard PCM for HIV prevention.
Interventions
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Project Enhance
The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
Standard prevention case management (PCM)
Participants will receive standard PCM for HIV prevention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receives primary health care at Fenway Community Health
* Identifies as a man who has sex with men
* Has engaged in unprotected anal or vaginal intercourse within 3 months of study enrollment
Exclusion Criteria
* Plans to relocate over the upcoming year
18 Years
MALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Fenway Community Health
OTHER
Responsible Party
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Fenway Community Health
Principal Investigators
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Kenneth Mayer, MD
Role: PRINCIPAL_INVESTIGATOR
Fenway Community Health and Brown University
Steven Safren, PhD
Role: PRINCIPAL_INVESTIGATOR
Fenway Community Health and Harvard Medical School
Conall O'Cleirigh, PhD
Role: STUDY_DIRECTOR
Fenway Community Health and Massachusetts General Hospital
Locations
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Fenway Community Health
Boston, Massachusetts, United States
Countries
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Other Identifiers
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