Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men (Enhance)
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|ClinicalTrials.gov Identifier: NCT00231972|
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : April 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Project Enhance Behavioral: Standard prevention case management (PCM)||Not Applicable|
In recent years, the spread of HIV and other STDs has increased, especially among men who have sex with men. This increase signifies continued sexual risk taking within this population. In order to curb the increase of HIV infections, prevention programs are needed. A standard prevention case management program has been developed; however, new programs that further improve outcomes are needed. This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management (PCM) in promoting safer sex practices in HIV-infected men.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing HIV Prevention Among HIV Infected Men|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Experimental: Project Enhance
Participants will receive the risk reduction program, Project Enhance
Behavioral: 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.
Other Name: Project Enhance Behavioral Intervention
Active Comparator: Active Comparison Condition
Participants will receive standard prevention case management
Behavioral: Standard prevention case management (PCM)
Participants will receive standard PCM for HIV prevention.
Other Name: Project Enhance Prevention Case Management
- Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up [ Time Frame: Measured at Months 3, 6, 9, and 12 ]
- Incidence of sexually transmitted diseases [ Time Frame: Measured at Months 3, 6, 9, and 12 ]
- Higher risk-reduction self-efficacy [ Time Frame: Measured at Months 3, 6, 9, and 12 ]
- Increased behavioral intentions to engage in safer behaviors [ Time Frame: Measured at Months 3, 6, 9, and 12 ]
- Increased risk-reduction strategies (other than condom use) [ Time Frame: Measured at Months 3, 6, 9, and 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231972
|United States, Massachusetts|
|Fenway Community Health|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Kenneth Mayer, MD||Fenway Community Health and Brown University|
|Principal Investigator:||Steven Safren, PhD||Fenway Community Health and Harvard Medical School|
|Study Director:||Conall O'Cleirigh, PhD||Fenway Community Health and Massachusetts General Hospital|