Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men (Enhance)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fenway Community Health
ClinicalTrials.gov Identifier:
NCT00231972
First received: September 30, 2005
Last updated: April 7, 2011
Last verified: February 2011

September 30, 2005
April 7, 2011
December 2003
July 2008   (final data collection date for primary outcome measure)
Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up [ Time Frame: Measured at Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
Reduction in rates of unprotected anal intercourse; measured at Months 3, 6, 9, and 12
Complete list of historical versions of study NCT00231972 on ClinicalTrials.gov Archive Site
  • Incidence of sexually transmitted diseases [ Time Frame: Measured at Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • Higher risk-reduction self-efficacy [ Time Frame: Measured at Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • Increased behavioral intentions to engage in safer behaviors [ Time Frame: Measured at Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • Increased risk-reduction strategies (other than condom use) [ Time Frame: Measured at Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • Incidence of sexually transmitted diseases; measured at Months 3, 6, 9, and 12
  • Higher risk-reduction self-efficacy; measured at Months 3, 6, 9, and 12
  • Increased behavioral intentions to engage in safer behaviors; measured at Months 3, 6, 9, and 12
  • Increased risk-reduction strategies (other than condom use); measured at Months 3, 6, 9, and 12
Not Provided
Not Provided
 
Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men
Enhancing HIV Prevention Among HIV Infected Men

This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • 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
  • Behavioral: Standard prevention case management (PCM)
    Participants will receive standard PCM for HIV prevention.
    Other Name: Project Enhance Prevention Case Management
  • Experimental: Project Enhance
    Participants will receive the risk reduction program, Project Enhance
    Intervention: Behavioral: Project Enhance
  • Active Comparator: Active Comparison Condition
    Participants will receive standard prevention case management
    Intervention: Behavioral: Standard prevention case management (PCM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infected
  • 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:

  • All episodes of unprotected anal intercourse occurred with only a single primary partner who is also HIV infected
  • Plans to relocate over the upcoming year
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231972
R01 MH68746, DAHBR 9A-ASPG, R01MH068746
No
Dr. Kenneth Mayer, Fenway Community Health
Fenway Community Health
National Institute of Mental Health (NIMH)
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
Fenway Community Health
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP