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

Sponsor
Fenway Community Health (Other)
Overall Status
Completed
CT.gov ID
NCT00231972
Collaborator
National Institute of Mental Health (NIMH) (NIH)
201
Enrollment
1
Location
2
Arms
55
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Project Enhance
  • Behavioral: Standard prevention case management (PCM)
 N/A

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Enhancing HIV Prevention Among HIV Infected Men
Study Start Date :
Dec 1, 2003
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Project Enhance Prevention Case Management

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up [Measured at Months 3, 6, 9, and 12]

    Secondary Outcome Measures

    1. Incidence of sexually transmitted diseases [Measured at Months 3, 6, 9, and 12]

    2. Higher risk-reduction self-efficacy [Measured at Months 3, 6, 9, and 12]

    3. Increased behavioral intentions to engage in safer behaviors [Measured at Months 3, 6, 9, and 12]

    4. Increased risk-reduction strategies (other than condom use) [Measured at Months 3, 6, 9, and 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fenway Community Health Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Fenway Community Health
    • National Institute of Mental Health (NIMH)

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00231972
    Other Study ID Numbers:
    • R01MH068746
    • DAHBR 9A-ASPG
    • R01MH068746
    First Posted:
    Oct 4, 2005
    Last Update Posted:
    Apr 8, 2011
    Last Verified:
    Feb 1, 2011
    Keywords provided by , ,
    HIV
    MSM
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Apr 8, 2011