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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Fenway Community Health
ClinicalTrials.gov Identifier:
NCT00231972
First received: September 30, 2005
Last updated: April 7, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention
HIV Infections
 Behavioral: Project Enhance
Behavioral: Standard prevention case management (PCM)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing HIV Prevention Among HIV Infected Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fenway Community Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 201
Study Start Date: December 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231972

Locations
United States, Massachusetts
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
  More Information

No publications provided

Responsible Party: Dr. Kenneth Mayer, Fenway Community Health
ClinicalTrials.gov Identifier: NCT00231972     History of Changes
Other Study ID Numbers: R01 MH68746, DAHBR 9A-ASPG, R01MH068746
Study First Received: September 30, 2005
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Fenway Community Health:
HIV
MSM

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013