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

April 7, 2011 updated by: Fenway Community Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Fenway Community Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up
Time Frame: Measured at Months 3, 6, 9, and 12
Measured at Months 3, 6, 9, and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of sexually transmitted diseases
Time Frame: Measured at Months 3, 6, 9, and 12
Measured at Months 3, 6, 9, and 12
Higher risk-reduction self-efficacy
Time Frame: Measured at Months 3, 6, 9, and 12
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
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
Measured at Months 3, 6, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fenway Community Health

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH068746 (U.S. NIH Grant/Contract)
  • DAHBR 9A-ASPG (National Institute of Mental Health (NIMH-DAHBR))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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