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

Primary Purpose

HIV Infections

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Project Enhance

Standard prevention case management (PCM)

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, MSM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Fenway Community Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Project Enhance

Active Comparison Condition

Arm Description

Participants will receive the risk reduction program, Project Enhance

Participants will receive standard prevention case management

Outcomes

Primary Outcome Measures

Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up

Secondary Outcome Measures

Incidence of sexually transmitted diseases

Higher risk-reduction self-efficacy

Increased behavioral intentions to engage in safer behaviors

Increased risk-reduction strategies (other than condom use)

Full Information

NCT ID

NCT00231972

First Posted

September 30, 2005

Last Updated

April 7, 2011

Sponsor

Fenway Community Health

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00231972

Brief Title

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

Acronym

Enhance

Official Title

Enhancing HIV Prevention Among HIV Infected Men

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

December 2003 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Fenway Community Health

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV, MSM

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Project Enhance

Arm Type

Experimental

Arm Description

Participants will receive the risk reduction program, Project Enhance

Arm Title

Active Comparison Condition

Arm Type

Active Comparator

Arm Description

Participants will receive standard prevention case management

Intervention Type

Behavioral

Intervention Name(s)

Project Enhance

Other Intervention Name(s)

Project Enhance Behavioral Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard prevention case management (PCM)

Other Intervention Name(s)

Project Enhance Prevention Case Management

Intervention Description

Participants will receive standard PCM for HIV prevention.

Primary Outcome Measure Information:

Title

Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up

Time Frame