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

NCT ID: NCT00231972

Last Updated: 2011-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Project Enhance

Participants will receive the risk reduction program, Project Enhance

Group Type EXPERIMENTAL

Project Enhance

Intervention Type BEHAVIORAL

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.

Active Comparison Condition

Participants will receive standard prevention case management

Group Type ACTIVE_COMPARATOR

Standard prevention case management (PCM)

Intervention Type BEHAVIORAL

Participants will receive standard PCM for HIV prevention.

Interventions

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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.

Intervention Type BEHAVIORAL

Standard prevention case management (PCM)

Participants will receive standard PCM for HIV prevention.

Intervention Type BEHAVIORAL

Other Intervention Names

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Project Enhance Behavioral Intervention Project Enhance Prevention Case Management

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Fenway Community Health

OTHER

Sponsor Role lead

Responsible Party

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Fenway Community Health

Principal Investigators

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Kenneth Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Fenway Community Health and Brown University

Steven Safren, PhD

Role: PRINCIPAL_INVESTIGATOR

Fenway Community Health and Harvard Medical School

Conall O'Cleirigh, PhD

Role: STUDY_DIRECTOR

Fenway Community Health and Massachusetts General Hospital

Locations

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Fenway Community Health

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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DAHBR 9A-ASPG

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH068746

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH068746

Identifier Type: NIH

Identifier Source: org_study_id

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