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

Fenway Community Health

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Standard prevention case management (PCM); Behavioral: Project Enhance

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00231972

R01MH068746 (U.S. NIH Grant/Contract)

DAHBR 9A-ASPG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Project Enhance

Experimental group

Description:

Participants will receive the risk reduction program, Project Enhance

Treatment:

Behavioral: Project Enhance

Active Comparison Condition

Active Comparator group

Description:

Participants will receive standard prevention case management

Treatment:

Behavioral: Standard prevention case management (PCM)