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

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: Project Enhance; Behavioral: Standard prevention case management (PCM)

• Registration Number: NCT00231972
• Lead Sponsor: Fenway Community Health

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2011-02
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Project Enhance	Project Enhance	Participants will receive the risk reduction program, Project Enhance
Active Comparison Condition	Standard prevention case management (PCM)	Participants will receive standard prevention case management

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of sexually transmitted diseases	Measured at Months 3, 6, 9, and 12
Higher risk-reduction self-efficacy	Measured at Months 3, 6, 9, and 12
Increased behavioral intentions to engage in safer behaviors	Measured at Months 3, 6, 9, and 12
Increased risk-reduction strategies (other than condom use)	Measured at Months 3, 6, 9, and 12

Trial Locations

Locations (1)

Fenway Community Health; 🇺🇸 Boston, Massachusetts, United States