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

Study Overview
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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.

Official Title
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Enhancing HIV Prevention Among HIV Infected Men

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Project Enhance
* Behavioral: Standard prevention case management (PCM)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project Enhance<br>Participants will receive the risk reduction program, Project Enhance | Behavioral: Project Enhance<br>* 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.<br>* Other names: Project Enhance Behavioral Intervention;|
| Active Comparator: Active Comparison Condition<br>Participants will receive standard prevention case management | Behavioral: Standard prevention case management (PCM)<br>* Participants will receive standard PCM for HIV prevention.<br>* Other names: Project Enhance Prevention Case Management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, MSM