HIV Counseling Intervention for Methadone-Maintained Patients - 2

Study Overview
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Brief Summary
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The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained Patients.

Detailed Description
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The purpose of this proposal is to evaluate, in methadone-maintained patients the association between an ADHD diagnosis and high-risk HIV/Hepatitis behavior. In addition, the investigators would like to determine whether a new manually-guided HIV intervention; RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounters is superior to standard HIV/Hepatitis psycho-education.

Official Title
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HIV Counseling Intervention for Methadone-Maintained Patients

Conditions
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Opioid-Related Disorders

Intervention / Treatment
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* Behavioral: Behavior Therapy-RISE
* Behavioral: Standard prevention Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must meet DSM-IV criteria for opiate dependence and currently in methadone maintenance treatment Able to give informed consent and capable of complying with study procedures Women who are of childbearing age and/or pregnant may be included Individuals who are HIV-positive or have Acquired Immunodeficiency Syndrome may be included Patients who demonstrate moderate to high HIV risk behaviors will be included Patients with low to no HIV risk behaviors will be excluded Patients receiving a stable dose of methadone for three weeks will be included Exclusion Criteria: Currently meets DSM-IV criteria for current Axis I psychiatric disorders (other than ADHD or substance abuse) which requires medical intervention, i.e., active suicide ideation, active psychosis, anxiety disorders, depression requiring hospitalization Patients who have exhibited suicidal or homicidal behavior within the past two years HIV positive patients must have knowledge of their status for a minimum of three weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

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: RISE intervention<br>Targeted RISE intervention- Behavior therapy Rise | Behavioral: Behavior Therapy-RISE<br>* manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter<br>|
| Active Comparator: Standard Education<br>Education intervention. Standard prevention education | Behavioral: Standard prevention Education<br>* standard psychosocial Education for HIV/hepatitis prevention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AIDS risk behavior based on the Risk Behavior Assessment |  | assessed monthly during 2 months of study or length of participation | 

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