Behavioral Intervention Trial for HIV-infected Injection Drug Users

Study Overview
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Brief Summary
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The purpose of this study is to test whether a ten-session behavioral intervention for HIV-infected injection drug users is effective in reducing sex and injection risk behaviors that put others at risk for HIV infection, increasing access to or utilization of HIV primary health care, and increasing adherence to HIV medications.

Detailed Description
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INSPIRE is a four-site (Baltimore, Miami, New York and San Francisco) randomized control trial to develop and evaluate the efficacy of a ten-session intervention for HIV-positive injection drug users. The primary goals of the intervention are to: decrease sex and injection risk behaviors that put others at risk for HIV infection, increase access to or utilization of HIV primary health care, and increase adherence to HIV medications. The intervention arm consists of 7 group sessions, 2 individual sessions, and one community experience. The control arm consists of 8 group sessions, aiming at controlling for demand (1st session) and attention (8 group sessions). Behavioral assessments and blood draws (for viral load and CD4 testing) occur at baseline, 6, and 12 month follow-up; a 3 month assessment involves behavioral assessment only. 1161 participants took baseline. Of these, 966 were randomized into the study, and 840, 807, and 821 participants took 3, 6, and 12 month follow-up assessments, respectively.

Official Title
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Intervention for Seropositive Injection Drug Users - Research and Evaluation (INSPIRE)

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Peer Mentoring Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older self-identify as a person who has injected drugs in the last 12 months self-identify as a person who has had sex with at least one opposite sex partner within the last 3 months self-identify as HIV-seropositive be confirmed as HIV seropositive through oral fluid (saliva) HIV testing live in the geographic region under study, agree to have their blood drawn for CD4 count and viral load testing be willing to provide basic contact information (for follow-up) be able to communicate in English not have participated in the full-pilot of this intervention and not have enrolled previously in the present study. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Behavioral: Peer Mentoring Intervention|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - unprotected vaginal/anal sex with HIV-negative or unknown serostatus partners in the past 3 months |  |  | 
| - lending needle or sharing cotton, cooker, or rinse water with HIV-negative or unknown serostatus partners in the past 3 months |  |  | 
| -health care visits for HIV primary care in the past 6 months |  |  | 
| -90% or more adherence to HIV medication yesterday and in the past week |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Proportion of HIV status disclosure to sex partners |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV drug users