Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users

Study Overview
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Brief Summary
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To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by comparing risk-behavior outcomes of four weekly intervention sessions with a time-and-attention-matched control condition.

Detailed Description
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This research study will test the effects of CHRP, a community-friendly risk reduction intervention, which is based on the Information-Motivation-Behavioral Skills model of health behavior change (IMB; Fisher & Fisher, 1992), and, thus, is designed to enhance knowledge, motivation, and behavior skills for reducing drug- and sex-related HIV risk behaviors. Outcomes assessed will include urine toxicology screens, self-reported HIV drug- and sex-related HIV risk behavior, HIV/AIDS knowledge, risk reduction motivation, and risk reduction behavioral skills. To measure the effects of CHRP, the investigators are proposing a two-condition (standard of care plus the CHRP intervention vs. standard of care plus a time-and-attention matched control condition) randomized design, balancing for participant gender. The investigators will assess participants at baseline, immediately post-intervention (i.e., at 4 weeks), and at 3-, 6-, and 12-month measurement points following the intervention. This assessment approach will allow the investigators to examine the trajectory of HIV risk reduction change including the decay or emergence of intervention effects.

Official Title
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Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users

Conditions
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HIV, Opioid Dependence

Intervention / Treatment
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* Behavioral: Community-friendly Health Recovery Program
* Behavioral: Time-and-Attention-Matched Control Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Opioid-dependent and seeking methadone maintenance treatment Report drug- or sex-related HIV risk behavior in previous 6 months Able to read and understand the questionnaires, Audio Computer Assisted Self Interview (ACASI), and consent form Available for the full duration of the study with no anticipated circumstances impeding participation (e.g., jail term) Not actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of a licensed clinical psychologist 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHRP Group<br>Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management). | Behavioral: Community-friendly Health Recovery Program<br>* Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).<br>* Other names: CHRP;|
| Active Comparator: Control Condition<br>The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management). | Behavioral: Time-and-Attention-Matched Control Condition<br>* Four weekly support groups and routine clinical services (i.e., daily methadone and case management).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrated Drug Risk Reduction Skills (0-100%) | Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe. | Baseline | 
| Demonstrated Drug Risk Reduction Skills (0-100%) | Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe. | Immediately Post-Intervention, at 4 weeks | 
| Demonstrated Drug Risk Reduction Skills (0-100%) | Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe. | 3-month follow up | 
| Demonstrated Drug Risk Reduction Skills (0-100%) | Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe. | 6-month follow up | 
| Demonstrated Drug Risk Reduction Skills (0-100%) | Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe. | 12-month follow up | 
| Safer Drug Use (0-4) | Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use. | Baseline | 
| Safer Drug Use (0-4) | Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use. | Immediately Post-Intervention, at 4 weeks | 
| Safer Drug Use (0-4) | Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use. | 3-month follow up | 
| Safer Drug Use (0-4) | Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use. | 6-month follow up | 
| Safer Drug Use (0-4) | Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use. | 12-month follow up | 
| Drug-related HIV-risk Reduction Knowledge (0-1) | Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge). | Baseline | 
| Drug-related HIV-risk Reduction Knowledge (0-1) | Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge). | Immediately Post-Intervention, at 4 weeks | 
| Drug-related HIV-risk Reduction Knowledge (0-1) | Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge). | 3-month follow up | 
| Drug-related HIV-risk Reduction Knowledge (0-1) | Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge). | 6-month follow up | 
| Drug-related HIV-risk Reduction Knowledge (0-1) | Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles). | 12-month follow up | 
| Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior. | Baseline | 
| Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior. | Immediately Post-Intervention, at 4 weeks | 
| Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior. | 3-month follow up | 
| Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior. | 6-month follow up | 
| Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior. | 12-month follow up | 
| Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior. | Baseline | 
| Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior. | Immediately Post-Intervention, at 4 weeks | 
| Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior. | 3-month follow up | 
| Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior. | 6-month follow up | 
| Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior. | 12-month follow up | 
| Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior. | Baseline | 
| Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior. | Immediately Post-Intervention, at 4 weeks | 
| Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior. | 3-month follow up | 
| Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior. | 6-month follow up | 
| Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior. | 12-month follow up | 
| Female Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica. | Baseline | 
| Female Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica. | Immediately Post-Intervention, at 4 weeks | 
| Female Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica. | 3-month follow up | 
| Female Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica. | 6-month follow up | 
| Female Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica. | 12-month follow up | 
| Male Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica. | Baseline | 
| Male Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica. | Immediately Post-Intervention, at 4 weeks | 
| Male Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica. | 3-month follow up | 
| Male Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica. | 6-month follow up | 
| Male Condom Skills (0-100%) | Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica. | 12-month follow up | 
| Condom Use (0-4) | Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use. | Baseline | 
| Condom Use (0-4) | Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use. | Immediately Post-Intervention, at 4 weeks | 
| Condom Use (0-4) | Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use. | 3-month follow up | 
| Condom Use (0-4) | Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use. | 6-month follow up | 
| Condom Use (0-4) | Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use. | 12-month follow up | 
| Sex-related HIV-risk Reduction Knowledge (0-1) | Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge. | Baseline | 
| Sex-related HIV-risk Reduction Knowledge (0-1) | Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge. | Immediately Post-Intervention, at 4 weeks | 
| Sex-related HIV-risk Reduction Knowledge (0-1) | Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge. | 3-month follow up | 
| Sex-related HIV-risk Reduction Knowledge (0-1) | Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge. | 6-month follow up | 
| Sex-related HIV-risk Reduction Knowledge (0-1) | Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge. | 12-month follow up | 
| Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior. | Baseline | 
| Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior. | Immediately Post-Intervention, at 4 weeks | 
| Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior. | 3-month follow up | 
| Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior. | 6-month follow up | 
| Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior. | 12-month follow up | 
| Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior. | Baseline | 
| Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior. | Immediately Post-Intervention, at 4 weeks | 
| Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior. | 3-month follow up | 
| Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior. | 6-month follow up | 
| Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior. | 12-month follow up | 
| Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior. | Baseline | 
| Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior. | Immediately Post-Intervention, at 4 weeks | 
| Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior. | 3-month follow up | 
| Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior. | 6-month follow up | 
| Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) | Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior. | 12-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methadone-maintenance, HIV, Risk behavior, Injection drug use, Condom use, Health care participation, Opioid replacement therapy