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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741350
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : February 27, 2014
Last Update Posted : February 27, 2014
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
APT Foundation, Inc.
Information provided by (Responsible Party):
University of Connecticut

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Results First Submitted Date  ICMJE November 20, 2013
Results First Posted Date  ICMJE February 27, 2014
Last Update Posted Date February 27, 2014
Study Start Date  ICMJE September 2006
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • Demonstrated Drug Risk Reduction Skills (0-100%) [ Time Frame: Baseline ]
    Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
  • Demonstrated Drug Risk Reduction Skills (0-100%) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
  • Demonstrated Drug Risk Reduction Skills (0-100%) [ Time Frame: 3-month follow up ]
    Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
  • Demonstrated Drug Risk Reduction Skills (0-100%) [ Time Frame: 6-month follow up ]
    Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
  • Demonstrated Drug Risk Reduction Skills (0-100%) [ Time Frame: 12-month follow up ]
    Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
  • Safer Drug Use (0-4) [ Time Frame: Baseline ]
    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.
  • Safer Drug Use (0-4) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Safer Drug Use (0-4) [ Time Frame: 3-month follow up ]
    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.
  • Safer Drug Use (0-4) [ Time Frame: 6-month follow up ]
    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.
  • Safer Drug Use (0-4) [ Time Frame: 12-month follow up ]
    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.
  • Drug-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: Baseline ]
    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).
  • Drug-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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).
  • Drug-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: 3-month follow up ]
    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).
  • Drug-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: 6-month follow up ]
    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).
  • Drug-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: 12-month follow up ]
    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").
  • Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: Baseline ]
    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.
  • Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: 3-month follow up ]
    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.
  • Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: 6-month follow up ]
    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.
  • Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: 12-month follow up ]
    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.
  • Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: Baseline ]
    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.
  • Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: 3-month follow up ]
    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.
  • Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: 6-month follow up ]
    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.
  • Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: 12-month follow up ]
    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.
  • Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: Baseline ]
    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.
  • Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: 3-month follow up ]
    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.
  • Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: 6-month follow up ]
    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.
  • Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5) [ Time Frame: 12-month follow up ]
    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.
  • Female Condom Skills (0-100%) [ Time Frame: Baseline ]
    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.
  • Female Condom Skills (0-100%) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Female Condom Skills (0-100%) [ Time Frame: 3-month follow up ]
    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.
  • Female Condom Skills (0-100%) [ Time Frame: 6-month follow up ]
    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.
  • Female Condom Skills (0-100%) [ Time Frame: 12-month follow up ]
    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.
  • Male Condom Skills (0-100%) [ Time Frame: Baseline ]
    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.
  • Male Condom Skills (0-100%) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Male Condom Skills (0-100%) [ Time Frame: 3-month follow up ]
    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.
  • Male Condom Skills (0-100%) [ Time Frame: 6-month follow up ]
    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.
  • Male Condom Skills (0-100%) [ Time Frame: 12-month follow up ]
    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.
  • Condom Use (0-4) [ Time Frame: Baseline ]
    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.
  • Condom Use (0-4) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Condom Use (0-4) [ Time Frame: 3-month follow up ]
    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.
  • Condom Use (0-4) [ Time Frame: 6-month follow up ]
    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.
  • Condom Use (0-4) [ Time Frame: 12-month follow up ]
    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.
  • Sex-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: Baseline ]
    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.
  • Sex-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Sex-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: 3-month follow up ]
    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.
  • Sex-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: 6-month follow up ]
    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.
  • Sex-related HIV-risk Reduction Knowledge (0-1) [ Time Frame: 12-month follow up ]
    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.
  • Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: Baseline ]
    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.
  • Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: 3-month follow up ]
    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.
  • Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: 6-month follow up ]
    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.
  • Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: 12-month follow up ]
    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.
  • Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: Baseline ]
    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.
  • Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: 3-month follow up ]
    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.
  • Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: 6-month follow up ]
    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.
  • Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: 12-month follow up ]
    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.
  • Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: Baseline ]
    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.
  • Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: Immediately Post-Intervention, at 4 weeks ]
    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.
  • Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: 3-month follow up ]
    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.
  • Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: 6-month follow up ]
    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.
  • Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5) [ Time Frame: 12-month follow up ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
HIV Risk and Risk Reduction Behaviors [ Time Frame: Prior to week one, week 4, month 3, month 6, and month 12 ]
HIV risk-reduction knowledge, motivation, and self-reported risky behavior will be measured via ACASI (Audio Computer Assisted Self Interview), a computer-based assessment instrument.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
Patient evaluation of treatment [ Time Frame: week 4, month 3, month 6, and month 12 ]
A patient evaluation of treatment form will be completed at the end of the intervention and at follow-up by all patients, with ratings of patient's satisfaction with the intervention, the degree of change of their condition, and perception of helpful or harmful aspects of the intervention they received.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: December 3, 2012)
  • Frequency of drug use [ Time Frame: Prior to week one, week four, month 3, month 6, and month 12 ]
    Patients will be screened via urine toxicology tests to determine use of illicit opiates and cocaine bi-weekly and at pre-, post-, and all 3 follow-up assessments. Patients also will report amount and frequency of drug use via computerized questionnaire at pre-, weekly, post-, and all 3 follow up assessments.
  • HIV informational, motivational, and behavioral skills [ Time Frame: Prior to week one, week four, month 3, month 6, and month 12 ]
    Subjects will be asked to report the number of sex partners they had and the number of times in the past month they engaged in sexual intercourse and the number of times condoms were used. Drug-related items will require participants to categorize and quantify their drug use during the prior month. Both data points will be collected via a computer-based assessment instrument. Behavioral skills, including condom applications and syringe cleaning will be assessed via demonstrations with replicas.
  • Self-reported drug craving and aversion and HIV-risk behavior knowledge [ Time Frame: Week one, week two, week three, and week four ]
    Patients will self-report their drug cravings using a computerized questionnaire. Weekly quizzes will be given with immediate feedback to further assess their knowledge of HIV-risk behavior.
  • Social Support [ Time Frame: Prior to week one, week four, month 3, month 6, and month 12 ]
    A social support questionnaire will be completed at pre-, post-, and follow-up measurement points. This measure consists of 15 items designed to assess perceived social support. Items from this widely used scale include availability of support and validation of support.
  • Clinician-related measures [ Time Frame: weeks one, two, three and four; month 3, month 6, month 12 ]
    Ratings of counselor adherence and competence and a working alliance will be collected weekly and at 3-, 6-, and 12-month follow-up assessment points, respectively.
 
Descriptive Information
Brief Title  ICMJE Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
Official Title  ICMJE Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
Brief Summary 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV
  • Opioid Dependence
Intervention  ICMJE
  • Behavioral: Community-friendly Health Recovery Program
    Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).
    Other Name: CHRP
  • Behavioral: Time-and-Attention-Matched Control Condition
    Four weekly support groups and routine clinical services (i.e., daily methadone and case management).
Study Arms  ICMJE
  • Experimental: CHRP Group
    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).
    Intervention: Behavioral: Community-friendly Health Recovery Program
  • Active Comparator: Control Condition
    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).
    Intervention: Behavioral: Time-and-Attention-Matched Control Condition
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2014)
304
Original Actual Enrollment  ICMJE
 (submitted: December 3, 2012)
339
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741350
Other Study ID Numbers  ICMJE H06-215
1R01DA022122-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Connecticut
Study Sponsor  ICMJE University of Connecticut
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • APT Foundation, Inc.
Investigators  ICMJE
Principal Investigator: Michael C Copenhaver, Ph.D. University of Connecticut
PRS Account University of Connecticut
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP