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

This study has been completed.
Sponsor:
Collaborators:
APT Foundation, Inc.
Information provided by (Responsible Party):
University of Connecticut
ClinicalTrials.gov Identifier:
NCT01741350
First received: November 30, 2012
Last updated: January 10, 2014
Last verified: January 2014

November 30, 2012
January 10, 2014
September 2006
May 2011   (final data collection date for primary outcome measure)
  • Demonstrated Drug Risk Reduction Skills (0-100%) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
HIV Risk and Risk Reduction Behaviors [ Time Frame: Prior to week one, week 4, month 3, month 6, and month 12 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01741350 on ClinicalTrials.gov Archive Site
Not Provided
Patient evaluation of treatment [ Time Frame: week 4, month 3, month 6, and month 12 ] [ Designated as safety issue: No ]
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.
Not Provided
  • Frequency of drug use [ Time Frame: Prior to week one, week four, month 3, month 6, and month 12 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
 
Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Opioid Dependence
  • 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).
  • 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
Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
June 2012
May 2011   (final data collection date for primary outcome measure)

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:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01741350
H06-215, 1R01DA022122-01A1
Yes
University of Connecticut
University of Connecticut
  • National Institute on Drug Abuse (NIDA)
  • APT Foundation, Inc.
Principal Investigator: Michael C Copenhaver, Ph.D. University of Connecticut
University of Connecticut
January 2014

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