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Completed

NCT Number: NCT01741350

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.

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Key information

Conditions

HIV Behavior Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Dependence Opioid-Related Disorders Risk-Taking Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APT Foundation

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

community-friendly health recovery program

Behavioral

Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).

Other names: CHRP

Time-and-Attention-Matched Control Condition

Behavioral

Four weekly support groups and routine clinical services (i.e., daily methadone and case management).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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").

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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.

  50. 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.

  51. 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.

  52. 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.

  53. 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.

  54. 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.

  55. 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.

  56. 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.

  57. 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.

  58. 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.

  59. 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.

  60. 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.

  61. 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.

  62. 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.

  63. 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.

  64. 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.

  65. 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.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • APT Foundation, Inc.
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Dec 4, 2012
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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