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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).
Four weekly support groups and routine clinical services (i.e., daily methadone and case management).
APT Foundation
New Haven, Connecticut, United States
Demonstrated Drug Risk Reduction Skills (0-100%)
Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
Time frame: Baseline
Demonstrated Drug Risk Reduction Skills (0-100%)
Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
Time frame: Immediately Post-Intervention, at 4 weeks
Demonstrated Drug Risk Reduction Skills (0-100%)
Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
Time frame: 3-month follow up
Demonstrated Drug Risk Reduction Skills (0-100%)
Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
Time frame: 6-month follow up
Demonstrated Drug Risk Reduction Skills (0-100%)
Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.
Time frame: 12-month follow up
Safer Drug Use (0-4)
Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.
Time frame: Baseline
Safer Drug Use (0-4)
Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.
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Time frame: Immediately Post-Intervention, at 4 weeks
Safer Drug Use (0-4)
Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.
Time frame: 3-month follow up
Safer Drug Use (0-4)
Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.
Time frame: 6-month follow up
Safer Drug Use (0-4)
Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.
Time frame: 12-month follow up
Drug-related HIV-risk Reduction Knowledge (0-1)
Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles") and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge).
Time frame: Baseline
Drug-related HIV-risk Reduction Knowledge (0-1)
Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles") and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge).
Time frame: Immediately Post-Intervention, at 4 weeks
Drug-related HIV-risk Reduction Knowledge (0-1)
Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles") and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge).
Time frame: 3-month follow up
Drug-related HIV-risk Reduction Knowledge (0-1)
Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles") and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge).
Time frame: 6-month follow up
Drug-related HIV-risk Reduction Knowledge (0-1)
Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles").
Time frame: 12-month follow up
Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.
Time frame: Baseline
Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.
Time frame: Immediately Post-Intervention, at 4 weeks
Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.
Time frame: 3-month follow up
Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.
Time frame: 6-month follow up
Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.
Time frame: 12-month follow up
Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: Baseline
Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: Immediately Post-Intervention, at 4 weeks
Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: 3-month follow up
Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: 6-month follow up
Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: 12-month follow up
Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.
Time frame: Baseline
Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.
Time frame: Immediately Post-Intervention, at 4 weeks
Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.
Time frame: 3-month follow up
Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.
Time frame: 6-month follow up
Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.
Time frame: 12-month follow up
Female Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.
Time frame: Baseline
Female Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.
Time frame: Immediately Post-Intervention, at 4 weeks
Female Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.
Time frame: 3-month follow up
Female Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.
Time frame: 6-month follow up
Female Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.
Time frame: 12-month follow up
Male Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.
Time frame: Baseline
Male Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.
Time frame: Immediately Post-Intervention, at 4 weeks
Male Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.
Time frame: 3-month follow up
Male Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.
Time frame: 6-month follow up
Male Condom Skills (0-100%)
Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.
Time frame: 12-month follow up
Condom Use (0-4)
Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.
Time frame: Baseline
Condom Use (0-4)
Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.
Time frame: Immediately Post-Intervention, at 4 weeks
Condom Use (0-4)
Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.
Time frame: 3-month follow up
Condom Use (0-4)
Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.
Time frame: 6-month follow up
Condom Use (0-4)
Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.
Time frame: 12-month follow up
Sex-related HIV-risk Reduction Knowledge (0-1)
Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.
Time frame: Baseline
Sex-related HIV-risk Reduction Knowledge (0-1)
Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.
Time frame: Immediately Post-Intervention, at 4 weeks
Sex-related HIV-risk Reduction Knowledge (0-1)
Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.
Time frame: 3-month follow up
Sex-related HIV-risk Reduction Knowledge (0-1)
Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.
Time frame: 6-month follow up
Sex-related HIV-risk Reduction Knowledge (0-1)
Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.
Time frame: 12-month follow up
Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.
Time frame: Baseline
Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.
Time frame: Immediately Post-Intervention, at 4 weeks
Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.
Time frame: 3-month follow up
Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.
Time frame: 6-month follow up
Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.
Time frame: 12-month follow up
Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: Baseline
Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: Immediately Post-Intervention, at 4 weeks
Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: 3-month follow up
Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: 6-month follow up
Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.
Time frame: 12-month follow up
Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.
Time frame: Baseline
Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.
Time frame: Immediately Post-Intervention, at 4 weeks
Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.
Time frame: 3-month follow up
Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.
Time frame: 6-month follow up
Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.
Time frame: 12-month follow up