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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741350
• Other study ID #: H06-215
• Secondary ID: 1R01DA022122-01A
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: January 10, 2014
• Start date: September 2006
• Est. completion date: June 2012

Study information

• Verified date: January 2014
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: June 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Opioid Dependence

Intervention

Behavioral:
• Community-friendly Health Recovery Program
Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).
• Time-and-Attention-Matched Control Condition
Four weekly support groups and routine clinical services (i.e., daily methadone and case management).

Locations

Country	Name	City	State
United States	APT Foundation	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	APT Foundation, Inc., National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. Review. — View Citation

Institute of Medicine (US) Committee on Community-Based Drug Treatment; Lamb S, Greenlick MR, McCarty D, editors. Bridging the Gap between Practice and Research: Forging Partnerships with Community-Based Drug and Alcohol Treatment. Washington (DC): National Academies Press (US); 1998. — View Citation

Outcome

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

External Links

•   Center for Health, Intervention, and Prevention