Clinical trial NCT01741350: Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
Official title: Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Opioid Dependence
Keywords: Methadone-maintenance
HIV
Risk behavior
Injection drug use
Condom use
Health care participation
Opioid replacement therapy
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: APT Foundation, Inc.
First posted: 2012-12-04
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by comparing risk-behavior outcomes of four weekly intervention sessions with a time-and-attention-matched control condition.

Detailed description: This research study will test the effects of CHRP, a community-friendly risk reduction intervention, which is based on the Information-Motivation-Behavioral Skills model of health behavior change (IMB; Fisher \& Fisher, 1992), and, thus, is designed to enhance knowledge, motivation, and behavior skills for reducing drug- and sex-related HIV risk behaviors. Outcomes assessed will include urine toxicology screens, self-reported HIV drug- and sex-related HIV risk behavior, HIV/AIDS knowledge, risk reduction motivation, and risk reduction behavioral skills.

To measure the effects of CHRP, the investigators are proposing a two-condition (standard of care plus the CHRP intervention vs. standard of care plus a time-and-attention matched control condition) randomized design, balancing for participant gender. The investigators will assess participants at baseline, immediately post-intervention (i.e., at 4 weeks), and at 3-, 6-, and 12-month measurement points following the intervention. This assessment approach will allow the investigators to examine the trajectory of HIV risk reduction change including the decay or emergence of intervention effects.

Eligibility criteria: 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:

Primary outcomes:
measure: Demonstrated Drug Risk Reduction Skills (0-100%)
timeFrame: Baseline
measure: Demonstrated Drug Risk Reduction Skills (0-100%)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Demonstrated Drug Risk Reduction Skills (0-100%)
timeFrame: 3-month follow up
measure: Demonstrated Drug Risk Reduction Skills (0-100%)
timeFrame: 6-month follow up
measure: Demonstrated Drug Risk Reduction Skills (0-100%)
timeFrame: 12-month follow up
measure: Safer Drug Use (0-4)
timeFrame: Baseline
measure: Safer Drug Use (0-4)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Safer Drug Use (0-4)
timeFrame: 3-month follow up
measure: Safer Drug Use (0-4)
timeFrame: 6-month follow up
measure: Safer Drug Use (0-4)
timeFrame: 12-month follow up
measure: Drug-related HIV-risk Reduction Knowledge (0-1)
timeFrame: Baseline
measure: Drug-related HIV-risk Reduction Knowledge (0-1)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Drug-related HIV-risk Reduction Knowledge (0-1)
timeFrame: 3-month follow up
measure: Drug-related HIV-risk Reduction Knowledge (0-1)
timeFrame: 6-month follow up
measure: Drug-related HIV-risk Reduction Knowledge (0-1)
timeFrame: 12-month follow up
measure: Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: Baseline
measure: Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: 3-month follow up
measure: Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: 6-month follow up
measure: Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: 12-month follow up
measure: Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: Baseline
measure: Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: 3-month follow up
measure: Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: 6-month follow up
measure: Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: 12-month follow up
measure: Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: Baseline
measure: Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: 3-month follow up
measure: Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: 6-month follow up
measure: Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)
timeFrame: 12-month follow up
measure: Female Condom Skills (0-100%)
timeFrame: Baseline
measure: Female Condom Skills (0-100%)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Female Condom Skills (0-100%)
timeFrame: 3-month follow up
measure: Female Condom Skills (0-100%)
timeFrame: 6-month follow up
measure: Female Condom Skills (0-100%)
timeFrame: 12-month follow up
measure: Male Condom Skills (0-100%)
timeFrame: Baseline
measure: Male Condom Skills (0-100%)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Male Condom Skills (0-100%)
timeFrame: 3-month follow up
measure: Male Condom Skills (0-100%)
timeFrame: 6-month follow up
measure: Male Condom Skills (0-100%)
timeFrame: 12-month follow up
measure: Condom Use (0-4)
timeFrame: Baseline
measure: Condom Use (0-4)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Condom Use (0-4)
timeFrame: 3-month follow up
measure: Condom Use (0-4)
timeFrame: 6-month follow up
measure: Condom Use (0-4)
timeFrame: 12-month follow up
measure: Sex-related HIV-risk Reduction Knowledge (0-1)
timeFrame: Baseline
measure: Sex-related HIV-risk Reduction Knowledge (0-1)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Sex-related HIV-risk Reduction Knowledge (0-1)
timeFrame: 3-month follow up
measure: Sex-related HIV-risk Reduction Knowledge (0-1)
timeFrame: 6-month follow up
measure: Sex-related HIV-risk Reduction Knowledge (0-1)
timeFrame: 12-month follow up
measure: Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: Baseline
measure: Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: 3-month follow up
measure: Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: 6-month follow up
measure: Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: 12-month follow up
measure: Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: Baseline
measure: Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: 3-month follow up
measure: Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: 6-month follow up
measure: Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: 12-month follow up
measure: Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: Baseline
measure: Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: Immediately Post-Intervention, at 4 weeks
measure: Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: 3-month follow up
measure: Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: 6-month follow up
measure: Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)
timeFrame: 12-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Foundation
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Michael C Copenhaver, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
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. Available from http://www.ncbi.nlm.nih.gov/books/NBK230402/