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: December 10, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
HIV
Opioid Dependence
Behavioral: Community-friendly Health Recovery Program
Behavioral: Time-and-Attention-Matched Control Condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Changes in HIV Risk Behaviors [ Time Frame: Over a 12-month period ] [ 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.


Secondary Outcome Measures:
  • Patient evaluation of treatment [ Time Frame: Over a 12-month period ] [ 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.


Other Outcome Measures:
  • Frequency of drug use [ Time Frame: Over a 12-month period ] [ 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: Over a 12-month period ] [ 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: Over a 12-month period ] [ 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: Over a 12-month period ] [ 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.


Enrollment: 339
Study Start Date: September 2006
Study Completion Date: June 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
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).
Behavioral: Time-and-Attention-Matched Control Condition
Four weekly support groups and routine clinical services (i.e., daily methadone and case management).

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, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741350

Locations
United States, Connecticut
APT Foundation
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
University of Connecticut
APT Foundation, Inc.
Investigators
Principal Investigator: Michael C Copenhaver, Ph.D. University of Connecticut
  More Information

Additional Information:
Publications:
Responsible Party: University of Connecticut
ClinicalTrials.gov Identifier: NCT01741350     History of Changes
Other Study ID Numbers: H06-215, 1R01DA022122-01A1
Study First Received: November 30, 2012
Last Updated: December 10, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Connecticut:
Methadone-maintenance
HIV
Risk behavior
Injection drug use
Condom use
Health care participation
Opioid replacement therapy

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013