Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
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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 |
- 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.
- 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.
- 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 |
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| United States, Connecticut | |
| APT Foundation | |
| New Haven, Connecticut, United States, 06519 | |
| 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 19, 2013