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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Opioid Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Community-friendly Health Recovery Program

Intervention Type BEHAVIORAL

Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).

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).

Group Type ACTIVE_COMPARATOR

Time-and-Attention-Matched Control Condition

Intervention Type BEHAVIORAL

Four weekly support groups and routine clinical services (i.e., daily methadone and case management).

Interventions

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Community-friendly Health Recovery Program

Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).

Intervention Type BEHAVIORAL

Time-and-Attention-Matched Control Condition

Four weekly support groups and routine clinical services (i.e., daily methadone and case management).

Intervention Type BEHAVIORAL

Other Intervention Names

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CHRP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No