- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02654366
Community Supported Risk Reduction for Syringe Exchange Participants
Social Network Intervention for Syringe Exchange Registrants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (for Baltimore Needle Exchange Program registrants):
- Baltimore Needle Exchange Program (BNEP) registration
- Injection heroin use
- Identifies a drug-free community support person (CSP)
- Not currently receiving substance abuse treatment
Exclusion Criteria (for BNEP registrants):
- Pregnancy
- Acute medical problem that requires urgent medical management
- Presence of a thought disorder, delusions, hallucinations, or imminent risk of harm to self or others
- Unable to read
Exclusion Criteria (for CSPs):
- Submission of a drug-positive urine sample
- Pregnancy
- Acute medical problem that requires urgent medical management
- Presence of a thought disorder, delusions, hallucinations, or imminent risk of harm to self or others
- Unable to read
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Community Supported Risk Reduction Group
Six weekly sessions will be scheduled during daytime and evening hours to accommodate the daily schedules of BNEP registrants and their CSPs.
Each session meets for 60 minutes.
Groups will consist of 5-6 BNEP registrant-CSP dyads (10-12 individuals).
While BNEP registrants and CSPs attending the group together will receive an attendance incentive, BNEP registrants attending without a CSP will not earn one.
The group leader will follow a manual that includes a structured outline.
The group manual content combines risk reduction / treatment readiness and community outreach approaches.
Following the introduction, each group session is divided into two components: 1) Risk Reduction and Treatment Readiness (30 min) and 2) Community Outreach skills (20 min).
|
The Risk Reduction and Treatment Readiness skills component includes six modules: 1) BNEP services and substance abuse treatment; 2) nature of chemical dependence (severity/chronicity and medical aspects); 3) infectious diseases (HIV and Hepatitis C virus (HCV) information); 4) injection drug use risk reduction (effective equipment cleaning and drug-splitting techniques); 5) sex risk reduction (reducing high-risk behaviors and effective condom use); and 6) overdose prevention. The Community Outreach skills component is devoted to discussing the benefits of recovery-focused social support, and directing BNEP registrants and their CSPs to participate in activities together (as determined in the group session) at least 1 time per week to work toward expanding the scope of drug-free social support. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived social support as assessed by the QRI "support" scale
Time Frame: Monthly for 3 months
|
The investigators anticipate that Baltimore Needle Exchange Program (BNEP) registrants will demonstrate greater levels of perceived social support (QRI "support" scale, a continuous measure) across follow-ups (compared to baseline).
Mixed model analyses will be used to evaluate change from baseline to follow-up measures (Months 1, 2, 3).
The two remaining QRI subscales ("conflict"; "depth") will also be examined using a similar analytic approach.
|
Monthly for 3 months
|
HIV drug risk behaviors as assessed by the Risk Behavior Survey
Time Frame: Monthly for 3 months
|
The investigators anticipate that BNEP registrants will have lower rates of any drug use risk behaviors (Risk Behavior Survey) across the 3-month evaluation compared to baseline.
Drug use risks include any use of a used needle, cooker and cotton for injection or splitting drugs.
Generalized Estimating Equations (GEE) will be used to assess change from baseline to follow-up measures (Months 1, 2, 3).
|
Monthly for 3 months
|
HIV sex risk behaviors as assessed by the Risk Behavior Survey
Time Frame: Monthly for 3 months
|
Changes in any sex risk behaviors (Risk Behavior Survey) will be examined using Generalized Estimating Equations (GEE) to assess change from baseline to follow-up measures (Months 1, 2, 3).
The investigators expect significant reductions only for the subset of individuals including a romantic partner as a Community Support Person (CSP).
|
Monthly for 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants enrolled in substance abuse treatment
Time Frame: Monthly for 3 months
|
Following each group session, BNEP registrants interested in enrolling in substance abuse treatment will have an opportunity to schedule a referral to a treatment program.
Substance abuse treatment enrollment (including treatment name, modality, start date, stop date, days in treatment) will be assessed at months 1, 2, 3 using a series of questions in the Risk Behaviors Survey.
|
Monthly for 3 months
|
Rates of injection drug use
Time Frame: Monthly for 3 months
|
The Drug Use, Injection, and Sexual Risk Behaviors Survey will be administered at months 1, 2, and 3 to assess rates of injection drug use.
|
Monthly for 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Kidorf, Ph.D, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00080615
- 1R34DA040507-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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