Community Supported Risk Reduction for Syringe Exchange Participants
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|ClinicalTrials.gov Identifier: NCT02654366|
Recruitment Status : Recruiting
First Posted : January 13, 2016
Last Update Posted : July 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Substance Use Disorders Risk Reduction||Behavioral: Risk Reduction Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||183 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Social Network Intervention for Syringe Exchange Registrants|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 2019|
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).
Behavioral: Risk Reduction Group
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.
- 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.
- 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).
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654366
|Contact: Michael Sklar, M.A.||email@example.com|
|Contact: James Blucher, M.A.||firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Michael Sklar, M.A. 410-550-1542 email@example.com|
|Contact: James Blucher, M.A. 410-550-6346 firstname.lastname@example.org|
|Principal Investigator: Michael Kidorf, Ph.D.|
|Principal Investigator:||Michael Kidorf, Ph.D||Johns Hopkins University|