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Community Supported Risk Reduction for Syringe Exchange Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02654366
Recruitment Status : Recruiting
First Posted : January 13, 2016
Last Update Posted : January 15, 2019
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Efforts to help syringe exchange registrants employ additional HIV risk reduction strategies are often thwarted by strong social networks that reinforce substance use and other risky injection use and sexual behaviors. The proposed study addresses this important problem by evaluating the feasibility and efficacy of a novel Community Supported Risk Reduction group. This structured intervention works with injection drug users and at least one drug-free family or friend to mobilize social support, teach HIV risk reduction skills, develop treatment readiness, and support participation in community activities designed to expand drug-free social networks.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Risk Reduction Behavioral: Risk Reduction Group Not Applicable

Detailed Description:
Participants of syringe exchange programs routinely suffer from untreated or under-treated substance use disorder, a situation that is associated with significant individual and public health costs. These individuals are also routinely embedded within social networks that reinforce continued drug use and related HIV-risk behaviors. The welfare of these individuals and the public's health can be improved by interventions directed toward reducing drug use risks and expanding drug-free support . Previous work by the investigators has demonstrated that an intervention combining an HIV risk reduction/treatment readiness group with behavioral contingencies is highly associated with increased rates of treatment enrollment and re-engagement, and reduced rates of drug use and HIV-injection risks, for up to one year. This protocol extends this work by adding a new component to the HIV risk reduction/treatment readiness group designed to expand social support and facilitate social network change. This intervention requires syringe exchange registrants to attend the group with a drug-free family or friend from their personal network that can provide stable support and encourage harm reduction and treatment seeking. This intervention uses an alteration network change model and posits that repeated exposure to drug-free community support collaterally reduces exposure to network members that support risk behaviors. This model also provides a pathway to modifying existing social networks by facilitating interaction with the personal social networks of drug-free family and friends. The intervention is supported by research showing that substance users report substantial pockets of drug-free family or friends in their social networks. It is also supported by community reinforcement principles that have shown efficacy in treatment samples, but have not been applied to out-of-treatment drug users. The present study has four primary aims. The first is to characterize natural drug-free support in the social networks of syringe exchangers. The second is to develop a Community Supported Risk Reduction group for syringe exchange participants and their community support. This group teaches skills for HIV risk reduction, treatment seeking, and healthy network expansion. The third and fourth aims are to obtain new data on the feasibility and efficacy of this intervention. Primary outcomes include changes in: 1) perceived social support, and 2) HIV risk behaviors.

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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
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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).
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.

Primary Outcome Measures :
  1. 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.

  2. 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).

  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).

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02654366

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Contact: Michael Sklar, M.A. 410-550-1542
Contact: James Blucher, M.A. 410-550-6346

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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Michael Sklar, M.A.    410-550-1542   
Contact: James Blucher, M.A.    410-550-6346   
Principal Investigator: Michael Kidorf, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Michael Kidorf, Ph.D Johns Hopkins University

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Responsible Party: Johns Hopkins University Identifier: NCT02654366     History of Changes
Other Study ID Numbers: IRB00080615
1R34DA040507-01 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Syringe exchange
HIV risk reduction
Drug-free community support

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders