Clinical trial NCT02654366: Community Supported Risk Reduction for Syringe Exchange Participants
Official title: Social Network Intervention for Syringe Exchange Registrants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Risk Reduction
Keywords: Syringe exchange
HIV risk reduction
Drug-free community support
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-01-13
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived social support as assessed by the QRI "support" scale
timeFrame: Monthly for 3 months
measure: HIV drug risk behaviors as assessed by the Risk Behavior Survey
timeFrame: Monthly for 3 months
measure: HIV sex risk behaviors as assessed by the Risk Behavior Survey
timeFrame: Monthly for 3 months
Secondary outcomes:
measure: Number of participants enrolled in substance abuse treatment
timeFrame: Monthly for 3 months
measure: Rates of injection drug use
timeFrame: Monthly for 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael Kidorf, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: