The Staying Safe Intervention (Ssafe)

The Staying Safe Intervention: Preventing HCV Among Young Opioid Injectors

The growing population of young people who inject drugs (PWID) is at extremely high risk for HCV infection through the use of contaminated injection equipment, yet, to date, no behavioral intervention has been sufficiently potent to produce significant reductions in HCV incidence among PWID. To address this critical public health need, our team developed Staying Safe (Ssafe), an innovative, strengths-based, socio-behavioral HCV prevention intervention found in preliminary research to be highly acceptable and feasible, with strong indications of efficacy. The proposed randomized, controlled trial will assess the effectiveness of the Ssafe intervention in reducing both injection-related HCV/HIV risk behavior and HCV incidence among young adults (ages 18-29) who inject opioids (heroin and/or prescription opioids).

Study Overview

Detailed Description

HCV infection is the most common chronic blood-borne infection in the U.S., with the overwhelming majority of new HCV infections occurring among people who inject drugs (PWID). Sharing syringes and other injection equipment is the primary risk factor for HCV transmission. HCV prevalence is extremely high in most U.S. PWID populations (typically ranging from ~40-70%). Research shows that young PWID (under age 30) engage in particularly high rates of risky injection, and that HCV incidence is highest in the first 3-5 years of an individual's injection career. The national significance of this public health problem is heightened by the recent epidemic of prescription opioid (PO) misuse in youth which has evolved into widespread heroin use and injection drug use, creating a new generation of young injectors at risk for HCV (and HIV). These trends demonstrate the urgent need for innovative new approaches to HCV prevention tailored to the growing population of young PWID.

To date, no behavioral intervention has been sufficiently potent to produce significant reductions in HCV incidence in at-risk groups of PWID. To address this critical gap, our team developed Staying Safe (Ssafe), an innovative, strengths-based, socio-behavioral HCV prevention intervention for young PWID. Ssafe addresses multi-level "upstream" determinants of risk that occur relatively early in the causal chain of risk, including eco-social conditions, social relations and risk situations, in addition to directly targeting risky injection practices. Ssafe trains and motivates PWID to better manage drug use in order to avoid situations and practices that promote risky injection (e.g., "binging" on drugs), and to implement health-protective behaviors (e.g., promoting risk-reduction norms in injection networks). In preliminary research we found Ssafe to be highly acceptable and feasible, with strong indications of efficacy.

In this study we propose to conduct a randomized controlled trial to assess the effectiveness of the Ssafe intervention (with a mobile phone-delivered booster application) in reducing injection-related risk behavior and HCV incidence among 18-29 year-olds (n=456) who inject opioids (heroin and/or POs) and test HCV and HIV antibody-negative at baseline. We hypothesize that Ssafe will significantly reduce injection risk behaviors and HCV infections relative to a time- and attention-matched control intervention. We will also examine whether Ssafe's effects are mediated by (a) drug use management practices (injection frequency, overdose, opioid intake, withdrawal episodes); (b) individual-level mechanisms of behavior change (motivation/self-efficacy, planning skills); and (c) key upstream socio-structural and network-level determinants of risk (social support, skills to avoid PWID-associated stigma, drug treatment and SEP utilization, injection network size and risk norms). The proposed trial promises to significantly advance our ability to prevent HCV infection in the growing population of young, PO-initiated injectors.

Study Type

Interventional

Enrollment (Anticipated)

456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • New York
      • New York, New York, United States, 10002
        • Recruiting
        • Staying Safe Study 235 Eldridge Street
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hepatitis C antibody-negative
  • HIV antibody-negative
  • Have injected drugs 4 or more times in the past 30 days
  • Current opioid use (verified by rapid urine screen)
  • Speak English
  • Willing to participate in assigned intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Staying Safe (Ssafe)
Ssafe is delivered in a small group format (consisting of approximately 10-12 participants) by a trained facilitator over 4 2.5-hour sessions (10 hours total). To help promote the maintenance of risk reduction over the trial's 12-month follow-up period, Ssafe participants will be provided with a novel interactive, smartphone-delivered "booster" application based on core Ssafe principles and risk reduction strategies.
Staying Safe motivates and teaches young people who inject drugs (PWID) planning skills and drug use management strategies to enable long-term risk avoidance and the implementation of healthy protective behaviors. Content is presented through guided discussions and role playing exercises, and relies heavily on interactive participation by group members to foster peer-based learning and social reinforcement processes.
Active Comparator: Healthy Living
Healthy Living is a time- and attention-matched control intervention of equivalent session structure and duration as Ssafe (4 2.5-hour sessions; 10 hours total), also delivered in a small group format (10-12 participants). Healthy Living participants will be provided with a publicly available, sleep hygiene-focused smartphone app to promote healthy sleep habits over the trial's follow-up period.
The content of the Healthy Living intervention is based on the DHHS' Eat Healthy, Be Active Community Workshop curriculum, supplemented with basic sleep hygiene education. Science-based dietary and light physical activity guidelines are demonstrated and promoted to help participants develop and maintain a healthy lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection risk behavior: Syringe-sharing
Time Frame: 3 months
number of times receptively shared syringes
3 months
Injection risk behavior: Syringe-sharing partners
Time Frame: 3 months
number of people receptively shared syringes with
3 months
Injection risk behavior: Secondary injection equipment-sharing
Time Frame: 3 months
number of times receptively shared secondary injection equipment (including cookers, cottons, water and water containers combined)
3 months
Injection risk behavior: Secondary injection equipment-sharing partners
Time Frame: 3 months
number of people receptively shared secondary injection equipment with (including cookers, cottons, water and water containers combined)
3 months
Injection risk behavior: Backloading
Time Frame: 3 months
number of times backloaded
3 months
Injection risk behavior: Backloading partners
Time Frame: 3 months
number of people backloaded with
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis C incidence
Time Frame: 12 months
hepatitis C antibody-positive rapid test result (OraQuick)
12 months
Overdose events
Time Frame: 3 months
opioid-related episodes involving loss of consciousness, non-responsiveness and/or administration of naloxone
3 months
Injection frequency
Time Frame: 30 days
average number of daily and monthly injections
30 days
Injection-related complications
Time Frame: 3 months
number and type of physical complications from injection drug use
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection network size
Time Frame: 3 months
number of people injected with (i.e., in the presence of these people)
3 months
Motivation/Self-efficacy to inject safely and manage opioid intake
Time Frame: 3 months
Total score on the Staying Safe Self-Efficacy Scale (8 items; possible score range = 0-32), an investigator-developed and validated instrument (Mateu-Gelabert et al., 2014).
3 months
OUD treatment participation
Time Frame: 3 months
participation in Medication-Assisted Treatment (MAT) for Opioid Use Disorder (OUD)
3 months
Opioid withdrawal
Time Frame: 3 months
frequency of opioid withdrawal episodes
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

January 12, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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