- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03418636
The Staying Safe Intervention (Ssafe)
The Staying Safe Intervention: Preventing HCV Among Young Opioid Injectors
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Honoria Guarino, PhD
- Phone Number: 212-845-4540
- Email: guarino@ndri.org
Study Contact Backup
- Name: Ramona Almenana, MPA
- Email: almenana@ndri.org
Study Locations
-
-
New York
-
New York, New York, United States, 10002
- Recruiting
- Staying Safe Study 235 Eldridge Street
-
Contact:
- Ramona Almenana, MPA
- Phone Number: 917-261-6456
- Email: almenana@ndri.org
-
Contact:
- Elizabeth Goodbody, BA
- Phone Number: 917-261-6456
- Email: goodbody@ndri.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 652
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.
Clinical Trials on Hepatitis C
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C Viral InfectionUnited States, New Zealand
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 4 | Hepatitis C Viral InfectionUnited States
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Beni-Suef UniversityCompletedChronic Hepatitis C Virus InfectionEgypt
-
Humanity and Health Research CentreBeijing 302 HospitalCompletedChronic Hepatitis C InfectionChina
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
Clinical Trials on Staying Safe (Ssafe)
-
National Bureau of Economic Research, Inc.Massachusetts General Hospital; Yale University; Massachusetts Institute of Technology and other collaboratorsCompleted
-
University of WashingtonCompleted
-
Oregon Health and Science UniversityNational Institute on Aging (NIA)Not yet recruitingCaregiver Burden | Mild Cognitive Impairment | Health Behavior | Social Behavior | Dementia Alzheimers | Caregiver Burnout | Old Age; Dementia
-
Dartmouth-Hitchcock Medical CenterNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific
-
Weill Medical College of Cornell UniversityHospital for Special Surgery, New York; Rheumatology Research FoundationRecruiting
-
University of WashingtonNational Institute on Drug Abuse (NIDA); Alliance for Child Welfare Excellence and other collaboratorsUnknownRelationship, Family (Foster) | Substance Use PreventionUnited States
-
Massachusetts General HospitalCompletedWaitlist Control | Staying Strong With Schools InterventionUnited States
-
Sarah BlaylockVA Office of Research and DevelopmentCompletedFall | Low VisionUnited States
-
New York UniversityNot yet recruiting
-
Penang Hospital, MalaysiaCompletedContinuous Ambulatory Peritoneal DialysisMalaysia