The Staying Safe Intervention

Hepatitis C Clinical Trial

— Ssafe  

Official title:

The Staying Safe Intervention: Preventing HCV Among Young Opioid Injectors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03418636
• Other study ID #: 652
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: May 2018
• Source: National Development and Research Institutes, Inc.
• Contact: Honoria Guarino, PhD
• Phone: 212-845-4540
• Email: guarino[@]ndri.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Opioid Use

Intervention

Behavioral:
• Staying Safe (Ssafe)
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.
• Healthy Living
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.

Locations

Country	Name	City	State
United States	Staying Safe Study 235 Eldridge Street	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Development and Research Institutes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Injection network size	number of people injected with (i.e., in the presence of these people)	3 months
Other	Motivation/Self-efficacy to inject safely and manage opioid intake	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
Other	OUD treatment participation	participation in Medication-Assisted Treatment (MAT) for Opioid Use Disorder (OUD)	3 months
Other	Opioid withdrawal	frequency of opioid withdrawal episodes	3 months
Primary	Injection risk behavior: Syringe-sharing	number of times receptively shared syringes	3 months
Primary	Injection risk behavior: Syringe-sharing partners	number of people receptively shared syringes with	3 months
Primary	Injection risk behavior: Secondary injection equipment-sharing	number of times receptively shared secondary injection equipment (including cookers, cottons, water and water containers combined)	3 months
Primary	Injection risk behavior: Secondary injection equipment-sharing partners	number of people receptively shared secondary injection equipment with (including cookers, cottons, water and water containers combined)	3 months
Primary	Injection risk behavior: Backloading	number of times backloaded	3 months
Primary	Injection risk behavior: Backloading partners	number of people backloaded with	3 months
Secondary	Hepatitis C incidence	hepatitis C antibody-positive rapid test result (OraQuick)	12 months
Secondary	Overdose events	opioid-related episodes involving loss of consciousness, non-responsiveness and/or administration of naloxone	3 months
Secondary	Injection frequency	average number of daily and monthly injections	30 days
Secondary	Injection-related complications	number and type of physical complications from injection drug use	3 months