The Staying Safe Intervention

NCT ID: NCT03418636

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2021-05-31

Brief 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).

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.

Conditions

Hepatitis C; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Staying Safe (Ssafe)

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Healthy Living

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Development and Research Institutes, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Staying Safe Study 235 Eldridge Street

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Honoria Guarino, PhD

Role: CONTACT

guarino@ndri.org

212-845-4540

Ramona Almenana, MPA

Role: CONTACT

almenana@ndri.org

Facility Contacts

Ramona Almenana, MPA

Role: primary

almenana@ndri.org

917-261-6456

Elizabeth Goodbody, BA

Role: backup

goodbody@ndri.org

917-261-6456

Other Identifiers

652

Identifier Type: -

Identifier Source: org_study_id