Recruiting

Staying Safe Intervention

Sponsor:

National Development and Research Institutes, Inc.

Code:

NCT03418636

Conditions

Hepatitis C

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

Interventions

Staying Safe (Ssafe)

Healthy Living

Study Details

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).

Conditions

Hepatitis C

Opioid Use

Study ID

NCT03418636

Start date

Jan 31, 2018

Status verified date

May, 2018

Completion date

May 31, 2021

Anticipated

Primary completion date

May 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

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 Design

Enrollment

456 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Primary outcome measure

  • Injection risk behavior: Syringe-sharing [ Time Frame: 3 months ]
  • Injection risk behavior: Syringe-sharing partners [ Time Frame: 3 months ]
  • Injection risk behavior: Secondary injection equipment-sharing [ Time Frame: 3 months ]
  • Injection risk behavior: Secondary injection equipment-sharing partners [ Time Frame: 3 months ]
  • Injection risk behavior: Backloading [ Time Frame: 3 months ]
  • Injection risk behavior: Backloading partners [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Honoria Guarino, PhD

212-845-4540guarino@ndri.org

Ramona Almenana, MPA

almenana@ndri.org

Locations

Staying Safe Study 235 Eldridge Street

Recruiting

New York, New York, United States, 10002

Contacts

Ramona Almenana, MPA

917-261-6456almenana@ndri.org

Elizabeth Goodbody, BA

917-261-6456goodbody@ndri.org

More Information

Sponsor

National Development and Research Institutes, Inc.

Last update posted

May 15, 2018

Last verified

May, 2018

Keywords

  • People who inject drugs
  • Hepatitis C prevention
  • Young adults
  • Behavioral interventions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by National Development and Research Institutes, Inc. on 2018-05-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.