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The Staying Safe Intervention

NCT03418636 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2018-05-15

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • National Development and Research Institutes, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03418636 on ClinicalTrials.gov