MedPath

Smartphone Intervention for Overdose and COVID-19

Not Applicable
Completed
Conditions
Substance Use Disorders
Overdose
COVID-19
Interventions
Device: iThrive WI Intervention
Registration Number
NCT05518461
Lead Sponsor
University of Wisconsin, Madison
Brief Summary

This study will examine if the use of a smartphone application called Thrive4Life Connect can help people who use drugs lower their risk of overdose and learn more about COVID-19 vaccines. 60 participants will be enrolled and can expect to be on study for up to 6 months.

Detailed Description

The mobile health system used in this study, called Thrive4Life Connect, has been developed for use in harm reduction settings with prior funding from the National Institute on Drug Abuse. Thrive4Life Connect is based on the Addiction Comprehensive Health Enhancement Support System (A-CHESS) and facilitates brief, behavioral interventions targeting knowledge gaps, motivation, and social connectedness. This app is being used in another study at University of Wisconsin-Madison (registered to NCT04268173).

The proposed study will develop new intervention content for assessing and increasing vaccine confidence and lowering overdose risk. The feasibility and preliminary efficacy will be tested using a pilot, pre-post study design with 60 people who have injected drugs in the past week and used opioids in the past 30 days. The investigators will examine feasibility outcomes based on study recruitment, retention, and intervention completion. Changes in knowledge about COVID-19 and overdose, motivation to reduce risk, and behavioral outcomes including overdose risk behaviors and vaccine uptake will be examined to establish preliminary efficacy.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • 18 years old or older
  • Willing to attend in person study encounters at any of the following Vivent Health locations: Milwaukee, Appleton, and Eau Claire
  • Used opioids to get high in the past 30 days
  • Injected drugs at least 2 times in the past 7 days
  • Express interest in reducing their overdose risk
Exclusion Criteria
  • None in addition to the inclusion criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
iThrive WI InterventioniThrive WI InterventionParticipants will receive COVID-19 and overdose-related educational and motivational content over the course of 12 weeks through the Thrive4Life Connect, a mobile health application. They will be invited to set goals for lowering overdose and COVID-19 risk.
Primary Outcome Measures
NameTimeMethod
Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Interventionup to 12 weeks

Study feasibility will be in part based on intervention content completion rates. The study will be considered feasible if participants complete any intervention content on at least 50% (i.e., 6) of the 12 weeks. We will report the number of participants who completed at least 6 of the 12 weeks.

Secondary Outcome Measures
NameTimeMethod
Number of Days in the Past Month Endorsing Overdose Risk Behaviorsbaseline, 3 months, 6 months

Preliminary effectiveness will in part be measured by examining the number of days in the previous month endorsing overdose risk behaviors at months 3 and 6 (relative to baseline/study enrollment). Overdose risk behavior frequency will be assessed by participant self-report.

Change in COVID-19 Vaccination Rates From Baselinebaseline, 3 months, 6 months

Preliminary effectiveness will in part be assessed by measuring the proportion of participants vaccinated against COVID-19 at baseline and at months 3 and 6.

Trial Locations

Locations (1)

University of Wisconsin

🇺🇸

Madison, Wisconsin, United States

© Copyright 2025. All Rights Reserved by MedPath