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Clinical Trials/NCT05518461
NCT05518461
Completed
Not Applicable

iThrive WI - A Smartphone Intervention for Overdose and Risk and COVID-19 Among People Who Use Drugs

University of Wisconsin, Madison1 site in 1 country60 target enrollmentDecember 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
University of Wisconsin, Madison
Enrollment
60
Locations
1
Primary Endpoint
Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 19, 2022
End Date
December 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention

Time Frame: up 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 Outcomes

  • Number of Days in the Past Month Endorsing Overdose Risk Behaviors(baseline, 3 months, 6 months)
  • Change in COVID-19 Vaccination Rates From Baseline(baseline, 3 months, 6 months)

Study Sites (1)

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