Smartphone Intervention for Overdose and COVID-19

Study Overview
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Brief Summary
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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
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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 effectiveness 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 effectiveness.

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

Conditions
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Substance Use Disorders, Overdose, COVID-19

Intervention / Treatment
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* Device: iThrive WI Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Preliminary outcomes will be measured from 60 participants at baseline (pre-test), followed by a 12-week intervention through the Thrive4Life Connect smartphone application, and re-assessment of outcomes at months 3 and 6.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iThrive WI Intervention<br>Participants 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. | Device: iThrive WI Intervention<br>* Participants 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Content completion rate assessed through 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% of the 12 weeks. | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of days in the past month endorsing overdose risk behaviors | 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). | baseline, 3 months, 6 months | 
| Change in COVID-19 Vaccination Rates from baseline | Preliminary effectiveness will in part be assessed by measuring the proportion of participants vaccinated against COVID-19 at months 3 and 6 (relative to baseline/study enrollment). | baseline, 3 months, 6 months |