Smartphone Intervention for Overdose and COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Substance Use Disorders; Overdose
• Intervention / Treatment: Device: iThrive WI Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53726
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iThrive WI Intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention	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.	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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). Overdose risk behavior frequency will be assessed by participant self-report.	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 baseline and at months 3 and 6.	baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Rachel E Gicquelais, PhD, MPH, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drug Misuse; Mental Disorders; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Chemically-Induced Disorders; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Prescription Drug Misuse; COVID-19; Substance-Related Disorders; Drug Overdose
• Other Study ID Numbers: 2022-0956; A545000 (Other Identifier: UW Madison); NUR/FACULTY AFFAIRS/ADMIN (Other Identifier: UW Madison); Protocol Version 7/29/2022 (Other Identifier: UW Madison); UG3DA044826-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The plan is to share results in an aggregate format and to not share any data that could be used to identify participants. The investigators will only report summary data to individuals outside the study team and expect to publish manuscripts based on information gathered in this study, but no participants will be identified in these shared results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No