Smartphone Intervention for Overdose and COVID-19

University of Wisconsin (UW)

Status: Completed

Conditions: COVID-19; Overdose; Substance Use Disorders

Treatments: Device: iThrive WI Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05518461

2022-0956

A545000 (Other Identifier)

UG3DA044826-01 (U.S. NIH Grant/Contract)

NUR/FACULTY AFFAIRS/ADMIN (Other Identifier)

Protocol Version 7/29/2022 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

iThrive WI Intervention

Experimental group

Description:

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.

Treatment:

Device: iThrive WI Intervention