Smartphone Intervention for Overdose and COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05518461
• Other study ID #: 2022-0956
• Secondary ID: A545000Protocol
• Status: Completed
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Drug Overdose
• Overdose
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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