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Completed

NCT Number: NCT05518461

Smartphone Intervention for Overdose and COVID-19

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.

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Key information

Conditions

Substance Use Disorders COVID-19 Chemically-Induced Disorders Coronaviridae Infections Coronavirus Infections Drug Misuse Drug Overdose Infections Lung Diseases Mental Disorders Nidovirales Infections Overdose Pneumonia Pneumonia, Viral Prescription Drug Misuse RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Substance-Related Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53726, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iThrive WI Intervention

Device

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.

Primary outcomes

  1. 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

  1. Number of Days in the Past Month Endorsing Overdose Risk Behaviors

    Time frame: baseline, 3 months, 6 months

    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.

  2. Change in COVID-19 Vaccination Rates From Baseline

    Time frame: baseline, 3 months, 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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