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Smartphone Intervention for Overdose and COVID-19

Primary Purpose

Substance Use Disorders, Overdose, COVID-19

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iThrive WI Intervention
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iThrive WI Intervention

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
August 25, 2022
Last Updated
August 21, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05518461
Brief Title
Smartphone Intervention for Overdose and COVID-19
Official Title
iThrive WI - A Smartphone Intervention for Overdose and Risk and COVID-19 Among People Who Use Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Overdose, COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iThrive WI Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
iThrive WI Intervention
Intervention 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.
Primary Outcome Measure Information:
Title
Content completion rate assessed through 12 weeks
Description
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.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Change in Number of days in the past month endorsing overdose risk behaviors
Description
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).
Time Frame
baseline, 3 months, 6 months
Title
Change in COVID-19 Vaccination Rates from baseline
Description
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).
Time Frame
baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel E Gicquelais, PhD, MPH
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Smartphone Intervention for Overdose and COVID-19

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