COVID-19, Overdose, Substance Use Disorders
Conditions
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 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.
Interventions
DEVICEiThrive 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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 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. |
| Change in COVID-19 Vaccination Rates From Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 25 |
Baseline characteristics
| Characteristic | iThrive WI Intervention |
|---|---|
| Age, Continuous | 34 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
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.
Time frame: up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iThrive WI Intervention | Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention | 40 Participants |
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 baseline and at months 3 and 6.
Time frame: baseline, 3 months, 6 months
Population: Losses to follow-up occurred at months 3 and 6, resulting in a different subgroup of participants included in each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| iThrive WI Intervention | Change in COVID-19 Vaccination Rates From Baseline | baseline | 30 Participants |
| iThrive WI Intervention | Change in COVID-19 Vaccination Rates From Baseline | 3 months | 16 Participants |
| iThrive WI Intervention | Change in COVID-19 Vaccination Rates From Baseline | 6 months | 17 Participants |
Secondary
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.
Time frame: baseline, 3 months, 6 months
Population: Losses to follow-up occurred across study measurement timepoints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| iThrive WI Intervention | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 6 months | 0 days |
| iThrive WI Intervention | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 3 months | 0 days |
| iThrive WI Intervention | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | baseline | 2 days |
| Using Opioids or Stimulants While Alone | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 6 months | 1 days |
| Using Opioids or Stimulants While Alone | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | baseline | 5 days |
| Using Opioids or Stimulants While Alone | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 3 months | 3 days |
| Injection Drug Use and/or Speedballing | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 3 months | 9 days |
| Injection Drug Use and/or Speedballing | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | baseline | 14 days |
| Injection Drug Use and/or Speedballing | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 6 months | 5 days |
| Opioid and Alcohol Use | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | baseline | 0 days |
| Opioid and Alcohol Use | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 3 months | 0 days |
| Opioid and Alcohol Use | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 6 months | 0 days |
| Opioid and Benzodiazepine Use | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 6 months | 0 days |
| Opioid and Benzodiazepine Use | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | baseline | 0 days |
| Opioid and Benzodiazepine Use | Number of Days in the Past Month Endorsing Overdose Risk Behaviors | 3 months | 0 days |