COVID-19 Pandemic
Conditions
Brief summary
People who inject drugs (PWIDs) are highly vulnerable to SARS-CoV-2 infection and to the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), however, rates of SARS-CoV-2 testing and vaccination uptake -vital to mitigating the spread of COVID-19 and achieving herd immunity - are lower among PWIDs compared to the general population. Building on our Phase I Rapid Acceleration of Diagnostics project, which found that contingency management (CM) increased testing utilization among PWIDs, the proposed project evaluates the comparative effectiveness of CM versus CM plus a brief motivational enhancement intervention on SARS-CoV-2 testing and vaccination uptake among PWIDs. This project has the potential to reduce COVID-19 health disparities among PWIDs and to decrease population level COVID-19 morbidity and mortality.
Detailed description
This study uses contingency management, specifically $10 financial incentives for participation in SARS-CoV-2 testing and $10 for participating in COVID-19 vaccination. It also uses a motivational enhancement intervention which is a brief conversation with clients to improve intrinsic motivation for testing and vaccination. Thus, the clinical trials portion of this study is a randomized control trial (N = 349) in which 177 participants will be assigned to contingency management plus the Connect2Test intervention and 172 will be assigned to the contingency management alone (i.e. services as usual). There will be a per site quota to ensure there are relatively equivalent numbers of participants per site to avoid site-specific biases. The data collection software (e.g., Qualtrics, PowerBI) will randomly assign individuals to condition in real time, after a participant consents to participate in the study.
Interventions
BEHAVIORALConnect2Test
Brief motivational enhancement intervention to improve the likelihood of testing and vaccination among syringe exchange clients
Sponsors
National Institute on Drug Abuse (NIDA)
University of Oregon
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 and older, understand English
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 Testing | Immediate post intervention (i.e., same day) | Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 Vaccination | Immediate post intervention (i.e., same day) | Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was vaccinated for COVID-19 at syringe exchange visit, data collected from vaccine records |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Connect2Test Intervention + Contingency Management $10 financial incentive for vaccination and $10 financial incentive for testing plus a brief feedback-based motivational enhancement intervention.
Connect2Test: Brief motivational enhancement intervention to improve the likelihood of testing and vaccination among syringe exchange clients | 177 |
| Contingency Management Alone $10 financial incentive for vaccination and $10 financial incentive for testing.
Connect2Test: Brief motivational enhancement intervention to improve the likelihood of testing and vaccination among syringe exchange clients | 172 |
| Total | 349 |
Baseline characteristics
| Characteristic | Connect2Test Intervention + Contingency Management | Contingency Management Alone | Total |
|---|---|---|---|
| Age, Continuous | 42.60 years STANDARD_DEVIATION 11.23 | 45.19 years STANDARD_DEVIATION 10.8 | 43.92 years STANDARD_DEVIATION 11.11 |
| Race/Ethnicity, Customized Hispanic | 13 Participants | 14 Participants | 27 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 92 Participants | 88 Participants | 180 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 72 Participants | 70 Participants | 142 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 11 Participants | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 50 Participants | 31 Participants | 81 Participants |
| Race (NIH/OMB) White | 109 Participants | 113 Participants | 222 Participants |
| Sex/Gender, Customized Bigender | 0 Participants | 2 Participants | 2 Participants |
| Sex/Gender, Customized Female | 53 Participants | 51 Participants | 104 Participants |
| Sex/Gender, Customized Male | 89 Participants | 88 Participants | 177 Participants |
| Sex/Gender, Customized Non-binary | 2 Participants | 4 Participants | 6 Participants |
| Sex/Gender, Customized None of the listed categories | 2 Participants | 2 Participants | 4 Participants |
| Sex/Gender, Customized Unknown or not reported | 31 Participants | 25 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 177 | 0 / 172 |
| other Total, other adverse events | 0 / 177 | 0 / 172 |
| serious Total, serious adverse events | 0 / 177 | 0 / 172 |
Outcome results
Primary
SARS-CoV-2 Testing
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record
Time frame: Immediate post intervention (i.e., same day)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Connect2Test Intervention + Contingency Management | SARS-CoV-2 Testing | Was tested | 54 Participants |
| Connect2Test Intervention + Contingency Management | SARS-CoV-2 Testing | Was not tested | 123 Participants |
| Contingency Management Alone | SARS-CoV-2 Testing | Was tested | 53 Participants |
| Contingency Management Alone | SARS-CoV-2 Testing | Was not tested | 119 Participants |
p-value: 0.94495% CI: [0.62, 1.56]Regression, Logistic
Primary
SARS-CoV-2 Testing
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record
Time frame: Up to 9-months after intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Connect2Test Intervention + Contingency Management | SARS-CoV-2 Testing | Was tested | 46 Participants |
| Connect2Test Intervention + Contingency Management | SARS-CoV-2 Testing | Was not tested | 131 Participants |
| Contingency Management Alone | SARS-CoV-2 Testing | Was tested | 46 Participants |
| Contingency Management Alone | SARS-CoV-2 Testing | Was not tested | 126 Participants |
p-value: 0.95295% CI: [0.62, 1.65]Regression, Logistic
Secondary
COVID-19 Vaccination
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was vaccinated for COVID-19 at syringe exchange visit, data collected from vaccine records
Time frame: Immediate post intervention (i.e., same day)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Connect2Test Intervention + Contingency Management | COVID-19 Vaccination | Was vaccinated | 9 Participants |
| Connect2Test Intervention + Contingency Management | COVID-19 Vaccination | Was not vaccinated | 168 Participants |
| Contingency Management Alone | COVID-19 Vaccination | Was vaccinated | 8 Participants |
| Contingency Management Alone | COVID-19 Vaccination | Was not vaccinated | 164 Participants |
p-value: 0.76895% CI: [0.43, 3.11]Regression, Logistic
Secondary
COVID-19 Vaccination
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was vaccinated for COVID-19 at syringe exchange visit, data collected from vaccine records
Time frame: Up to 9-months after intervention
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Connect2Test Intervention + Contingency Management | COVID-19 Vaccination | Was vaccinated | 19 Participants |
| Connect2Test Intervention + Contingency Management | COVID-19 Vaccination | Was not vaccinated | 158 Participants |
| Contingency Management Alone | COVID-19 Vaccination | Was vaccinated | 5 Participants |
| Contingency Management Alone | COVID-19 Vaccination | Was not vaccinated | 167 Participants |
p-value: 0.00895% CI: [1.43, 10.94]Regression, Logistic