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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DA055982-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connect2Test Intervention + Contingency Management | Experimental | $10 financial incentive for vaccination and $10 financial incentive for testing plus a brief feedback-based motivational enhancement intervention. |
|
| Contingency Management Alone | Active Comparator | $10 financial incentive for vaccination and $10 financial incentive for testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connect2Test | Behavioral | Brief motivational enhancement intervention to improve the likelihood of testing and vaccination among syringe exchange clients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediate post intervention (i.e., same day) |
| 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 | Up to 9-months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediate post intervention (i.e., same day) |
| COVID-19 Vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oregon | Eugene | Oregon | 97403 | United States |
In line with funding requirements, we will share data with our data coordination center and the national institutes of health
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Immediate post intervention (i.e., same day) |
|
Adverse event data was collected from completion of randomization through the 9-month follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Marie Mauricio, PhD | University of Oregon | 602-920-7459 | amariem@uoregon.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2022 | Jan 3, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2022 | Jan 3, 2024 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2022 | Jan 3, 2024 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
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
| Up to 9-months after intervention |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
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| 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 | Posted | Count of Participants | Participants | Up to 9-months after intervention |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | Immediate post intervention (i.e., same day) |
|
|
|
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| 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 | Posted | Count of Participants | Participants | Up to 9-months after intervention |
|
|
|
|
| 0 |
| 177 |
| 0 |
| 177 |
| 0 |
| 177 |
| EG001 | 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 | 0 | 172 | 0 | 172 | 0 | 172 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |