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| ID | Type | Description | Link |
|---|---|---|---|
| 3R01DA037628-05S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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PWIDs have been an underserved population in the context of the current pandemic; thus, little is known about the prevalence of COVID-19 and the acceptability and possible reach of testing for COVID-19 among PWIDs. To address this gap, this study leverages a current partnership with HIV Alliance (HIVA) in Oregon and our Community and Scientific Advisory Board to support implementation and sustainability of a COVID-19 testing program. Specifically, we will use community-based participatory approaches to develop, implement, and evaluate a COVID-19 testing program offered through HIVA's Syringe Services Programs (SSP), a natural point of care for PWIDs. The COVID-19 testing program will include procedures for sample collection, transmission of specimens to the University of Oregon CLIA-certified laboratory, and results reporting. Our clinical trial is a randomized control trial focused improving the uptake of testing through a motivational enhancement intervention: Connect2Test.
People who inject drugs (PWIDs) are a socially vulnerable population and are exposed to risk factors including unstable housing and underlying medical conditions such as human immunodeficiency virus (HIV), tuberculosis (TB), and viral hepatitis that put them at increased risk for severe COVID-19 symptoms, including death. PWIDs also experience barriers such as a history of stigmatization and discrimination by health care systems and exposure to misinformation about testing that reduces access to health care services and testing. Because timely receipt of services relative to symptoms onset is critical for positive health outcomes and to reduce SARS-CoV-2 transmission, lack of testing has significant implications for PWID, highlighting an urgent need to increase testing uptake among this population. Despite this, PWIDs have been an underserved population in the context of the current pandemic; thus, little is known about the prevalence of COVID-19 and the acceptability and possible reach of testing for COVID-19 among PWIDs. To address this gap, this study leverages a current partnership with HIV Alliance (HIVA) in Oregon and our Community and Scientific Advisory Board to support implementation and sustainability of a COVID-19 testing program. Specifically, we will use community-based participatory approaches to develop, implement, and evaluate a COVID-19 testing program offered through HIVA's Syringe Services Programs (SSP), a natural point of care for PWIDs. Moreover, SSPs may offer a natural venue for dissemination and delivery of a vaccine, once available. The COVID-19 testing program will include procedures for sample collection, transmission of specimens to the University of Oregon CLIA-certified laboratory, and results reporting. For aim 1, we will assess the testing program utilization. For aim 2, we will develop and test a brief motivational enhancement intervention to optimize testing utilization among PWIDs. Using a randomized control trial, we will evaluate intervention effects on utilization of COVID-19 testing resources. For aim 3, we will collect data from syringe exchange staff and key volunteers on program acceptability, feasibility, appropriateness, adoption, and implementation barriers and facilitators related to the testing program and intervention. The current project has the potential to enhance COVID-19 testing access and reach among a significantly underserved population who experience multiple risks that make it difficult to prevent SARS-CoV-2 exposure and transmission and who are at increased risk for severe COVID-19 symptoms, if they were to contract the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connect2Test Intervention | Experimental | A brief MI intervention to motivate individuals to participate in COVID-19 testing after receiving syringe exchange services |
|
| Control | No Intervention | Services as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connect2Test Intervention | Behavioral | Brief assessment based feedback and motivational interviewing intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Individual Participation in COVID-19 Testing | Binary outcome, yes/no participated in COVID-19 tested, reported by CLIA laboratory | Immediately post-intervention assessment of whether clients participated in COVID-19 testing following either the brief intervention or services as usual |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40167545 | Derived | Mauricio AM, Cioffi CC, Sanders AM, Kosty D, Fernandes L, Mueller MV, Stormshak EA. A mixed methods evaluation of a motivational enhancement intervention to increase SARS-CoV-2 testing among people experiencing houselessness and people who inject drugs. Psychol Serv. 2025 Nov;22(4):688-698. doi: 10.1037/ser0000939. Epub 2025 Mar 31. |
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We will share IPD in line with requirements and protocols put forth by the RADx-UP data coordinating center (CDCC)
We will share IPD in the timeline put forth by the RADx-UP data coordinating center (CDCC)
We will share IPD in line with requirements and protocols put forth by the RADx-UP data coordinating center (CDCC)
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| ID | Title | Description |
|---|---|---|
| FG000 | Connect2Test Intervention | A brief MI intervention to motivate individuals to participate in COVID-19 testing after receiving syringe exchange services Connect2Test Intervention: Brief assessment based feedback and motivational interviewing intervention |
| FG001 | Control | Services as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Connect2Test Intervention | A brief MI intervention to motivate individuals to participate in COVID-19 testing after receiving syringe exchange services Connect2Test Intervention: Brief assessment based feedback and motivational interviewing intervention |
| BG001 | Control |
| 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 | Individual Participation in COVID-19 Testing | Binary outcome, yes/no participated in COVID-19 tested, reported by CLIA laboratory | Posted | Count of Participants | Participants | Immediately post-intervention assessment of whether clients participated in COVID-19 testing following either the brief intervention or services as usual |
|
1 day (single point in time)
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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 | A brief MI intervention to motivate individuals to participate in COVID-19 testing after receiving syringe exchange services Connect2Test Intervention: Brief assessment based feedback and motivational interviewing intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Marie Mauricio, Research Associate Professor | 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 | Apr 23, 2021 | May 11, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2023 | May 11, 2023 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2021 | May 11, 2023 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Services as usual |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants Tested Previously for SARS-CoV-2 | Participants were asked to report whether they had ever been tested before for SARS-CoV-2. Response choices were yes or no. The baseline report indicates individuals who responded, "yes". | Count of Participants | Participants |
|
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | Control | Services as usual | 0 | 100 | 0 | 100 | 0 | 100 |
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