Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04852848 |
| Other study ID # |
11162020.013 |
| Secondary ID |
3R01DA037628-05S |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 14, 2021 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
June 2022 |
| Source |
University of Oregon |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
