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Creating a Sustainable Infrastructure for SARS-CoV-2 Testing (COVID-19) at Syringe Exchange Programs

Creating a Sustainable Infrastructure for SARS-COV-2 (COVID-19) Testing at Syringe Exchange Programs

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04852848
Enrollment
205
Registered
2021-04-21
Start date
2021-04-14
Completion date
2021-06-30
Last updated
2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Brief 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.

Detailed 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.

Interventions

BEHAVIORALConnect2Test Intervention

Brief assessment based feedback and motivational interviewing intervention

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Oregon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18 and over * Attend Syringe Services Program * English speaking

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Individual Participation in COVID-19 TestingImmediately post-intervention assessment of whether clients participated in COVID-19 testing following either the brief intervention or services as usualBinary outcome, yes/no participated in COVID-19 tested, reported by CLIA laboratory

Countries

United States

Participant flow

Participants by arm

ArmCount
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
105
Control
Services as usual
100
Total205

Baseline characteristics

CharacteristicControlTotalConnect2Test Intervention
Age, Continuous42.9 years
STANDARD_DEVIATION 13.7
43.1 years
STANDARD_DEVIATION 18.6
43.2 years
STANDARD_DEVIATION 13.6
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants23 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
71 Participants148 Participants77 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
17 Participants34 Participants17 Participants
Participants Tested Previously for SARS-CoV-266 Participants144 Participants78 Participants
Race (NIH/OMB)
American Indian or Alaska Native
7 Participants12 Participants5 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants5 Participants4 Participants
Race (NIH/OMB)
More than one race
13 Participants28 Participants15 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
17 Participants34 Participants17 Participants
Race (NIH/OMB)
White
59 Participants123 Participants64 Participants
Region of Enrollment
United States
100 participants205 participants105 participants
Sex/Gender, Customized
Man
60 Participants125 Participants65 Participants
Sex/Gender, Customized
Other or Unknown
12 Participants23 Participants11 Participants
Sex/Gender, Customized
Woman
28 Participants57 Participants29 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1050 / 100
other
Total, other adverse events
0 / 1050 / 100
serious
Total, serious adverse events
0 / 1050 / 100

Outcome results

Primary

Individual Participation in COVID-19 Testing

Binary outcome, yes/no participated in COVID-19 tested, reported by CLIA laboratory

Time frame: Immediately post-intervention assessment of whether clients participated in COVID-19 testing following either the brief intervention or services as usual

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Connect2Test InterventionIndividual Participation in COVID-19 Testing25 Participants
ControlIndividual Participation in COVID-19 Testing21 Participants
p-value: 0.629895% CI: [0.61, 2.27]Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026