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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Behavioral: Connect2Test Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • University of Oregon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Services as usual
Experimental: Connect2Test Intervention; A brief MI intervention to motivate individuals to participate in COVID-19 testing after receiving syringe exchange services	Behavioral: Connect2Test Intervention; Brief assessment based feedback and motivational interviewing intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Oregon
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 11162020.013; 3R01DA037628-05S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share IPD in line with requirements and protocols put forth by the RADx-UP data coordinating center (CDCC)
• IPD Sharing Time Frame: We will share IPD in the timeline put forth by the RADx-UP data coordinating center (CDCC)
• IPD Sharing Access Criteria: We will share IPD in line with requirements and protocols put forth by the RADx-UP data coordinating center (CDCC)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No