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Motivation, Syringe Exchange, and COVID-19

Primary Purpose

COVID-19 Pandemic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Connect2Test
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Pandemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 and older, understand English

Exclusion Criteria:

  • none

Sites / Locations

  • University of Oregon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Connect2Test Intervention + Contingency Management

Contingency Management Alone

Arm Description

$10 financial incentive for vaccination and $10 financial incentive for testing plus a brief feedback-based motivational enhancement intervention.

$10 financial incentive for vaccination and $10 financial incentive for testing.

Outcomes

Primary Outcome Measures

SARS-CoV-2 Testing
Yes/no indicator of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from testing intake data

Secondary Outcome Measures

COVID-19 Vaccination
Yes/no indicator of whether or not person was vaccinated for COVID-19 at syringe exchange visit, data collected from vaccine intake data

Full Information

First Posted
September 7, 2022
Last Updated
August 8, 2023
Sponsor
University of Oregon
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05534061
Brief Title
Motivation, Syringe Exchange, and COVID-19
Official Title
Motivational Enhancement to Augment Contingency Management for SARS-CoV-2 Testing and Vaccination Utilization Among Syringe Exchange Clients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 = 350) in which 175 participants will be assigned to contingency management plus the Connect2Test intervention and 175 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
349 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Connect2Test Intervention + Contingency Management
Arm Type
Experimental
Arm Description
$10 financial incentive for vaccination and $10 financial incentive for testing plus a brief feedback-based motivational enhancement intervention.
Arm Title
Contingency Management Alone
Arm Type
Active Comparator
Arm Description
$10 financial incentive for vaccination and $10 financial incentive for testing.
Intervention Type
Behavioral
Intervention Name(s)
Connect2Test
Other Intervention Name(s)
Motivational Enhancement
Intervention Description
Brief motivational enhancement intervention to improve the likelihood of testing and vaccination among syringe exchange clients
Primary Outcome Measure Information:
Title
SARS-CoV-2 Testing
Description
Yes/no indicator of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from testing intake data
Time Frame
One time point only (~15 minute survey), when a participant engages in COVID-19 testing at a syringe exchange site, no longitudinal follow-up
Secondary Outcome Measure Information:
Title
COVID-19 Vaccination
Description
Yes/no indicator of whether or not person was vaccinated for COVID-19 at syringe exchange visit, data collected from vaccine intake data
Time Frame
One time point only (~15 minute survey), when a participant engages in COVID-19 vaccination at a syringe exchange site, no longitudinal follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 and older, understand English Exclusion Criteria: none
Facility Information:
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In line with funding requirements, we will share data with our data coordination center and the national institutes of health
IPD Sharing URL
https://radx-up.org/

Learn more about this trial

Motivation, Syringe Exchange, and COVID-19

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