Motivation, Syringe Exchange, and COVID-19

COVID-19 Pandemic Clinical Trial

Official title:

Motivational Enhancement to Augment Contingency Management for SARS-CoV-2 Testing and Vaccination Utilization Among Syringe Exchange Clients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05534061
• Other study ID #: 11162020.013b
• Secondary ID: 1U01DA055982-01
• Status: Completed
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 = 349) in which 177 participants will be assigned to contingency management plus the Connect2Test intervention and 172 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 and older, understand English

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Behavioral:
• Connect2Test
Brief motivational enhancement intervention to improve the likelihood of testing and vaccination among syringe exchange clients

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Oregon	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 Testing	Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record	Immediate post intervention (i.e., same day)
Primary	SARS-CoV-2 Testing	Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record	Up to 9-months after intervention
Secondary	COVID-19 Vaccination	Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was vaccinated for COVID-19 at syringe exchange visit, data collected from vaccine records	Immediate post intervention (i.e., same day)
Secondary	COVID-19 Vaccination	Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was vaccinated for COVID-19 at syringe exchange visit, data collected from vaccine records	Up to 9-months after intervention