Motivation, Syringe Exchange, and COVID-19

NCT ID: NCT05534061

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2023-06-30

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 = 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.

Conditions

COVID-19 Pandemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Connect2Test Intervention + Contingency Management

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

Group Type: EXPERIMENTAL

Connect2Test

Intervention Type: BEHAVIORAL

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

Contingency Management Alone

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

Group Type: ACTIVE_COMPARATOR

Connect2Test

Intervention Type: BEHAVIORAL

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

Interventions

Connect2Test

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Motivational Enhancement

Eligibility Criteria

Inclusion Criteria

• 18 and older, understand English

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Oregon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oregon

Eugene, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1U01DA055982-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11162020.013b

Identifier Type: -

Identifier Source: org_study_id