NCT05534061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

September 7, 2022

Results QC Date

November 27, 2023

Last Update Submit

January 30, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (2)

  • COVID-19 Vaccination

    Immediate post intervention (i.e., same day)

  • COVID-19 Vaccination

    Up to 9-months after intervention

Study Arms (2)

Connect2Test Intervention + Contingency Management

EXPERIMENTAL

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

Behavioral: Connect2Test

Contingency Management Alone

ACTIVE COMPARATOR

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

Behavioral: Connect2Test

Interventions

Connect2TestBEHAVIORAL

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

Also known as: Motivational Enhancement
Connect2Test Intervention + Contingency ManagementContingency Management Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and older, understand English

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Anne Marie Mauricio, PhD
Organization
University of Oregon

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 9, 2022

Study Start

August 8, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 28, 2024

Results First Posted

February 28, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

In line with funding requirements, we will share data with our data coordination center and the national institutes of health

Shared Documents
STUDY PROTOCOL, SAP, ICF
More information

Locations