NCT04852848

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

April 14, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 6, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

April 19, 2021

Results QC Date

April 18, 2023

Last Update Submit

May 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Connect2Test Intervention

EXPERIMENTAL

A brief MI intervention to motivate individuals to participate in COVID-19 testing after receiving syringe exchange services

Behavioral: Connect2Test Intervention

Control

NO INTERVENTION

Services as usual

Interventions

Brief assessment based feedback and motivational interviewing intervention

Connect2Test Intervention

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

  • Mauricio AM, Cioffi CC, Sanders AM, Kosty D, Fernandes L, Mueller MV, Stormshak EA. A mixed methods evaluation of a motivational enhancement intervention to increase SARS-CoV-2 testing among people experiencing houselessness and people who inject drugs. Psychol Serv. 2025 Nov;22(4):688-698. doi: 10.1037/ser0000939. Epub 2025 Mar 31.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Anne Marie Mauricio, Research Associate Professor
Organization
University of Oregon

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 21, 2021

Study Start

April 14, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 6, 2023

Results First Posted

June 6, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

We will share IPD in line with requirements and protocols put forth by the RADx-UP data coordinating center (CDCC)

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
We will share IPD in the timeline put forth by the RADx-UP data coordinating center (CDCC)
Access Criteria
We will share IPD in line with requirements and protocols put forth by the RADx-UP data coordinating center (CDCC)

Locations