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Supported Employment COVID-19 Rapid Testing for PWID

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ClinicalTrials.gov Identifier: NCT05984966
Recruitment Status : Recruiting
First Posted : August 9, 2023
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
University of Oregon

Study Description
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Brief Summary:
This community-engaged project aims to improve the accessibility of rapid tests through a supported employment program for people who inject drugs (PWID). The program is called Peer Connect2Test (PeerC2T). PWID will be recruited by a community partner who provides syringe exchange services. PWID will the trained by the community partner to become peer health workers (PHW) to distribute SARS-CoV-2 rapid tests to other PWID. Investigators expect that PeerC2T will improve knowledge, self-efficacy, and health behaviors among PHW (Aim 1). The study will use the RE-AIM framework in Aims 2 and 3 to evaluate whether PeerC2T improves SARS-CoV-2 testing uptake among other PWID (RE; Aim 2), and identify intervention considerations (AIM; Aim 3). The overall goal of this project is develop a transformative community-driven intervention in partnership with a community partner to promote widespread access to rapid testing among PWID.

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: Supported Employment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Supported Employment to Create a Community Culture of COVID-19 Rapid Testing Among People Who Inject Drugs: PeerConnect2Test
Actual Study Start Date : August 3, 2023
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Supported Employment
Supported employment program (Peer Connect2Test) for people who inject drugs to provide SARS-CoV-2 rapid tests to others in their networks
 Behavioral: Supported Employment
PeerC2T is part of a supported employment program where PWID are trained and supported to provide PWID with job skills to be able to act as Peer Health Worker to facilitate distribution of rapid SARS-CoV-2 testing to other PWID. The effect of the training on the Peer Health Worker themself will be evaluated (Aim 1). In addition, in Aim 2 they will distribute the rapid test kits in places of residence such as tents, shelters, apartments, trailers, or houses or locations where other PWID frequently engage with services such as syringe exchange. The kit is the BinaxNOW COVID-19 Antigen Self Test, which is approved to be used as a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. PWID community members will be offered a free test kit, and the Peer Health Worker will record whether the community member elected to take the test (yes/no), and they will also collect administrative demographic data on the PWID.
Other Name: Peer Connect2Test


Outcome Measures
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Primary Outcome Measures :
  1. Qualitative semi-structured interview with PWID Peer Health Worker [ Time Frame: 3 months post intervention involvement ]
    Includes:(a) provided participant with purpose and meaning; (b) helped them create more meaningful social relationships; (c) provided opportunities for engaging with society in a positive way; (d) helped them feel competent and capable; and (e) facilitated optimism about the future. Coded using NVivo text-analysis software.

  2. Change in Self-efficacy of PWID Peer Health Worker [ Time Frame: Change from Baseline Self-efficacy at 3 months ]
    To test Aim 1 using qualitative data, we will develop self-efficacy items based on skills taught in the supported employment training 5-point response option (1 = Strongly disagree, 5 = strongly agree).

  3. Change in Behavioral Intentions of Peer Health Worker [ Time Frame: Change from Baseline Behavior at 3 months ]
    To test Aim 1, we will adapt questions from the Preventative Medicine Attitudes and Activities Questionnaire, and using the same response option, reframe the items based on how often they intend to engage in the behavior. We will develop the knowledge items based on skills taught in the training. Higher scores indicate greater behavioral intentions.

  4. Change in Flourishing Scale (Well-Being) [ Time Frame: Change from Baseline Flourishing (well-being) at 3 months ]
    To test Aim 1, we will use an 8-item summary measure of self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. Questions pertain to experiences over the past 4-weeks (e.g., My social relationships are supportive and rewarding, I am engaged and interested in my daily activities) and responses are indicated on a 7-point scale (1 = Strongly disagree, 7 = Strongly agree). The possible range of scores is from 8 (lowest possible) to 56 (highest PWB possible). A high score represents a person with many psychological resources and strengths

  5. Percent of people who inject drugs who agree to testing for COVID-19 [ Time Frame: through study completion, an average of 1 year ]
    Peer Health Workers will offer a rapid test to 1000 PWID. The percent of PWID who agree to take the test serves as this measure for Aim 2a.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 and older, understand English

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984966


Contacts
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Contact: Camille C Cioffi 541-346-4755 ccioffi@uoregon.edu

Locations
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United States, Oregon
University of Oregon Recruiting
Eugene, Oregon, United States, 97403
Contact: Camille C Cioffi, PhD       ccioffi@uoregon.edu   
Contact: Leslie Leve, PhD       leve@uoregon.edu   
Sponsors and Collaborators
University of Oregon
  Study Documents (Full-Text)

Documents provided by University of Oregon:
Study Protocol and Informed Consent Form  [PDF] June 27, 2023

More Information
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Responsible Party: University of Oregon
ClinicalTrials.gov Identifier: NCT05984966    
Other Study ID Numbers: STUDY00000657
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share data with the RADx-UP Data Coordination Center at Duke University. Data will be de-identified and available to other researchers for further use.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Upon study completion. Timeframe available determined by the National Institutes of Health.
URL: https://radx-up.org/research/cdes/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No