Supported Employment COVID-19 Rapid Testing for PWID

Sponsor
University of Oregon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05984966
Collaborator
(none)
350
1
1
15.5
22.5

Study Details

Study Description

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
  • Behavioral: Supported Employment
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

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 Names:
  • Peer Connect2Test
  • Outcome Measures

    Primary Outcome Measures

    1. Qualitative semi-structured interview with PWID Peer Health Worker [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 [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 [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) [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 18 and older, understand English
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Oregon Eugene Oregon United States 97403

    Sponsors and Collaborators

    • University of Oregon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oregon
    ClinicalTrials.gov Identifier:
    NCT05984966
    Other Study ID Numbers:
    • STUDY00000657
    First Posted:
    Aug 9, 2023
    Last Update Posted:
    Aug 9, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 9, 2023