Supported Employment COVID-19 Rapid Testing for PWID

Health Behavior Clinical Trial

Official title:

Supported Employment to Create a Community Culture of COVID-19 Rapid Testing Among People Who Inject Drugs: PeerConnect2Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984966
• Other study ID #: STUDY00000657
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: University of Oregon
• Contact: Camille C Cioffi
• Phone: 541-346-4755
• Email: ccioffi[@]uoregon.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and older, understand English

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Health Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative semi-structured interview with PWID Peer Health Worker	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.	3 months post intervention involvement
Primary	Change in Self-efficacy of PWID Peer Health Worker	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).	Change from Baseline Self-efficacy at 3 months
Primary	Change in Behavioral Intentions of Peer Health Worker	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.	Change from Baseline Behavior at 3 months
Primary	Change in Flourishing Scale (Well-Being)	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	Change from Baseline Flourishing (well-being) at 3 months
Primary	Percent of people who inject drugs who agree to testing for COVID-19	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.	through study completion, an average of 1 year