RADx-UP Phase 3D (Oregon Saludable: Juntos Podemos)

NCT05910879 | Active Not Recruiting

• 2 other identifiers: STUDY000007901U01MD018311-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The ongoing Oregon Saludable: Juntos Podemos (OSJP, Healthy Oregon: Together We Can) project was developed to directly address the COVID-19 related health disparities among Latinx communities through community engagement funded by Phase I and II of the RADx-UP initiative. This project is organized by the University of Oregon's Oregon Saludable: Juntos Podemos (OSJP) project. In this Phase III study, study investigators build on the successful Phase I and Phase II partnerships with Latinx-serving community-based organizations and the project's established Community Scientific Advisory Board (CSAB) to employ a data-informed approach for implementing preventive interventions designed to advance health equity and ameliorate health disparities among vulnerable populations. Based on identity-stress and stereotype threat models for racial and ethnic minorities, study investigators will further tailor the Promotores de Salud COVID-19 evidence-based health promotion intervention to experimentally evaluate a brief behavioral self-affirming implementation intention (SAII) intervention; an approach that is evidence-based for increasing acceptance of health messaging, increasing intentions to change, increasing health promoting behaviors, and decreasing psychological distress. In collaboration with the Mexican Consulate (MC), research team members will attend the MC mobile events, invite MC attendees to participate in the research study and complete a survey, offer the Promotores de Salud, and SAII intervention to all attendees (if event is assigned to the intervention condition), and distribute rapid tests to participants.

Conditions

Health Behavior; Health Care Utilization; Vaccine Hesitancy

Keywords

Latinx; SARS-CoV-2; COVID-19; Hispanic; Vaccine; Vaccine Acceptance

Outcome Measures

Primary Outcomes (4)

• Rapid Testing Acceptance

  Participants are offered to take home 0-4 SARS-CoV-2 rapid home test kits after enrolling in the project. The primary hypothesis focuses on increasing the likelihood a participant will take home testing kits for COVID-19. After the Promotores only intervention or the Promotores plus SAII intervention, the number or test kits participants choose to take home are recorded.

  One time point only (Day 1 for ~5 minute), when a participant engages in receiving test kits, no longitudinal follow-up

• Vaccine Hesitancy/Acceptance

  Vaccine hesitancy is assessed via the Vaccine Acceptance scales of the RADx Common Data Elements and project specific measures. In total, there are 10 items recorded on a 6-point Likert scale of "Strongly Agree" to "Strongly Disagree" on participant's level of agreement to statements on how accepting they are about the vaccine. Mean score will be calculated with range of 1-6 rated on a scale of "1. Strongly Agree" to "6. Strongly Disagree", then reverse coded. Low score on vaccine acceptance is a worse outcome and a high score on vaccine acceptance is a better outcome.

  Change from baseline attitudes towards COVID-19 vaccines at 30 days

• Coronavirus-Related eHealth Literacy Scale (CoV-eHEALS)

  Coronavirus-Related eHealth Literacy Scale (CoV-eHEALS) is an 8-item measure to assess an individual's self-rated ability (on a 5-point Likert scale) to use the internet to find and utilize health information about the coronavirus. An average mean score CoV-eHEALS score is computed, with a minimum value of 8 and a maximum value of 40. Higher scores indicate better literacy and thus a better outcome.

  Change from baseline health behaviors at 30 days

• COVID-19 Knowledge & Attitudes (KAPs)

  The COVID-19 Knowledge \& Attitudes (KAPs) measure is used to assess survey respondent's knowledge and attitudes about COVID-19. A 7-item scale based on common key factors related to COVID-19 is measured on a 5-point scale ranging from "1. Definitely False" to "5. Definitely True". An overall knowledge score is calculated based on a mean of the scores for each item. This scale has a minimum value of 7 and a maximum value of 35. Higher scores indicate better knowledge and thus a better outcome.

  Change from baseline health behaviors at 30 days

Secondary Outcomes (1)

• Broadband internalizing symptoms

  Change from baseline symptoms at 30 days

Study Arms (2)

Promotores Health Education only condition

ACTIVE COMPARATOR

The Promotores de Salud Health Education intervention includes: (1) a culturally tailored health education to increase knowledge about COVID-19 and the benefits of testing; (2) motivational interviewing (MI) strategies to explore personal, social, and behavioral barriers to testing and to discuss available resources to resolve these barriers; (3) emotional support to address testing-related concerns and anxieties that may dissuade Latinx individuals from getting tested; and (4) service navigation. When promotores (community health advocates) are on-site at Mexican Consulate events, they will provide information about COVID-19 and preventive behaviors using in-person instruction on effective mask wearing, hand washing, and physical distancing, as well as the importance of repeated testing and vaccines.

Behavioral: Promotores de Salud (Health Education)

Self-Affirmation Implementation Intentions (SAII) intervention (plus Promotores Health Education)

EXPERIMENTAL

The SAII is designed to reduce stigma and enhance uptake of health messaging. SAII couples; (a) self-affirming interventions that focus on restoring self-integrity in the face of identity threats, with (b) implementation intention interventions focus on whether realization of goal intentions for health behaviors is facilitated by forming an "implementation intention" that spells out when, where, and how of goal striving in advance.

Behavioral: Self-Affirmation Implementation Intentions (SAII) Intervention; Behavioral: Promotores de Salud (Health Education)

Interventions

Self-Affirmation Implementation Intentions (SAII) Intervention BEHAVIORAL

In an "brief" exercise, participants are asked to provide a personal story and positive experience during the challenging and sometimes stressful COVID19 pandemic, "…a time when you felt successful and proud of yourself. …You can also tell us about a time that you did something to help someone in need." The self-affirmation is designed to offset effects of threats to self. In the next section participants are asked to formulate an if-then plan with one preferred self-affirmation-inducing cognition: "If I feel sad, threatened, or discriminated against, then I will… a)…think about things I value about myself, b)…remember things that I have succeeded in, c) …think about what I stand for, or d)…think about things that are important to me". After selecting response, participants read the full If-Then plan out loud and are provided with a paper copy of their exercise to take home.

Self-Affirmation Implementation Intentions (SAII) intervention (plus Promotores Health Education)

Promotores de Salud (Health Education) BEHAVIORAL

The Promotores de Salud intervention includes: (1) a culturally tailored health education to increase knowledge about COVID-19 and the benefits of testing; (2) motivational interviewing (MI) strategies to explore personal, social, and behavioral barriers to testing and to discuss available resources to resolve these barriers; (3) emotional support to address testing-related concerns and anxieties that may dissuade Latinx individuals from getting tested; and (4) service navigation. When promotores (community health advocates) are on-site at Mexican Consulate events, they will provide information about COVID-19 and preventive behaviors using in-person instruction on effective mask wearing, hand washing, and physical distancing, as well as the importance of repeated testing and vaccines.

Promotores Health Education only condition; Self-Affirmation Implementation Intentions (SAII) intervention (plus Promotores Health Education)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older
• Attending a Mexican Consulate event that our team is attending

You may not qualify if:

• Unable to understand Spanish or English or another language translated by a qualified translator at a 5th grade level
• Individual has previously enrolled in the research project

Sponsors & Collaborators

• University of Oregon: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

• Ramirez Garcia JI, Oro V, Budd EL, Mauricio AM, Cioffi CC, Anda S, McWhirter EH, DeGarmo DS, Leve LD. A Translational Case Study of a Multisite COVID-19 Public Health Intervention Across Sequenced Research Trials: Embedding Implementation in a Community Engagement Phased Framework. Am J Public Health. 2024 May;114(S5):S396-S401. doi: 10.2105/AJPH.2024.307669.

  PMID: 38776498 DERIVED

MeSH Terms

Conditions

Health Behavior; Patient Acceptance of Health Care; Vaccination Hesitancy; COVID-19

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior; Treatment Adherence and Compliance; Vaccination Refusal; Treatment Refusal; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Dave DeGarmo, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 20, 2023
• Study Start: April 22, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be shared in accordance with timeframes set by the RADX-UP CDCC
• Access Criteria: The RADX-UP CDCC will make these determinations

Locations

US (1)