Clinical trial NCT05910879: RADx-UP Phase 3D (Oregon Saludable: Juntos Podemos)
Official title: Enhancing SARS-CoV-2 Rapid Testing Acceptance in Latinx Communities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Behavior
Health Care Utilization
Vaccine Hesitancy
Keywords: Latinx
SARS-CoV-2
COVID-19
Hispanic
Vaccine
Vaccine Acceptance
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-06-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: There remains a critical need to understand and address barriers to testing among vulnerable populations. Consistent evidence from national initiatives have shown that Latinx individuals are underrepresented at SARS-CoV-2 testing sites, suggesting that better understanding of psychosocial and behavioral barriers is needed. Latinx individuals are more likely to test positive when testing, with representative data showing that for every 1 percent increase in underrepresentation of Latinx persons in testing, a state's mortality rate is 1.04 percentage points more over-representative compared to non-Latinx COVID-19 mortality rates. Further compounding challenges for Latinx communities is mounting evidence demonstrating the deleterious effects of racial and ethnic discrimination on mental and physical health, which has only been exacerbated by the COVID-19 pandemic.

The key targets of the SAII intervention will be structural social determinants of health (i.e., discrimination and mistrust) as barriers to testing acceptance. The study research team will employ demonstrated survey collection strategies to accomplish the following specific aims in partnership with the project's existing relationships with the state health authority and the study's community partners:

Aim 1. Pilot test rapid SARS-CoV-2 test distribution and an English and Spanish version of the SAII intervention. In the first quarter of Year 1, the study research team will tailor and pilot the existing "ultra-brief" SAII intervention to be offered in Spanish and English. The study research team will consult with the project's established community partners and CSAB to develop manualized protocols and train the research study team to administer an oral version of SAII that can be readily applied by the study research team and does not require English language proficiency or literacy. The study research team will also be trained to distribute SARS-CoV-2 rapid test kits. The purpose of Aim 1 will be to assess if the new protocol has acceptable levels of usability with this population.

Aim 2. Conduct a clustered randomized trial (CRT) testing a health equity effectiveness hypothesis. The study research team will use a 2-group × 2-time (pre-post) design to randomly assign 400 participants sampled from Mexican Consulate event attendees to either an SAII + Promotores de Salud condition or to a control condition (Promotores de Salud only) and test (a) hypothesized main effects of the SAII intervention on testing and vaccine acceptance and health outcomes, and (b) hypothesized buffering effects of COVID-19 stressors and discrimination on testing and health outcomes.

The research strategy for this project involves a data-informed approach for the study design, with the primary aim of testing a SAII intervention hypothesized to reduce barriers to SARS-CoV-2 testing. In Aim 1, the study research team will tailor and pilot a brief intervention (SAII) designed to increase health messaging uptake and rapid testing acceptance for a vulnerable population - Latinx individuals. The SAII is an "ultra-brief" exercise, where participants are asked to formulate an if-then plan with one preferred self-affirmation-inducing cognition. Together with the project's CSAB, study investigators will tailor the extant SAII intervention to be offered in Spanish and English. Based on practicing and piloting activities, the investigative team will examine the length of SAII intervention delivery, any comprehension or translation challenges, and cultural appropriateness to iteratively refine the SAII protocols for the Latinx population before study activities begin. In addition, the study research team will be trained on the use and distribution of SARS-CoV-2 rapid testing kits. Both the rapid testing distribution and the SAII will be examined for Aim 1.

In Aim 2, study investigators will experimentally evaluate the effectiveness of SAII using a 2-group × 2-time (pre-post) clustered randomized trial. The study research team will randomly assign 400 participants sampled from Mexican Consulate event attendees to either an SAII + Promotores de Salud condition or to a control condition (the Promotores de Salud only). For Aim 2, members of the study research team will approach individuals attending an event and confirm their eligibility using a recruitment screener to determine individual's eligibility. If individuals are eligible, the research team will invite them to: 1) complete the research survey; 2) receive the Promotores de Salud, and 3) receive free COVID-19 rapid testing kits. If the event is assigned to the Intervention Condition, the participants will also receive the ultra-brief SAII.

Study investigators hypothesize (a) the SAII will increase SARS-CoV-2 rapid testing, testing and vaccine acceptance, and health outcomes through enhancing health promotion messaging, reducing stigma, and affirming self-perceptions; and (b) the SAII will serve as a buffer that moderates (lowers) negative effects of COVID-19-related stressors and discrimination on testing and health outcomes. The study research team will conduct project activities at events sponsored by the Mexican Consulate throughout the state of Oregon.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rapid Testing Acceptance
timeFrame: One time point only (Day 1 for ~5 minute), when a participant engages in receiving test kits, no longitudinal follow-up
measure: Vaccine Hesitancy/Acceptance
timeFrame: Change from baseline attitudes towards COVID-19 vaccines at 30 days
measure: Coronavirus-Related eHealth Literacy Scale (CoV-eHEALS)
timeFrame: Change from baseline health behaviors at 30 days
measure: COVID-19 Knowledge & Attitudes (KAPs)
timeFrame: Change from baseline health behaviors at 30 days
Secondary outcomes:
measure: Broadband internalizing symptoms
timeFrame: Change from baseline symptoms at 30 days
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Dave DeGarmo, PhD
role: PRINCIPAL_INVESTIGATOR
References: