Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05910879
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-06-08
Brief Title:
RADx-UP Phase 3D Oregon Saludable Juntos Podemos
Sponsor:
University of Oregon
Organization:
University of Oregon
Study Overview
Official Title:
Enhancing SARS-CoV-2 Rapid Testing Acceptance in Latinx Communities
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oregons 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 projects 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
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 projects 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 states mortality rate is 104 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 ie 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 projects existing relationships with the state health authority and the studys 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 projects 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 projects 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 individuals 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
The key targets of the SAII intervention will be structural social determinants of health ie 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 projects existing relationships with the state health authority and the studys 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 projects 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 projects 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 individuals 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01MD018311-01 | NIH | None | httpsreporternihgovquickSearch1U01MD018311-01 |