Health BehaviorNCT05910879
RADx-UP Phase 3D (Oregon Saludable: Juntos Podemos)
A study testing Self-Affirmation Implementation Intentions (SAII) Intervention and Promotores de Salud (Health Education) in people with Health Behavior and Health Care Utilization, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Behavior, Health Care Utilization, Vaccine Hesitancy
- What is being tested?
- Self-Affirmation Implementation Intentions (SAII) Intervention and Promotores de Salud (Health Education)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- Attending a Mexican Consulate event that our team is attending
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing SARS-CoV-2 Rapid Testing Acceptance in Latinx Communities
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.
Read the 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.
- Conditions
- Health Behavior, Health Care Utilization, Vaccine Hesitancy
- Being tested
- Self-Affirmation Implementation Intentions (SAII) Intervention, Promotores de Salud (Health Education)
- Keywords
- Latinx, SARS-CoV-2, COVID-19, Hispanic, Vaccine, Vaccine Acceptance
- Medical subject headings
- Health Behavior, Patient Acceptance of Health Care, Vaccination Hesitancy, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Affirmation Implementation Intentions (SAII) InterventionBehavioural
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.
Promotores de Salud (Health Education)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cluster Randomized Trial: Promotores Health Education Only | 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. Receives: Behavioral: Promotores de Salud (Health Education) |
| Cluster Randomized Trial: SAII + 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. Receives: Behavioral: Self-Affirmation Implementation Intentions (SAII) Intervention; Behavioral: Promotores de Salud (Health Education) |
| Pilot Phase: Self-Affirmation Implementation Intentions (SAII) Intervention | Experimental | The pilot phase included administration of the SAII to bicultural, bilingual staff members (n = 5) and to community members at a Mexican Consulate event (n = 20). Receives: Behavioral: Self-Affirmation Implementation Intentions (SAII) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment (single time point)
Vaccine Hesitancy/Acceptance
Attitudes toward COVID-19 vaccines were assessed at 30-day follow-up using the Vaccine Acceptance scale from the RADx Common Data Elements and project-specific measures. The scale includes 7 items rated on a 6-point Likert scale ranging from 1 (Strongly Agree) to 6 (Strongly Disagree). Items were reverse coded, and a mean score was calculated (range 1-6), with higher scores indicating greater vaccine acceptance (better outcome).
Measured: 30 days post-intervention
Coronavirus-Related eHealth Literacy Scale (CoV-eHEALS)
Coronavirus-Related eHealth Literacy Scale (CoV-eHEALS) is an 8-item measure assessing an individual's self-rated ability to use the internet to find and utilize health information about the coronavirus. Each item is rated on a 5-point Likert scale (1 to 5), and a mean score is calculated (range 1-5), with higher scores indicating greater eHealth literacy (better outcome).
Measured: 30 days post-intervention
COVID-19 Knowledge & Attitudes (KAPs)
The COVID-19 Knowledge \& Attitudes (KAPs) measure assesses respondents' knowledge and attitudes about COVID-19. The scale includes 7 items rated on a 5-point scale ranging from 1 (Definitely False) to 5 (Definitely True). A mean score is calculated (range 1-5), with higher scores indicating greater knowledge and more favorable attitudes (better outcome).
Measured: 30 days post-intervention
Secondary outcomes (1)
Broadband Internalizing Symptoms
Depression and anxiety symptoms were assessed using the PhenX Toolkit measures, including 2 items for depression and 2 items for anxiety. Participants reported how often they had been bothered by each problem during the past 2 weeks. Items were rated on a scale from 0 (None/not at all) to 4 (Severe/nearly every day). A mean score was calculated across the 4 items (range 0-4), with higher scores indicating greater symptom severity (worse outcome).
Measured: 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start22 Apr 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Dave DeGarmo, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910879
- Sponsor's protocol ID
- STUDY00000790
- Other IDs
- 1U01MD018311-01
- Status last verified
- Jan 2026
- First submitted
- 8 Jun 2023
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all Tier 1 \& 2 data IPD with the RADx-UP CDCC.
Publications
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.
PubMed 38776498
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing SARS-CoV-2 Rapid Testing Acceptance in Latinx Communities
- ClinicalTrials.gov ID
- NCT05910879
- Acronym / sponsor ID
- STUDY00000790
- Conditions
- Health Behavior, Health Care Utilization, Vaccine Hesitancy
- Keywords
- Latinx, SARS-CoV-2, COVID-19, Hispanic, Vaccine, Vaccine Acceptance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 20 Jun 2023 (actual)
- Results
- Posted 12 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cluster Randomized Trial: Promotores Health Education Only | Active comparator | Behavioral: Promotores de Salud (Health Education)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. |
| Cluster Randomized Trial: SAII + Promotores Health Education | Experimental | Behavioral: Self-Affirmation Implementation Intentions (SAII) Intervention, Behavioral: Promotores de Salud (Health Education)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. |
| Pilot Phase: Self-Affirmation Implementation Intentions (SAII) Intervention | Experimental | Behavioral: Self-Affirmation Implementation Intentions (SAII) InterventionThe pilot phase included administration of the SAII to bicultural, bilingual staff members (n = 5) and to community members at a Mexican Consulate event (n = 20). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 or older
- Attending a Mexican Consulate event that our team is attending
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Affirmation Implementation Intentions (SAII) InterventionIn 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. | Behavioural | Cluster Randomized Trial: SAII + Promotores Health Education, Pilot Phase: Self-Affirmation Implementation Intentions (SAII) Intervention |
| Promotores de Salud (Health Education)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. | Behavioural | Cluster Randomized Trial: Promotores Health Education Only, Cluster Randomized Trial: SAII + Promotores Health Education |
Primary outcome
Rapid Testing Acceptance
Time frame: At enrollment (single time point)
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.
Vaccine Hesitancy/Acceptance
Time frame: 30 days post-intervention
Attitudes toward COVID-19 vaccines were assessed at 30-day follow-up using the Vaccine Acceptance scale from the RADx Common Data Elements and project-specific measures. The scale includes 7 items rated on a 6-point Likert scale ranging from 1 (Strongly Agree) to 6 (Strongly Disagree). Items were reverse coded, and a mean score was calculated (range 1-6), with higher scores indicating greater vaccine acceptance (better outcome).
Coronavirus-Related eHealth Literacy Scale (CoV-eHEALS)
Time frame: 30 days post-intervention
Coronavirus-Related eHealth Literacy Scale (CoV-eHEALS) is an 8-item measure assessing an individual's self-rated ability to use the internet to find and utilize health information about the coronavirus. Each item is rated on a 5-point Likert scale (1 to 5), and a mean score is calculated (range 1-5), with higher scores indicating greater eHealth literacy (better outcome).
COVID-19 Knowledge & Attitudes (KAPs)
Time frame: 30 days post-intervention
The COVID-19 Knowledge \& Attitudes (KAPs) measure assesses respondents' knowledge and attitudes about COVID-19. The scale includes 7 items rated on a 5-point scale ranging from 1 (Definitely False) to 5 (Definitely True). A mean score is calculated (range 1-5), with higher scores indicating greater knowledge and more favorable attitudes (better outcome).
1 secondary outcome
Broadband Internalizing Symptoms
Time frame: 30 days post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38776498Ramirez 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.
- Individual participant dataSharing planned: Yes. We will share all Tier 1 \& 2 data IPD with the RADx-UP CDCC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave DeGarmo, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Affirmation Implementation Intentions (SAII) Intervention and Promotores de Salud (Health Education) in people with Health Behavior and Health Care Utilization, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid Testing Acceptance (time frame: At enrollment (single time point)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.