COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) Phase II

NCT05082935 | Completed Results

• 2 other identifiers: 10032020.002.23P50DA048756-03S3
• Study Type: interventional
• Target: 1,463
• Locations: 1 country
• Sites: 1

Brief Summary

The global SARS-CoV-2 pandemic that causes the severe respiratory illness COVID-19 is the worst health crisis that the United States has faced in a century. Although this highly contagious virus has infected millions of Americans already, the disease burdens are disproportionately born by historically underserved populations such as Latinx communities. In Oregon, 13% of the population that is Latinx represents approximately 25.7% of COVID-19 cases and are burdened with more than twice the cases per 100,000 individuals compared to non-Hispanic Oregonians (10,677 versus 4,616, respectively). Furthermore, only 54.9% of eligible Latinx Oregonians are vaccinated compared to the 76.2% statewide vaccination rate. An urgent need exists to reach Oregon's Latinx community to prevent SARS-CoV-2 transmission and increase vaccine acceptance. The overall goal of this study is to implement a Promotores de Salud behavioral health intervention to increase the reach, access, uptake, and impact of testing and vaccination in Latinx communities in Oregon. This project will fully integrate with the National institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) consortium and its Coordination and Data Collection Center (CDCC). The study team will add testing venues based on feedback from the Oregon Health Authority (OHA) and our county and community partners to test if a "partner-optimized venue placement strategy" yields more Latinx individuals tested than placement of sites based upon residential density used in the ongoing testing in Phase I of this study (Clinical Trial ID: NCT04793464). In addition, evaluation of the Promotores de Salud intervention held during testing events will test whether culturally competent education results in greater use of strategies that reduce transmission of COVID-19 at the community and individual level and increases the number of individuals who choose to be vaccinated, as a function of fidelity of the intervention. Over time, this project will help communities institutionalize optimal local testing frameworks supported by University of Oregon laboratory facilities for testing capacity, technical support for testing logistics, and collection of data on health behaviors, testing rates, and sustainability. The resulting structures and systems will be poised for future scale-up to other vulnerable communities and/or for other public health purposes.

Conditions

Health Behavior; Health Care Utilization

Keywords

Latinx; SARS-CoV-2; COVID-19; Hispanic; Testing; Vaccination

Outcome Measures

Primary Outcomes (5)

• Testing Barriers and Hesitancy

  This measure is built around the following question: "Did you have any of the following concerns or face any of the following challenges when deciding to get tested today? Select all that apply." Participants are asked to indicate 'yes', 'somewhat', or 'no' in response to a list of 13 options. Scale ranges from 0-2 with higher scores indicating a higher number of barriers faced. This measure is adapted from the paper Development and psychometric testing of a barriers to HIV testing scale among individuals with HIV infection in Sweden; The Barriers to HIV testing scale-Karolinska version (Wiklander et al., 2015).

  Change from baseline to 30 days

• Vaccination Attitudes Examination (VAX) Scale

  Participants are asked to rate their agreement (6-point Likert scale: strongly agree to strongly disagree) on 15 qualitative statements about vaccinations. For example, "I feel safe after being vaccinated" and "Vaccination programs are a big con." Means range from 1-6 with higher scores associating with higher vaccination acceptance. This measure is adapted from the VAX Scale (Martin et al., 2017).

  Change from baseline to 30 days

• COVID-19 Prevention Health Behaviors

  From the PhenX toolkit, Protocol - COVID-19 Knowledge, Attitudes, and Avoidant Behaviors, participants are asked to indicate "Which of the following have you done in the last seven days to keep yourself safe from coronavirus? Only consider actions that you took or decisions that you made personally." There are a total of 3 possible items participants rate as a binary, Yes/No, response. The count of 'yes' responses are recorded. The scale will range from 0-3. A higher score indicates more preventative behaviors.

  Change from baseline to 30 days

• COVID-19 Knowledge and Attitudes 1

  Participants were asked: "In your opinion, how effective are the following actions for keeping you safe from COVID-19?" A list of 3 prevention strategies are listed. Participants indicate their response on a scale Very Effective (5) to Not Effective at AlI (1). Scale range is 1-5. A mean value is computed. Higher scores indicate a better outcome.

  Change from baseline to 30 days

• COVID-19 Knowledge and Attitudes 2

  Participants were asked: "How safe or unsafe are the following actions for avoiding exposure to coronavirus?" A list of 3 activities are listed and responses are on scale of 1 (Extremely Unsafe) to 4 (Extremely Safe). Mean scores were calculated. Scores range between 1-4. Higher score means a worse outcome.

  Change from baseline to 30 days

Study Arms (2)

Partner-optimized venue placement strategy

EXPERIMENTAL

The Phase II intervention involves outreach from community partners to attend testing at existing events organized by community partners, such as the Mexican Consulate. At the event, it includes the on-site Promotores de Salud psychoeducation related to SARS-CoV-2 health related behaviors.

Behavioral: Phase II Promotores de Salud

Active Comparator, Residential density-located venue placement strategy

EXPERIMENTAL

This is the Phase I intervention (Clinical Trial ID: NCT04793464). It includes the Phase I Promotores de Salud intervention, which consists of outreach to promote testing and vaccination at re-occurring testing events that have been selected for sites that have a high residential density of Latinx persons. At the testing events, it includes the on-site Promotores de Salud psychoeducation related to SARS-CoV-2 health related behaviors.

Behavioral: Phase I Promotores de Salud Outreach

Interventions

Phase II Promotores de Salud BEHAVIORAL

Community partners (e.g., Mexican Consulate) select events for testing and use their usual outreach methods to attract participants to the site and their event. Then, at the community partner's event, the research team holds COVID-19 testing events and the Promotores de Salud health behavior intervention is delivered by bilingual research staff. The health behavior intervention includes: 1) psychoeducation to promote hand-washing, social distancing, mask wearing if unvaccinated, and continued testing to mitigate the spread of COVID-19 and psychoeducation to address vaccine hesitancy; 2) information support and service navigation to address logistical challenges associated with testing and vaccination (e.g., scheduling health care visits, transportation, language barriers); 3) motivational interviewing to explore personal, social, and behavioral barriers to testing and vaccination, and to discuss available resources.

Also known as: Phase II Outreach + Promotores on Site

Partner-optimized venue placement strategy

Phase I Promotores de Salud Outreach BEHAVIORAL

Testing events re-occur every two weeks at the same location and time, based on census density on Latinx individuals for site selection. Outreach conducted by promotores occurs to increase attendance at the testing events. Outreach is culturally responsive (e.g., culturally tailored radio announcements, social media posts, community canvassing, referral by community leaders).

Also known as: Phase I Outreach

Active Comparator, Residential density-located venue placement strategy

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Proportion Tested: Age 3 or older
• Proportion Tested: Received testing at study testing site
• Individual Survey: 15 or older

You may not qualify if:

• Individual Survey: Unable to understand Spanish or English or another language translated by a qualified translator at a 5th grade level

Sponsors & Collaborators

• University of Oregon: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Related Publications (2)

• Leve LD, DeGarmo DS, Searcy J, Budd EL, Ramirez Garcia JI, Mauricio AM, Cresko WA. Attendance of Underserved Populations at Field-Based Health Services Events: Application of Quasi-Experimental Methods that Accommodate the COVID-19 Pandemic. Prev Sci. 2025 Jan 20. doi: 10.1007/s11121-025-01769-z. Online ahead of print.

  PMID: 39828881 DERIVED

• 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; COVID-19

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Leslie Leve
• Organization: University of Oregon

leve@uoregon.edu

541-346-9528

Study Officials

• Leslie D Leve, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Lorry Lokey Chair, College of Education; Associate Director, Prevention Science Institute; Associate Vice President for Research

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 19, 2021
• Study Start: September 15, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: July 22, 2024
• Results First Posted: July 22, 2024

Record last verified: 2024-07

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)