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

NCT04793464 | Completed Results

• 2 other identifiers: 10032020.002P50DA048756-02S2
• Study Type: interventional
• Target: 1,623
• 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. This disparity is notable in Oregon, where the 13% of the population that is Latinx represents approximately 44% of COVID-19 cases. An urgent need exists to reach Oregon's Latinx community to prevent SARS-CoV-2 transmission. The overall goal of this study is to implement a Promotores de Salud intervention to increase the reach, access, uptake, and impact of testing 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). With guidance and leadership from the study's Latinx Community and Scientific Advisory Board, 38 testing sites have been established to test the Promotores de Salud intervention. The investigators will test whether the Promotores de Salud intervention will increase testing rates and promote better health behaviors in communities over time. The investigators will test the intervention using a randomized control trial comparing the intervention to county outreach services as usual. Evaluation of the Promotores de Salud intervention held during a testing event (compared to distribution of a pamphlet only) will test whether culturally competent education results in greater use of strategies that reduce transmission of COVID-19 at the community and individual level. The investigators have designed a working group structure with teams focused on: Community Engagement, Molecular Biology, Data Science, and Implementation Science. These working groups are coordinated by an Administrative Hub and guided by the study's Latinx Community and Scientific Advisory Board. 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 (e.g., vaccination campaigns).

Conditions

Health Behavior; Health Care Utilization

Keywords

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

Outcome Measures

Primary Outcomes (7)

• COVID-19 Prevention Health Behaviors 1

  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 even days to keep yourself safe from coronavirus? Only consider actions that you took or decisions that you made personally." There are a total of 17 possible items participants rate as a binary, Yes/No, response. The count of 'yes' responses was recorded. The scale will range from 0-17. A higher score indicates more preventative behaviors.

  Change from baseline health behaviors at 30 days

• COVID-19 Prevention Health Behaviors 2

  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 five days?" There are 5 items that increase risk for COVID-19, rated on a checklist (check indicates participation in behavior). A mean was taken across all items.The scale ranges from 0-5 with 5 indicating greater risk behavior.

  Change from baseline health behaviors at 30 days

• COVID-19 Knowledge and Attitudes 1

  Participants are asked, "How can the novel coronavirus be transmitted?" adapted from the PhenX toolkit COVID-19 COMMUNITY RESPONSE SURVEY, KNOWLEDGE \& ATTITUDES TOWARDS COVID-19. Participants to indicate using a Yes/No response to "Close contact with an infected person who has symptoms". Counts of 'yes' responses are given.

  Change from baseline COVID-19 attitudes and knowledge at 30 days

• COVID-19 Knowledge and Attitudes 2

  Participants are asked, "How can the novel coronavirus be transmitted?" adapted from the PhenX toolkit COVID-19 COMMUNITY RESPONSE SURVEY, KNOWLEDGE \& ATTITUDES TOWARDS COVID-19. Participants to indicate using a Yes/No response to 'Close contact with an infected person even if they aren't showing symptoms of infection'. Counts of 'yes' responses are provided.

  Change from baseline COVID-19 attitudes and knowledge at 30 days

• COVID-19 Knowledge and Attitudes 3

  Participants were asked: "In your opinion, how effective are the following actions for keeping you safe from COVID-19?" A list of 6 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 COVID-19 attitudes and knowledge at 30 days

• COVID-19 Knowledge and Attitudes 4

  Participants were asked: "How safe or unsafe are the following actions for avoiding exposure to coronavirus?" A list of 11 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 COVID-19 attitudes and knowledge at 30 days

• Attitudes Towards COVID-19 Vaccines

  Participants are asked, "How likely are you to get vaccinated for coronavirus once a vaccination is available to the public?" on a 5-item response scale of "Very likely" to "Definitely not". The item was computed on a scale of 1-5 with 5 indicating greater likelihood of receiving the vaccine and lower vaccine hesitancy. Higher scores indicate a better outcome.

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

Secondary Outcomes (1)

• Broadband Internalizing Symptoms

  Change from baseline symptoms at 30 days

Study Arms (2)

Promotores

EXPERIMENTAL

The Promotores de Salud intervention involves specified outreach and psychoeducation on SARS-CoV-2 health related behaviors.

Behavioral: Promotores de Salud

Control

ACTIVE COMPARATOR

Services as usual includes outreach as usual strategies and pamphlets on site at events.

Behavioral: Services as usual

Interventions

Promotores de Salud BEHAVIORAL

The Promotores de Salud intervention is delivered by a paid Promotor(a) who is a trusted member of the community where the testing site is located. The intervention includes: (1) psychoeducation 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 are on-site at testing 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.

Also known as: Promotores

Promotores

Services as usual BEHAVIORAL

Services as usual, our control condition, includes strategies that are typically conducted by county and community-based organizations that serve under-represented groups to notify people of testing opportunities related to COVID-19. These include Facebook advertisements, email announcements, circulation to other community-based organizations and state agencies (e.g., Oregon Health Authority, county public health), and other flyer distribution means. This condition also includes a pamphlet about health behaviors and community resources handed out by testing facilitators at testing events.

Also known as: Control

Control

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 (5)

• Budd EL, McWhirter EH, De Anda S, Mauricio AM, Mueller MV, Cioffi CC, Nash A, Van Brocklin K, Yarris K, Jackson A, Terral H, Ramirez Garcia JI; Juntos Podemos Community and Scientific Advisory Board; Cresko WA, DeGarmo DS, Leve LD. Development and design of a culturally tailored intervention to address COVID-19 disparities among Oregon's Latinx communities: A community case study. Front Public Health. 2022 Sep 23;10:962862. doi: 10.3389/fpubh.2022.962862. eCollection 2022.

  PMID: 36211681 BACKGROUND

• Searcy JA, Cioffi CC, Tavalire HF, Budd EL, Cresko WA, DeGarmo DS, Leve LD. Reaching Latinx Communities with Algorithmic Optimization for SARS-CoV-2 Testing Locations. Prev Sci. 2023 Aug;24(6):1249-1260. doi: 10.1007/s11121-022-01478-x. Epub 2023 Jan 9.

  PMID: 36622480 RESULT

• Anda S, Budd EL, Halvorson S, Mauricio AM, McWhirter EH, Cioffi CC, Garcia JIR, Cresko WA, Leve LD, DeGarmo DS. Effects of a Health Education Intervention for COVID-19 Prevention in Latinx Communities: A Cluster-Randomized Controlled Trial. Am J Public Health. 2022 Nov;112(S9):S923-S927. doi: 10.2105/AJPH.2022.307129.

  PMID: 36446063 RESULT

• DeGarmo DS, De Anda S, Cioffi CC, Tavalire HF, Searcy JA, Budd EL, Hawley McWhirter E, Mauricio AM, Halvorson S, Beck EA, Fernandes L, Currey MC, Ramirez Garcia J, Cresko WA, Leve LD. Effectiveness of a COVID-19 Testing Outreach Intervention for Latinx Communities: A Cluster Randomized Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2216796. doi: 10.1001/jamanetworkopen.2022.16796.

  PMID: 35708690 RESULT

• 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
• Restrictive Agreement: No

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: PRINCIPAL INVESTIGATOR
• PI Title: Lorry Lokey Professor, College of Education; Associate Director, Prevention Science Institute

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 11, 2021
• Study Start: February 4, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 8, 2024
• Results First Posted: May 8, 2024

Record last verified: 2024-04

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)