COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) (OSJP)
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|ClinicalTrials.gov Identifier: NCT04793464|
Recruitment Status : Completed
First Posted : March 11, 2021
Last Update Posted : February 28, 2023
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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).
|Condition or disease||Intervention/treatment||Phase|
|Health Behavior Health Care Utilization||Behavioral: Promotores de Salud Behavioral: Services as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1626 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Scaling Up SARS-CoV-2 Testing to Serve Latinx Communities|
|Actual Study Start Date :||February 4, 2021|
|Actual Primary Completion Date :||December 31, 2022|
|Actual Study Completion Date :||December 31, 2022|
The Promotores de Salud intervention involves specified outreach and psychoeducation on SARS-CoV-2 health related behaviors.
Behavioral: Promotores de Salud
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.
Other Name: Promotores
Active Comparator: Control
Services as usual includes outreach as usual strategies and pamphlets on site at events.
Behavioral: Services as usual
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.
Other Name: Control
- Latinx testing engagement [ Time Frame: One time point only (~15 minute), when a participant engages in COVID-19 testing at a testing site, no longitudinal follow-up ]Number and proportion of Latinx community members tested at each site, defined by the number and proportion of Latinx tested divided by the total census block frequency of Latinx individuals above the age of 3.
- COVID-19 Prevention Health Behaviors [ Time Frame: Change from baseline health behaviors at 30 days ]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 17 possible items participants rate as a binary, Yes/No, response. The scale will range from 0-17. Participants are also asked "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). The scale ranges from 0-5 with 5 indicating greater risk behavior.
- COVID-19 Knowledge and Attitudes [ Time Frame: Change from baseline COVID-19 attitudes and knowledge at 30 days ]
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. The sum of responses indicates overall knowledge of transmission out of a possible score of 2 with 2 indicating greater knowledge.
Participants are also asked: "In your opinion, how effective are the following actions for keeping you safe from COVID-19?" A list of 5 prevention strategies are listed. Participants indicate their response on a scale Very Effective (5) to Not Effective at All. The possible score ranges from 5 to 25.
The are also 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).
- Attitudes Towards COVID-19 Vaccines [ Time Frame: Change from baseline attitudes towards COVID-19 vaccines at 30 days ]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 will be computed on a scale of 1-5 with 5 indicating greater likelihood of receiving the vaccine and lower vaccine hesitancy.
- Broadband internalizing symptoms [ Time Frame: Change from baseline symptoms at 30 days ]Participants respond to the Phenx Toolkit depression (2 items) and anxiety (2 items) subscales regarding how much or how often they have been bothered by each problem during the past 2 weeks. Items are rated on a scale ranging from 0-4, where 0="none/not at all" and 4= "severe/nearly every day". A mean score will be computed from the 4 items, with higher scores indicating more symptoms.
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|Ages Eligible for Study:||3 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Proportion Tested: Age 3 or older
- Proportion Tested: Received testing at study testing site
- Individual Survey: 15 or older
• Individual Survey: Unable to understand Spanish or English or another language translated by a qualified translator at a 5th grade level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04793464
|United States, Oregon|
|University of Oregon|
|Eugene, Oregon, United States, 97403|
|Principal Investigator:||Leslie D Leve, PhD||University of Oregon|
Documents provided by Leslie Leve,, University of Oregon:
|Responsible Party:||Leslie Leve,, Lorry Lokey Professor, College of Education; Associate Director, Prevention Science Institute, University of Oregon|
|Other Study ID Numbers:||
P50DA048756-02S2 ( U.S. NIH Grant/Contract )
|First Posted:||March 11, 2021 Key Record Dates|
|Last Update Posted:||February 28, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||We will share IPD with the RADx-Up CDCC. All Tier 1 data elements required by the CDCC will be shared.|
Statistical Analysis Plan (SAP)
Informed Consent Form (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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|