Clinical trial NCT05082935: COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) Phase II
Official title: Optimizing SARS-CoV-2 Testing and Promotores Interventions to Serve Latinx Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Health Care Utilization
Keywords: Latinx
SARS-CoV-2
COVID-19
Hispanic
Testing
Vaccination
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2021-10-19
Enrollment: 1463
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This study will test, compare, and determine if targeted placement of testing events at venues identified each month as viable by the Oregon Health Authority, Community Based Organizations, and our community partners ("partner-optimized venue placement strategy") will increase the number of Latinx individuals who get tested. All testing events will receive the Promotores de Salud intervention, which includes Spanish/English bilingual community health workers (i.e., promotores) from the local communities delivering health information to everyone attending testing events.

Promotores will deliver the Promotores de Salud intervention and promote strategies that are effective in mitigating the spread of COVID-19. They will also emphasize the continued importance of preventive strategies given the increasing availability of vaccines and addressing vaccine hesitancy. This health information will be shared at testing events via brief verbal interactions and printed materials (i.e., brochures and infographics). The intervention will also specifically address logistical challenges associated with vaccination uptake (e.g., lack of transportation, language barriers, and difficulty locating vaccination opportunities), which are additional factors driving vaccine hesitancy among Latinx communities. The Promotores de Salud intervention was designed to build relationships with Latinx community members and facilitate trust.

To assess the proportion of Latinx community members tested at each site, the investigators will use de-identified health information from a patient registry provided to the study by the University of Oregon's (UO) COVID-19 clinical genomics laboratory, who are processing the tests. The investigators anticipate engaging a greater proportion of Latinx community members, relative to overall county demographics, at the testing events. The investigators also expect to enroll more proportionally more Latinx individuals as these events, relative to Phase I events. The overall study population is expected to be 75% Hispanic and 25% non-Hispanic, with 87% of individuals identifying as White in both ethnic groups and the remaining 13% identifying as African American, Asian, Pacific Islander, American Indian/Alaska Native, or more than one race. The investigators anticipate testing approximately 100 people per month, across 11 months and 24 events, for a total of 1,100 individuals tested. To assess health behaviors, a subset of adult participants at each testing event will be invited to participate in a research survey, administered at testing (baseline) and again 30 days later (T2). Of the 1,100 individuals tested, the team anticipates that 50% will choose to participate in the research survey for a total of 550 individual participants. Survey data from baseline to T2 will be used to examine the effectiveness of the promotores intervention, as a function of intervention fidelity.

Quality Assurance, Data Checks, Source Data Verification, Data Dictionary, and Standard Operating Procedures: Data and biospecimens will be collected in-person at testing sites, requiring direct interaction with participants. In order to report SARS-CoV-2 infection results back to each participant, name, date of birth, and contact information are collected. To fulfill reporting requirements to the Oregon Health Authority, county of residence and zip code are also collected for each person tested. Data used to evaluate the efficacy of intervention will involve aggregate variables derived from data collected as part of the diagnostic testing procedure and will be aggregated at the level of the testing site (e.g., tests performed, race and ethnicity percentages, etc.).

For the collection of SARS-CoV-2 samples, testing facilitators will guide participants in the self-collection process. For anterior nares, participants are instructed to place the nasal swab about 1cm into their nostril and rotate it, making contact with the nasal membrane for 10 seconds, then repeating the process with the same swab in the other nostril. Testing site staff can assist participants who have low dexterity or physical impairments in sample collection. In case of an injury during sample collection, the partnering community organization staff will direct the participant to the appropriate medical resources. Samples will be placed into sterile barcoded vials (1 ml Matrix, barcoded screw-cap tubes) that each contain 500 microliters (μl) of DNA/RNA Shield. Each Matrix tube will then be closed tightly and will be placed in a standard plastic laboratory microcentrifuge tube rack with eight rows and twelve columns (8-by-12 rack with 96 positions). This rack will then be externally decontaminated by brief submersion in accelerated hydrogen peroxide (H202). Each 96-position microcentrifuge tube rack will then be labeled and placed in a sterile temporary container with an icepack. At the end of the day all racks will be transported to the COVID-19 clinical genomics Laboratory at UO, ensuring that they will arrive no longer than 48 hours after collection.

Each 96 well collection plate will next proceed to molecular processing using the standard, FDA approved Thermo Fisher TaqPath or Diacarta Quantivirus analysis protocols, which are similar nucleic acid amplification tests (NAAT). All steps of this approved protocol will be followed exactly, including the appropriate reagents, volumes, inclusion of appropriate positive and negative controls and the software analysis system and parameters. Hamilton liquid handling robots (Hamilton, Microlab VANTAGE 2.0) are used to aliquot from 96 tube matrix racks and for subsequent qPCR amplification. All laboratory assays and reporting will be automated through the use of barcodes, robotics, 96 and 384 well qPCR machines, and the use of a fully HIPAA and CAP3 compliant Laboratory Information Management System (LIMS) built by L7 informatics (https://l7informatics.com/), which organizes and relays information from lab instruments to secure databases. The results for each sample, and associated metadata, are then associated with each assigned barcode and can then be disseminated, as appropriate, to the Oregon Health Authority, the appropriate county health department, and the individual. Test results will be available within 48 hours and no later than 4 days to the individual and/or the health authority. After testing occurs, researchers will have access to aggregate, community-level (e.g., counts and prevalence rates), de-identified data prepared by the data managers in collaboration with the UO's CLIA clinical genomics laboratory. The data will include three protected health identifiers: site zip code, participant zip code, and testing date. It will also include demographic data this is not protected health information such as age range, race, and ethnicity. These data will be used to assess outreach activities aimed at increasing participation of Latinx community members in SARS-COV-2 testing. The primary outcome for this aspect of the study is site-level testing rates of Latinx individuals.

Sample Size Assessment, Plan for Missing Data, Statistical Analysis Plan: To test the hypothesis that partner-optimized venue placement (Phase II) yields more Latinx individuals tested than placement of sites based upon residential density (Phase I), analyses will employ comparative effectiveness research approaches (CER) using a clustered quasi-experimental comparison of our implementation outreach. These analyses comprise two study arms to compare the number of Latinx tested between top-performing Phase I sites (census geo-located venue placement) contrasted with Phase II (partner-optimized venue placement). The primary outcome for partner-optimized venue placement will be the number of Latinx tested specified as a generalized linear multilevel count of test samples collected, nesting events over time within site locations. To address internal validity threats to the quasi-experimental design, study investigators will employ propensity score matching procedures for all pooled data analyses comparing the two conditions. Primary analyses are powered to detect medium effects.

To test the hypothesis that accurate and culturally tailored information delivered by promotores at testing events will result in individual level outcomes, study investigators will evaluate whether implementation fidelity of the Promotores de Salud health intervention will improve testing, reduce vaccination hesitancy, and increase vaccine acceptance and improve health literacy. Social determinants of testing and vaccination analyses will focus on the contextual determinants of pre-post change in the likelihood of vaccination, repeated testing for those unvaccinated, and reduced vaccine hesitancy. Analyses will focus on within-intervention group pre-post change specified as linear mixed models for vaccine hesitancy and generalized linear mixed models for testing counts and vaccine acceptance. These analyses are powered to detect small to moderate effects.

Two primary sources of missing data are expected, item non-response and attrition over time. For dropout, investigators will conduct standard attrition analyses to compare baseline characteristics between attriters and completers. They will consider propensity score matching procedures and complier average causal effects models to address substantial differences. For item non-response and scale score development, investigators will require 70% of scale items be present for scoring. They will test whether scale level data are missing completely at random (MCAR) within waves and then across waves. If data are not MCAR, under assumptions of missing at random (MAR, i.e., data are not dependent on missing values of the intervention response variable), investigators will employ one of two recommended approaches for SEM, full information maximum likelihood (FIML) or multiple imputation (MI). Although these approaches can be problematic when data are non-ignorable missing, they are still recommended for handling missingness, particularly with covariates associated with attrition. Both methods provide more efficient standard errors than listwise or pairwise deletion, or mean substitution. Should missing data or attrition be associated with covariates, investigators will include appropriate covariates in hypothesis testing.

Finally, data will be collected in accordance with Tier 1 "common data elements" from the national Duke Coordination and Data Collection Center (CDCC). The CDCC directly assists each individual RADx-UP project to optimize engagement, outreach, testing strategies, and to facilitate co-learning opportunities between and among RADx-UP projects. Key outcome data and the testing procedures for obtaining the sample, analysis platform, analysis procedures, and test resulting will be collected and represented in a consistent manner for harmonization across the consortium, integrated with test reporting requirements under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Testing Barriers and Hesitancy
timeFrame: Change from baseline to 30 days
measure: Vaccination Attitudes Examination (VAX) Scale
timeFrame: Change from baseline to 30 days
measure: COVID-19 Prevention Health Behaviors
timeFrame: Change from baseline to 30 days
measure: COVID-19 Knowledge and Attitudes 1
timeFrame: Change from baseline to 30 days
measure: COVID-19 Knowledge and Attitudes 2
timeFrame: Change from baseline to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Leslie D Leve, PhD
role: PRINCIPAL_INVESTIGATOR
References: