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临床试验/NCT05082935
NCT05082935已完成不适用

Optimizing SARS-CoV-2 Testing and Promotores Interventions to Serve Latinx Communities

University of Oregon2 个研究点 分布在 1 个国家目标入组 1,463 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,463
试验地点
2
主要终点
Testing Barriers and Hesitancy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Testing Barriers and Hesitancy

时间窗: Change from baseline to 30 days

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).

Vaccination Attitudes Examination (VAX) Scale

时间窗: Change from baseline to 30 days

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).

COVID-19 Prevention Health Behaviors

时间窗: Change from baseline to 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 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.

COVID-19 Knowledge and Attitudes 1

时间窗: Change from baseline to 30 days

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.

COVID-19 Knowledge and Attitudes 2

时间窗: Change from baseline to 30 days

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leslie Leve,

Professor and Lorry Lokey Chair, College of Education; Associate Director, Prevention Science Institute; Associate Vice President for Research

University of Oregon

研究点 (2)

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