跳至主要内容
临床试验/NCT04793464
NCT04793464已完成不适用

Scaling Up SARS-CoV-2 Testing to Serve Latinx Communities

University of Oregon2 个研究点 分布在 1 个国家目标入组 1,623 人开始时间: 2021年2月4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
1,623
试验地点
2
主要终点
COVID-19 Prevention Health Behaviors 2

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. 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).

详细描述

A total of 38 communities have established a testing site with testing events held every other week (bi-weekly). The study randomized counties at the site level within county. The investigators used a priori stratification by county as sample size is small. Half of all sites in a county were assigned to the control condition (services as usual), and the other half to the intervention condition (Promotores de Salud). Randomly assigned communities receive one of two outreach strategies: Services as usual (culturally tailored flyers, radio announcements, social media posts, health behavior pamphlet on site) or services as usual plus the Promotores de Salud intervention, where a paid, trusted community member reaches out to community members to motivate them to utilize the free testing services and improve COVID-19 related health behaviors. 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 provided to the study by the University of Oregon's (UO) COVID-19 clinical genomics laboratory, who are processing the tests. To assess health behaviors, a subset of adult participants at each site will be invited to participate in a research survey, administered at baseline and again 30 days later. For both approaches, the study anticipates engaging a greater proportion Latinx community members, relative to overall county demographics. The overall study population is expected to be 85% Hispanic and 15% non-Hispanic, with 84% of individuals identifying as White in both ethnic groups and the remaining 16% identifying as African American, Asian, Pacific Islander, American Indian/Alaska Native, or more than one race. There will be 19 sites per study group (38 total) and up to roughly 3,600 adult individuals in the intervention (n = 1,800) or control conditions (n = 1,800).

This study also leverages data from a patient registry from the University of Oregon's COVID-19 clinical genomics laboratory.

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. Parents are instructed to collect the sample for their child if the child is under 10 years old, or if the minor child requests parental assistance. 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 wet ice at 4Cdegrees. If possible at each site, racks will be periodically transferred either to a refrigerator (4C) or freezer (-20C) for storage. At the end of the day all racks will be transported on wet ice to the COVID-19 clinical genomics Laboratory at UO, ensuring that they will arrive no longer than 48 hours after collection and preferably within 12-24 hours. If the testing site is located too distally for hand transport, tube racks will be secured and shipped by express methods on dry ice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

COVID-19 Prevention Health Behaviors 2

时间窗: 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 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.

COVID-19 Knowledge and Attitudes 1

时间窗: 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 to "Close contact with an infected person who has symptoms". Counts of 'yes' responses are given.

COVID-19 Knowledge and Attitudes 4

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

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.

Attitudes Towards COVID-19 Vaccines

时间窗: 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 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.

COVID-19 Prevention Health Behaviors 1

时间窗: 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 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.

COVID-19 Knowledge and Attitudes 2

时间窗: 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 to 'Close contact with an infected person even if they aren't showing symptoms of infection'. Counts of 'yes' responses are provided.

COVID-19 Knowledge and Attitudes 3

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

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.

次要结局

  • Broadband Internalizing Symptoms(Change from baseline symptoms at 30 days)

研究者

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

Leslie Leve,

Lorry Lokey Professor, College of Education; Associate Director, Prevention Science Institute

University of Oregon

研究点 (2)

Loading locations...

相似试验