Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations
Enhancing Rapid Health Response in National Crises: Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations Through Community-Academic Partnerships
調査の概要
状態
詳細な説明
Accurate and early diagnosis of COVID-19 infections are critical for rapid initiation of quarantine interventions to reduce population spread and to provide appropriate medical care to reduce related morbidity and mortality during the current pandemic. The purpose of this study is to assess the feasibility of establishing a drive-through rapid COVID-19 testing site at a federally-qualified health center (FQHC) during a global health crisis to mitigate health consequences in socioeconomically disadvantaged populations. The investigators also seek to evaluate the effectiveness of community-driven communication in increasing access to rapid testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in this population. This will inform public health decisions about improving access to testing for SARS-CoV-2 in underserved populations, particularly those receiving care in FQHCs or community health centers.
The specific aims of the study are to:
Aim 1. To determine the feasibility of a community-engaged research partnership to support rapid SARS-CoV-2 testing for symptomatic patients of all ages in the underserved population during the COVID-19 crisis. A rapid testing strategy (drive-through testing site) at a FQHC using Mayo Clinic Laboratory (MCL) diagnostic processing will be piloted.
Aim 2. To compare the effectiveness of community-driven messaging in increasing uptake of rapid SARS-CoV-2 testing compared with usual sources of health information. A simple random sample will be drawn of FQHC patients (N=1000, age 18+) with 1:1 randomization of communication about COVID-19 and availability of rapid testing from the FQHC versus usual sources (control).
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- This study will include all patients receiving clinically indicated testing for COVID-19 at a federally qualified health center (FQHC, Open Cities Health Center, St. Paul, MN).
- There will be no formal recruitment of patients in this research.
Exclusion Criteria:
-
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Observational Intervention
Rapid SARS-CoV-2 testing strategy
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Rapid testing strategy at an FQHC using Mayo Clinic Laboratory (MCL) diagnostic processing with a real-time polymerase chain reaction assay for SARS-CoV-2 and a Mayo Clinic drive-through collection protocol.
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Behavioral Intervention
Community-driven messages to promote COVID-19 testing
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A one-time communication about the availability of COVID-19 testing at the FQHC to patients randomized to the intervention group using any available means of communication (text and/or mailed letter).
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intervention Feasibility Measures - FQHC Staff
時間枠:6-months after intervention start
|
FQHC staff will complete a comprehensive electronic survey adapted from the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) instrument to assess feasibility of community-engaged research partnership to support testing site (Weiner BJ, et al.
Implementation Science.
2017;12(1):108.).
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6-months after intervention start
|
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2. Uptake of rapid SARS-CoV-2 testing strategy at the FQHC- Effectiveness of community-driven messaging to patients
時間枠:6-months after intervention start
|
Comparison of number of tests completed per group (intervention vs. control)
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6-months after intervention start
|
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Uptake of rapid SARS-CoV-2 testing strategy at the FQHC
時間枠:9-months after intervention start
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Comparison of number of tests completed per group (intervention vs. control)
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9-months after intervention start
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intervention Satisfaction Measures - Participant Satisfaction with COVID-19 testing
時間枠:6-months after intervention start
|
All randomized patients will complete a comprehensive survey with questions probing satisfaction with the drive-through testing site (ease of use, process, return of results, etc.).
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6-months after intervention start
|
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5. Intervention Satisfaction Measures - Participant Satisfaction with community-driven messaging
時間枠:6-months after intervention start
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Compare the satisfaction of community-driven messaging on availability of rapid SARS-CoV-2 testing at the FQHC (intervention vs. control)
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6-months after intervention start
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協力者と研究者
スポンサー
捜査官
- 主任研究者:LaPrincess C Brewer, MD, MPH、Mayo Clinic
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 20-004046
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。