Noe C. Crespo , Job Godino , Alma Behar , Patricia Dionicio , Carolina Lopez de la Torre , Kiria Fraga , Marco Santoscoy , John P. Elder , Eyal Oren , Chii-Dean Lin , Elva M. Arredondo , Hala Madanat , Christian B. Ramers
{"title":"COVID-19预防计划:针对拉丁美洲人预防COVID-19家庭和社区传播的量身定制行为干预的基本原理和方法。","authors":"Noe C. Crespo , Job Godino , Alma Behar , Patricia Dionicio , Carolina Lopez de la Torre , Kiria Fraga , Marco Santoscoy , John P. Elder , Eyal Oren , Chii-Dean Lin , Elva M. Arredondo , Hala Madanat , Christian B. Ramers","doi":"10.1016/j.cct.2025.108046","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>COVID-19 has disproportionately affected underserved communities, such as Latinos living in the U.S. <em>Promotoras</em> (Community Health Workers) may be effective at delivering tailored and culturally relevant strategies to prevent household spread and the burden of SARS-CoV-2 among Latinos and other minority groups.</div></div><div><h3>Purpose</h3><div>To develop, implement, and test the clinic-based <em>promotora</em>-led COVID-19 Prevention Program (CPP) to reduce transmission of SARS-CoV-2 in 256 Latino households and the community.</div></div><div><h3>Design</h3><div>CPP is a two-group randomized controlled trial designed to test the immediate, mid-term, and long-term effectiveness of the <em>promotora-</em>led intervention, as well as test its effectiveness on short- and long-term behavioral, mental, and physical health outcomes. The primary outcome is household infection rate assessed at 6 weeks and 6-, 12-, and 24-months based on a binary indicator (yes vs. no) of evidence of a new infection via antigen, real-time reverse transcriptase-polymerase chain reaction (RT-PCR), or antibody SARS-CoV-2 test results within household members. Patients in the intervention group will receive enhanced standard-of-care, including tailored, real-time text messaging and virtual counseling, delivered by <em>promotoras</em>. Patients in the control group will receive the clinical standard of care. Analyses will test for household-level group differences in new infections related to an identified index case.</div></div><div><h3>Discussion</h3><div>Preventing household spread of SARS-CoV-2 is an important strategy to reduce the overall burden of SARS-CoV-2 among Latinos. The CPP is a scalable and tailored approach that has the potential to serve as a model to address future respiratory disease outbreaks, especially among uninsured, low-income, and medically underserved communities.</div><div>Trial registration: <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> Identifier <span><span>NCT05697068</span><svg><path></path></svg></span> (1/20/2023).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108046"},"PeriodicalIF":1.9000,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"COVID Prevention Program: Rationale and methodology of a tailored behavioral intervention to prevent household and community spread of COVID-19 among Latinos\",\"authors\":\"Noe C. Crespo , Job Godino , Alma Behar , Patricia Dionicio , Carolina Lopez de la Torre , Kiria Fraga , Marco Santoscoy , John P. Elder , Eyal Oren , Chii-Dean Lin , Elva M. Arredondo , Hala Madanat , Christian B. Ramers\",\"doi\":\"10.1016/j.cct.2025.108046\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>COVID-19 has disproportionately affected underserved communities, such as Latinos living in the U.S. <em>Promotoras</em> (Community Health Workers) may be effective at delivering tailored and culturally relevant strategies to prevent household spread and the burden of SARS-CoV-2 among Latinos and other minority groups.</div></div><div><h3>Purpose</h3><div>To develop, implement, and test the clinic-based <em>promotora</em>-led COVID-19 Prevention Program (CPP) to reduce transmission of SARS-CoV-2 in 256 Latino households and the community.</div></div><div><h3>Design</h3><div>CPP is a two-group randomized controlled trial designed to test the immediate, mid-term, and long-term effectiveness of the <em>promotora-</em>led intervention, as well as test its effectiveness on short- and long-term behavioral, mental, and physical health outcomes. The primary outcome is household infection rate assessed at 6 weeks and 6-, 12-, and 24-months based on a binary indicator (yes vs. no) of evidence of a new infection via antigen, real-time reverse transcriptase-polymerase chain reaction (RT-PCR), or antibody SARS-CoV-2 test results within household members. Patients in the intervention group will receive enhanced standard-of-care, including tailored, real-time text messaging and virtual counseling, delivered by <em>promotoras</em>. Patients in the control group will receive the clinical standard of care. Analyses will test for household-level group differences in new infections related to an identified index case.</div></div><div><h3>Discussion</h3><div>Preventing household spread of SARS-CoV-2 is an important strategy to reduce the overall burden of SARS-CoV-2 among Latinos. 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COVID Prevention Program: Rationale and methodology of a tailored behavioral intervention to prevent household and community spread of COVID-19 among Latinos
Background
COVID-19 has disproportionately affected underserved communities, such as Latinos living in the U.S. Promotoras (Community Health Workers) may be effective at delivering tailored and culturally relevant strategies to prevent household spread and the burden of SARS-CoV-2 among Latinos and other minority groups.
Purpose
To develop, implement, and test the clinic-based promotora-led COVID-19 Prevention Program (CPP) to reduce transmission of SARS-CoV-2 in 256 Latino households and the community.
Design
CPP is a two-group randomized controlled trial designed to test the immediate, mid-term, and long-term effectiveness of the promotora-led intervention, as well as test its effectiveness on short- and long-term behavioral, mental, and physical health outcomes. The primary outcome is household infection rate assessed at 6 weeks and 6-, 12-, and 24-months based on a binary indicator (yes vs. no) of evidence of a new infection via antigen, real-time reverse transcriptase-polymerase chain reaction (RT-PCR), or antibody SARS-CoV-2 test results within household members. Patients in the intervention group will receive enhanced standard-of-care, including tailored, real-time text messaging and virtual counseling, delivered by promotoras. Patients in the control group will receive the clinical standard of care. Analyses will test for household-level group differences in new infections related to an identified index case.
Discussion
Preventing household spread of SARS-CoV-2 is an important strategy to reduce the overall burden of SARS-CoV-2 among Latinos. The CPP is a scalable and tailored approach that has the potential to serve as a model to address future respiratory disease outbreaks, especially among uninsured, low-income, and medically underserved communities.
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.