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.

Trial Registration: Clinicaltrials.gov Identifier NCT05697068 (1/20/2023).