CASCADIA: a prospective community-based study protocol for assessing SARS-CoV-2 vaccine effectiveness in children and adults using a remote nasal swab collection and web-based survey design.

INTRODUCTION: Although SARS-CoV-2 vaccines were first approved under Emergency Use Authorization by the Food and Drug Administration in late 2020 for adults, authorisation for young children 6 months to <5 years of age did not occur until 2022. These authorisations were based on clinical trials, understanding real-world vaccine effectiveness (VE) in the setting of emerging variants is critical. The primary goal of this study is to evaluate SARS-CoV-2 VE against infection among children aged >6 months and adults aged <50 years. METHODS: CASCADIA is a 4-year community-based prospective study of SARS-CoV-2 VE among 3500 adults and paediatric populations aged 6 months to 49 years in Oregon and Washington, USA. At enrolment and regular intervals, participants complete a sociodemographic questionnaire. Individuals provide a blood sample at enrolment and annually thereafter, with optional blood draws every 6 months and after infection and vaccination. Participants complete weekly self-collection of anterior nasal swabs and symptom questionnaires. Swabs are tested for SARS-CoV-2 and other respiratory pathogens by reverse transcription-PCR, with results of selected pathogens returned to participants; nasal swabs with SARS-CoV-2 detected will undergo whole genome sequencing. Participants who test positive for SARS-CoV-2 undergo serial swab collection every 3 days for 21 days. Serum samples are tested for SARS-CoV-2 antibody by binding and neutralisation assays. ANALYSIS: The primary outcome is SARS-CoV-2 infection. Cox regression models will be used to estimate the incidence rate ratio associated with SARS-CoV-2 vaccination among the paediatric and adult population, controlling for demographic factors and other potential confounders. ETHICS AND DISSEMINATION: All study materials including the protocol, consent forms, data collection instruments, participant communication and recruitment materials, were approved by the Kaiser Permanente Interregional Institutional Review Board, the IRB of record for the study. Results will be disseminated through peer-reviewed publications, presentations, participant newsletters and appropriate general news media.

Developing Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program in a Latino-Based Community Health Center.

INTRODUCTION: Colon cancer is the second leading cause of cancer death in the United States, and screening rates are disproportionately low among Latinos. One factor thought to contribute to the low screening rate is the difficulty Latinos encounter in understanding health information, and therefore in taking appropriate health action. Therefore, we used Boot Camp Translation (BCT), a patient engagement approach, to engage Latino stakeholders (ie, patients, clinic staff) in refining the messages and format of colon cancer screening reminders for a clinic-based direct mail fecal immunochemical testing (FIT) program. METHODS: Patient participants were Latino, ages 50 to 75 years, able to speak English or Spanish, and willing to participate in the in-person kickoff meeting and follow-up phone calls over a 3-month period. We held separate BCT sessions for English- and Spanish-speaking participants. As part of the in-person meetings, a bilingual colon cancer expert presented on colon health and screening messages and BCT facilitators led interactive sessions where participants reviewed materials and reminder messages in various modalities (eg, letter, text). Participants considered what information about colon cancer screening was important, the best methods to share these messages, and the timing and frequency with which these messages should be delivered to patients to encourage FIT completion. We used follow-up phone calls to iteratively refine materials developed based on key learnings from the in-person meeting. RESULTS: Twenty-five adults participated in the in-person sessions (English [n = 12]; Spanish [n = 13]). Patient participants were primarily enrolled in Medicaid/uninsured (76%) and had annual household incomes less than $20,000 (67%). Key themes distilled from the sessions included increasing awareness that screening can prevent colon cancer, stressing the urgency of screening, emphasizing the motivating influence of family, and using personalized messages from the practice such as 'I' or 'we' statements in letters or automated phone call reminders delivered by humans. Participants in both sessions noted the importance of receiving an automated or live alert before a FIT kit is mailed and a reminder within 2 weeks of FIT kit mailing. DISCUSSION: Using BCT, we successfully incorporated participant feedback to adapt culturally relevant health messages to promote FIT testing among Latino patients served by community clinics. Materials will be tested in the larger Participatory Research to Advance Colon Cancer Prevention (PROMPT) trial.