Ethics approval and consent to participate
ADVERSE EVENTS
This multi-site collaborative study is approved by the Yale institutional review for all participating sites (IRB protocol ID: 2000032184, Version 7.0, March 6, 2023). The Data Safety and Monitoring Board reviews study progress, experiences and adverse events, biannually. Consent forms in English and Spanish have been developed for interview and focus group participants and stuff/implementers (see Supplemental File 4). Survey responses will be recorded under randomly generated alphanumeric codes. Such a procedure ensures voluntary consent while ensuring that the respondent’s name never appears on either the consent form or the survey instrument. We will not include any identifiable information on any reports, presentations or publication that may ensue from this study. After the entire study is completed, all identifying contact information will be destroyed. All study databases will be de-identified and archived at the Inter-university Consortium for Political and Social Research. In addition, we will train personnel in each of our community-based organizations implementing components of the intervention in informed consent procedures and confidentiality. All methods will be carried out in accordance with relevant guidelines and regulations (Declaration of Helsinki).