Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
To ensure the confidentiality of participants, all data will be coded by subject number. Data recorded on paper will be kept in locked cabinets with access only by members of the research team. There will be strict limited access to electronically stored data as well, using password protection. Research records will be kept confidential following national regulations. The subject’s name or other personal identifiers will not be included with specimens sent to the laboratory, which will be identified only by a code number. Interviewers and support staff will be trained on procedures for maintaining confidentiality. Text messages will be neutral and not contain information about the participant’s HIV status, e.g., appointment reminders will say “Your appointment is on Tuesday at 3pm”. At each visit, staff will ask about social harms, complete a detailed report, link the participant to community resources for support, and report social harms to the ethics review board. If multiple social harms are observed, the study procedures and text message content will be reviewed by the study team and community advisory boards and recommended changes submitted to regulatory bodies for review.The recorded in-depth interviews will be transcribed and, for interviews conducted in isiZulu, then translated to English. As part of the transcription and translation, investigators will delete any identifying information to ensure the final transcripts protect confidentiality. Recordings will be stored in password-protected files on a secure, firewalled server at the HSRC and the study site in South Africa. Only the research team, the translator, and the transcriptionist will be permitted access.