Recruitment, consent, and randomization
After identification by study coordinators, a clinician will ask potential participants if they are interested or willing to participate in the study. Those who are interested in the study will be introduced to a research coordinator to discuss the study and assess eligibility. Those who do not agree to participate will continue with their routine clinical care. Potential participants who become aware of the study through social media, adverts or peers, will call or email the research coordinators at the phone number or email address provided in the advertisements or posts. If the person is eligible, they will be invited to the CRU.Informed consent and all other study procedures will be obtained and performed in accordance with the relevant guidelines and regulations of the Johns Hopkins University (JHU) and the Declaration of Helsinki [After obtaining written informed consent, the participant will be randomly assigned, by the study manager or principal investigator, to either the control or the intervention arm and notified of their assignment by the research coordinator. Randomization will be determined using the online software, Sealed Envelope Ltd©, and will be overseen by the study manager.