Follow-up procedures for participants in the home ART group
ADVERSE EVENTS, ADVERSE EVENT
Follow-up visits at months 9, 12, and 15 will take place at the home or a location of the participant’s choice. Appointments for the home delivery, i.e., date and time that it will be available at home or a location easily accessible to the participants for follow-up, will be made at the time of ART initiation. Appointments will be made prior to ART supply running out, and confidential, neutral text message reminders will be provided for participants who have access to private messaging and phone calls. Participants will be able to reschedule their appointments by text message. Contact information will be provided for study staff, who participants can contact with questions. Clinic details will be provided to the participant who can contact the clinic at any time.At the follow-up visits, participants will have their identification confirmed and GPS location collected, complete a questionnaire including adverse event and social harm screening, complete labs for ART and TPT monitoring, and collect ART resupply, and counselors will answer questions and provide support for HIV care. Participants will have their blood pressure measured if indicated. Participants will receive counseling and be referred to local clinics for further evaluation and treatment as needed. Participants will complete a questionnaire on clinical review, their experience accessing care, including barriers to care, linkage to care, uptake of ART, adherence, adverse events, lab testing, social harms, risk behavior, cost of engaging in care, HIV clinical care, and knowledge about HIV treatment for clinical and prevention benefits. Deliveries may be conducted as no-contact deliveries, with visits via telehealth and self-collected DBS specimens for monitoring if COVID-19 restrictions or other limitations on mobility are put in place.