Criteria for discontinuing or modifying allocated interventions {11b}
tuberculosis
OPPORTUNISTIC INFECTIONS, ADVERSE EVENTS, TUBERCULOSIS, STIS, ADVERSE EFFECTS, ADVERSE EVENT
Participants will be encouraged to visit the clinic for medical concerns outside of ART monitoring and adherence counseling. During participant ART resupply and monitoring visits, they will complete a standardized symptom screening questionnaire for adverse effects of ART, tuberculosis, opportunistic infections, and STIs. Furthermore, all participants on TDF/FTC or 3TC/TDF will receive the standard ART lab monitoring, including a creatinine test to monitor their renal function. Participants who have severe (grade 3/4) adverse effects, according to the DAIDS guidelines and serious adverse effects, will be referred to the clinic for medical evaluation and appropriate diagnostic testing. We have established relationships with the clinics who expect to see study participants. All participants who experience adverse events will receive follow-up until the adverse event is resolved. The SMART ART study clinical monitor, based at the University of Washington Coordinating Center, will review all severe (grade 3/4) and serious adverse events to ensure follow-up and reporting. Participants who have two viral loads with >1500 copies/mL will be referred to the participating local HIV clinic(s) for evaluation for drug resistance and initiation of second-line ART. Participants who are referred back to the clinic will continue to receive their study follow-up visits and can return to home delivery or smart locker delivery with ART monitoring and refills once they are clinically stable.