Adverse event reporting and harms {22}
nausea and vomiting, tuberculosis, gastrointestinal disturbance
OPPORTUNISTIC INFECTIONS, ADVERSE EVENTS, TUBERCULOSIS, STIS, ADVERSE EFFECTS, ADVERSE EVENT, EVENTS
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. Serious adverse events (SAEs) will be documented and reported to involved regulatory bodies per their regulations. Serious adverse events will also be reported to the UW ICRC Coordinating Centre Clinical Monitor, who will track the events until resolved. SAE reports will be reviewed to determine if the SAE could have been avoided.Participants who initiate ART and who will collect ART refills from the mobile van will receive a phone call 1 week and 30 days after ART initiation to enquire about adverse events and refer participants to the clinic for evaluation if necessary. 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/EFV will receive the standard ART screening, including a creatinine test to monitor their renal function, at mobile van visits. Clinical side effects of TDF/FTC or 3TC/EFV include gastrointestinal disturbance (nausea and vomiting) and vivid dreams. Participants will be referred to the clinic for symptoms or signs requiring further investigation and/or treatment. We have established relationships with the clinics who expect to see study participants.All cases of social harm for participants will be documented. To ensure we are aware of all cases of adverse events associated with HIV results, we will ask each participant specifically about any social harm experienced as a result of learning HIV results at the follow-up visits. Staff will gather additional information about social harm for reports. Study staff are well versed in community-based organizations where individuals and couples can access on-going psychological support and help in case of gender violence and will provide information about these organizations to individuals and couples as needed. In addition to providing specific counseling, staff will refer participants for support to local organizations. The study teams have trained staff able to handle crisis situations due to couple conflict or difficulties in coping with positive HIV test results.