Follow-up procedures for ART monitoring in the community (smart locker) and home delivery groups
BLOOD
Blood specimens will be collected for viral load and creatinine monitoring according to national guidelines. In the smart locker group, participants will self-collect DBS for viral load testing. In the home ART delivery group, specimens will either be collected by staff or, for no contact deliveries, by participants. For participants on fixed dose combination TDF/3TC/DGT, the first-line regimen in South Africa, safety labs will consist of viral load monitoring at months 6 and 12 and creatinine monitoring following local guidelines. Creatinine monitoring will be conducted using the StatSensor. If the StatSensor is not available, 5mL of blood will be collected for creatinine testing in the lab and the result made available to the participant. Participants with significantly raised creatinine levels (an increase of >0.5 mg/dL) will be referred to the clinic for investigation and management.HIV viral load testing will use the gold standard PCR viral load test, using plasma or DBS specimen) or the validated Xpert assay. The viral load result will be made available to the participant, with counseling to help with the interpretation of the result.Participants will receive a non-identifying text message within 1 week to communicate that “all is going well” (i.e., if their viral load is suppressed), contacting them to have additional adherence counseling—“contact us for more information” (i.e., if first viral load not suppressed), or asking them to come into the clinic for assessment for treatment failure (i.e., if two viral loads are not suppressed following intervening adherence counseling). Adherence counseling for participants with VL > 1500 copies/mL will identify barriers and strategies to increase ART adherence.If indicated by local guidelines, cotrimoxazole (Bactrim) and/or isoniazid prophylaxis will be provided to participants following national guidelines and for whom it is not contra-indicated. At each study visit, female participants will be asked about pregnancy and referred for antenatal care if they report missed periods and/or signs or symptoms of pregnancy. They will be encouraged to remain on ART to decrease the risk for mother to child transmission of HIV. Pregnant participants are eligible to remain in the study and will continue to have follow-up visits.