Parent Study Intervention Arm
Patients randomly assigned to this arm were monitored using the investigational intensified monitoring strategy. This strategy consisted of 3-monthly viral load monitoring at month 9, 12, 15, 18, 21 and 24 (after start of ART in initiating patients or after the last viral load measurement in patients on ART). If a viral load measurement > 1000 copies/ml was detected, the patient was called back for a follow-up study visit at the next monthly medication collection visit (4 weeks after detection of elevated viral load). Upon arrival drug level testing was performed, repeated the viral load measurement, and a dried blood spot prepared and stored at room temperature. Procedures following this depended on the result of drug level testing:If drug levels were detected by drug level testing, the result of the viral load measurement was awaited. If the repeat viral load was > 1000 copies/ml, the dried blood spot was shipped directly by courier to the World Health Organization (WHO) reference laboratory for drug resistance testing. The reference laboratory provided feedback by means of a digital resistance report to the coordinating research physician. The patient would be called back for a second follow-up study visit at the next monthly medication visit (8 weeks after detection of elevated viral load), either for prescription of second-line therapy or continuation of first-line therapy, guided by the result of resistance testing.If drug level monitoring at the first follow-up visit indicated that drug levels were not detected, intensified counseling was performed at the same visit and first-line therapy was maintained, regardless of the result of the repeat viral load measurement. The patient would not be called back and the next viral load would be performed at the next scheduled 3-monthly time point. However, if the viral load result at this visit was again > 1000 copies/ml, drug resistance testing would be performed regardless of the outcome of drug level testing.The study was conducted at the Ndlovu medical centre in the rural area of Elandsdoorn where adherence among people living with HIV has not been broadly investigated, which serves the larger Moutse area, situated in the Sekhukhune District Municipality in Limpopo province. It is estimated that the area has about 140–150,000 inhabitants of whom only 4% have tertiary education [