Evaluation of an Intensified Treatment Monitoring Strategy to Prevent Accumulation and Spread of HIV-1 Drug Resistance in Low- and Middle-income Countries (ITREMA).

This study will enroll adult HIV-1 infected patients who are about to initiate or have already initiated first-line ART. Patient enrollment and randomization will be performed at two different time points. Timing and criteria for enrollment and randomization are as follows:

1. ART naïve patients: Patients are eligible for enrollment initiation of treatment with first-line ART. Randomization is performed after availability of the first routine viral load measurement, performed at month 6 of treatment.
2. Patients on ART: Patients are eligible for enrollment after ≥ 1 year of virologically suppressive first-line ART and only if a last viral load with a result <1000 copies/mL was performed within the last 6 months. Randomization is performed 6 months after the last viral load (VL) result.

A total number of 600 patients will be randomized into two trial arms. The trial will be conducted on-site at one of the clinical facilities of Ndlovu Care Group (http://www.ndlovucaregroup.co.za/), one of the partners in the project. This facility, Ndlovu Medical Centre, is situated in the town of Elandsdoorn, Limpopo, South Africa, and provides medical service to local South African patients who are unable to pay medical insurance. The Ndlovu Care Group distributes antiretroviral medication in the framework of the South African Department of Health antiretroviral treatment programme. This clinic is currently providing ART to >3600 patients. Patients on ART return to the clinic monthly for collection of medication, pill count and adherence counselling, which allows intensification of monitoring without substantial change of the infrastructure or frequency of visits.

After randomisation, patients in both study arms will return for study follow-up visits on a three-monthly basis, at month 9, 12, 15, 18, 21 and 24 after start of ART or after the last VL measurement. In addition, patients will be called back for additional study visits (max. 2) in case of a detected viral load >1000 copies/ml during any of these visits. All visits in both arms, including aforementioned additional call back visits will coincide with standard of care medication collection visits to the clinic. In case of a switch to second-line therapy, patients in both arms will continue three-monthly follow-up visits in an observational manner, and guidelines for monitoring of second-line therapy are followed.

Control arm: