How is the safety of the patients on ARVs monitored?
All participants in DART are monitored in the same way. They routinely visit the clinic once a month but can additionally visit the clinic if the need arises. On a scheduled visit they are seen by the counsellors and nurses, who evaluate them and may recommend them to see a doctor. Otherwise they routinely see a doctor every three months. On a routine visit, they have blood taken for CD4 count and other tests including kidney and liver function. These tests are available to the clinicians for participants in the LCM arm but those of the CMO arm are not returned to the clinicians unless they show severe side-effectsA small group of independent experts regularly monitors the results in the LCM and CMO groups. Each time they have recommended the study continue. If either group were clearly doing worse, they would recommend closing the trial. This has happened with the STI study within DART.
