Efficacy assessment The primary measure of efficacy for the randomized clinical trial is the time to ART eligibility and the time to CD4 counts of less than 200 and 350 cells/mm3. Secondary measures of efficacy will include changes in WHO Clinical Staging, development of IRIS, time to hospitalization, time to death, time to initiation of ARVs and CD4 response to ARVs as well as the development of IRIS among those who initiate ARVs.