9. DATA ANALYSIS/STATISTICAL METHODS 9.1. Sample Size Determination Based on a pre and post ART assessment in Burkino Faso and Uganda we anticipate that the quality of life score (MOS-HIV) in ART naïve patients will increase at least by 15 points for physical health summary (PHS) between baseline and 12 months ART use (34, 35). We estimate there will be an additional 5 points improvement in those receiving C4LTM which would give 20 point improvement for those on C4LTM and 15 points for those not on call for Life. In those already on ART we estimate an improvement for those established on ART with a 5 point improvement for those on C4LTM and nil for those not accessing C4LTM. We also estimate a 5 point increase in mental health score in those receiving C4LTM compared to no change in those without C4LTM starting ART, and a lower improvement of 2 points in mental health score in those already on ART. The study is powered on the PHS for QOL. For a power of 0.9 and precision of 0.05 we would need a minimum of 273 in each arm (overall 546) patients, if the mean PHS among patients with C4L was 58.2 compared to 55.2 among patients without C4L. We will include a 10% LTFUP/mortality rate to give a sample size of 600.