effect of readytouse supplementary food on mortality in severely immunocompromised hivinfected individuals in africa initiating antiretroviral therapy reality an openlabel parallelgroup randomised controlled trial background in subsaharan africa severely immunocompromised hivinfected individuals have a high risk of mortality during the first few months after starting antiretroviral therapy art we hypothesise that universally providing readytouse supplementary food rusf would increase early weight gain thereby reducing early mortality compared with current guidelines recommending readytouse therapeutic food rutf for severely malnourished individuals onlymethods we did a 222 factorial openlabel parallelgroup trial at inpatient and outpatient facilities in eight urban or periurban regional hospitals in kenya malawi uganda and zimbabwe eligible participants were artnaive adults and children aged at least 5 years with confirmed hiv infection and a cd4 cell count of fewer than 100 cells per l who were initiating art at the facilities we randomly assigned participants 11 to initiate art either with rusf or without norusf 12 weeks of peanutbased rusf containing 1000 kcal per day and micronutrients given as two 92 g packets per day for adults and one packet 500 kcal per day for children aged 512 years regardless of nutritional status in both groups individuals received supplementation with rutf only when severely malnourished ie bodymass index bmi 07 through 48 weeks adults and adolescents aged 13 years and older in the rusf group had significantly greater gains in weight bmi and muac than the norusf group p0004 0004 and 003 respectively the most common type of serious adverse event was specific infections occurring in 90 10 of 897 participants assigned rusf and 87 10 of 908 assigned norusf by week 48 205 participants had serious adverse events in both groups p081 and 181 had grade 4 adverse events in the rusf group compared with 172 in the nonrusf group p045interpretation in severely immunocompromised hivinfected