Data monitoring: Interim analysis
INFECTIOUS DISEASES, INFECTIOUS DISEASE
The first interim analysis will be conducted when 50% of the participants complete the study medication. Trial monitoring is conducted independent of the investigators by internal monitors at the Infectious Diseases Institute. The Trial Steering Committee is composed of Stavia Turyahabwe, program manager at the NTP in Uganda; Angom Esther, Nurse in charge at Lira Regional Referral Hospital; Dr Agnes Kiragga, a senior statistician with experience in HIV clinical trials and cohort studies; and Elizabeth Tindyebwa, a lay representative from the Friends’ Council (patient group) at the Infectious Disease Institute, Uganda. Since this trial is unblinded, the DMB will have access to intervention assignment. They will ensure that we protect the safety of the participants while assuring study integrity. The DMB will periodically (every 6 months) review the data, including interim analyses, and communicate any concerns to the study team and TSC.