Schedule of enrollment, intervention, and assessment.
CRF
ADVERSE EVENT, CRF
W = week; *extra visit will be done when adverse event occurs during the study.At the end study, a total drug consumption adherence will be assessed using MPR. Meanwhile, each patient has monthly clinical follow-ups as standard of care in the clinic. Study follow-up visits include clinical and laboratory procedures as presented in
Data management are managed in the HIV Integrated Care Unit, Cipto Mangunkusumo Hospital. All research staff have overall responsibility for maintaining the study CRFs. Corrections to the paper CRF documents must be made by striking through the incorrect entry with a single line (taking care not to obliterate or render the original entry illegible) and entering the correct information adjacent to the incorrect entry. Corrections to paper CRFs must be initialed and dated by the person making the correction. The researchers are responsible for maintaining accurate, complete, and up-to-date records. These forms are to be completed on an on-going basis during the course of the study.