Integrated traditional Chinese medicine intervention for delaying HIV morbidity: study protocol for a multicentre randomised controlled trial

Table 3 Schedule of data collection

	Screening and baseline	Treatment period														Follow-up period
Visits	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19
Week number	− 7 to 0	4	8	12	16	20	24	28	32	36	40	44	48	52	56	60	64	68	72
Time window (days)	×	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6	± 6
Inclusion/exclusion criteria	×
Informed consent	×
History/demographics	×
Time to endpoint events or endpoint incidence		×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×
Common symptom score	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×
TCM syndrome score	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×
VL	×																		×
CD4+, CD8, CD4/CD8	×			×			×			×			×			×			×
NK, CD4+CD45RA+T, CD4+CD45RO+T	×																		×
IL-4, IL-17, TNF-a, INF-γ	×																		×
QOL and PRO	×						×						×						×
Blood, urine, stool routine	×						×						×						×
Liver and kidney function	×						×						×						×
Electrocardiogram	×						×						×						×
Physical examination	×						×						×						×
Adverse events	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×
Combined medication	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×	×

Abbreviations: TCM traditional Chinese medicine, VL HIV virological load, NK natural killer cell, IL interleukin, QOL quality of life, PRO patient-reported outcomes

ISSN: 1745-6215