Protocol for a multicenter, real-world study of HIV pre-exposure prophylaxis among men who have sex with men in China (CROPrEP)

Table 3 Schedule of the CROPrEP project

Procedures	Screening/Enrollment	FU 1 m ± 7d^d	FU 3 m ± 7d	FU 6 m ± 7d	FU 9 m ± 7d	FU 12 m ± 7d
Informed consent	×
Self-administrated questionnaire	×	×	×	×	×	×
Interviews
Relevant medical history	×
Current/concomitant medication	×	×	×	×	×	×
Adverse events or side effects		×	×	×	×	×
Medication return and allocation	×	×	×	×	×	×
HIV/STIs testing
HIV screening	×	×	×	×	×	×
HIV Western Blot^a	×	×	×	×	×	×
HIV RNA Pooling PCR^b	×	×	×	×	×	×
HIV resistance testing^c
HIV-1 viral load^c
Syphilis	×	×	×	×	×	×
HSV-2	×	×	×	×	×	×
Safety assessment
Routine blood tests	×	×	×	×	×	×
Routine urine tests	×	×	×	×	×	×
Liver functions tests	×	×	×	×	×	×
Renal functions tests	×	×	×	×	×	×
Blood glucose and lipids	×	×	×	×	×	×
Bone mineral density	×			×		×
Hepatitis B virus	×			×		×
Adherence lab assessment
Blood drug level testing		×	×	×	×	×

Abbreviations: FU Follow-up, m Month(s), d Day, HSV-2 Herpes simplex virus 2
^aAnyone who screens positive for HIV will have the results confirmed by western blotting
^bAnyone who screens negative for HIV will have the results confirmed by HIV RNA pooling PCR test
^cAnyone who tests positive for HIV will have their samples further tested for HIV resistance and viral load
^dVisit window, 7 days

ISSN: 1471-2334