Table 3.
Procedures | Screening/Enrollment | FU 1 m ± 7dd |
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 Blota | × | × | × | × | × | × |
HIV RNA Pooling PCRb | × | × | × | × | × | × |
HIV resistance testingc | ||||||
HIV-1 viral loadc | ||||||
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