Table 2.
Follow-up schedule | Screening/enrolment/baseline | Follow-up 1 | Subsequent Follow-ups |
---|---|---|---|
Timeline | Week −2 or 0a, b | Month 1 | Month 3 and every 3 months thereafterc |
Informed consent | X | ||
Review eligibility | X | X | X |
Medical historyd | X | ||
Renal function (creatinine clearance) | X | Xe | |
Serious adverse events, pregnancy (if applicable) | X | X | |
Hepatitis C testing | X | Xf | |
STI testing g | X | X | |
HIV testingg | X | X | X |
Dispense study medication | X | X | X |
Survey of adherence and behaviour | X | Xh |
aResults of all tests conducted in the preceding 2 weeks are accepted at enrolment. Only the HIV test should be conducted not earlier than 7 days within starting PrEP
bVisits may be combined if HIV test result available
cAs per NSW and National PrEP guidelines
dInformation in relation to eligibility for PrEP
eAt 3 months and every 6 months thereafter
fConsider annual testing for HCV, or more often in men with substantial risk
gHIV and STI tests conducted per current standard of care according to the National HIV and STI testing guidelines. Data obtained electronically quarterly from ACCESS study
hBehavioural data collected on consenting participants