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Table 2 EPIC-NSW study flowchart

From: Expanded HIV pre-exposure prophylaxis (PrEP) implementation in communities in New South Wales, Australia (EPIC-NSW): design of an open label, single arm implementation trial

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

  1. 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
  2. bVisits may be combined if HIV test result available
  3. cAs per NSW and National PrEP guidelines
  4. dInformation in relation to eligibility for PrEP
  5. eAt 3 months and every 6 months thereafter
  6. fConsider annual testing for HCV, or more often in men with substantial risk
  7. 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
  8. hBehavioural data collected on consenting participants