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Table 4 Study objectives and endpoints

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

Study objectives Endpoints
i. Assess the incidence of HIV among PrEP study participants i. Incidence of HIV infection per 100 person-years among study participants
ii. Measure the population-level impact of the rapid roll-out of PrEP on HIV diagnoses among GBM in NSW over a two-year period ii. The annual number of HIV diagnoses among gay and bisexual men notified to the NSW Ministry of Health in the 12 months following full study enrolment
iii. Evaluate the rate of PrEP uptake among high risk GBM in NSW iii. Rate of enrolment to the study by clinic type and clinic location
iv. Assess the incidence of STI (gonorrhoea, chlamydia and infectious syphilis) among people prescribed PrEP iv. Incidence of STI (gonorrhoea, chlamydia and infectious syphilis) per 100 person-years among study participants
v. Describe patterns of PrEP use and medication adherence to the recommended PrEP medication schedule in those prescribed PrEP v. Patterns of daily TDF/FTC PrEP use and adherence to the medication schedule among study participants (those who opted into brief surveys about adherence and risk behaviour