Outcomes and data collection

The primary outcome measure was the proportion of patients with newly diagnosed HIV infection among those who were tested by the HCT staff in the ED. Secondary outcome measures included patient characteristics such as age, sex, presenting complaint, South African Triage Scale (SATS) score, disposition and previous diagnosis of HIV infection. Presenting complaint was recorded as free text and coded using Medical Dictionary for Regulatory Activities (MedDRA). The severity of illness was quantified using SATS (a locally implemented triage score), as is standard of care.[33] Data were prospectively collected on case report forms by HCT staff, who also noted whether or not subjects consented to a rapid POC HIV test, and their POC HIV test results. Data forms were scanned and entered using intelligent character recognition (ICR) DataFax software (DataFax, Clinical DataFax Systems Inc., Hamilton, Ontario, Canada) and centrally double-verified by independent data technicians.