Early Syphilis Screening in HIV Patients

Following informed consent, a targeted physical examination was performed by trained study clinicians (operators 2–5, see below) to identify signs of early syphilis (i.e. rash, ulcers, mucous patches or condyloma lata). An electronic case report form (eCRF) was used to collect demographic (birth date, sex assigned at birth, current gender, ethnicity, area of residency) and clinical information (history of previous syphilis, date of HIV diagnosis and current antiretroviral therapy) via face-to-face or telephonic survey according to the participant time availability. Date and results of the closest (up to 134 days before the enrolment date) viral load (copies/mm³) and CD4 cell count (cells/mm³) were collected from laboratory results in the corresponding electronic medical record. In clinic A, as part of routine care all patients with newly diagnosed HIV were tested using p24 HIV antigen and CD4 rapid tests. Additionally, patients who had been lost to follow-up and were re-engaged in the HIV care program were also tested for CD4 rapid test. Two samples were obtained from each participant: capillary blood (CB) from finger prick and serum from venous blood. CB was used for RDTs performed at point-of-care and serum for both RDTs and reference tests performed at a reference laboratory.