Protocol, rationale and design of SELPHI: a randomised controlled trial assessing whether offering free HIV self-testing kits via the internet increases the rate of HIV diagnosis

• DOI: 10.1186/s12879-018-3433-x
• Publication Date: 2018-10-23T18:25:50Z
• Authors: Michelle M. Gabriel; David T. Dunn; Andrew Speakman; Leanne McCabe; Denise Ward; T. Charles Witzel; Justin Harbottle; Simon Collins; Mitzy Gafos; Fiona M. Burns; Fiona C. Lampe; Peter Weatherburn; Andrew Phillips; Sheena McCormack; Alison J. Rodger
• Keywords: Medical microbiology; Parasitology

Among men who have sex with (MSM) in the UK, an estimated 28% never tested for HIV and only 27% of those at higher risk test least every 6 months. self-testing (HIVST), where person takes their own blood/saliva sample processes it themselves, offers opportunity to remove many structural social barriers testing. Although several randomised controlled trials are assessing impact providing HIVST on rates testing, none addressing whether this results increased diagnoses that link clinical care. Linking care is critical outcome because way access antiretroviral treatment (ART). We describe here design a large, internet-based trial HIVST, called SELPHI, which aims inform key question. The SELPHI study, ongoing promoted via networking website app advertising, enroll negative men, trans women, aged over 16 years, living England Wales. Apart from physical delivery kits, all processes, including recruitment, take place online. In two-stage randomisation, participants first (3:2) receive free baseline or no HIVST. At 3 months, allocated (and meeting further eligibility criteria) subsequently (1:1) offer regular (every months) testing reminders, versus such offer. primary both randomisations laboratory-confirmed diagnosis, ascertained linkage national surveillance database. will provide reliable evidence offering internet increases confirmed two reflect dual objectives detecting prevalent infections (possibly long-standing) more rapid diagnosis incident infections. It anticipated future provision UK. DOI 10.1186/ISRCTN20312003 registered 24/10/2016.