Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B (TINIES for BBVs)

During the Covid-19 pandemic era, patients indicated that they find a model of care incorporating remote consultations to be acceptable [1-3]. Remote accessibility to care can be enhanced by using new technology to allow small volume testing for routine blood samples. This study aims to prospectively validate the use of small volume blood sampling for routine HIV-1 and Hepatitis B Virus (HBV) viral load (VL), liver function tests (LFTs) and creatinine, and assess the acceptability of this method of blood sampling to people living with HIV (PLWH). These tests form the usual minimum required for safe monitoring on a routine basis to determine viral activity, liver and renal function in patients either on or off antiviral therapy. The UK based Doctors Laboratory TINIES small volume blood testing kits comprise microcontainers manufactured by BD Diagnostics designed for sample collection from skin puncture, along with home testing pack with lancets, instructions and Royal Mail postal packs. We will collect TINIES samples alongside routine venepuncture samples in people attending their routine clinic follow ups. We will then send kits to different participants to collect samples in their own home, along with a follow up questionnaire (written/online). Finally, we will conduct a more in-depth telephone interview for a subset of patients to qualitatively assess acceptability. Routine use of this method of testing could revolutionise care of people living with chronic blood borne viruses, for example HIV and chronic HBV. TINIES could enable remote monitoring, increasing ease of access to care, reducing clinic appointment burden in otherwise healthy individuals, and reduce labour costs in the NHS, for example, by reducing phlebotomy appointments.

Inclusion Criteria:HIV-1 positive patients attending routine clinic follow up at MMC. Patients who are expected to have a detectable viral load will be actively approached.Patients with a diagnosis of HBV attending routine outpatient follow up at MMC.>18 years of ageAble to give informed consentExclusion Criteria:Patients will need to be able to read the instructions, or follow a simple video, for home testing kits