TINIES for BBVs_V1.0
Research type
Research Study
Full title
Small Volume Blood Testing Validity and Acceptability for HIV-1 and/or Hepatitis B
IRAS ID
320422
Contact name
Stuart Flanagan
Contact email
Sponsor organisation
Noclor on behalf on Central and North West London NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study aims to answer two questions: 1) Is it possible to accurately measure Human Immunodeficiency Virus (HIV) and hepatitis B virus (HBV) viral load using finger prick small volume blood sampling (TINIES) and 2) do people living with HIV and HBV find home testing with small volume finger prick blood samples (TINIES) acceptable? The main benefit of using TINIES self-testing is that it gives the person living with HIV or HBV, the option to do their blood tests at home and have a telephone clinic appointment. This minimises unnecessary trips to the hospital, which may be more convenient for people living with HIV or HBV, and may reduce burden on phlebotomy services. Adults, living with HBV or HIV who attend Mortimer Market Centre for their care are eligible for this study. It will be a single site study, aiming to collect all data aver 6-12 months. There are two phases. In the first phase, participants attending for their routine blood test appointment will be offered an additional finger prick blood test to collect and additional viral load, renal and liver function blood test. These will be compared with the venepuncture blood sample to validate TINIES sampling. In the second phase, people attending clinic will be asked if they consent to having a TINIES self-testing kit sent to their home. They will be asked to complete an online questionnaire, and a small cohort a telephone interview, to ascertain their views on this method of blood sampling.
REC name
HSC REC A
REC reference
22/NI/0179
Date of REC Opinion
16 Jan 2023
REC opinion
Further Information Favourable Opinion