Clinical trial NCT05690607: Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B (TINIES for BBVs)
Official title: Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Hepatitis B
Lead sponsor: Central and North West London NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: British HIV Association (BHIVA)
First posted: 2023-01-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Majority of people living with HIV (\>90%) attending for blood tests will have undetectable viral load, those patients with any of the following criteria will be proactively approached

* Recent (in last 6 months) HIV VL \>50 copies/mL
* Reporting intermittent (\<90% daily) adherence in last 6 months
* - not currently taking ART

Conversely, the majority of people living with HBV will have a detectable viral load (due to specific criteria for starting treatment). Therefore, people on treatment for HBV will be proactively approached.

Brief summary: 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.

Detailed description: Covid-19 has accelerated the move towards increased use of remote healthcare\[4\]. This model is well-suited to people living with chronic blood borne virus (BBV) infections, as they are often asymptomatic and need only routine monitoring to assess for disease progression, response to treatment and medication adverse effects\[5, 6\]. However, routine blood tests still require the patient to attend the hospital for venepuncture to collect several 6 millilitre (ml) tubes twice a year. The Covid-19 pandemic led to a decrease in routine blood monitoring for HIV and HBV, due to a combination of the patient and clinician attempting to reduce hospital exposure\[2, 7\]. This may have a negative impact on patient care due to missed drug toxicity or changes in viral load necessitating drug initiation or changes. Given the post covid-19 shift to remote healthcare for routine appointments is likely to continue in the NHS\[1\], a mechanism of remote blood monitoring would be beneficial to patients and clinicians.

Screening for syphilis, hepatitis and HIV using home testing with small volume finger prick blood samples has become established in sexual health services \[8, 9\]. Despite this, home-test finger prick blood sampling use in routine monitoring for patients living with HIV and HBV has not been explored. Finger prick dried blood spots have been investigated as a method of collection for measuring HIV and HBV viral load, particularly in resource-limited settings\[10-13\]. However, the use of dried blood spots for routine monitoring in high-income setting outpatient clinics is limited by reduced sensitivity in detecting low viral loads, and reduced ability to measure other routine blood tests, including haematology and biochemistry.

There are few published studies investigating HIV-1 viral load measurement on finger prick blood collected in microcontainers, and none investigating HBV viral load. Studies have found self-taken home HIV tests are acceptable to service-users and increase the uptake of HIV testing in key populations, such as MSM and trans people. In contrast, in a London black African community, TINIES for HIV screening were unpopular and it was unfeasible to scale up their use within primary care\[16, 17\]. Online posting of tests to be self-taken in the home environment is becoming highly acceptable to service users, while recognising this may lead to reduced uptake in certain vulnerable groups\[18\].

Apart from enabling ongoing monitoring in the event of a future lockdown, there are other reasons why remote testing may be beneficial in clinical care of people living with BBV. Testing at home will reduce the burden of hospital visits for otherwise healthy people, reducing time off work for appointments and travel costs. There may also be a cost reduction for both the UK Health Service (NHS), for example by reducing venepuncture appointments. Stigma of attending the hospital may reduce uptake of regular blood monitoring, and remote testing may overcome this barrier.

Eligibility criteria: 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 age
* Able to give informed consent

Exclusion Criteria:

* Patients will need to be able to read the instructions, or follow a simple video, for home testing kits

Primary outcomes:
measure: Detection, sensitivity and specificity of HIV RNA viral load
timeFrame: 6 months
measure: Detection, sensitivity and specificity of HBV DNA viral load
timeFrame: 6 months
measure: Feasibility and acceptability of small volume testing for home sampling
timeFrame: 12 months
Secondary outcomes:
measure: Assessing concordance between liver function test parameters from finger prick compared to standard venepuncture
timeFrame: 12 months
measure: Feasibility for small volume blood samples collected for other experimental markers
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Central and North West London NHS Trust
name: Stuart Flanagan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abstracts of the 5th Joint Conference of the British HIV Association (BHIVA) with the British Association for Sexual Health and HIV (BASHH), Virtual, 19-21 April 2021. HIV Med. 2021 Aug;22 Suppl 2:3-126. doi: 10.1111/hiv.13129. No abstract available.
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