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

January 10, 2023 updated by: Central and North West London NHS Foundation Trust

Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV: Phase 1
People (over 18 years) living with HIV-1 attending London Mortimer Market Centre for routine blood tests as part of their HIV care.
Other: Doctors Laboratory TINIES small volume blood testing kit
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.
HIV: Phase 2
Subset of HIV participants sent TINIES test kit to use in home environment
Other: Doctors Laboratory TINIES small volume blood testing kit
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.
HBV: Phase 1
People (over 18 years) living with HBV patients attending London Mortimer Market Centre for routine blood tests as part of their HBV care.
Other: Doctors Laboratory TINIES small volume blood testing kit
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.
HBV: Phase 2
Subset of participants sent TINIES test kit to use in home environment
Other: Doctors Laboratory TINIES small volume blood testing kit
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection, sensitivity and specificity of HIV RNA viral load
Time Frame: 6 months
To determine the limit of detection, sensitivity and specificity of HIV RNA viral load quantification from finger prick whole blood collected in EDTA microcontainers tested when compared to standard venepuncture 6ml EDTA tubes.
6 months
Detection, sensitivity and specificity of HBV DNA viral load
Time Frame: 6 months
To determine the limit of detection, sensitivity and specificity of HBV DNA viral load quantification from finger prick whole blood collected in EDTA microcontainers, compared to standard venepuncture 6ml EDTA tubes.
6 months
Feasibility and acceptability of small volume testing for home sampling
Time Frame: 12 months
To assess the feasibility and acceptability of small volume testing for home sampling for routine blood tests for routine HIV and hepatitis B monitoring.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing concordance between liver function test parameters from finger prick compared to standard venepuncture
Time Frame: 12 months
Assess concordance between liver function test parameters and creatinine collected from 600µl finger prick compared to standard venepuncture 6ml EDTA tubes
12 months
Feasibility for small volume blood samples collected for other experimental markers
Time Frame: 12 months
Investigate feasibility for small volume blood samples collected for other experimental markers e.g., host response
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central and North West London NHS Foundation Trust

Collaborators

British HIV Association (BHIVA)

Investigators

  • Principal Investigator: Stuart Flanagan, MBBS, Central and North West London NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 23, 2023

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

January 22, 2024

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Estimate)

January 19, 2023

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-396-2065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The study protocol, full study report, anonymised patient level dataset and statistical code for generating the results will be made available to external parties on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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