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

HIV Infections Clinical Trial

— TINIES  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05690607
• Other study ID #: F-396-2065
• Status: Not yet recruiting
• Start date: January 23, 2023
• Est. completion date: January 22, 2024

Study information

• Verified date: January 2023
• Source: Central and North West London NHS Foundation Trust
• Contact: Gosala Gopalakrishnan, PhD
• Phone: 020 7679 6097
• Email: g.gopalakrishnan[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 22, 2024
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Central and North West London NHS Foundation Trust	British HIV Association (BHIVA)

References & Publications (15)

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. — View Citation

Angus B, Brook G, Awosusi F, Barker G, Boffito M, Das S, et al. BHIVA guidelines for the routine monitoring of adult HIV-1 positive individuals (2019 interim update). In. Herfordshire, UK: British HIV Association; 2019

Bestsennyy O, Gilbert G, Harris A, Rost J. Telehealth: A quarter-trillion-dollar post-COVID-19 reality. In: McKinsey Insights. New York: McKinsey & Company; 2021

Campbell C, Wang T, Smith DA, Freeman O, Noble T, Várnai KA, et al. Impact of the COVID-19 pandemic on routine surveillance for adults with chronic hepatitis B virus (HBV) infection in the UK. medRxiv 2021:2021.2011.2010.21265651

Dodds C, Mugweni E, Phillips G, Park C, Young I, Fakoya I, Wayal S, McDaid L, Sachikonye M, Chwaula J, Flowers P, Burns F. Acceptability of HIV self-sampling kits (TINY vial) among people of black African ethnicity in the UK: a qualitative study. BMC Public Health. 2018 Apr 13;18(1):499. doi: 10.1186/s12889-018-5256-5. Erratum In: BMC Public Health. 2018 Jul 12;18(1):866. — View Citation

El-Nahal WG, Shen NM, Keruly JC, Jones JL, Fojo AT, Lau B, Manabe YC, Moore RD, Gebo KA, Lesko CR, Chander G. Telemedicine and visit completion among people with HIV during the coronavirus disease 2019 pandemic compared with prepandemic. AIDS. 2022 Mar 1;36(3):355-362. doi: 10.1097/QAD.0000000000003119. — View Citation

European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18. — View Citation

Fidler S, Lewis H, Meyerowitz J, Kuldanek K, Thornhill J, Muir D, Bonnissent A, Timson G, Frater J. A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study. Sci Rep. 2017 Oct 20;7(1):13658. doi: 10.1038/s41598-017-13287-2. — View Citation

Fong Y, Markby J, Andreotti M, Beck I, Bourlet T, Brambilla D, Frenkel L, Lira R, Nelson JAE, Pollakis G, Reigadas S, Richman D, Sawadogo S, Waters L, Yang C, Zeh C, Doherty M, Vojnov L. Diagnostic Accuracy of Dried Plasma Spot Specimens for HIV-1 Viral Load Testing: A Systematic Review and Meta-analysis. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):261-273. doi: 10.1097/QAI.0000000000002855. — View Citation

Fung BM, Perumpail M, Patel YA, Tabibian JH. Telemedicine in Hepatology: Current Applications and Future Directions. Liver Transpl. 2022 Feb;28(2):294-303. doi: 10.1002/lt.26293. Epub 2021 Oct 7. — View Citation

Jackson K, Tekoaua R, Li X, Locarnini S. Real-world application of the Xpert(R) HBV viral load assay on serum and dried blood spots. J Med Virol. 2021 Jun;93(6):3707-3713. doi: 10.1002/jmv.26662. Epub 2020 Nov 22. — View Citation

Lange B, Roberts T, Cohn J, Greenman J, Camp J, Ishizaki A, Messac L, Tuaillon E, van de Perre P, Pichler C, Denkinger CM, Easterbrook P. Diagnostic accuracy of detection and quantification of HBV-DNA and HCV-RNA using dried blood spot (DBS) samples - a systematic review and meta-analysis. BMC Infect Dis. 2017 Nov 1;17(Suppl 1):693. doi: 10.1186/s12879-017-2776-z. — View Citation

Roger S, Lefeuvre C, Grison M, Ducancelle A, Lunel-Fabiani F, Pivert A, Le Guillou-Guillemette H. Evaluation of the Aptima HBV Quant Dx assay for semi-quantitative HBV viral load from dried blood spots. J Clin Virol. 2020 Aug;129:104524. doi: 10.1016/j.jcv.2020.104524. Epub 2020 Jun 27. — View Citation

Rossetti R, Smith T, Luo W, Taussig J, Valentine-Graves M, Sullivan P, Ingersoll JM, Kraft CS, Ethridge S, Wesolowski L, Delaney KP, Owen SM, Johnson JA, Masciotra S. Performance evaluation of the Aptima HIV-1 RNA Quant assay on the Panther system using the standard and dilution protocols. J Clin Virol. 2020 Aug;129:104479. doi: 10.1016/j.jcv.2020.104479. Epub 2020 Jun 1. — View Citation

Seguin M, Dodds C, Mugweni E, McDaid L, Flowers P, Wayal S, Zomer E, Weatherburn P, Fakoya I, Hartney T, McDonagh L, Hunter R, Young I, Khan S, Freemantle N, Chwaula J, Sachikonye M, Anderson J, Singh S, Nastouli E, Rait G, Burns F. Self-sampling kits to increase HIV testing among black Africans in the UK: the HAUS mixed-methods study. Health Technol Assess. 2018 Apr;22(22):1-158. doi: 10.3310/hta22220. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection, sensitivity and specificity of HIV RNA viral load	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
Primary	Detection, sensitivity and specificity of HBV DNA viral load	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
Primary	Feasibility and acceptability of small volume testing for home sampling	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	Assessing concordance between liver function test parameters from finger prick compared to standard venepuncture	Assess concordance between liver function test parameters and creatinine collected from 600µl finger prick compared to standard venepuncture 6ml EDTA tubes	12 months
Secondary	Feasibility for small volume blood samples collected for other experimental markers	Investigate feasibility for small volume blood samples collected for other experimental markers e.g., host response	12 months