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

NCT05690607 | Unknown

• 1 other identifier: F-396-2065
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections; Hepatitis B

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Assessing concordance between liver function test parameters from finger prick compared to standard venepuncture

  12 months

• Feasibility for small volume blood samples collected for other experimental markers

  12 months

Study Arms (4)

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

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

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

HBV: Phase 2

Subset of participants sent TINIES test kit to use in home environment

Other: Doctors Laboratory TINIES small volume blood testing kit

Interventions

Doctors Laboratory TINIES small volume blood testing kit OTHER

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; HBV: Phase 2; HIV: Phase 1; HIV: Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central and North West London NHS Foundation Trust: lead
• British HIV Association (BHIVA): collaborator

Related 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.

  PMID: 34435437 BACKGROUND

• 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.

  PMID: 34711737 BACKGROUND

• 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.

  PMID: 34506686 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28427875 BACKGROUND

• 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

  BACKGROUND

• Campbell C, Wang T, Smith DA, Freeman O, Noble T, Varnai KA, Harris S, Salih H, Roadknight G, Little S, Glampson B, Mercuri L, Papadimitriou D, Jones CR, Taylor V, Chaudhry A, Phan H, Borca F, Olza J, Warricker F, Romao L, Ramlakhan D, English L, Klenerman P, Andersson MI, Collier J, Nastouli E, Khakoo SI, Gelson W, Cooke GS, Woods K, Davies J, Barnes E, Matthews PC. Impact of the COVID-19 pandemic on routine surveillance for adults with chronic hepatitis B virus (HBV) infection in the UK. Wellcome Open Res. 2023 Nov 15;7:51. doi: 10.12688/wellcomeopenres.17522.2. eCollection 2022.

  PMID: 38721280 BACKGROUND

• 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.

  PMID: 29143616 BACKGROUND

• 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.

  PMID: 33174623 BACKGROUND

• 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.

  PMID: 32629186 BACKGROUND

• 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.

  PMID: 34732684 BACKGROUND

• 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.

  PMID: 29057945 BACKGROUND

• 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.

  PMID: 32531665 BACKGROUND

• 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.

  PMID: 29653536 BACKGROUND

• 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.

  PMID: 29717978 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

HBV DNA viral load will be measured from finger prick whole blood collected in microcontainers and compared to standard venepuncture 6ml EDTA tubes.

MeSH Terms

Conditions

HIV Infections; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Stuart Flanagan, MBBS

  Central and North West London NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gosala Gopalakrishnan, PhD

CONTACT

020 7679 6097; g.gopalakrishnan@ucl.ac.uk

Stuart Flanagan, MD MBBS

CONTACT

stuart.flanagan@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: January 23, 2023
• Primary Completion: September 30, 2023
• Study Completion: January 22, 2024
• Last Updated: January 19, 2023

Record last verified: 2023-01