HIV InfectionsTINIESNCT05690607
Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B (TINIES for BBVs)
An observational study of HIV Infections and Hepatitis B, run by Central and North West London NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Hepatitis B
- What is being tested?
- Doctors Laboratory TINIES small volume blood testing kit
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2023to 22 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients will need to be able to read the instructions, or follow a simple video, for home testing kits
Trial locations and contacts
No sites are listed yet.
Stuart Flanagan, MD MBBS contact
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections, Hepatitis B
- Being tested
- Doctors Laboratory TINIES small volume blood testing kit
- Medical subject headings
- HIV Infections, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doctors Laboratory TINIES small volume blood testing kitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Other: Doctors Laboratory TINIES small volume blood testing kit | |
| HBV: Phase 2 | Subset of participants sent TINIES test kit to use in home environment Receives: Other: Doctors Laboratory TINIES small volume blood testing kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (2)
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start23 Jan 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion22 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central and North West London NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- British HIV Association (BHIVA)
- Responsible party
- Sponsor
- Investigators
- Stuart Flanagan, MBBS, Principal investigator, Central and North West London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690607
- Sponsor's protocol ID
- F-396-2065
- Acronym
- TINIES
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 34435437El-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.
PubMed 34711737Fung 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.
PubMed 34506686Bestsennyy O, Gilbert G, Harris A, Rost J. Telehealth: A quarter-trillion-dollar post-COVID-19 reality. In: McKinsey Insights. New York: McKinsey & Company; 2021
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.
PubMed 28427875Angus 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
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.
PubMed 38721280Lange 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.
PubMed 29143616Jackson 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.
PubMed 33174623Roger 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.
PubMed 32629186Fong 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.
PubMed 34732684Fidler 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.
PubMed 29057945Rossetti 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.
PubMed 32531665Dodds 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.
PubMed 29653536Seguin 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.
PubMed 29717978
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Volume Blood Testing Validity and Acceptability for HIV-1 and Hepatitis B
- ClinicalTrials.gov ID
- NCT05690607
- Acronym / sponsor ID
- TINIES / F-396-2065
- Conditions
- HIV Infections, Hepatitis B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central and North West London NHS Foundation TrustUniversity, hospital or other
- Collaborators
- British HIV Association (BHIVA)
- Study start
- 23 Jan 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 22 Jan 2024 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV: Phase 1 | – | Other: Doctors Laboratory TINIES small volume blood testing kitPeople (over 18 years) living with HIV-1 attending London Mortimer Market Centre for routine blood tests as part of their HIV care. |
| HIV: Phase 2 | – | Other: Doctors Laboratory TINIES small volume blood testing kitSubset of HIV participants sent TINIES test kit to use in home environment |
| HBV: Phase 1 | – | Other: Doctors Laboratory TINIES small volume blood testing kitPeople (over 18 years) living with HBV patients attending London Mortimer Market Centre for routine blood tests as part of their HBV care. |
| HBV: Phase 2 | – | Other: Doctors Laboratory TINIES small volume blood testing kitSubset of participants sent TINIES test kit to use in home environment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients will need to be able to read the instructions, or follow a simple video, for home testing kits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doctors Laboratory TINIES small volume blood testing kitDoctors 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. | Other | HBV: Phase 1, HBV: Phase 2, HIV: Phase 1, HIV: Phase 2 |
Primary outcome
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.
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.
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.
2 secondary outcomes
Assessing concordance between liver function test parameters from finger prick compared to standard venepuncture
Time frame: 12 months
Feasibility for small volume blood samples collected for other experimental markers
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 34435437Abstracts 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.
- Background: PubMed 34711737El-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.
- Background: PubMed 34506686Fung 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.
- BackgroundBestsennyy 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: PubMed 28427875European 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.
- BackgroundAngus 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: PubMed 38721280Campbell 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.
- Background: PubMed 29143616Lange 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.
- Background: PubMed 33174623Jackson 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.
- Background: PubMed 32629186Roger 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.
- Background: PubMed 34732684Fong 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.
- Background: PubMed 29057945Fidler 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Flanagan, MD MBBS contact
Stuart Flanagan, MBBS principal investigator
Central and North West London NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Hepatitis B, run by Central and North West London NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gosala Gopalakrishnan, PhD (020 7679 6097, g.gopalakrishnan@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection, sensitivity and specificity of HIV RNA viral load (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05690607, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.