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HIV/AIDSNCT04246983

Point-of Care Ultrasound for Patients With HIV

A study testing Opportunistic infection Ultrasound (OpUS) screening in people with HIV/AIDS and Opportunistic Infections, HIV Related, run by Erasmus Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rationale: Point-of-care ultrasound (POCUS) is increasingly used by various specialists in the Netherlands, but its role in managing patients with HIV is unclear. In settings endemic for tuberculosis, Fast Assessment with Sonography for HIV/Tuberculosis (FASH) has proven its value to detect extrapulmonary tuberculosis… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Opportunistic infection Ultrasound (OpUS) screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteNetherlands
Study dates
1 Jul 2020to 1 Dec 2022
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • new patients with HIV presenting with a CD4 T-cell count below 350 cells/mm3
  • patients with HIV who are admitted to hospital

Who cannot join

  • absence of informed consent

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

About this study

Official title: Introducing Point-of-care Ultrasound at the Bedside for Diagnosing Opportunistic Diseases in Patients With HIV

Rationale: Point-of-care ultrasound (POCUS) is increasingly used by various specialists in the Netherlands, but its role in managing patients with HIV is unclear. In settings endemic for tuberculosis, Fast Assessment with Sonography for HIV/Tuberculosis (FASH) has proven its value to detect extrapulmonary tuberculosis in patients with HIV. However, there is no data to support POCUS for patients with HIV in resource affluent settings.

Objective: The investigators aim to determine the feasibility and diagnostic value of POCUS in detecting opportunistic disease in HIV patients with advanced disease stages in the Netherlands.

Read more

Study design: The investigators will perform a prospective observational pilot study.

Study population: The investigators will include new adult patients with HIV presenting with a cluster of differentiation 4 (CD4) T-cell count below 350 cells/mm3, and all adult HIV patients requiring admission to hospital. Intervention (if applicable): The investigators will perform a focused ultrasound examination including FASH, and ultrasound of the lung, liver and kidneys. In case of positive findings additional examinations will be undertaken to determine the underlying pathology and/or treatment started as indicated. In case of negative findings, patients will be followed for 12 months to observe for (possibly missed) opportunistic infections.

Main study parameters/endpoints: Our primary outcomes include acceptability of POCUS by patients, interobserver variation in interpretation of POCUS images, and number of diagnosed AIDS and non-AIDS related problems. Secondary outcomes include sensitivity and specificity, negative predictive value and positive predictive value of our POCUS protocol. In addition, incidence rates of opportunistic infections will be compared to a historical matched control group.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The ultrasound examination is painless and without risk to the participants. It will take approximately 30 minutes and will be combined with routine visits to the hospital. Benefits include potential earlier detection of opportunistic disease, while adverse effects may arise from false positive findings requiring further examinations which may cause stress or anxiety. The rate of false positive findings in POCUS has not been formally investigated, but appears low. The effect of POCUS in advanced HIV/AIDS can only be studied in HIV patients.

Being tested
Opportunistic infection Ultrasound (OpUS) screening
Keywords
HIV, Opportunistic disease, Ultrasound
Medical subject headings
Acquired Immunodeficiency Syndrome, AIDS-Related Opportunistic Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opportunistic infection Ultrasound (OpUS) screeningDiagnostic test

    this point-of-care ultrasound protocol will include lung ultrasound, assessment of pericardial and pleural effusions, ascites, abdominal lymphadenopathy and splenic micro abscesses, as well as a focused ultrasound of liver and kidneys.

Study groups in NCT04246983
Study groupRoleWhat they receive
Patients with HIV undergoing point of care ultrasoundExperimentalNot described
Receives: Diagnostic Test: Opportunistic infection Ultrasound (OpUS) screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptance rate of point-of-care ultrasound by patients

    Measured: 1 day

  2. interobserver variation in interpretation of ultrasound images

    Measured: 1 day

  3. Number of diagnosed AIDS and non-AIDS related problems

    Measured: 1 year

Secondary outcomes (2)

  1. Sensitivity and specificity, negative predictive value and positive predictive value of our ultrasound protocol to diagnose opportunistic disease.

    Measured: 1 year

  2. Number of diagnosed AIDS and non-AIDS related problems compared to a historic control group

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2020
  2. Study start1 Jul 2020
  3. Primary completion1 Dec 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246983
Sponsor's protocol ID
NL72666.078.20
Status last verified
Dec 2022
First submitted
24 Jan 2020
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heller T, Wallrauch C, Goblirsch S, Brunetti E. Focused assessment with sonography for HIV-associated tuberculosis (FASH): a short protocol and a pictorial review. Crit Ultrasound J. 2012 Nov 21;4(1):21. doi: 10.1186/2036-7902-4-21.

    PubMed 23171481

  • Heller T, Mtemang'ombe EA, Huson MA, Heuvelings CC, Belard S, Janssen S, Phiri S, Grobusch MP. Ultrasound for patients in a high HIV/tuberculosis prevalence setting: a needs assessment and review of focused applications for Sub-Saharan Africa. Int J Infect Dis. 2017 Mar;56:229-236. doi: 10.1016/j.ijid.2016.11.001. Epub 2016 Nov 9.

    PubMed 27836795

  • Giordani MT, Tamarozzi F, Kaminstein D, Brunetti E, Heller T. Point-of-care lung ultrasound for diagnosis of Pneumocystis jirovecii pneumonia: notes from the field. Crit Ultrasound J. 2018 Apr 17;10(1):8. doi: 10.1186/s13089-018-0089-0.

    PubMed 29666966

  • Hunter L, Belard S, Janssen S, van Hoving DJ, Heller T. Miliary tuberculosis: sonographic pattern in chest ultrasound. Infection. 2016 Apr;44(2):243-6. doi: 10.1007/s15010-015-0865-8. Epub 2015 Dec 11.

    PubMed 26661658

  • Agostinis P, Copetti R, Lapini L, Badona Monteiro G, N'Deque A, Baritussio A. Chest ultrasound findings in pulmonary tuberculosis. Trop Doct. 2017 Oct;47(4):320-328. doi: 10.1177/0049475517709633. Epub 2017 May 25.

    PubMed 28541140

  • Giordani MT, Brunetti E, Binazzi R, Benedetti P, Stecca C, Goblirsch S, Heller T. Extrapulmonary mycobacterial infections in a cohort of HIV-positive patients: ultrasound experience from Vicenza, Italy. Infection. 2013 Apr;41(2):409-14. doi: 10.1007/s15010-012-0336-4. Epub 2012 Sep 24.

    PubMed 23001543

  • Schouten M, van Velde AJ, Snijdewind IJ, Verbon A, Rijnders BJ, van der Ende ME. [Late diagnosis of HIV positive patients in Rotterdam, the Netherlands: risk factors and missed opportunities]. Ned Tijdschr Geneeskd. 2013;157(15):A5731. Dutch.

    PubMed 23575291

  • French MA, Price P, Stone SF. Immune restoration disease after antiretroviral therapy. AIDS. 2004 Aug 20;18(12):1615-27. doi: 10.1097/01.aids.0000131375.21070.06.

    PubMed 15280772

  • Huson M, Rokx C. Exploring the role of point-of-care ultrasound for people with HIV in a resource affluent setting: A prospective observational study. Int J STD AIDS. 2023 Nov;34(13):984-989. doi: 10.1177/09564624231188744. Epub 2023 Jul 27.

    PubMed 37500120

Questions about this trial

What is this clinical trial studying?

A study testing Opportunistic infection Ultrasound (OpUS) screening in people with HIV/AIDS and Opportunistic Infections, HIV Related, run by Erasmus Medical Center at 1 site in Netherlands.

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 2 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: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptance rate of point-of-care ultrasound by patients (time frame: 1 day). 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 NCT04246983, which also lists 9 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 20 Dec 2022.

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