Point-of Care Ultrasound for Patients With HIV

NCT04246983 | Completed

• 1 other identifier: NL72666.078.20
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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 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. 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.

Conditions

HIV/AIDS; Opportunistic Infections, HIV Related

Keywords

HIV; Opportunistic disease; Ultrasound

Outcome Measures

Primary Outcomes (3)

• Acceptance rate of point-of-care ultrasound by patients

  1 day

• interobserver variation in interpretation of ultrasound images

  1 day

• Number of diagnosed AIDS and non-AIDS related problems

  1 year

Secondary Outcomes (2)

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

  1 year

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

  1 year

Study Arms (1)

Patients with HIV undergoing point of care ultrasound

EXPERIMENTAL

Diagnostic Test: Opportunistic infection Ultrasound (OpUS) screening

Interventions

Opportunistic infection Ultrasound (OpUS) screening DIAGNOSTIC_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.

Patients with HIV undergoing point of care ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- absence of informed consent

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (9)

• 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.

  PMID: 23171481 BACKGROUND

• 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.

  PMID: 27836795 BACKGROUND

• 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.

  PMID: 29666966 BACKGROUND

• 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.

  PMID: 26661658 BACKGROUND

• 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.

  PMID: 28541140 BACKGROUND

• 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.

  PMID: 23001543 BACKGROUND

• 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.

  PMID: 23575291 BACKGROUND

• 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.

  PMID: 15280772 BACKGROUND

• 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.

  PMID: 37500120 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; AIDS-Related Opportunistic Infections

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Mischa Huson, MD, PhD

  Erasmus Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 29, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)