NCT04246983

Point-of Care Ultrasound for Patients With HIV

Completed NA Last updated 20 December 2022

What this trial tests

NA trial testing Opportunistic infection Ultrasound (OpUS) screening in HIV/AIDS in 34 participants. Completed in 1 December 2022.

Timeline

1 July 2020

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Erasmus Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	34
Start date	1 July 2020
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	1 location across Netherlands

Drugs / interventions tested

• Opportunistic infection Ultrasound (OpUS) screening

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Opportunistic Infections, HIV Related — all drugs for Opportunistic Infections, HIV Related →

Sponsor

Erasmus Medical Center

Who can join

18 and older, any sex, with HIV/AIDS or Opportunistic Infections, HIV Related. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exploring the role of point-of-care ultrasound for people with HIV in a resource affluent setting: A prospective observational study.
   Huson M, Rokx C. · · 2023 · cited 3× · PMID 37500120 · DOI 10.1177/09564624231188744