We aim to determine the feasibility and diagnostic value of POCUS in detecting opportunistic disease in HIV patients with advanced disease stages in the Netherlands.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secundary 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.
Background summary
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/TB
(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.
Study objective
We 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
We will perform a prospective observational pilot study
Study burden and risks
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.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Patients newly presenting with HIV to the outpatient clinic with a CD4 T-cell
count below 350 cells/mm3, and all patients with HIV requiring admission to
hospital.
Exclusion criteria
Absence of informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72666.078.20 |