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Evaluation of values and preferences for a novel POC urine LAM test (Fujifilm SILVAMP TB) – a qualitative study

Evaluation of values and preferences for a novel POC urine LAM test (Fujifilm SILVAMP TB) – a qualitative study - FujiLAM_qualitative_study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00021003
Enrollment
50
Registered
2020-03-23
Start date
2020-09-23
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B20-B24 A15-A19

Interventions

Group 1: Semi-structured interviews will be conducted at in the first half and toward the end of the trial. We are aiming to include 15 healthcare providers, 3 decision makers and 15 patients or until

Sponsors

Universitätsklinikum Heidelberg Sektion Klinische Tropenmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult aged = 18 years old Either: (1) Routine healthcare worker participating in either of the two prospective studys on FujilAM and Omega CD4 or (2) Patient or parent of patient tested or to be tested with FujiLAM or Omega CD4 as part of the study or (3) decision maker involved with implementation of novel tests.

Exclusion criteria

Exclusion criteria: adolescents and parents of patients aged < 18 years, Unable to provide consent

Design outcomes

Primary

MeasureTime frame
1. To investigate user perspectives on FujiLAM (including perspectives of end- users (such as patients), but also professional users such as laboratory technicians, clinicians, nurses, and decision-makers for use as a diagnostic test in PLHIV 2. To investigate and compare experiences and challenges with diagnostic testing for TB in PLHIV using the different diagnostic approaches (FujiLAM, AlereLAM, Xpert, microscopy, culture) 3. To understand feasibility and preferences with regard to diagnosing TB in PLHIV and how FujiLAM changes these

Secondary

MeasureTime frame
1. To investigate and compare experiences and challenges with diagnostic testing for TB in children using the different diagnostic approaches (FujiLAM, AlereLAM, Xpert, microscopy, culture) 2. To understand feasibility and preferences with regard to diagnosing TB in children and how FujiLAM changes these

Countries

Malawi, Zambia

Contacts

Public ContactClaudia Denkinger

Universitätsklinikum Heidelberg Sektion Klinische Tropenmedizin

claudia.denkinger@uni-heidelberg.de+49 6221 56-36637

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026