HIV/AIDS Tuberculosis Malaria HCV
Conditions
Interventions
EDE Scanner
EDE diagnostic Scanner
Sponsors
EDE Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV): • Male or female, aged =18 years • Asymptomatic/symptomatic patients suspected of HIV, or symptomatic patients suspected of TB, malaria, or HCV based on physician’s clinical evaluation, which may include laboratory (eg, liver function tests, CBC) or radiological (eg, chest X-ray) tests per routine clinical practice • Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for the respective infectious disease (HIV/TB/malaria/HCV) - per routine standard of care, in parallel • Provision of signed informed consent For Group 2 (healthy participants): • Male or female, aged =18 years • Healthy participant, as determined by physician’s judgment • Participant undergoing routine blood test as per standard of care • Participant agrees to undergo non-invasive EDE scanner test • Participant permits use of the routine blood sample to conduct a standard diagnostic test for HIV, malaria, or HCV; or, participant agrees to provide a sputum sample to conduct a standard diagnostic test for TB • No evidence of active infectious disease or any infectious disease in the past 8 weeks • No history of any of the following in the past 6 months (at minimum): close contact with infected patients or infectious disease department, open/unprotected relations, drug abuse, blood transfusions • Provision of signed informed consent For Group 3 (suspected MDR-TB patients): • Male or female, aged =18 years • Patients with documented pulmonary TB due to strains of Mycobacterium tuberculosis, currently on TB treatment as per routine clinical practice and suspected of MDR-TB based on physician’s clinical evaluation (eg, lack of treatment response to both isoniazid and rifampicin) • Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for MDRTB (per routine standard of care), in parallel • Provision of signed informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV): • Current or previous history of treatment for HIV, TB, malaria, or HCV • Patients suspected to be co-infected with more than one of the infectious diseases of interest (HIV/TB/malaria/HCV) • Current or previous participation in any investigational drug or medical device study in the past 3 months • Patients on any concomitant antibiotic or antiviral treatment For Group 2 (healthy participants): • Current or previous participation in any investigational drug or medical device study in the past 3 months • Participants on any concomitant antibiotic or antiviral treatment For Group 3 (suspected MDR-TB patients): • Previous history of treatment for MDR-TB or extensive drug resistance TB (XDR-TB) • Current or previous participation in any investigational drug or medical device study in the past 3 months • Patients on any concomitant antibiotic or antiviral treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the sensitivity, specificity, PPV, and NPV of EDE scanner in the detection of infectious diseases of interest (HIV, TB, malaria). | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the frequency of symptoms (at enrollment) among patients screened positive and screened negative via EDE scanner, for each infectious disease of interest (HIV, TB, malaria), among patients with confirmed disease* | — |
Countries
Kenya
Contacts
Public ContactDeborah Lo Forte
EDE Research
Outcome results
None listed