Health Condition 1: A488- Other specified bacterial diseases
Conditions
Interventions
Intervention1: DOSA UTI Strip Test: The DOSA-UTI test strip is a rapid, non-invasive in vitro diagnostic tool designed to detect urinary tract infections (UTIs) by identifying bacterial pathogens in u
Sponsors
ACCORD Academic and Clinical Central Office for Research and Development
Eligibility
Inclusion criteria
Inclusion criteria: Field performance trial of DOSA UTI Strip test: 1. Willing and able to provide written or audio (verbal) informed consent 2. 16 - 65 years male and female 3. Not pregnant 4. UTI symptoms (assessed by ASHA) Field usability and theory of change study: 1. Willing and able to provide written or audio (verbal) informed consent 2. Supervisors and ASHAs linked to the participating PHCs. 3. Household members (male and female) from 16 years upwards linked to each of the PHCs. 4. Doctors at participating PHCs 5. Pharmacists in proximity to the PHCs 6. Attendance to the Health, Sanitation and Nutrition Day
Exclusion criteria
Exclusion criteria: Field performance trial of DOSA UTI Strip test: 1. In addition to not meeting the inclusion criteria, see below 2. Unwilling or unable to provide written / audio (verbal) informed consent. 3. Aged less than 16 years or over 65 years Field usability and theory of change study: 1. In addition to not meeting the inclusion criteria, see below 2. Unwilling or unable to provide written / audio (verbal) informed consent. 3. Household members (male and female) under 16 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study will be the determination of the diagnostic performance of the DOSA UTI Strip Test (nitrite + leukocyte esterase) in terms of sensitivity and specificity as well as positive and negative predictive value compared to a commercial UTI dipstick test (nitrite + leukocyte esterase), urine culture test results of the presence of bacteria (nitrite + leukocyte esterase), and microscopy test results of pus cells in urine (leukocyte esterase).Timepoint: 8 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of the study will be epidemiological data of the main UTI causing pathogens & resistance profiles in the study area obtained from Vitek-2 system-based bacterial species identification & antibiotic susceptibility testing results as well as some new whole genome sequencing data of UTI causing bacteria.Timepoint: 8 months;Tertiary end points will provide data of how Tatrangi (UTI) is recognised, understood, treated & prevented within village households. Focus groups with ASHA will elicit in-depth discussions on knowledge, attitudes & practices of their interactions with the community on the condition. Insights will also be gathered on the usability of the performance test. Finally, the introduction of the DOSA kit at the Health, Nutrition & Sanitation through co-design methods will look at how this changes knowledge, attitudes & practices around the symptoms, treatment & prevention.Timepoint: 8 months | — |
Countries
India
Contacts
Public ContactDr Debadatta Dhar
Assam University
Outcome results
None listed