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CTRI Number  CTRI/2024/01/061298 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 08/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of a Point-of-Care Test for G6PD Detection in India 
Scientific Title of Study   Clinical evaluation of a point-of-care spectrophotometric test for detecting G6PD deficiency 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RES-00398 version 3.0 dated 23/11/2022  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajasubramaniam Shanmugam 
Designation  Scientist F 
Affiliation  Indian Council of Medical Research- National Institute of Research in Tribal Health (ICMR-NIRTH) 
Address  ICMR-NIRTH Campus, Nagpur Rd, Dhanvantri Nagar, Garha

Jabalpur
MADHYA PRADESH
482003
India 
Phone  2370800  
Fax  91-761-2370935  
Email  raja.rmrct@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajasubramaniam Shanmugam 
Designation  Scientist F 
Affiliation  Indian Council of Medical Research- National Institute of Research in Tribal Health (ICMR-NIRTH) 
Address  ICMR-NIRTH Campus, Nagpur Rd, Dhanvantri Nagar, Garha

Jabalpur
MADHYA PRADESH
482003
India 
Phone  2370800  
Fax  91-761-2370935  
Email  raja.rmrct@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajasubramaniam Shanmugam 
Designation  Scientist F 
Affiliation  Indian Council of Medical Research- National Institute of Research in Tribal Health (ICMR-NIRTH) 
Address  ICMR-NIRTH Campus, Nagpur Rd, Dhanvantri Nagar, Garha

Jabalpur
MADHYA PRADESH
482003
India 
Phone  2370800  
Fax  91-761-2370935  
Email  raja.rmrct@gmail.com  
 
Source of Monetary or Material Support  
PATH is providing technical and financial support for this project with the funding received from the [Foreign, Commonwealth and Development Office (FCDO) and Bill & Melinda Gates Foundation (BMGF)]. 
 
Primary Sponsor  
Name  PATH 
Address  2201 Westlake Ave Suite 200, Seattle, WA 98121, United States 
Type of Sponsor  Other [NGOs, Trust, Charitable Institution] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nitika  National Institute of Malaria Research  Sector 8, Dwarka, , New Delhi, Delhi - 110077
New Delhi
DELHI 		 25307424

drnitikaaiims@gmail.com 
Dr Rajasubramaniam Shanmugam  National Institute of Research in Tribal Health (NIRTH)  ICMR-NIRTH Campus, Nagpur Rd, Dhanvantri Nagar, Garha, Jabalpur, Madhya Pradesh 482003
Jabalpur
MADHYA PRADESH 		 2370800
91-761-2370935
raja.rmrct@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics committee, National Institute of Malaria Research(NIMR)  Approved 
Institutional Ethics committee,National Institute of Research in Tribal Health  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diagnostic accuracy study
-Individuals attending the health care facility
-Age greater than equal to 8 years
-Body temperature greater than equal 37.5⁰C (axillary) or with a history of fever in the last 48 hours (self-report)
- Willing to provide written informed consent/ written assent

Usability assessment study
-18 years of age or older
-Considered an intended user of point-of-care G6PD deficiency test
-Study staff member responsible for operation and use of the POC tests
-Willing and able to provide informed consent and comply with study requirements 
 
ExclusionCriteria 
Details  Diagnostic accuracy participants
- Considered by the on-duty doctor to be too sick to undergo recruitment
- Less than 8 years of age
- Unwilling to provide informed consent
- Received a blood transfusion in the past three months
- Children who have a LAR to provide consent other than Parents
- Previously participated in the same study

Usability study
- Unwilling to provide informed consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Estimates of diagnostic performance (positive percent agreement, negative percent agreement, positive predictive value (PPV), and negative predictive value (NPV) of the Wondfo G6PD/Hb test classification of G6PD status compared to the reference assay in venous blood.

Overall percentage agreement between the Wondfo G6PD/Hb test and the reference hemoglobin assay for the classification of anemia status in capillary and venous whole blood specimens. 		 Outcome assessments will be done at the completion of study enrollments. 
 
Secondary Outcome  
Outcome  TimePoints 
Diagnostic performance (positive percent agreement, negative percent agreement, PPV, & NPV) of the SD Biosensor STANDARD G6PD test classification of G6PD status compared to the reference assay.

Diagnostic performance (positive percent agreement, negative percent agreement, PPV, & NPV) of the SD Biosensor STANDARD G6PD test classification of anemia status compared to hemoglobin reference assay.

Percent of trained health workers who can accurately comprehend key messaging included in the Wondfo G6PD/Hb test packaging & labels.

Percent of trained health workers who can accurately run & interpret the Wondfo G6PD/Hb test & SD Biosensor STANDARD G6PD test result outputs. 		 Outcome assessments will be done at the completion of study enrollments. 
 
Target Sample Size   Total Sample Size="1030"
Sample Size from India="1030" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Data are available indefinitely at the Harvard dataverse. A dataset-specific link will be made available upon the publication of the dataset, under the PATH Dx G6PD dataverse

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 31-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a cross-sectional diagnostic accuracy study with 1,000 participants and 30 health worker participants. Febrile patients will be recruited from outpatient departments (OPDs) of Netaji Subhash Chandra Bose (NSCB) Medical College and Govt. Seth Govind Das (Victoria) District Hospital situated in the urban setting under the supervision of staff from the National Institute of Research in Tribal Health (NIRTH). The health worker participants will include trained intended users of Glucose-6-Phosphate Dehydrogenase (G6PD) tests. Finger-stick blood samples will be taken to perform a standard commercial malaria RDT to identify Plasmodium falciparum and questionnaire. 
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