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CTRI Number  CTRI/2018/12/016519 [Registered on: 03/12/2018] Trial Registered Prospectively
Last Modified On: 06/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross-sectional study with cohort study of a sub-group of the study population 
Study Design  Other 
Public Title of Study   Prevalence and characteristics of tuberculosis in people living with HIV 
Scientific Title of Study   A study on the prevalence and characteristics of tuberculosis in people living with HIV in a tertiary care hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragadeesh T 
Designation  Junior Resident 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Medicine, Kasturba Hospitals, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9788851601  
Fax    
Email  sapnet94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavitha Saravu 
Designation  Professor and Chief 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Medicine, Kasturba Hospitals, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448107636  
Fax    
Email  kavithasaravu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pragadeesh T 
Designation  Junior Resident 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Medicine, Kasturba Hospitals, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9788851601  
Fax    
Email  sapnet94@gmail.com  
 
Source of Monetary or Material Support  
Department of General Medicine, Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Kasturba Hospitals 
Address  Kasturba Hospitals, Madhav Nagar, Manipal, 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T Pragadeesh  Kasturba Hospital  Department of General Medicine, Kasturba Hospital, Manipal
Udupi
KARNATAKA 
9788851601

sapnet94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, (2) ICD-10 Condition: A15-A19||Tuberculosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients who are either newly diagnosed with HIV or previously diagnosed people living with HIV, under the care of Kasturba Hospitals 
 
ExclusionCriteria 
Details  All pediatric HIV patients; any patient fulfilling the inclusion criteria, but who do not have CD4 counts tested in the last 6 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of tuberculosis in PL-HIV  At the time of seeing the patient (day 0) 
 
Secondary Outcome  
Outcome  TimePoints 
Practice of Isoniazid Prophylactic Therapy in PL-HIV  0, 3 months and 6 months 
 
Target Sample Size   Total Sample Size="249"
Sample Size from India="249" 
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)   04/12/2018 
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="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

        Tuberculosis is the most common opportunistic infection and the most common cause of mortality in PL-HIV. This is a study targeting this co-epidemic, with the objective of assessing the prevalence and characteristics of tuberculosis in PL-HIV, stratified by their CD-4 count, presenting to a tertiary care hospital. Informed consent will be obtained from both newly diagnosed and previously diagnosed people living with HIV under the care of the Department of General Medicine, and will be recruited under the study based on the inclusion and exclusion criteria

          Data will be collected on the socio-demographic, clinical and laboratory characteristics  of the patients, using a structured proforma. Past history of tuberculosis will also be recorded. The test records captured to ascertain tuberculosis are a part of the standard of care. No additional tests will be done as a part of the study. The data collected will be analysed and the prevalence and characteristics of tuberculosis will be measured and stratified based on CD4 count status of the patient. As a second objective, the practice of Isoniazid prophylactic therapy in people living with HIV and its outcomes is also being studied. The study participants who are on IPT (started as a part of the standard of care) will be followed up to assess the outcome of the same, for a duration of 6 months.

 
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