| CTRI Number |
CTRI/2024/12/078030 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Intervention to reduce treatment delays and loss to follow up among TB patients |
|
Scientific Title of Study
|
Reducing pre treatment loss to follow up among individuals diagnosed with TB through behavioral nudging intervention. A multi-centric mixed methods implementation study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 076 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KARIKALAN NAGARAJAN |
| Designation |
Scientist D |
| Affiliation |
ICMR-National Institute of Research in Tuberculosis |
| Address |
Department of Social and Behavioral Research, First floor clinic building,
ICMR-National Institute of Research in Tuberculosis,
No 1 Mayor Sathiyamoorthy St Chetpet Chennai
Tamil Nadu
Chennai
TAMIL NADU
600031
India |
| Phone |
72992265822 |
| Fax |
|
| Email |
drkarikalan82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KARIKALAN NAGARAJAN |
| Designation |
Scientist D |
| Affiliation |
ICMR-National Institute for Research in Tuberculosis |
| Address |
Department of Social and Behavioral Research, First floor clinic building,
ICMR-National Institute for Research in Tuberculosis,
No 1 Mayor Sathiyamoorthy St Chetpet Chennai
Tamil Nadu
Chennai
TAMIL NADU
600031
India |
| Phone |
72992265822 |
| Fax |
|
| Email |
drkarikalan82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KARIKALAN NAGARAJAN |
| Designation |
Scientist D |
| Affiliation |
ICMR-National Institute for Research in Tuberculosis |
| Address |
Department of Social and Behavioral Research, First floor clinic building,
ICMR-National Institute for Research in Tuberculosis,
No 1 Mayor Sathiyamoorthy St Chetpet Chennai
Tamil Nadu
Chennai
TAMIL NADU
600031
India |
| Phone |
72992265822 |
| Fax |
|
| Email |
drkarikalan82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subhebdu Kumar Acharya |
ICMR Regional Medical Research center Bhubaneswar, |
Main Building 2nd Floor, Chandra Sekhar Pur Nalco Nagar Bhubaneswar 751023
Khordha
ORISSA |
9444554099
a.subhendu@gmail.com |
| Dr N Karikalan |
ICMR-National Institute for Research in Tuberculosis |
Floor 1, Clinic Building, Department of Social and Behavioral Research, No1 Mayor Sathya moorthy Road, Chetpet, Chennai 600031
Chennai
TAMIL NADU |
7299226582
karikalan.n@icmr.gov.in |
| Dr K Asha |
ICMR-National Institute of Occupational Health |
3rd Floor Health sciences division, ICMR-National Institute of Occupational Health Meghani Nagar, Ahmedabad-380016, Gujarat, INDIA
Ahmadabad
GUJARAT |
08197080581
asha.k@gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ICMR- REGIONAL MEDICAL RESEARCH CENTRE, BHUBANESWAR INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
| ICMR-National Institute of Occupational Health Human Ethics Committee |
Approved |
| IEC-ICMR-National Institute for Research in Tuberculosis |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioral Nudging Intervention |
The intervention will consist of providing brief behavioural nudging ( a form of gentle persuasion) to support timely treatment initiation among individuals affected by TB. The nudging tools will consist of paper based cards with nudging messages printed on it which will be delivered by study intervention staff to the individuals affected by TB
|
| Comparator Agent |
Standard of Care |
The control arm will consist of provision of information education and communication (IEC) which is routinely given to TB patients in health centers . IEC is provided to improve basic TB awareness and sensitization to TB patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All newly diagnosed adult tuberculosis patients |
|
| ExclusionCriteria |
| Details |
Patients aged less that 18 yrs , re-treatment TB patients and those not willing to be part of study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will use TB patient treatment records and will estimate the reduction in treatment initiation gaps and loss to follow up |
Baseline, eighth week and 24th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| we will assess implementation process of a behavioural nudging intervention from the perspective of patients, caregivers and health care provider’s using qualitative interviews |
end of intervention period |
|
|
Target Sample Size
|
Total Sample Size="1300"
Sample Size from India="1300"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/12/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Rationale : Pretreatment loss to follow-up (PTLFU) and treatment initiation delays remains a major gap in the TB patient cascade of care in India and needs to addressed to ensure the End TB goals of India by 2025. It is a critical point of attrition in the TB care cascade. Objective : To assess gaps in the patient referral process and treatment initiation gaps among newly diagnosed DS-TB patient To evaluate the incremental effectiveness of a patient behavioural nudging intervention in reducing PTLFU rates as compared to enhanced standard of care Evaluate the implementation process of a behavioural nudging intervention from the perspective of patients, caregivers and health care provider’s Outcomes
The study would provide an evidence on the impacts of behavioural nudging intervention in terms of reduction in PTLFU rates and treatment initiation delays in settings where it is high. The study tries to assess behavioural nudging as tool for bringing in healthy behavior change among TB patients |