| CTRI Number |
CTRI/2018/03/012761 [Registered on: 22/03/2018] Trial Registered Prospectively |
| Last Modified On: |
22/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on requirements for prevention and control of infectious diseases and adverse events from spreading and becoming an emergency at ground crossing (Border Check Post) of North India. |
|
Scientific Title of Study
|
A study on assessment of core capacities for Public Health Emergencies of International Concern (PHEIC) at a selected Point of Entry (PoE) of North India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahuldeep Singh |
| Designation |
2nd Year Master of Public Health Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal (Udupi)
Udupi
KARNATAKA
576104
India |
| Phone |
9872559086 |
| Fax |
|
| Email |
roniedr.singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar Sumit |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal (Udupi)
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
sumitsharma315@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahuldeep Singh |
| Designation |
2nd year Master of Public Health Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal (Udupi)
Udupi
KARNATAKA
576104
India |
| Phone |
9872559086 |
| Fax |
|
| Email |
roniedr.singh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Attari Border Quarantine, ICP Attari, Amritsar |
|
|
Primary Sponsor
|
| Name |
Dr Rahuldeep Singh |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 576104 (Udupi) Karnataka |
| Type of Sponsor |
Other [Self sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahuldeep Singh |
Integrated Check Post Attari |
MI Room, Arrivals Gate no. 3, Attari road border
Amritsar
PUNJAB |
9872559086
roniedr.singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Travelers using ground crossing as a Point of Entry into India or exit from India. Though they may present with travel sickness, fever or quarantinable diseases (such as yellow fever, zika, polio). |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
travelers using the ground crossing as a Point of Entry into India or Exit from India and officials present at the ground crossing who are willing to participate in the study after informed written consent. |
|
| ExclusionCriteria |
| Details |
travelers and officials who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This research will help in Understanding on the implementation status in relation to requirements of IHR (2005) at Ground crossing Integrated Check Post Attari, Wagah border, Amritsar. |
January 2018 to June 2018 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This research will be helpful in identifying gaps to strengthen existing capacities to improve safety of International travelers and reduce risk of import of infections. |
January 2018 to June 2018 |
| It will be useful in assessing the strengths and areas for improvement towards implementing the requirement of IHR (2005) |
January 2018 to June 2018 |
| It will help in understanding the knowledge, Awareness and Risk Perceptions among travelers and the need to create awareness among them regarding travel health. |
January 2018 to June 2018 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2018 |
| Date of Study Completion (India) |
31/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
This research is part of the Post Graduate Thesis/Dissertation. Publication after the final submission of the thesis. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Globalization and the spread of disease have made public health a matter of international concern. International airports, ports and ground crossings are required to have health units for undertaking public health measures during routine times and specific measures during the time of Public health emergency of International Concern (PHEIC). The exposure to hazards, the conditions of vulnerability that are present and insufficient capacity or measures to reduce or cope with the potential negative consequences calls upon proactive, all hazards approach, especially, at International Points of entry. Regarding the public health response, articles 5 and 13 of the (IHR) International Health Regulations (2005) state that each country shall develop, strengthen and maintain as soon as possible but not later than five years from the entry into force of this regulations, the capacity to respond well and quickly to PHEIC as set out in the core capacity requirements for surveillance and response. This legal instrument contain rights and obligation for countries concerning prevention, surveillance and response health measures applied to international travelers at Point of Entry (POEs). All 194 WHO Member States including India agreed to implement the IHR (2005). International travel can pose various risks to health, depending on the characteristics of both the traveler and the travel. Failure to respond in a timely manner by local public health authorities undermines the IHR and can be detrimental to the national economy. Border Health strategies minimizing the risk of importation and exportation of disease through POEs, as well as across porous land borders, are generally not a common feature of national surveillance systems. Border health approaches, for the most part, can leverage tools and strategies in the existing public health systems and infrastructure. The risk of international spread of diseases is decreased through effective standing public health measures and response capacity at designated airports, ports and ground crossings in all countries. Similarly, the prime aim of Airport and Border Quarantine, Amritsar is to prevent any infectious disease entering into our country which is not prevalent in India e.g. Yellow Fever, SARS, Zika. Meaningful interaction with other agencies will be a key factor strategy implementation of International Health Regulations, 2005. This Research uses a WHO Core Capacity Assessment tool and In-depth Interviews with travelers using the ground crossing ICP, Attari as a Point of Entry into India or Exit from India as well as the officials present at the ground crossing who are willing to participate in the study.
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