| CTRI Number |
CTRI/2025/07/090139 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Hepatitis A Virus PRevalence, Educational assessment for Vaccination, Evaluation of Natural immunity and Treatment. |
|
Scientific Title of Study
|
Hepatitis A Virus PRevalence, Educational assessment for Vaccination, Evaluation of Natural immunity and Treatment. |
| Trial Acronym |
HAVPREVENT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRamit Mahajan |
| Designation |
Professor |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Gastroenterology, 3rd Floor, Dayanand Medical College and Hospital, (HDHI) Civil Lines, Ludhiana.
Ludhiana
PUNJAB
141001
India |
| Phone |
9779497094 |
| Fax |
911612302620 |
| Email |
mahajan.ramit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirandeep Kaur |
| Designation |
Professor |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Pharmacology, ROom no. 404, Dayanand Medical College and Hospital, College Campus, Civil Lines, Ludhiana.
Ludhiana
PUNJAB
141001
India |
| Phone |
9815277755 |
| Fax |
911612302620 |
| Email |
kiransondhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKirandeep Kaur |
| Designation |
Professor |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Pharmacology, ROom no. 404, Dayanand Medical College and Hospital, College Campus, Civil Lines, Ludhiana.
Ludhiana
PUNJAB
141001
India |
| Phone |
9815277755 |
| Fax |
911612302620 |
| Email |
kiransondhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Ludhiana. |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital Ludhiana |
| Address |
Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab. |
| Type of Sponsor |
Private medical college |
|
|
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 Ramit Mahajan |
Dayanand Medical College and Hospital |
Department of Gastroenterology HDHI building.
Ludhiana
PUNJAB |
9779497094
911612302620
mahajan.ramit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HAV Vaccination Counseling |
Brief (5-10 minute) standardized counselling session regarding HAV vaccination benefits, addressing common concerns (cost, safety etc.) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Retrospective Component: All patients (age greater than equal to 18 years) with positive HAV IgM test results from Jan 1, 2022, to Dec 31, 2024
Prospective Component: All consenting adults (age greater than equal to 18 years) with cirrhosis admitted in Gastroenterology Department between 1 July 2025, and September 30 2025
Patients with negative or unknown HAV vaccination status
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Pregnant women
Inability to provide informed consent (for seroprevalence and attitudes components)
Previous documented HAV vaccination (for attitudes and intervention component only)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of complications (ALF, ACLF) |
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall mortality and cause-specific mortality
Length of hospital stay (days)
ICU admission: indication, duration of stay, organ support required
Interventions: need for plasma exchange, continuous renal replacement therapy (CRRT), mechanical ventilation, or liver transplantation
Adverse events and secondary infections |
|
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
01/08/2025 |
| 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="3"
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 - NO
|
|
Brief Summary
|
The HAV-PREVENT study is a mixed-methods observational study aimed at understanding the epidemiology of Hepatitis A virus infections and vaccination attitudes in North India. The study comprises three components: (1) a retrospective analysis of HAV cases over 3 years to characterize clinical outcomes and complications, (2) a cross-sectional seroprevalence survey of HAV antibodies in patients with cirrhosis, and (3) an assessment of knowledge, attitudes, and practices regarding HAV vaccination with a brief educational intervention. The study aims to identify risk factors for severe complications, evaluate the burden of HAV-related hospitalizations, and develop targeted prevention strategies. Results will inform vaccination policies and public health interventions for HAV prevention in high-risk populations. |