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Influenza Vaccine Uptake Among Healthcare Workers

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ClinicalTrials.gov Identifier: NCT05521763
Recruitment Status : Recruiting
First Posted : August 30, 2022
Last Update Posted : September 15, 2022
Sponsor:
Collaborators:
Institute of Epidemiology, Disease Control and Research
Sylhet M.A.G.Osmani Medical College
Mymensingh Medical College Hospital
Rajshahi Medical College
Khulna Medical College Hospital
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Background:

  1. Burden: Health-care workers (HCWs), such as doctors, nurses, and support staff involved in direct or indirect patient care, are at increased risk of influenza virus infections. HCWs may also transmit and spread influenza among hospitalized patients and other caregivers. HCWs often (40-83%) work while experiencing influenza-like illness (ILI), increasing the likelihood of influenza transmission to colleagues and patients.
  2. Knowledge gap: Despite the World Health Organization recommendation for seasonal influenza vaccination among priority target groups such as health care workers, the low-income country such as Bangladesh lacks a seasonal influenza vaccination policy among this high-risk group, and vaccine uptake remains low.
  3. Relevance: This study aims to generate preliminary data on HCWs willingness to get seasonal influenza vaccines following vaccine availability and factors associated with vaccine uptakes. The data from the study will support policymakers to increase awareness and develop influenza vaccination policy among top priority groups such as health care workers.

Hypothesis: The investigators hypothesize that awareness and availability of influenza vaccine supply would increase influenza vaccine uptake among health care workers

Objectives:

  1. To assess influenza vaccine uptake among healthcare workers (HCWs) following awareness and availability of influenza vaccine supply in study hospitals
  2. To explore HCWs barriers and Motivators for influenza vaccine uptake
  3. To understand policy makers' perspectives on the feasibility of influenza vaccination among HCWs and to share with the National Immunization Technical Advisory Group (NITAG) for a policy decision regarding influenza vaccination

Methods:

The study will be conducted at four tertiary-level public teaching hospitals in Bangladesh. The investigators will use a cluster randomized controlled trial design. The intervention will be randomly allocated at the facility level and will include four arms: i) availability of influenza vaccine supply; ii) influenza vaccine awareness; iii) both influenza vaccine supply and influenza vaccine awareness, and iv) control arm with no intervention. The investigators will assess influenza vaccine uptake before and after intervention and between different study arms. The investigators will also explore the barriers and motivators of vaccine uptake using a qualitative approach. To understand the policy makers' perspectives and opinions regarding influenza vaccination among health care workers, the investigators will conduct in-depth interviews.

Outcome measures/variables:

  1. The proportion of influenza vaccine uptake among health care workers before and after intervention and between different study arms
  2. Different motivators and barriers to influenza vaccine uptake

Condition or disease Intervention/treatment Phase
Influenza Vaccines Behavioral: ensuring the availability of influenza vaccine supply & developing influenza vaccine awareness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Seasonal Influenza Vaccine Uptake Among Health Care Workers Following Awareness and Availability of Influenza Vaccine Supply in Tertiary Care Hospitals, Bangladesh
Actual Study Start Date : March 12, 2022
Estimated Primary Completion Date : December 29, 2022
Estimated Study Completion Date : February 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
Experimental: Intervention package with the availability of vaccine supply only
  1. The investigators will work with the supplier to make that vaccine available at the hospital premises. Then a vaccination booth will be set up at the hospital premises and will administer the vaccine at the MRP.
  2. All HCWs will be notified about only vaccine availability information by the hospital director and respective heads.
  3. A list of all staff working in the study hospitals will be prepared, and they will be provided with an influenza vaccination record card with a unique identification number. The study staff will ensure receipt of vaccination cards for all participants.
  4. A short message (SMS) will be delivered over the mobile phone number to all participants, e.g. vaccination program duration, venue, time, vaccine price, to cascade vaccination information to participants.
  5. Posters with only vaccine delivery information (i.e. vaccination duration, vaccination venue, vaccine price) will be displayed at key hospital locations.
Behavioral: ensuring the availability of influenza vaccine supply & developing influenza vaccine awareness

The four interventions will be:

i) ensuring the availability of influenza vaccine supply; ii) developing influenza vaccine awareness; iii) both ensuring influenza vaccine supply and developing influenza vaccine awareness and iv) control arm with no intervention.


Experimental: Intervention package with vaccinationation awareness only
  1. The hospital director and respective heads will notify all HCWs about participating in the vaccination awareness program facilitated by the study team.
  2. The investigators will arrange separate seminars for each group of HCWs in the hospital to sensitize participants about the significance of receiving the influenza vaccine and the risk and benefits of influenza vaccination.
  3. Posters containing messages on the importance of influenza vaccination will be displayed at key hospital locations, e.g., the main entrance of the hospital, nursing station, vaccine delivery point/place, doctors' room, nurses' room, intern doctors' room, common room canteen etc.
Behavioral: ensuring the availability of influenza vaccine supply & developing influenza vaccine awareness

The four interventions will be:

i) ensuring the availability of influenza vaccine supply; ii) developing influenza vaccine awareness; iii) both ensuring influenza vaccine supply and developing influenza vaccine awareness and iv) control arm with no intervention.


Experimental: Intervention package with a combination of vaccine availability and awareness
  1. The investigators will work with the study hospital authority, Influenza vaccine manufacturer, and supplier company to set up a vaccination booth at the hospital premises to administer the vaccine at the market-rated price (MRP) by hospital nurses.
  2. The hospital director and respective department heads will notify all HCWs to receive the offered influenza vaccine.
  3. A list of all staff working in the study hospitals will be prepared, and they will be provided with an influenza vaccination record card with a unique identification number.
  4. The investigators will arrange separate seminars for each group of HCWs in the hospital to sensitize participants about the significance of receiving the influenza vaccine and the risk and benefits of influenza vaccination.
  5. A short message (SMS) will be delivered over the mobile phone number to all participants.
  6. Posters with key messages will be displayed at key hospital locations,
Behavioral: ensuring the availability of influenza vaccine supply & developing influenza vaccine awareness

The four interventions will be:

i) ensuring the availability of influenza vaccine supply; ii) developing influenza vaccine awareness; iii) both ensuring influenza vaccine supply and developing influenza vaccine awareness and iv) control arm with no intervention.


No Intervention: No intervention
In the control facility, we will not intervene in the existing knowledge and practice about influenza vaccination of the HCWs.



Primary Outcome Measures :
  1. Influenza vaccine uptake among HCWs [ Time Frame: up to 4 months ]
    The proportion of influenza vaccine uptake among health care workers before and after intervention and between different study arms


Secondary Outcome Measures :
  1. Motivators and barriers of influenza vaccine uptake [ Time Frame: up to 4 months ]
    Different motivators and barriers of influenza vaccine uptake



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All HCWs who will be working at the study hospitals during the intervention period as well as consented to participate in the study will be included as participants

Exclusion Criteria:

  • HCWs not directly or indirectly involved in patient care, such as basic medical science faculties (e.g. anatomy, physiology, biochemistry, forensic medicine, pathology, and microbiology), will not be included as participants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05521763


Contacts
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Contact: Dr Md Zakiul Hassan, MSc +8802222277001-10 ext 2547 zhassan@icddrb.org
Contact: Dr Fahmida Chowdhury, MPH +8802222277001-10 ext 2550 fahmida_chow@icddrb.org

Locations
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Bangladesh
Sylhet MAG Osmani Medical College Hospital Recruiting
Sylhet, Bangladesh
Contact: Dr Shishir Ranjan Chakraborty, FCPS    0821811726    chakrabortysrdr@gmail.com   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Institute of Epidemiology, Disease Control and Research
Sylhet M.A.G.Osmani Medical College
Mymensingh Medical College Hospital
Rajshahi Medical College
Khulna Medical College Hospital
Centers for Disease Control and Prevention
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT05521763    
Other Study ID Numbers: PR-21150
First Posted: August 30, 2022    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Vaccination Awareness
Healthcare Workers
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs