NCT05521763

Brief Summary

Background:

  1. 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. 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. 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.
  4. 4.To assess influenza vaccine uptake among healthcare workers (HCWs) following awareness and availability of influenza vaccine supply in study hospitals
  5. 5.To explore HCWs barriers and Motivators for influenza vaccine uptake
  6. 6.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
  7. 7.The proportion of influenza vaccine uptake among health care workers before and after intervention and between different study arms
  8. 8.Different motivators and barriers to influenza vaccine uptake

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2023

Completed
Last Updated

September 15, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

August 17, 2022

Last Update Submit

September 11, 2022

Conditions

Keywords

Vaccination AwarenessHealthcare Workers

Outcome Measures

Primary Outcomes (1)

  • Influenza vaccine uptake among HCWs

    The proportion of influenza vaccine uptake among health care workers before and after intervention and between different study arms

    up to 4 months

Secondary Outcomes (1)

  • Motivators and barriers of influenza vaccine uptake

    up to 4 months

Study Arms (4)

Intervention package with the availability of vaccine supply only

EXPERIMENTAL

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

Intervention package with vaccinationation awareness only

EXPERIMENTAL

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

Intervention package with a combination of vaccine availability and awareness

EXPERIMENTAL

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

No intervention

NO INTERVENTION

In the control facility, we will not intervene in the existing knowledge and practice about influenza vaccination of the HCWs.

Interventions

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.

Intervention package with a combination of vaccine availability and awarenessIntervention package with the availability of vaccine supply onlyIntervention package with vaccinationation awareness only

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sylhet MAG Osmani Medical College Hospital

Sylhet, Bangladesh

RECRUITING

Related Publications (28)

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  • Chiu S, Black CL, Yue X, Greby SM, Laney AS, Campbell AP, de Perio MA. Working with influenza-like illness: Presenteeism among US health care personnel during the 2014-2015 influenza season. Am J Infect Control. 2017 Nov 1;45(11):1254-1258. doi: 10.1016/j.ajic.2017.04.008. Epub 2017 May 16.

    PMID: 28526310BACKGROUND
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    PMID: 24798250BACKGROUND
  • Turnberg W, Daniell W, Duchin J. Influenza vaccination and sick leave practices and perceptions reported by health care workers in ambulatory care settings. Am J Infect Control. 2010 Aug;38(6):486-8. doi: 10.1016/j.ajic.2009.12.006. Epub 2010 Feb 21.

    PMID: 20176412BACKGROUND
  • Barberis I, Myles P, Ault SK, Bragazzi NL, Martini M. History and evolution of influenza control through vaccination: from the first monovalent vaccine to universal vaccines. J Prev Med Hyg. 2016 Sep;57(3):E115-E120.

    PMID: 27980374BACKGROUND
  • Gasparini R, Amicizia D, Lai PL, Bragazzi NL, Panatto D. Compounds with anti-influenza activity: present and future of strategies for the optimal treatment and management of influenza. Part II: Future compounds against influenza virus. J Prev Med Hyg. 2014 Dec;55(4):109-29.

    PMID: 26137785BACKGROUND
  • Frenzel E, Chemaly RF, Ariza-Heredia E, Jiang Y, Shah DP, Thomas G, Graviss L, Raad I. Association of increased influenza vaccination in health care workers with a reduction in nosocomial influenza infections in cancer patients. Am J Infect Control. 2016 Sep 1;44(9):1016-21. doi: 10.1016/j.ajic.2016.03.024. Epub 2016 May 5.

    PMID: 27158088BACKGROUND
  • Amodio E, Restivo V, Firenze A, Mammina C, Tramuto F, Vitale F. Can influenza vaccination coverage among healthcare workers influence the risk of nosocomial influenza-like illness in hospitalized patients? J Hosp Infect. 2014 Mar;86(3):182-7. doi: 10.1016/j.jhin.2014.01.005. Epub 2014 Feb 6.

    PMID: 24581755BACKGROUND
  • Benet T, Regis C, Voirin N, Robert O, Lina B, Cronenberger S, Comte B, Coppere B, Vanhems P. Influenza vaccination of healthcare workers in acute-care hospitals: a case-control study of its effect on hospital-acquired influenza among patients. BMC Infect Dis. 2012 Feb 1;12:30. doi: 10.1186/1471-2334-12-30.

    PMID: 22292886BACKGROUND
  • Vaccines against influenza WHO position paper - November 2012. Wkly Epidemiol Rec. 2012 Nov 23;87(47):461-76. No abstract available. English, French.

    PMID: 23210147BACKGROUND
  • Al Awaidy S, Althaqafi A, Dbaibo G; Middle East/North Africa Influenza Stakeholder Network (MENA-ISN). A Snapshot of Influenza Surveillance, Vaccine Recommendations, and Vaccine Access, Drivers, and Barriers in Selected Middle Eastern and North African Countries. Oman Med J. 2018 Jul;33(4):283-290. doi: 10.5001/omj.2018.54.

    PMID: 30038727BACKGROUND
  • Eaton JL, Mohr DC, McPhaul KM, Kaslow RA, Martinello RA. Access, Education and Policy Awareness: Predictors of Influenza Vaccine Acceptance Among VHA Healthcare Workers. Infect Control Hosp Epidemiol. 2017 Aug;38(8):970-975. doi: 10.1017/ice.2017.113. Epub 2017 Jun 23.

    PMID: 28641586BACKGROUND
  • Abu-Gharbieh E, Fahmy S, Rasool BA, Khan S. Influenza vaccination: healthcare workers attitude in three Middle East countries. Int J Med Sci. 2010 Sep 21;7(5):319-25. doi: 10.7150/ijms.7.319.

    PMID: 20922053BACKGROUND
  • Van Hooste WLC, Bekaert M. To Be or Not to Be Vaccinated? The Ethical Aspects of Influenza Vaccination among Healthcare Workers. Int J Environ Res Public Health. 2019 Oct 18;16(20):3981. doi: 10.3390/ijerph16203981.

    PMID: 31635299BACKGROUND
  • Hollmeyer H, Hayden F, Mounts A, Buchholz U. Review: interventions to increase influenza vaccination among healthcare workers in hospitals. Influenza Other Respir Viruses. 2013 Jul;7(4):604-21. doi: 10.1111/irv.12002. Epub 2012 Sep 18.

    PMID: 22984794BACKGROUND
  • Naleway AL, Henkle EM, Ball S, Bozeman S, Gaglani MJ, Kennedy ED, Thompson MG. Barriers and facilitators to influenza vaccination and vaccine coverage in a cohort of health care personnel. Am J Infect Control. 2014 Apr;42(4):371-5. doi: 10.1016/j.ajic.2013.11.003.

    PMID: 24679562BACKGROUND
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    PMID: 26858382BACKGROUND
  • Looijmans-van den Akker I, van Delden JJ, Verheij TJ, van der Sande MA, van Essen GA, Riphagen-Dalhuisen J, Hulscher ME, Hak E. Effects of a multi-faceted program to increase influenza vaccine uptake among health care workers in nursing homes: A cluster randomised controlled trial. Vaccine. 2010 Jul 12;28(31):5086-92. doi: 10.1016/j.vaccine.2010.05.003. Epub 2010 May 23.

    PMID: 20580740BACKGROUND
  • Dini G, Toletone A, Sticchi L, Orsi A, Bragazzi NL, Durando P. Influenza vaccination in healthcare workers: A comprehensive critical appraisal of the literature. Hum Vaccin Immunother. 2018 Mar 4;14(3):772-789. doi: 10.1080/21645515.2017.1348442. Epub 2017 Oct 20.

    PMID: 28787234BACKGROUND
  • Azziz-Baumgartner E, Alamgir AS, Rahman M, Homaira N, Sohel BM, Sharker MA, Zaman RU, Dee J, Gurley ES, Al Mamun A, Mah-E-Muneer S, Fry AM, Widdowson MA, Bresee J, Lindstrom S, Azim T, Brooks A, Podder G, Hossain MJ, Rahman M, Luby SP. Incidence of influenza-like illness and severe acute respiratory infection during three influenza seasons in Bangladesh, 2008-2010. Bull World Health Organ. 2012 Jan 1;90(1):12-9. doi: 10.2471/BLT.11.090209. Epub 2011 Oct 4.

    PMID: 22271960BACKGROUND
  • Hassan MZ, Shirin T, Rahman M, Alamgir ASM, Jahan N, Al Jubayer Biswas MA, Khan SH, Basher MAK, Islam MA, Hussain K, Islam MN, Rabbany MA, Haque MA, Chakraborty SR, Parvin SR, Rahman M, Chowdhury F. Seasonal influenza vaccine uptake among healthcare workers in tertiary care hospitals, Bangladesh: Study protocol for influenza vaccine supply and awareness intervention. BMC Public Health. 2022 Sep 24;22(1):1819. doi: 10.1186/s12889-022-14182-w.

Related Links

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Central Study Contacts

Dr Md Zakiul Hassan, MSc

CONTACT

Dr Fahmida Chowdhury, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 30, 2022

Study Start

March 12, 2022

Primary Completion

December 29, 2022

Study Completion

February 12, 2023

Last Updated

September 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations