NCT05378438

Brief Summary

This study is designed to assess the impact of the first introduction of microscope-based health education on people's attitude and practice towards disease prevention in Nepal, measured by vaccine acceptance rate. Such health education has an important role to play in communities where vaccine acceptance is low.

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
1,252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2023

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

May 12, 2022

Last Update Submit

July 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Differential vaccine acceptance rates between intervention and control group

    Data will be collected for baseline as well as post intervention after 3 months of workshop. For both the intervention and control group, number of vaccinated among the participants for provided COVID-19 vaccine and Typhoid vaccine will be made. Comparative analysis will be made in both the study groups before and after the intervention program.

    Within 3 months of intervention

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants allocated in this arm will be approached for a workshop related to microbe literacy. Using a microscope, live demonstration of the biological samples brought by the participants will be carried out by the team of researchers. Participants will be assisted to place biological materials under the microscope, manipulate the slides and discover the profusion of microbial life from the immediate environment. The session will be followed by question and answer round related to concurrent hygiene practices and basic sanitation to prevent infections including vaccines.

Other: Microbe literacy Program in the form of workshop

Control arm

NO INTERVENTION

Participants in this arm will be consented for the study and baseline data collection will be made but there will not be any intervention. Data will be collected for baseline as well as post interventional vaccination status among the studied population.

Interventions

Two to Three hours of workshop on microbe literacy will be conducted as an intervention. Workshop includes discussion on various common microorganisms causing diseases, their sources, relationship with surroundings and management. Prime focus of the session will be on management via treatments and risk reduction via vaccination.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People aged 18 years or older who are resident of the study target area
  • People who stayed at least for 6 months on the area of study
  • People who agrees with the procedure of study and follow ups visits
  • People who provide consent for their participation will be recruited in the study.

You may not qualify if:

  • People under 18 years of age will not be enrolled into study due to their limitation of understanding and implementation of the content of workshop given as intervention.
  • People who do not wish to participate in the trial
  • Those with currently ongoing court hearing and deprive of freedom will not be enrolled for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nepal Health Research Council

Kathmandu, Bagmati, 44600, Nepal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Chief

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 18, 2022

Study Start

July 15, 2022

Primary Completion

September 30, 2022

Study Completion

April 17, 2023

Last Updated

July 6, 2022

Record last verified: 2022-07

Locations