- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05378438
Impact of Microbe Literacy Initiative on Improved Vaccine Uptake in Peri-urban Slum Areas in Kathmandu, Nepal
July 5, 2022 updated by: Dr. Pradip Gyanwali,MD, Nepal Health Research Council
Impact of Microbe Literacy Initiative on Improved Vaccine Uptake in Peri-urban Slum Areas in Kathmandu, Nepal: A Community Based Cluster Randomized Controlled Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1252
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bagmati
-
Kathmandu, Bagmati, Nepal, 44600
- Nepal Health Research Council
-
Contact:
- Dr. Pradip Gyanwali, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
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.
|
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.
|
No Intervention: Control arm
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differential vaccine acceptance rates between intervention and control group
Time Frame: Within 3 months of intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 15, 2022
Primary Completion (Anticipated)
September 30, 2022
Study Completion (Anticipated)
April 17, 2023
Study Registration Dates
First Submitted
May 12, 2022
First Submitted That Met QC Criteria
May 12, 2022
First Posted (Actual)
May 18, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 5, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 39/2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vaccine Acceptance
-
Children's Hospital of PhiladelphiaNoble Medical, LLCCompletedHealth Behavior | Human Papillomavirus | Acceptance Processes | Social Acceptance | Vaccine AcceptanceUnited States
-
NYU Langone HealthCompleted
-
Martin-Luther-Universität Halle-WittenbergNot yet recruiting
-
Raincy Montfermeil Hospital GroupRecruiting
-
Tristen InagakiCompleted
-
Newcastle UniversityUniversity of Bristol; University of Liverpool; University of AberdeenUnknownAcceptance, SocialUnited Kingdom
-
Valduce HospitalCompleted
-
Tulane UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedCOVID-19 | Colorectal Cancer | Influenza | Health Behavior | Vaccine-Preventable Diseases | Vaccine Hesitancy | Healthcare Patient AcceptanceUnited States
-
Bronx-Lebanon Hospital Center Health Care SystemCompletedInfant Acceptance of MedicationUnited States
-
Southern Methodist UniversityCompleted
Clinical Trials on Microbe literacy Program in the form of workshop
-
Mayo ClinicCompletedType 1 Diabetes
-
Rennes University HospitalTerminated
-
Zagazig UniversityUnknownCesarean Section Complications
-
Universidade do PortoNot yet recruiting
-
University Hospitals Cleveland Medical CenterCompleted
-
Sanford HealthCompletedRadiation Induced Fibrosis to the Head and NeckUnited States
-
Memorial Sloan Kettering Cancer CenterQueens Cancer Center of Queens HospitalCompletedRectal Cancer | Colon CancerUnited States
-
University of California, IrvineVA Long Beach Healthcare SystemNot yet recruitingDiabetes Mellitus | Diabetic Kidney Disease | CKD Stage 4 | CKD Stage 5 | CKD Stage 3 | Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
-
Hong Kong Baptist UniversityCompletedHealthy ParticipantsChina