Vaccine AcceptanceNCT05378438
Impact of Microbe Literacy Initiative on Improved Vaccine Uptake in Peri-urban Slum Areas in Kathmandu, Nepal
A study testing Microbe literacy Program in the form of workshop in people with Vaccine Acceptance, run by Nepal Health Research Council at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Acceptance
- What is being tested?
- Microbe literacy Program in the form of workshop
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,252 participants
- Where
- 1 siteNepal
- Study dates
- 15 Jul 2022to 17 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Nepal Health Research Council
Kathmandu, Bagmati, 44600
Dr. Pradip Gyanwali, MD
About this study
Official title: 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.
- Conditions
- Vaccine Acceptance
- Being tested
- Microbe literacy Program in the form of workshop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbe literacy Program in the form of workshopOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start15 Jul 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion17 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine AcceptanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nepal Health Research Council
- Sponsor type
- Other government
- Collaborators
- Microbe Literacy Initiative, Partnership for Sustainable Development Nepal (PSDNepal)
- Responsible party
- Principal investigator, Dr. Pradip Gyanwali,MD, Nepal Health Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378438
- Sponsor's protocol ID
- 39/2022
- Status last verified
- Jul 2022
- First submitted
- 12 May 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Microbe Literacy Initiative on Improved Vaccine Uptake in Peri-urban Slum Areas in Kathmandu, Nepal: A Community Based Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05378438
- Acronym / sponsor ID
- 39/2022
- Conditions
- Vaccine Acceptance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,252 participants (estimated)
- Lead sponsor
- Nepal Health Research CouncilOther government
- Collaborators
- Microbe Literacy Initiative, Partnership for Sustainable Development Nepal (PSDNepal)
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 17 Apr 2023 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Microbe literacy Program in the form of workshopParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbe literacy Program in the form of workshopTwo 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. | Other | Intervention Arm |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbe literacy Program in the form of workshop in people with Vaccine Acceptance, run by Nepal Health Research Council at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential vaccine acceptance rates between intervention and control group (time frame: Within 3 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.