VaccinationMLI-SargodhaNCT07771738
Microbe-Literacy Germ-Watching Workshops for Hygiene and Vaccine Acceptance in Sargodha, Pakistan
A study testing Microbe-literacy germ-watching workshop in people with Vaccination and Hygiene, run by Development Synergies International (Private) Limited at 1 site in Pakistan.
Trial summary
This cluster randomized controlled trial evaluated whether a single microscope-based "germ-watching" workshop, delivered by Lady Health Workers (LHWs) to mothers and female caregivers of children under three years, improves hygiene practices, vaccination attitudes and intentions, routine immunization, and trust in… Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccination, Hygiene, Vaccine Hesitancy
- What is being tested?
- Microbe-literacy germ-watching workshop
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 31 Aug 2024
- 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 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother or female caregiver, permanent resident of the study area
- At least one child aged under 3 years
- Written informed consent
Who cannot join
- Already enrolled in a similar intervention
- Unable to participate due to physical/psychological constraints
- Intending to relocate during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Vaccine Acceptance, Hygiene, and Trust in Community Health Workers Through a Microbe-Literacy Intervention: A Cluster Randomized Controlled Trial in Sargodha District, Pakistan
This cluster randomized controlled trial evaluated whether a single microscope-based "germ-watching" workshop, delivered by Lady Health Workers (LHWs) to mothers and female caregivers of children under three years, improves hygiene practices, vaccination attitudes and intentions, routine immunization, and trust in LHWs. Twelve Union Councils in Sargodha District, Pakistan, were allocated 1:1 to the intervention or routine services, with outcomes measured by structured baseline and endline surveys and facility immunization records.
Read the detailed description
In intervention clusters, LHWs used portable microscopes (>=400x) to show caregivers the microorganisms present in their own household water and food samples during a single 120-minute workshop for 25-30 participants, linking observed microbes to hygiene and vaccine-preventable disease. Control clusters received routine LHW services and standard national health messaging. Allocation used restricted, covariate-constrained randomization at the Union Council level; outcome data entry and analysis were blinded to allocation. Analyses accounted for clustering.
- Being tested
- Microbe-literacy germ-watching workshop
- Keywords
- Microbe literacy, Germ watching, Lady health workers, Immunization, Handwashing, Health education, Cluster randomized trial
- Medical subject headings
- Vaccination Hesitancy, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbe-literacy germ-watching workshopBehavioural
Group demonstration (25-30 participants) using portable microscopes to visualize microorganisms in participants' own environmental samples, linked to hygiene and immunization messages
| Study group | Role | What they receive |
|---|---|---|
| Microbe-literacy workshop (Intervention) | Experimental | Routine LHW services PLUS a single 120-minute microscope-based germ-watching workshop. Receives: Behavioral: Microbe-literacy germ-watching workshop |
| Routine services (Control) | No intervention | Routine LHW services and standard national health messaging; no workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of caregivers/children reporting always washing hands (self-reported)
Percentage of caregivers (and their children) reporting they "always" wash hands with soap / before eating, from a structured interviewer-administered survey item, compared between arms.
Measured: Baseline and 4 months (endline, immediately after the intervention period)
Third-dose oral polio vaccine (OPV3) coverage (facility records)
Percentage of index children with a documented third dose of oral polio vaccine, ascertained from facility immunization records, compared between arms.
Measured: 4 months (endline)
Proportion with self-reported completion of the age-appropriate immunization schedule
Percentage of caregivers reporting the index child had received all age-appropriate vaccinations (structured survey item), compared between arms.
Measured: Baseline and 4 months (endline)
Secondary outcomes (5)
Proportion reporting high trust in Lady Health Workers
Percentage of caregivers responding "yes, a lot" to a single-item survey question on trust in Lady Health Workers for vaccine information, compared between arms.
Measured: Baseline and 4 months (endline)
Proportion aware that germs cause infectious disease
Percentage of caregivers identifying germs (rather than, e.g., "bad weather") as the cause of infectious disease on a survey item, compared between arms.
Measured: Baseline and 4 months (endline)
Proportion perceiving vaccines as safe
Percentage of caregivers responding "yes, safe" to a survey item on perceived vaccine safety, compared between arms.
Measured: Baseline and 4 months (endline)
Proportion intending to vaccinate ("very likely")
Percentage of caregivers responding "very likely" to a survey item on intention to vaccinate the child in future, compared between arms.
Measured: Baseline and 4 months (endline)
Proportion willing to recommend vaccination to others
Percentage of caregivers responding "yes" to a survey item on willingness to recommend vaccination to other mothers, compared between arms.
Measured: Baseline and 4 months (endline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 May 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccinationStudies 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
- Model description
- Cluster-randomized
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Development Synergies International (Private) Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Microbe Literacy Initiative, National University of Science and Technology, Pakistan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771738
- Sponsor's protocol ID
- DSI-24-00001
- Other IDs
- NMDC/DRC/225/09/063-ERC
- Acronym
- MLI-Sargodha
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified participant data available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Vaccine Acceptance, Hygiene, and Trust in Community Health Workers Through a Microbe-Literacy Intervention: A Cluster Randomized Controlled Trial in Sargodha District, Pakistan
- ClinicalTrials.gov ID
- NCT07771738
- Acronym / sponsor ID
- MLI-Sargodha / DSI-24-00001
- Keywords
- Microbe literacy, Germ watching, Lady health workers, Immunization, Handwashing, Health education, Cluster randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Development Synergies International (Private) LimitedUniversity, hospital or other
- Collaborators
- Microbe Literacy Initiative, National University of Science and Technology, Pakistan
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 18 Aug 2026 (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 cluster randomized controlled trial evaluated whether a single microscope-based "germ-watching" workshop, delivered by Lady Health Workers (LHWs) to mothers and female caregivers of children under three years, improves hygiene practices, vaccination attitudes and intentions, routine immunization, and trust in LHWs. Twelve Union Councils in Sargodha District, Pakistan, were allocated 1:1 to the intervention or routine services, with outcomes measured by structured baseline and endline surveys and facility immunization records.
Detailed description
In intervention clusters, LHWs used portable microscopes (>=400x) to show caregivers the microorganisms present in their own household water and food samples during a single 120-minute workshop for 25-30 participants, linking observed microbes to hygiene and vaccine-preventable disease. Control clusters received routine LHW services and standard national health messaging. Allocation used restricted, covariate-constrained randomization at the Union Council level; outcome data entry and analysis were blinded to allocation. Analyses accounted for clustering.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized
| Arm | Type | Receives |
|---|---|---|
| Microbe-literacy workshop (Intervention) | Experimental | Behavioral: Microbe-literacy germ-watching workshopRoutine LHW services PLUS a single 120-minute microscope-based germ-watching workshop. |
| Routine services (Control) | No intervention | –Routine LHW services and standard national health messaging; no workshop |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mother or female caregiver, permanent resident of the study area
- At least one child aged under 3 years
- Written informed consent
Key exclusion criteria (3 listed)
- Already enrolled in a similar intervention
- Unable to participate due to physical/psychological constraints
- Intending to relocate during the study period
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 germ-watching workshopGroup demonstration (25-30 participants) using portable microscopes to visualize microorganisms in participants' own environmental samples, linked to hygiene and immunization messages | Behavioural | Microbe-literacy workshop (Intervention) |
Primary outcome
Proportion of caregivers/children reporting always washing hands (self-reported)
Time frame: Baseline and 4 months (endline, immediately after the intervention period)
Percentage of caregivers (and their children) reporting they "always" wash hands with soap / before eating, from a structured interviewer-administered survey item, compared between arms.
Third-dose oral polio vaccine (OPV3) coverage (facility records)
Time frame: 4 months (endline)
Percentage of index children with a documented third dose of oral polio vaccine, ascertained from facility immunization records, compared between arms.
Proportion with self-reported completion of the age-appropriate immunization schedule
Time frame: Baseline and 4 months (endline)
Percentage of caregivers reporting the index child had received all age-appropriate vaccinations (structured survey item), compared between arms.
5 secondary outcomes
Proportion reporting high trust in Lady Health Workers
Time frame: Baseline and 4 months (endline)
Proportion aware that germs cause infectious disease
Time frame: Baseline and 4 months (endline)
Proportion perceiving vaccines as safe
Time frame: Baseline and 4 months (endline)
Proportion intending to vaccinate ("very likely")
Time frame: Baseline and 4 months (endline)
Proportion willing to recommend vaccination to others
Time frame: Baseline and 4 months (endline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided. De-identified participant data available from the corresponding author on reasonable request.
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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 germ-watching workshop in people with Vaccination and Hygiene, run by Development Synergies International (Private) Limited at 1 site in Pakistan.
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 3 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: finished, as of the sponsor's last update on 18 Aug 2026. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of caregivers/children reporting always washing hands (self-reported) (time frame: Baseline and 4 months (endline, immediately after the intervention period)). The study lists 3 primary outcomes in all. 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 18 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.