NCT07771738

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 11, 2026

Last Update Submit

August 14, 2026

Conditions

HygieneVaccine HesitancyVaccinationHealth Knowledge Attitudes and Practice

Keywords

Microbe literacyGerm watchingLady health workersImmunizationHandwashingHealth educationCluster randomized trial

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline and 4 months (endline)

Secondary Outcomes (5)

  • Proportion reporting high trust in Lady Health Workers

    Baseline and 4 months (endline)

  • Proportion aware that germs cause infectious disease

    Baseline and 4 months (endline)

  • Proportion perceiving vaccines as safe

    Baseline and 4 months (endline)

  • Proportion intending to vaccinate ("very likely")

    Baseline and 4 months (endline)

  • Proportion willing to recommend vaccination to others

    Baseline and 4 months (endline)

Study Arms (2)

Microbe-literacy workshop (Intervention)

EXPERIMENTAL

Routine LHW services PLUS a single 120-minute microscope-based germ-watching workshop.

Behavioral: Microbe-literacy germ-watching workshop

Routine services (Control)

NO INTERVENTION

Routine LHW services and standard national health messaging; no workshop

Interventions

Microbe-literacy germ-watching workshopBEHAVIORAL

Group demonstration (25-30 participants) using portable microscopes to visualize microorganisms in participants' own environmental samples, linked to hygiene and immunization messages

Microbe-literacy workshop (Intervention)

Eligibility Criteria

Age14 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Details14 Years and older (parental/guardian consent for participants under 18). Mothers and female caregivers of children under three years, resident in selected Union Councils of Sargodha District. Probability Sample (cluster).
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mother or female caregiver, permanent resident of the study area
  • At least one child aged under 3 years
  • Written informed consent

You may not qualify if:

  • Already enrolled in a similar intervention
  • Unable to participate due to physical/psychological constraints
  • Intending to relocate during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Study

Sargodha, Punjab Province, 40100, Pakistan

Location

MeSH Terms

Conditions

Vaccination HesitancyHealth Education

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health Care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Outcome assessment/analysis blinded
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster-randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 18, 2026

Study Start

May 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

August 18, 2026

Record last verified: 2026-08

Locations

PA(1)