ClinicalTrials.gg
CompletedNCT05721274GLIDEUpdated Apr 26, 2024

Community Engagement and Conditional Incentives to Accelerate Polio

An interventional study of Community mobilization and Conditional community incentives in Polio, Immunization; Infection and Incentives, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 1 Day to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
840
Allocation
Randomized
Ages
1 Day to 59 Months
Sex
All
01

Study summary

Immunization is one of the most cost-effective and successful public health strategy in reducing the health, economic and societal burden of many infectious diseases. Pakistan and Afghanistan remain the only countries where polio is endemic, and Pakistan reports the most cases in the world. Although the rate is lower than in previous years, the situation remains alarming. This study objective is to decrease polio vaccine refusals and zero-dose vaccines by motivating behaviour change

Read the detailed description

Study Design:The study will adopt a pretest/post-test quasi-experimental approach with two intervention UCs and two control UCs. For each target, intervention SHRUC, a separate, matched control SHRUC of comparable size and location will be identified for eventual pre-post comparison. Children under-five will be eligible for inclusion.

Intervention: The intervention package will include community mobilization and incentivization. Clusters will be formed on a population of 2000-2500 in each intervention UC, thus approximately ten clusters in each. Project will form or liaise with community groups or committees (male and female) in each cluster, which are already operational in many parts of the target UCs. However, to focus on reducing polio vaccine refusals, our program will adopt a unique incentivization approach, preceded by trust-building community mobilization. Clusters will be determined based on the existing micro plans of the PPEP. Microplans are a population-based set of components, at UC-level, used by the program for delivering polio vaccination efficiently. Baseline and end-line surveys will be conducted in the target and control UCs.

Study Site: The study will be conduucted in district Karachi, Sindh and other in district Bannu, KP.

Intervention UCs: Haji Mureed Goth Karchi and Mira-Khel KP COntrol UCs : Nazivmabad UC 49 Karachi and Khwajamad- Bannu)

The research team will engage with multiple village/mohalla committees in the intervention UCs to address and eliminate misconceptions about polio. One-to-one meetings and group sessions which will be led by the committee members, to provide messages on childhood immunization with project-specific IEC material, will be held in each targeted cluster. These platforms would be helpful to identify and counsel their underlying fears and socio-psychological factors about the vaccines, such as painful neonatal experiences, mishandling, doubts, fear of vaccine-related side effects, distrust, etc.

The community-based incentives will be conditional based on the decrease in vaccine refusal rates within stipulated time. Communities successful in achieving these targets will be rewarded incentives to improve their infrastructure, including sanitation and hygiene, and water resources.

02

Conditions studied

  • Polio
  • Immunization; Infection
  • Incentives

Keywords

  • Community engagment
  • Theory of change
03

In context

Poliomyelitis

274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.

This study's enrollment of 840 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Household with at least one child 0-59 months of age

Exclusion criteria

Exclusion Criteria:

  • Thise not willing to participate in study
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
840 participants (actual)

Study arms

  • Experimental
    Intervention

    The study will adopt a pretest/post-test quasi-experimental design. The approach of the proposed project is to implement a participatory community engagement and demand creation strategy with trust-building community mobilization and a conditional community-based incentive scheme to reduce the refusals to vaccination and improve polio immunization coverage in intervention UCs. Clusters will be formed on a population of 1500-2000 in each intervention UC. Committees would be formed with approximately 5-7 prominent members of the community. Intervention Non-cash, incentives would be given and decided with consensus by UC committees and aim to improve infrastructure linked to health including water and sanitation and toilets in the community.

    Behavioral: Community mobilization and Conditional community incentives

  • No intervention
    Control arm

    This would be the standard of care

Interventions

  • BehavioralCommunity mobilization and Conditional community incentives

    Non-cash, incentives would be given to clusters which improve the polio vaccine coverage and reduce the refusals and these incentives would be decided with consensus by community and costs would be shared

06

What researchers measure

Primary outcomes

  1. Vaccine refusals

    Number of polio vaccine refusals in polio campaign

    Time frame: at 9 months

  2. Fully Immunized Children

    This would be children who are fully vaccinated appropriate to the age

    Time frame: at 9 months

  3. IPV coverage

    this would be injectable polio vaccine coverage in children below five years of age

    Time frame: at 9 months

07

Study locations

1 site
  • Jai Das
    Karachi, Sindh 74800, Pakistan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2022 to primary completion in Mar 2024, 15 months.

Of 16 interventional studies with no phase under Poliomyelitis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 22. This study's 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2023
First posted
Feb 9, 2023
StartActual
Dec 1, 2022
Primary completionActual
Mar 31, 2024
CompletionActual
Mar 31, 2024
Last update
Apr 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05721274
Responsible party
Dr Jai Kumar Das (Assistant Professor and Assistant Director, Aga Khan University) — Principal investigator
First posted
Feb 9, 2023
Start date
Dec 1, 2022
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024
Last update
Apr 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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