PolioGLIDENCT05721274
Community Engagement and Conditional Incentives to Accelerate Polio
A study testing Community mobilization and Conditional community incentives in people with Polio and Immunization; Infection, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Polio, Immunization; Infection, Incentives
- What is being tested?
- Community mobilization and Conditional community incentives
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2022to 31 Mar 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 1 day to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Household with at least one child 0-59 months of age
Who cannot join
- Thise not willing to participate in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Last Mile - Community Engagement and Conditional Incentives to Accelerate Polio Eradication in Conflict-affected Areas of Pakistan
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.
- Conditions
- Polio, Immunization; Infection, Incentives
- Being tested
- Community mobilization and Conditional community incentives
- Keywords
- Community engagment, Theory of change
- Medical subject headings
- Poliomyelitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community mobilization and Conditional community incentivesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Community mobilization and Conditional community incentives |
| Control arm | No intervention | This would be the standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine refusals
Number of polio vaccine refusals in polio campaign
Measured: at 9 months
Fully Immunized Children
This would be children who are fully vaccinated appropriate to the age
Measured: at 9 months
IPV coverage
this would be injectable polio vaccine coverage in children below five years of age
Measured: at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Dec 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolioStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention is based on behaviour change theory
- Masking
- None (open label)
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jai Kumar Das, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721274
- Sponsor's protocol ID
- 2022-7125-20666
- Acronym
- GLIDE
- Status last verified
- Apr 2024
- First submitted
- 12 Jan 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Das JK, Khan A, Tabassum F, Padhani ZA, Habib A, Mirani M, Rahman AR, Khan ZA, Rizvi A, Ahmed I, Bhutta Z. The Last Mile-Community Engagement and Conditional Incentives to Accelerate Polio Eradication in Pakistan: Study Protocol for a Quasi-Experimental Trial. Methods Protoc. 2023 Sep 8;6(5):83. doi: 10.3390/mps6050083.
PubMed 37736966
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Last Mile - Community Engagement and Conditional Incentives to Accelerate Polio Eradication in Conflict-affected Areas of Pakistan
- ClinicalTrials.gov ID
- NCT05721274
- Acronym / sponsor ID
- GLIDE / 2022-7125-20666
- Conditions
- Polio, Immunization; Infection, Incentives
- Keywords
- Community engagment, Theory of change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 9 Feb 2023 (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.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention is based on behaviour change theory
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Community mobilization and Conditional community incentivesThe 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. |
| Control arm | No intervention | –This would be the standard of care |
Who may qualify
- Ages
- 1 day to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Household with at least one child 0-59 months of age
Key exclusion criteria (1 listed)
- Thise not willing to participate in 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 |
|---|---|---|
| Community mobilization and Conditional community incentivesNon-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 | Behavioural | Intervention |
Primary outcome
Vaccine refusals
Time frame: at 9 months
Number of polio vaccine refusals in polio campaign
Fully Immunized Children
Time frame: at 9 months
This would be children who are fully vaccinated appropriate to the age
IPV coverage
Time frame: at 9 months
this would be injectable polio vaccine coverage in children below five years of age
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 26 Apr 2024.
- Derived from this study: PubMed 37736966Das JK, Khan A, Tabassum F, Padhani ZA, Habib A, Mirani M, Rahman AR, Khan ZA, Rizvi A, Ahmed I, Bhutta Z. The Last Mile-Community Engagement and Conditional Incentives to Accelerate Polio Eradication in Pakistan: Study Protocol for a Quasi-Experimental Trial. Methods Protoc. 2023 Sep 8;6(5):83. doi: 10.3390/mps6050083.
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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 Community mobilization and Conditional community incentives in people with Polio and Immunization; Infection, run by Aga Khan University 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 1 inclusion and 1 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 26 Apr 2024. 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?
Vaccine refusals (time frame: at 9 months). 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?
On the ClinicalTrials.gov record for NCT05721274, which also lists 1 linked publication.
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 26 Apr 2024.