PolioNCT01697280
Polio NID and Routine EPI Integration Trial Pakistan
A study testing Vaccine promotion messages, Vaccination Verification. and Distribution of Plastic Pouches to retain vaccination card in people with Polio, run by Aga Khan University at 1 site in Pakistan.
Trial summary
This study aims to assess if pictorial messages promoting routine immunization during supplementary campaigns for oral polio vaccine in areas with poor DTP3 vaccine coverage can improve immunization rates. A cluster randomized trial design in low literature populations will be used. Read more about this study
- Who is it for?
- Ages 3 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Polio
- What is being tested?
- Vaccine promotion messages, Vaccination Verification. and Distribution of Plastic Pouches to retain vaccination card
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,560 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2012to May 2013
- 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 3 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Households with children aged 3-14 months
- Resident of selected cluster
- Willing to consent for participation in the study
Who cannot join
- Households with children aged below 3 months or above 14 months
- Non-resident of selected cluster
- Refusing to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Routine Immunization Coverage Through Educational Messages Delivered During Polio NIDs in Pakistan: A Cluster Randomized Trial
This study aims to assess if pictorial messages promoting routine immunization during supplementary campaigns for oral polio vaccine in areas with poor DTP3 vaccine coverage can improve immunization rates. A cluster randomized trial design in low literature populations will be used.
Read the detailed description
The overall objective of this study is to assess whether supplementary immunization activities (SIAs) held for polio eradication can be used to improve routine immunization coverage in Pakistan.
Primary research objectives:
(i) To assess effectiveness of educational messages regarding routine immunization during SIAs held for polio on improving routine immunization coverage in Pakistan.
Secondary research objectives:
(i) To assess maternal knowledge about routine immunization in the intervention and control arms.
(ii) To estimate vaccination card retention in the intervention and control arms.
This study will be completed in 12 months, between March 2012 to February 2013. Overall, three major operational steps have been defined for the study as follow:
Baseline vaccine coverage survey: This is a 02-months activity in which a baseline household vaccine coverage survey will be carried out to independently assess the immunization coverage and socio-demographic indicators in the study areas. Participation in this survey will be voluntary and written consent from participants will be obtained prior to administering the study questionnaire.
Training of vaccinators/volunteers and distribution of plastic pouches: The project research staff (Research Associate/Senior Research Assistants) will be exclusively trained by Principal Investigator/Research Supervisor on educational material. Having completed the baseline coverage survey, a one-day training session will be organized by trained project staff to provide trainings to participating EPI vaccinators/volunteers on the vaccine promotion educational messages to be delivered during intervention. These trainings will be held at a common venue (EPI center/public hospital) in the selected towns for this study. The messages will be low-literacy, of very short duration, and will be delivered with the help of pictorial cards which were previously developed for and used in a similar department-run study in Karachi. These educational messages will include the following messages:
- Vaccines can save a child's life
- Children who are immunized on time are less likely to become ill
- Unimmunized children can become disabled for life
- Photograph of the nearest EPI center where vaccines are offered free of charge, as well as its address and timings
Additionally, at the start of this project, all EPI centers in the study areas will be provided with plastic pouches to be given to parents of all children coming to EPI centers for vaccinations. These pouches will be used to store a child's immunization card. In order to assess the likely change in vaccination card retention, we will compare the proportion of vaccination cards available on pre-and-post coverage assessment in both intervention and control groups.
Endline vaccine coverage survey/outcome assessment. Outcome assessment will be done through a representative endline survey assessing vaccine coverage for Penta-3 and Measles-1 in the study areas, 3 months after the NID was held. Participation in this survey will be voluntary and written consent from study participants will be obtained prior too administering the study questionnaire.
NID = National Immunization Days SNID = Sub-national Immunization Days EPI: Expanded Programme on Immunization SIA - Supplementary Immunization Activity CHW = Community Health Worker AKU = Aga Khan University, Karachi, Pakistan
- Conditions
- Polio
- Being tested
- Vaccine promotion messages, Vaccination Verification., Distribution of Plastic Pouches to retain vaccination card
- Keywords
- Polio supplementary immunization activities, Routine EPI vaccine, Integration of polio NID and routine EPI
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine promotion messagesBehavioural
The messages will be low-literacy, of very short duration, and will be delivered with the help of pictorial cards. These educational messages will include the following messages:
- Vaccines can save a child's life
- Children who are immunized on time are less likely to become ill
- Unimmunized children can become disabled for life
- Photograph of the nearest EPI center where vaccines are offered free of charge, as well as its address and timings.
Vaccination Verification.Other
EPI vaccinators/volunteers will identify and record details of un/under-vaccinated children less than 12 months old in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity.
Distribution of Plastic Pouches to retain vaccination cardOther
At the start of this project, all EPI centers in the study areas will be provided with plastic pouches to be given to parents of all children coming to EPI centers for vaccinations. These pouches will be used to store a child's immunization card.
| Study group | Role | What they receive |
|---|---|---|
| Educational messages only | Experimental | EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization Receives: Behavioral: Vaccine promotion messages; Other: Distribution of Plastic Pouches to retain vaccination card |
| Immunization status verification only | Experimental | EPI vaccinators/volunteers will identify and record details of un/under-vaccinated children less than 12 months old in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity. Receives: Other: Vaccination Verification.; Other: Distribution of Plastic Pouches to retain vaccination card |
| Education and vaccine verification | Experimental | EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization, identify and record details of un/under-vaccinated children in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity. Receives: Behavioral: Vaccine promotion messages; Other: Vaccination Verification.; Other: Distribution of Plastic Pouches to retain vaccination card |
| Status quo | No intervention | No interventional activity will take place in this group. Therefore, the status quo (routine services) will be maintained during Polio NID |
What is being measured
The primary outcome is the main question the study is designed to answer.
age appropriate vaccination of children 3 - 14 months old at the time of the endline survey
Age appropriate vaccination for the purposes of this study is defined as the administration of:
- All scheduled doses of the DPT/Hepatitis-B/Hib (Penta) vaccine within 14 days of the recommended age for children 3 - 11 months of age, and
- First dose of the measles vaccine (Measles-1) for children 9 - 14 months of age.
Measured: 03 months after intervention (polio NID)
Secondary outcomes (2)
Maternal knowledge about routine immunization
Maternal knowledge about nearest EPI facility, names of EPI vaccines that child is age-eligible to receive, cost of vaccination and importance about vaccination will be assessed during end line vaccine coverage survey.
Measured: 03 months after intervention
Retention of immunization cards
The number of children who received routine EPI vaccine had vaccination card available on the end-line survey. Immunization cards will help to verify dates and number of doses that child has received.
Measured: 03 months after intervention (polio NID)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Anita Kaniz Mehdi Zaidi, Aga Khan University
- Investigators
- Anita KM Zaidi, MBBS, FAAP, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697280
- Sponsor's protocol ID
- 1952-Ped-ERC-11
- Status last verified
- Jan 2014
- First submitted
- 2 Apr 2012
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Routine Immunization Coverage Through Educational Messages Delivered During Polio NIDs in Pakistan: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01697280
- Acronym / sponsor ID
- 1952-Ped-ERC-11
- Conditions
- Polio
- Keywords
- Polio supplementary immunization activities, Routine EPI vaccine, Integration of polio NID and routine EPI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,560 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Oct 2012 (estimated)
- 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 aims to assess if pictorial messages promoting routine immunization during supplementary campaigns for oral polio vaccine in areas with poor DTP3 vaccine coverage can improve immunization rates. A cluster randomized trial design in low literature populations will be used.
Detailed description
The overall objective of this study is to assess whether supplementary immunization activities (SIAs) held for polio eradication can be used to improve routine immunization coverage in Pakistan.
Primary research objectives:
(i) To assess effectiveness of educational messages regarding routine immunization during SIAs held for polio on improving routine immunization coverage in Pakistan.
Secondary research objectives:
(i) To assess maternal knowledge about routine immunization in the intervention and control arms.
(ii) To estimate vaccination card retention in the intervention and control arms.
This study will be completed in 12 months, between March 2012 to February 2013. Overall, three major operational steps have been defined for the study as follow:
Baseline vaccine coverage survey: This is a 02-months activity in which a baseline household vaccine coverage survey will be carried out to independently assess the immunization coverage and socio-demographic indicators in the study areas. Participation in this survey will be voluntary and written consent from participants will be obtained prior to administering the study questionnaire.
Training of vaccinators/volunteers and distribution of plastic pouches: The project research staff (Research Associate/Senior Research Assistants) will be exclusively trained by Principal Investigator/Research Supervisor on educational material. Having completed the baseline coverage survey, a one-day training session will be organized by trained project staff to provide trainings to participating EPI vaccinators/volunteers on the vaccine promotion educational messages to be delivered during intervention. These trainings will be held at a common venue (EPI center/public hospital) in the selected towns for this study. The messages will be low-literacy, of very short duration, and will be delivered with the help of pictorial cards which were previously developed for and used in a similar department-run study in Karachi. These educational messages will include the following messages:
- Vaccines can save a child's life
- Children who are immunized on time are less likely to become ill
- Unimmunized children can become disabled for life
- Photograph of the nearest EPI center where vaccines are offered free of charge, as well as its address and timings
Additionally, at the start of this project, all EPI centers in the study areas will be provided with plastic pouches to be given to parents of all children coming to EPI centers for vaccinations. These pouches will be used to store a child's immunization card. In order to assess the likely change in vaccination card retention, we will compare the proportion of vaccination cards available on pre-and-post coverage assessment in both intervention and control groups.
Endline vaccine coverage survey/outcome assessment. Outcome assessment will be done through a representative endline survey assessing vaccine coverage for Penta-3 and Measles-1 in the study areas, 3 months after the NID was held. Participation in this survey will be voluntary and written consent from study participants will be obtained prior too administering the study questionnaire.
NID = National Immunization Days SNID = Sub-national Immunization Days EPI: Expanded Programme on Immunization SIA - Supplementary Immunization Activity CHW = Community Health Worker AKU = Aga Khan University, Karachi, Pakistan
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Educational messages only | Experimental | Behavioral: Vaccine promotion messages, Other: Distribution of Plastic Pouches to retain vaccination cardEPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization |
| Immunization status verification only | Experimental | Other: Vaccination Verification., Other: Distribution of Plastic Pouches to retain vaccination cardEPI vaccinators/volunteers will identify and record details of un/under-vaccinated children less than 12 months old in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity. |
| Education and vaccine verification | Experimental | Behavioral: Vaccine promotion messages, Other: Vaccination Verification., Other: Distribution of Plastic Pouches to retain vaccination cardEPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization, identify and record details of un/under-vaccinated children in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity. |
| Status quo | No intervention | –No interventional activity will take place in this group. Therefore, the status quo (routine services) will be maintained during Polio NID |
Who may qualify
- Ages
- 3 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Households with children aged 3-14 months
- Resident of selected cluster
- Willing to consent for participation in the study
Key exclusion criteria (3 listed)
- Households with children aged below 3 months or above 14 months
- Non-resident of selected cluster
- Refusing to consent
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 |
|---|---|---|
| Vaccine promotion messagesThe messages will be low-literacy, of very short duration, and will be delivered with the help of pictorial cards. These educational messages will include the following messages: 1. Vaccines can save a child's life 2. Children who are immunized on time are less likely to become ill 3. Unimmunized children can become disabled for life 4. Photograph of the nearest EPI center where vaccines are offered free of charge, as well as its address and timings. | Behavioural | Education and vaccine verification, Educational messages only |
| Vaccination Verification.EPI vaccinators/volunteers will identify and record details of un/under-vaccinated children less than 12 months old in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity. | Other | Education and vaccine verification, Immunization status verification only |
| Distribution of Plastic Pouches to retain vaccination cardAt the start of this project, all EPI centers in the study areas will be provided with plastic pouches to be given to parents of all children coming to EPI centers for vaccinations. These pouches will be used to store a child's immunization card. | Other | Education and vaccine verification, Educational messages only, Immunization status verification only |
Primary outcome
age appropriate vaccination of children 3 - 14 months old at the time of the endline survey
Time frame: 03 months after intervention (polio NID)
Age appropriate vaccination for the purposes of this study is defined as the administration of: 1. All scheduled doses of the DPT/Hepatitis-B/Hib (Penta) vaccine within 14 days of the recommended age for children 3 - 11 months of age, and 2. First dose of the measles vaccine (Measles-1) for children 9 - 14 months of age.
2 secondary outcomes
Maternal knowledge about routine immunization
Time frame: 03 months after intervention
Retention of immunization cards
Time frame: 03 months after intervention (polio NID)
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 16 Jan 2014.
Related trials for Polio
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)
RecruitingPhase 3
A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
Poliomyelitis
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.
Anita KM Zaidi, MBBS, FAAP principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccine promotion messages, Vaccination Verification. and Distribution of Plastic Pouches to retain vaccination card in people with Polio, 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 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 16 Jan 2014. 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?
age appropriate vaccination of children 3 - 14 months old at the time of the endline survey (time frame: 03 months after intervention (polio NID)). 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 16 Jan 2014.