Polio NID and Routine EPI Integration Trial Pakistan

Polio Clinical Trial

Official title:

Improving Routine Immunization Coverage Through Educational Messages Delivered During Polio NIDs in Pakistan: A Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697280
• Other study ID #: 1952-Ped-ERC-11
• Status: Completed
• Phase: N/A
• First received: April 2, 2012
• Last updated: January 15, 2014
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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:

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4560
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 14 Months

Eligibility

Inclusion Criteria:

1. Households with children aged 3-14 months

2. Resident of selected cluster

3. Willing to consent for participation in the study

Exclusion Criteria:

1. Households with children aged below 3 months or above 14 months

2. Non-resident of selected cluster

3. Refusing to consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Polio
• Poliomyelitis

Intervention

Behavioral:
• Vaccine promotion messages
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.

Other:
• 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.
• Distribution of Plastic Pouches to retain vaccination card
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.

Locations

Country	Name	City	State
Pakistan	Thatta, Hyderabad	Thatta, Hyderabad	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	World Health Organization

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	03 months after intervention (polio NID)	No
Secondary	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.	03 months after intervention	No
Secondary	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.	03 months after intervention (polio NID)	No