Clinical trial NCT01697280: Polio NID and Routine EPI Integration Trial Pakistan
Official title: Improving Routine Immunization Coverage Through Educational Messages Delivered During Polio NIDs in Pakistan: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polio
Keywords: Polio supplementary immunization activities
Routine EPI vaccine
Integration of polio NID and routine EPI
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2012-10-02
Enrollment: 4560
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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:

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

Eligibility criteria: 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

Primary outcomes:
measure: age appropriate vaccination of children 3 - 14 months old at the time of the endline survey
timeFrame: 03 months after intervention (polio NID)
Secondary outcomes:
measure: Maternal knowledge about routine immunization
timeFrame: 03 months after intervention
measure: Retention of immunization cards
timeFrame: 03 months after intervention (polio NID)
Other outcomes:
Locations:
city: Thatta, Hyderabad
country: Pakistan
facility: Thatta, Hyderabad
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Anita KM Zaidi, MBBS, FAAP
role: PRINCIPAL_INVESTIGATOR
References: