Polio NID and Routine EPI Integration Trial Pakistan

NCT01697280 | Completed DMC

• 1 other identifier: 1952-Ped-ERC-11
• Study Type: interventional
• Target: 4,560
• Locations: 1 country
• Sites: 1

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.

Conditions

Polio

Keywords

Polio supplementary immunization activities; Routine EPI vaccine; Integration of polio NID and routine EPI

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  03 months after intervention (polio NID)

Secondary Outcomes (2)

• Maternal knowledge about routine immunization

  03 months after intervention

• Retention of immunization cards

  03 months after intervention (polio NID)

Study Arms (4)

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

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.

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.

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

Interventions

Vaccine promotion messages BEHAVIORAL

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: 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.

Education and vaccine verification; Educational messages only

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.

Education and vaccine verification; Immunization status verification only

Distribution of Plastic Pouches to retain vaccination card OTHER

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.

Education and vaccine verification; Educational messages only; Immunization status verification only

Eligibility Criteria

• Age: 3 Months - 14 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Households with children aged 3-14 months
• Resident of selected cluster
• Willing to consent for participation in the study

You may not qualify if:

• Households with children aged below 3 months or above 14 months
• Non-resident of selected cluster
• Refusing to consent

Sponsors & Collaborators

• Aga Khan University: lead
• World Health Organization: collaborator

Study Sites (1)

Thatta, Hyderabad

Thatta, Hyderabad, Sindh, Pakistan

Location

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Anita KM Zaidi, MBBS, FAAP

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Paediatrics and Child Health

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: October 2, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

PA (1)