NCT03341195

Brief Summary

Routine childhood immunization (RCI) in Pakistan is well below the recommended coverage of 90% with rates as low as 16% in certain regions (Pakistan DHS 2012-3). This has led to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable diseases (Kazi.Bull WHO 2016). Mobile phone communication is widespread in developing countries and has proven a potential method of directly connecting pregnant women and mothers to health services (Kharbanda. Expert Review of Vaccine 2014). The investigators propose conducting a mixed methods proof of concept cluster randomized trial (CRT) to assess the effectiveness of different types of SMS messaging and automated calls to improve RCI and understand the perceptions and barriers that may affect SMS and automated call-based interventions at participants levels. the investigators will conduct the study at urban and rural sites in Pakistan. The investigators will examine an important public health question - do low cost, automated SMS, and automated messages improve RCI coverage in resource-constrained settings? Further, investigators will compare the effectiveness of reminder, educational and interactive text messages for improving RCI and will generate socio-cultural data regarding the impact of participants health beliefs that will be important for setting up the appropriate interventions in other LMICs.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

November 7, 2017

Last Update Submit

November 14, 2017

Conditions

Keywords

SMSAutomated callsRoutine immunizationmHealth

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life

    The final outcome of vaccine will be measured at 20 weeks of life, between control and intervention arm and between intervention arms

    Vaccination status at 20th week of life of the particpants

Secondary Outcomes (1)

  • The secondary outcome will measure the mean improvement in on-time vaccination for routine immunization scheduled at 6, 10 and 14 weeks of life

    On-time vaccination for routine immunization scheduled at 6, 10 and 14 weeks of life

Study Arms (5)

1. One way SMS messages.

ACTIVE COMPARATOR

Parents/caregiver will receive one way educational/reminder/proactive SMS messages related to routine immunization once a week till 20 weeks of age.

Behavioral: SMS messages and automated calls

2. Two Way SMS messages

ACTIVE COMPARATOR

Parents/caregiver will receive two way (interactive) educational/reminder/proactive SMS messages related to routine immunization once a week till 20 weeks of age-parents will have the option to reply and receive more information related to immunization through text messages.

Behavioral: SMS messages and automated calls

3. One way automated calls.

ACTIVE COMPARATOR

Parents/caregiver will receive one way educational/reminder/proactive automated phone call related to routine immunization once a week till 20 weeks of age.

Behavioral: SMS messages and automated calls

4.Two way interactive automated calls

ACTIVE COMPARATOR

Parents/caregiver will receive two way (interactive) educational/reminder/proactive automated phone call related to routine immunization once a week till 20 weeks of age-parents will have the option to reply and receive more information related to immunization through phone call.

Behavioral: SMS messages and automated calls

5. Control Arm

NO INTERVENTION

One time counseling at the baseline survey.

Interventions

The intervention consists of SMS and automated calls based messages

1. One way SMS messages.2. Two Way SMS messages3. One way automated calls.4.Two way interactive automated calls

Eligibility Criteria

Age1 Day - 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

  • Kazi AM, Ahsan N, Khan A, Jamal S, Kalimuddin H, Ghulamhussain N, Wajidali Z, Muqeet A, Zaidi F, Subzlani M, McKellin W, Ali A, Collet JP. Personalized Text Messages and Automated Calls for Improving Vaccine Coverage Among Children in Pakistan: Protocol for a Community-Based Cluster Randomized Clinical Trial. JMIR Res Protoc. 2019 May 30;8(5):e12851. doi: 10.2196/12851.

MeSH Terms

Conditions

TuberculosisPoliomyelitisDiphtheriaWhooping CoughTetanusHaemophilus InfectionsHepatitis BPneumococcal Infections

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesCorynebacterium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesClostridium InfectionsPasteurellaceae InfectionsBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesStreptococcal Infections

Study Officials

  • Abdul M Kazi, MBBS,MPH

    The Aga Khan University, Pakistan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul M Kazi, MBBS,MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized trial, four intervention arm and one control arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor Research

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 14, 2017

Study Start

January 1, 2018

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share