NCT04449107

Brief Summary

The vision of the investigators is to build capacity in technology-driven healthcare innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept (POC) study to tackle the lack of awareness around immunization, which is a major health issue in developing countries. Mobile apps and social media have been shown to be effective in various programmes worldwide, but there is limited data from LMICs on the use of digital technologies in improving routine immunization (RI) coverage.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

April 14, 2020

Last Update Submit

June 25, 2020

Conditions

Keywords

Mobile applicationroutine childhood immunization

Outcome Measures

Primary Outcomes (2)

  • improvement in RI coverage

    to see a 10 percent increase in RI through personalized smart mobile phone-based application at 10 and 14 weeks of age according to the EPI schedule versus standard care

    12 weeks

  • Improvement in timeline

    To see a 10 percent increase in RI within 1 week of the original timeline at 10, and 14 weeks versus standard care

    12 weeks

Secondary Outcomes (2)

  • Perceptions and barriers related to routine immunization (Interview guide in form of in depth interview will be administered).

    6 weeks

  • perceptions and barriers of a mobile phone based application to improve immunization coverage (interview guide in form of in depth interview will be administered)

    4 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The intervention arm in addition to the standard counselling will include receiving text messages, voice messages, pictorial messages and video messages regarding vaccination once a week till the child turns 14 weeks

Behavioral: Android based mobile phone application

Control Arm

NO INTERVENTION

The control group will receive one-time standard verbal counselling at the time of initial visit for on-time EPI vaccines at 10 and 14 weeks of age as recommended by EPI, government of Pakistan.

Interventions

An android based mobile application will be developed. The application will have features and capacity for text messages, voice messages, pictorial messages and video messages. The content of the messages will be according to the findings of Paigham e sehat project and the four messages domains would be educational, reminder, religious and adverse effects. In addition, pictorial and video messages would be used as per freely available through EPI programme Pakistan.

Intervention Arm

Eligibility Criteria

Age6 Weeks - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • parent or guardian or at least one person in the household has a working android based smart mobile phone
  • ability to use android based smart phone
  • Parent or guardian providing consent.

You may not qualify if:

  • If the family will not be visiting AKU for 10- and 14-week RI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

  • Kazi AM, Qazi SA, Khawaja S, Ahsan N, Ahmed RM, Sameen F, Khan Mughal MA, Saqib M, Ali S, Kaleemuddin H, Rauf Y, Raza M, Jamal S, Abbasi M, Stergioulas LK. An Artificial Intelligence-Based, Personalized Smartphone App to Improve Childhood Immunization Coverage and Timelines Among Children in Pakistan: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 4;9(12):e22996. doi: 10.2196/22996.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A mixed methods study will be conducted in which a smart phone application will be developed based on the findings of qualitative component of the study, which will have features for text, voice, video and pictorial messages for the participant caregivers to improve RI on 10th and 14th week of child age.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 14, 2020

First Posted

June 26, 2020

Study Start

February 27, 2020

Primary Completion

August 30, 2020

Study Completion

December 31, 2020

Last Updated

June 26, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

The database will reside on a central computer at AKU managed by the study staff. Mobile numbers will not be shared except to track patterns of use. Only relevant study staff will have access to study data allowed by the local ethics committee. Participants' information will be given a study code, and no personal identifiers will be shared. Data confidentiality will be maintained at all times. No personal identifiers will be used in any reports or publication of the study. No individual identifier such as names of participants and area of location will be shared. In addition, a confidentiality agreement has been signed with the universities stating that the numbers provided will only be used for the purpose of the trial.

Locations