Evaluate the Role of a Personalized Smartphone Based Application to Improve Childhood Immunization Coverage

Mobile Application Clinical Trial

Official title:

To Evaluate the Role of a Personalized Smartphone-based Application to Improve Childhood Immunization Coverage and Timelines Among Children in Pakistan

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04449107
• Other study ID #: 2019-1534-5556
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pakistan is one of the countries with the highest rates of child death in the world. It ranks 4th in child mortality, with 60% deaths due to vaccine-preventable diseases (VPDs). The immunization coverage in Pakistan is estimated to be 59%, which is still well below the desired level, leading to continued polio transmission, large measles outbreaks, and thousands of deaths from vaccine-preventable illnesses. In addition, Pakistan is a major polio epidemic country and among 3 countries in the world requiring proof of polio vaccination for international travel. Pakistan demographic and health survey in 2017-2018 suggests 88% percent of children had received BCG vaccine due at birth, 86% and 95% had received the first dose of pentavalent and polio vaccine respectively due at the 6th week. Furthermore, 75% and 86% of children had received the third dose of the pentavalent and polio vaccines, respectively, due at 14th week and measles vaccination was 73%, which is due at 9 months. However, these rates are at 1 year of age and much higher than vaccination coverage rate at scheduled time and among conflict hits and displaced populations. Improved RI coverage is recommended as the priority public health strategy to reduce VPDs and eradicate polio in Pakistan and worldwide.

According to immunization coverage surveys, 1 in 5 children are unimmunized. A major reason for poor childhood vaccine coverage is low immunization uptake, when parents are unable to complete the entire series of vaccines in accordance with the scheduled timelines. Some of the reasons include: (1) the family is not in favor of getting their child immunized, (2) low trust in vaccines provided through Expanded Programme on Immunization (EPI) and government health care providers, and (3) caregivers have forgotten their child's next vaccination due date or child's EPI card is misplaced. These barriers may be modified with additional support through education and behavior change strategies. In addition, with more pressing issues of food and shelter, preventive health often takes the back seat, and parents and caregivers forget or ignore the subsequent doses of vaccines for their children. There is an immense need to encourage parents' care seeking and collaboration with the health care providers to improve initial vaccine uptake and the completion of all doses according to the schedule. New innovative and cost-effective techniques are necessary for practical solutions to improve vaccination uptake and coverage.

Mobile phones offer a new medium to provide education and advocate families or caregivers to enable behavior change so as to improve immunization uptake. Mobile phone use has also increased in countries with low RI coverage and a high risk of VPDs. Good examples are Nigeria and Pakistan, where there were around 170 and 140 million mobile phone subscribers, respectively, in 2014. There are limited data from LMICs set up on the role of SMS-based interventions for improvement of RI coverage, and conventional 1-way reminder SMS text messages were used by most of the studies as the intervention. Overall, very few studies compared reminders, educational, and interactive SMS messages related to childhood vaccination uptake. Although some of the studies have shown some behavior change for improvement in vaccination coverage, more rigorous application of health behavior change model needs to be applied to understand the impact of reminder, educational, and interactive messages on behavior change related to improvement in RI coverage. However, data from developing countries regarding the role of automated calls in improving vaccine coverage are limited.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 328
• Est. completion date: December 31, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 2 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Mobile Application
• Routine Childhood Immunization

Intervention

Behavioral:
• Android based mobile phone application
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.

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	NED University of Engineering and Technology, University of Surrey

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Perceptions and barriers related to routine immunization (Interview guide in form of in depth interview will be administered).	Perceptions regarding risks of infectious diseases preventable by vaccines and vaccine safety and efficacy.; Perceptions and barriers to vaccinating children including difficulties in visiting RI centers.; This will help us in understanding the types of (1) barriers perceived by caregivers, (2) designing the Randomized Controlled Trial and study methodology.	6 weeks
Secondary	perceptions and barriers of a mobile phone based application to improve immunization coverage (interview guide in form of in depth interview will be administered)	Perceptions and barriers that may affect the use of mobile phone application in implementing the phone-based intervention to improve immunization coverage; Usability and preferences of mobile phone app to improve routine immunization coverage; This will help in developing personalized mobile phone application and content of the messages according to the barriers of the participants to bring in behavior change in order to improve immunization coverage and timelines; Measurement tool is the 14 weeks vaccination as per EPI schedule.	4 weeks