Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan

NCT ID: NCT03341195

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

SMS text messages have shown to be effective for mobile health or mHealth having a considerable impact on disease prevention efforts in developing countries. Mobile phone and SMS texting provide an excellent solution to challenges like travel and complex intercultural contact. SMS based interventions have been quite effective in different programs, particularly in treatment adherence, smoke cessation, health care appointment attendance, antenatal care attendance and compliance with immunization. In addition adding incentives to SMS messages have shown a positive association, however, there is a cost implication for scaling up this model at a country level. Given the mobile phone access and acceptability in the LMIC, there is great potential for SMS based intervention to improve Immunization coverage in LMIC setup.

One major reservation for SMS based interventions is the level of literacy. However, there has been mixed input related to the preference of phones calls as compared to text messages in populations of low literacy and resource-constrained settings. Mobile phone text messages in local languages, pictorial messages and in combination with a phone call can further reduce this gap.

Most of the studies evaluating the impact of text messages on vaccination have been conducted in the United States with a major focus on flu vaccine among children and teenagers. The participants covered in these studies are from low income background at an academic medical center and is quite different from resource constraint settings of LMICs due to poor immunization registries and electronic records. There is limited data from LMICs set up on the role of SMS based interventions for improvement of RI coverage and conventional one-way reminder text messages were used by most of the studies as the intervention. Overall very few investigators compared reminders, educational and interactive SMS messages related to childhood vaccination uptake. Although some of the investigators 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. Very few studies have compared the effect of educational, reminders and interactive messages in improving uptake and on-time routine immunization.

In this study the investigators would like to examine an important public health question - do low cost, automated SMS messages and calls improve RI coverage among participants in resource-constrained settings? In this study, we would like to compare the effectiveness of reminder, educational and interactive text messages and phone calls for improving RI uptake in Pakistani participants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis Polio Diphtheria Pertussis Tetanus Haemophilus Influenzae Type b Infection Hepatitis B Pneumococcal Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

SMS Automated calls Routine immunization mHealth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized trial, four intervention arm and one control arm
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1. One way SMS messages.

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

Group Type ACTIVE_COMPARATOR

SMS messages and automated calls

Intervention Type BEHAVIORAL

The intervention consists of SMS and automated calls based messages

2. Two Way SMS messages

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.

Group Type ACTIVE_COMPARATOR

SMS messages and automated calls

Intervention Type BEHAVIORAL

The intervention consists of SMS and automated calls based messages

3. One way automated calls.

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

Group Type ACTIVE_COMPARATOR

SMS messages and automated calls

Intervention Type BEHAVIORAL

The intervention consists of SMS and automated calls based messages

4.Two way interactive automated calls

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.

Group Type ACTIVE_COMPARATOR

SMS messages and automated calls

Intervention Type BEHAVIORAL

The intervention consists of SMS and automated calls based messages

5. Control Arm

One time counseling at the baseline survey.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SMS messages and automated calls

The intervention consists of SMS and automated calls based messages

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria:

* The inclusion criteria includes being a child from the HDSS site, being less than 14 days of age with parent/guardian or at least one person in the household having a working mobile phone connection and parent/guardian providing consent to participate in the study.

Exclusion Criteria:

* The exclusion criteria includes a child from outside HDSS area or family plans to stay in the catchment area for less than 20 weeks
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Grand Challenges Canada

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Abdul Momin Kazi

Senior Instructor Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abdul M Kazi, MBBS,MPH

Role: PRINCIPAL_INVESTIGATOR

The Aga Khan University, Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Abdul M Kazi, MBBS,MPH

Role: CONTACT

Phone: +922134864232

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32813276 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31148544 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4320-Ped_ERC-16

Identifier Type: -

Identifier Source: org_study_id