Vaccination FailureNCT01859546
SMS Reminders to Improve the on Time Vaccination Rates Among Children in Pakistan
A study testing Short message service in people with Vaccination Failure, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Vaccines are one of the best public health tools available to achieve the Millennium Development Goal (MDG) # 4 of decreasing child mortality. A major reason for poor childhood vaccine coverage is the lack of awareness among parents regarding the need for immunization in children, and the importance of completing the… Read more about this study
- Who is it for?
- Ages 1 week to 18 weeksHealthy volunteers can take part
- Conditions the study is for
- Vaccination Failure
- What is being tested?
- Short message service
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 18 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child should be less than 14 days of age
- Parent/guardian or at least one person in the household having a valid cell phone connection
- Parent/guardian provides consent
Who cannot join
- Child more than 14 days of age
- Not a valid cell phone connection in the household
- Parent/guardian not providing consent
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Asghar Ali, MBA,M.Phil, +92 213 486 4385, asghar.ali@aku.edu
Abdul Momin Kazi, MBBS,MPH
About this study
Official title: Automated SMS Reminders to Parents on Their Cell Phones Can Significantly Improve the on Time Vaccination Rates for Children in Pakistan
Vaccines are one of the best public health tools available to achieve the Millennium Development Goal (MDG) # 4 of decreasing child mortality. A major reason for poor childhood vaccine coverage is the lack of awareness among parents regarding the need for immunization in children, and the importance of completing the entire series of vaccines. This result in significant drop-out between vaccines delivered at birth and later in the infancy period. New innovative methods involving technologies are needed to be employed to increase the vaccine coverage. This study is being conducted in Karachi, Pakistan and main study objective is
- To assess the effectiveness of SMS reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children.
Read the detailed description
Pakistan has the 4th highest burden of child mortality in the world with over 60% of all deaths due to infectious diseases, many of them vaccine-preventable. Vaccines are one of the best public health tools available to achieve the Millennium Development Goal (MDG) # 4 of decreasing child mortality. The immunization coverage in Pakistan is still well below the desired level, leading to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable illnesses. Mobile phone use has seen a tremendous rise in Pakistan in this decade. There are greater than100 million mobile phones subscribers in Pakistan. Short message service (SMS) as a reminder tool can be extremely effective in health care settings at public health scale. Customized SMS messages can be designed as personally tailored messages with text and/or pictures, and used to remind and inquire parents regarding vaccination for their children according to the EPI schedule. A major advantage of SMS as a communication tool is that automated messages can be generated at specific times through computer programming, hence minimizing the need for valuable human resources. Messages are delivered directly with minimal intrusiveness, while maintaining privacy of the household members. Most importantly, the cost of sending automated SMS messages is extremely low, once the original infrastructure is established. We plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (SMS) in improving the on-time routine immunization for children in Pakistan. This study will be conducted in an urban- squatter settlement area, in Karachi where the Aga Khan University's Department of Paediatrics and Child Health is conducting an active demographic surveillance on maternal and child health. Our experimental plan has three components: First, we will conduct baseline survey of parents at our study sites to explore their preferences for text for immunization reminders. Simultaneously, we will develop a computerized application for reminders scheduling. This application will contain the phone number, message information, language preferences and date on which the message will be sent. It will be interfaced with the gateway to send the message. Lastly, we will conduct a randomized controlled trial to determine the effectiveness of automated SMS reminders to parents in improving the on-time vaccination rates in children. If the result shows that the vaccines compliance can be increased through the SMS reminders, this program can be incorporated with the existing systems to collect the cell phone numbers of parents at the time of child's first contact with the health system and sending auto generated reminders for vaccine compliance at national level.
- Conditions
- Vaccination Failure
- Being tested
- Short message service
- Keywords
- SMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short message serviceBehavioural
Short message service reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children
| Study group | Role | What they receive |
|---|---|---|
| One time standard verbal counseling | No intervention | The control group will receive one time standard verbal counseling at the time of initial visit related to EPI vaccination |
| SMS Reminders | Experimental | Short message service (SMS) - SMS reminders for EPI vaccination at 6, 10 and 14 weeks of life sent in the week that these vaccines are due Receives: Behavioral: Short message service |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of SMS reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children in Pakistan
We plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (SMS) in improving the on-time routine immunization for children in Pakistan.
Measured: 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccination FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Dr Abdul Momin Kazi, Aga Khan University
- Investigators
- Ibrahim M Abdel Rahim, MBBS, Study director, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859546
- Sponsor's protocol ID
- 2013/311074-0
- Other IDs
- 2013/311074-0
- Status last verified
- May 2013
- First submitted
- 14 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kazi AM, Ali M, Zubair K, Kalimuddin H, Kazi AN, Iqbal SP, Collet JP, Ali SA. Effect of Mobile Phone Text Message Reminders on Routine Immunization Uptake in Pakistan: Randomized Controlled Trial. JMIR Public Health Surveill. 2018 Mar 7;4(1):e20. doi: 10.2196/publichealth.7026.
PubMed 29514773
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated SMS Reminders to Parents on Their Cell Phones Can Significantly Improve the on Time Vaccination Rates for Children in Pakistan
- ClinicalTrials.gov ID
- NCT01859546
- Acronym / sponsor ID
- 2013/311074-0
- Conditions
- Vaccination Failure
- Keywords
- SMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaccines are one of the best public health tools available to achieve the Millennium Development Goal (MDG) # 4 of decreasing child mortality. A major reason for poor childhood vaccine coverage is the lack of awareness among parents regarding the need for immunization in children, and the importance of completing the entire series of vaccines. This result in significant drop-out between vaccines delivered at birth and later in the infancy period. New innovative methods involving technologies are needed to be employed to increase the vaccine coverage. This study is being conducted in Karachi, Pakistan and main study objective is
- To assess the effectiveness of SMS reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children.
Detailed description
Pakistan has the 4th highest burden of child mortality in the world with over 60% of all deaths due to infectious diseases, many of them vaccine-preventable. Vaccines are one of the best public health tools available to achieve the Millennium Development Goal (MDG) # 4 of decreasing child mortality. The immunization coverage in Pakistan is still well below the desired level, leading to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable illnesses. Mobile phone use has seen a tremendous rise in Pakistan in this decade. There are greater than100 million mobile phones subscribers in Pakistan. Short message service (SMS) as a reminder tool can be extremely effective in health care settings at public health scale. Customized SMS messages can be designed as personally tailored messages with text and/or pictures, and used to remind and inquire parents regarding vaccination for their children according to the EPI schedule. A major advantage of SMS as a communication tool is that automated messages can be generated at specific times through computer programming, hence minimizing the need for valuable human resources. Messages are delivered directly with minimal intrusiveness, while maintaining privacy of the household members. Most importantly, the cost of sending automated SMS messages is extremely low, once the original infrastructure is established. We plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (SMS) in improving the on-time routine immunization for children in Pakistan. This study will be conducted in an urban- squatter settlement area, in Karachi where the Aga Khan University's Department of Paediatrics and Child Health is conducting an active demographic surveillance on maternal and child health. Our experimental plan has three components: First, we will conduct baseline survey of parents at our study sites to explore their preferences for text for immunization reminders. Simultaneously, we will develop a computerized application for reminders scheduling. This application will contain the phone number, message information, language preferences and date on which the message will be sent. It will be interfaced with the gateway to send the message. Lastly, we will conduct a randomized controlled trial to determine the effectiveness of automated SMS reminders to parents in improving the on-time vaccination rates in children. If the result shows that the vaccines compliance can be increased through the SMS reminders, this program can be incorporated with the existing systems to collect the cell phone numbers of parents at the time of child's first contact with the health system and sending auto generated reminders for vaccine compliance at national level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One time standard verbal counseling | No intervention | –The control group will receive one time standard verbal counseling at the time of initial visit related to EPI vaccination |
| SMS Reminders | Experimental | Behavioral: Short message serviceShort message service (SMS) - SMS reminders for EPI vaccination at 6, 10 and 14 weeks of life sent in the week that these vaccines are due |
Who may qualify
- Ages
- 1 week to 18 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child should be less than 14 days of age
- Parent/guardian or at least one person in the household having a valid cell phone connection
- Parent/guardian provides consent
Key exclusion criteria (3 listed)
- Child more than 14 days of age
- Not a valid cell phone connection in the household
- Parent/guardian not providing consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short message serviceShort message service reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children | Behavioural | SMS Reminders |
Primary outcome
To assess the effectiveness of SMS reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children in Pakistan
Time frame: 10 Months
We plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (SMS) in improving the on-time routine immunization for children in Pakistan.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
- Derived from this study: PubMed 29514773Kazi AM, Ali M, Zubair K, Kalimuddin H, Kazi AN, Iqbal SP, Collet JP, Ali SA. Effect of Mobile Phone Text Message Reminders on Routine Immunization Uptake in Pakistan: Randomized Controlled Trial. JMIR Public Health Surveill. 2018 Mar 7;4(1):e20. doi: 10.2196/publichealth.7026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibrahim M Abdel Rahim, MBBS study director
World Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short message service in people with Vaccination Failure, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of SMS reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children in Pakistan (time frame: 10 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013.