mHealthNCT05042011
Role of mHealth-based Interventions Including Social Media to Improve Childhood Immunization Coverage During COVID 19 Pandemic in Pakistan: Qualitative Study
An observational study of mHealth and Social Media, run by Aga Khan University at 1 site in Pakistan.
Trial summary
In order to improve routine immunization uptake during COVID-19 pandemic, and to understand the perceptions and barriers related to vaccine hesitancy and coverage during COVID 19 and to explore the need for COVID-19 vaccination, separately and as a part of routine immunization, the investigators will be using… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- mHealth, Social Media, Vaccine Hesitancy
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 30 Nov 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Caregivers of children less than one year of age and Health care providers working inthe HDSS sites.
Who may be able to join
- Caregivers of children less than one year of age will be enrolled from HDSS sites.
- Health care providers including (doctors, nurses, pharmacists, LHVs, Vaccinators, LHWs, etc.) will also be recruited from these sites.
Who cannot join
- The exclusion criteria include the children from outside the health demographic surveillance system (HDSS) area and if the family does not plan to stay in the catchment area.
- Health care providers will be excluded who are from outside the HDSS.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Abdul Momin Kazi, MBBS, MPH, +92 21 34864335, momin.kazi@aku.edu
About this study
In order to improve routine immunization uptake during COVID-19 pandemic, and to understand the perceptions and barriers related to vaccine hesitancy and coverage during COVID 19 and to explore the need for COVID-19 vaccination, separately and as a part of routine immunization, the investigators will be using qualitative methodology to explore and understand the role of mHealth and social media interventions, that are most suitable in Pakistani context to improve vaccination coverage during COVID-19 pandemic.
Read the detailed description
The application of information and communication technologies (through such digital health methods as SMS, phone calls and automated calls, smartphone apps and wearable technology) has paved the way for modification of health-related knowledge and bring in the behavior change and practices to decrease vaccine hesitancy and improve immunization uptake. Mass and social media are influential in the dissemination of information regarding the COVID-19 pandemic, as well as the development and use of vaccines, not only for COVID-19 but also CRI. However, the same low-cost/free and accessible methods (social media platforms) that enable low/middle-income populations to communicate, connect and access information can also be the main factor in the distribution and prevalence of unregulated, unverified misinformation. In particular, the anti-vaccination movement, which has been identified as a major factor for vaccine hesitancy is the result of spreading misinformation through these same social media platforms.
In light of the current pandemic and distancing measures, CRI coverage is adversely affected as caregivers avoid tertiary care hospitals or primary health centers. This has further increased the risk of outbreak for vaccine-preventable diseases, as well as economic burden due to morbidity and mortality and delay in caregiver getting back to work. A recent survey by an international consortium also illustrated a decline in vaccination coverage across all milestone age groups, except for vaccines administered at birth in hospital like Hepatitis B. Hence due to reduced vaccination rates, various countries are experiencing outbreaks of previously controlled diseases globally like measles, rubella, tuberculosis, and rotavirus, and has even caused new mutated strains of polio to reemerge. However, for the first time in almost three decades there has been the significant decrease in the coverage of DPT3 vaccine dose.
Pakistan is identified as a LMIC with high vaccine hesitancy and is third among countries with the most unvaccinated/under-vaccinated children. It ranks fourth in global child mortality, with 60% of deaths due to infectious diseases that are vaccine-preventable. The EPI coverage for fully immunized children were estimated to be 65% and 88% at national level respectively in the past two survey reports. However, rates for Sindh province are even lower with fully immunized children rates of 39% and 80% respectively. Further Pakistan is among three polios endemic country and among top 5 countries with the most unvaccinated and under-vaccinated children. With further decrease in immunization rates due to current pandemic, vaccination coverage has only plummeted all time low coverage further due to disruption in vaccination services and demand, causing new outbreaks of previously controlled diseases like new polio strains, measles and rubella. Hence it is eminent to explore new strategies included mhealth and social media to bring in the behavior change in order to improve vaccine uptake. In addition, it is also important to understand the perceptions and barriers related to vaccine hesitancy and coverage during COVID 19 and come up with strategies to finalize our interventions.
- Conditions
- mHealth, Social Media, Vaccine Hesitancy, Covid19
- Keywords
- Covid19, childhood routine immunization (CRI), mHealth, social media
- Medical subject headings
- Vaccination Hesitancy, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Hesitancy towards childhood routine immunization (Interview)
Questions To understand the perceptions and barriers related to routine immunization during COVID-19 pandemic
Measured: 2 months
COVID-19 vaccine hesitancy (Interview)
Questions To understand the perceptions and barriers related to COVID-19 vaccine for adults and as part of routine immunization
Measured: 2 months
Role of mHealth and social media (Interview)
Questions To understand the role of mHealth and social media in improving childhood immunization coverage and COIVD-19 vaccine during COVID-19
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Mar 2021
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for mHealthStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Dr Abdul Momin Kazi, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042011
- Sponsor's protocol ID
- 2020-5316-14620
- Status last verified
- Sep 2021
- First submitted
- 19 Mar 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of mHealth-based Interventions Including Social Media to Improve Childhood Immunization Coverage During COVID 19 Pandemic in Pakistan: Qualitative Study
- ClinicalTrials.gov ID
- NCT05042011
- Acronym / sponsor ID
- 2020-5316-14620
- Conditions
- mHealth, Social Media, Vaccine Hesitancy, Covid19
- Keywords
- Covid19, childhood routine immunization (CRI), mHealth, social media
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 13 Sep 2021 (actual)
- 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.
In order to improve routine immunization uptake during COVID-19 pandemic, and to understand the perceptions and barriers related to vaccine hesitancy and coverage during COVID 19 and to explore the need for COVID-19 vaccination, separately and as a part of routine immunization, the investigators will be using qualitative methodology to explore and understand the role of mHealth and social media interventions, that are most suitable in Pakistani context to improve vaccination coverage during COVID-19 pandemic.
Detailed description
The application of information and communication technologies (through such digital health methods as SMS, phone calls and automated calls, smartphone apps and wearable technology) has paved the way for modification of health-related knowledge and bring in the behavior change and practices to decrease vaccine hesitancy and improve immunization uptake. Mass and social media are influential in the dissemination of information regarding the COVID-19 pandemic, as well as the development and use of vaccines, not only for COVID-19 but also CRI. However, the same low-cost/free and accessible methods (social media platforms) that enable low/middle-income populations to communicate, connect and access information can also be the main factor in the distribution and prevalence of unregulated, unverified misinformation. In particular, the anti-vaccination movement, which has been identified as a major factor for vaccine hesitancy is the result of spreading misinformation through these same social media platforms.
In light of the current pandemic and distancing measures, CRI coverage is adversely affected as caregivers avoid tertiary care hospitals or primary health centers. This has further increased the risk of outbreak for vaccine-preventable diseases, as well as economic burden due to morbidity and mortality and delay in caregiver getting back to work. A recent survey by an international consortium also illustrated a decline in vaccination coverage across all milestone age groups, except for vaccines administered at birth in hospital like Hepatitis B. Hence due to reduced vaccination rates, various countries are experiencing outbreaks of previously controlled diseases globally like measles, rubella, tuberculosis, and rotavirus, and has even caused new mutated strains of polio to reemerge. However, for the first time in almost three decades there has been the significant decrease in the coverage of DPT3 vaccine dose.
Pakistan is identified as a LMIC with high vaccine hesitancy and is third among countries with the most unvaccinated/under-vaccinated children. It ranks fourth in global child mortality, with 60% of deaths due to infectious diseases that are vaccine-preventable. The EPI coverage for fully immunized children were estimated to be 65% and 88% at national level respectively in the past two survey reports. However, rates for Sindh province are even lower with fully immunized children rates of 39% and 80% respectively. Further Pakistan is among three polios endemic country and among top 5 countries with the most unvaccinated and under-vaccinated children. With further decrease in immunization rates due to current pandemic, vaccination coverage has only plummeted all time low coverage further due to disruption in vaccination services and demand, causing new outbreaks of previously controlled diseases like new polio strains, measles and rubella. Hence it is eminent to explore new strategies included mhealth and social media to bring in the behavior change in order to improve vaccine uptake. In addition, it is also important to understand the perceptions and barriers related to vaccine hesitancy and coverage during COVID 19 and come up with strategies to finalize our interventions.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Caregivers of children less than one year of age and Health care providers working inthe HDSS sites.
Key inclusion criteria (2 listed)
- Caregivers of children less than one year of age will be enrolled from HDSS sites.
- Health care providers including (doctors, nurses, pharmacists, LHVs, Vaccinators, LHWs, etc.) will also be recruited from these sites.
Key exclusion criteria (2 listed)
- The exclusion criteria include the children from outside the health demographic surveillance system (HDSS) area and if the family does not plan to stay in the catchment area.
- Health care providers will be excluded who are from outside the HDSS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hesitancy towards childhood routine immunization (Interview)
Time frame: 2 months
Questions To understand the perceptions and barriers related to routine immunization during COVID-19 pandemic
COVID-19 vaccine hesitancy (Interview)
Time frame: 2 months
Questions To understand the perceptions and barriers related to COVID-19 vaccine for adults and as part of routine immunization
Role of mHealth and social media (Interview)
Time frame: 2 months
Questions To understand the role of mHealth and social media in improving childhood immunization coverage and COIVD-19 vaccine during COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of mHealth and Social Media, 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 2 inclusion and 2 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 13 Sep 2021. 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?
Hesitancy towards childhood routine immunization (Interview) (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2021.