Use of SMS and Interactive Reminders to Improve Timely Immunization Coverage
Condition: Immunization; Infection; SMS
Study type: Interventional

Summary: 
      Pakistan has one of the highest infant mortality rates in the world. One child in eleven dies
      before their fifth birthday. In part, this is due to the low coverage rate of routine
      childhood immunizations. Since Pakistan is a Low Middle Income Country (LMIC) it is essential
      that an immunization intervention be developed that is suitable for its socioeconomic
      setting. The tele-density of Pakistan exceeds 70% and the cost of SMS in Pakistan is very
      low. Moreover the use of SMS in the country has broadened beyond the conventional use of
      peer-peer chat to include social networking, SMS banking, delivery tracking, advertising,
      business, disaster management, and identity verification. This study will utilise this
      prevalence of mobile phones to assess whether simple and interactive sms reminders can serve
      to increase childhood immunization coverage and timeliness.

      The pilot study will be carried out only in 2 EPI (Extended program on Immunization) centers
      at Korangi. The pilot will determine whether automated text messages produce increased
      immunization coverage in the reminder groups compared to the control group. 656 participants
      will be enrolled at Penta-1 and will be followed up until measles-2 vaccination. The results
      of proposed pilot will provide the basis for a large scale-up study in urban and rural
      settings in Pakistan.
    

Detailed description: 
      Hypothesis:

      The coverage rate of Penta-3, Measles-1 and Measles-2 in infants in Karachi will improve
      with:

        1. Short text Messaging Service (SMS) reminders

        2. Interactive reminders

      Aims:

        1. To determine if SMS reminders increases timely vaccine coverage rate in infants from
           Karachi.

        2. To determine if Interactive reminders increases the timely vaccine coverage rate in
           infants from Karachi.

      Background and Rationale:

      The World Health Organization's (WHO) goal is to protect all people at risk against
      vaccine-preventable diseases. The availability of vaccines, however, does not mean that all
      eligible children are vaccinated. Despite several decades of global efforts in program
      implementation, vaccine-preventable diseases still contribute 25% of the 10 million
      deaths/year in under-5 children occurring worldwide. The Expanded Program on Immunization
      (EPI) does provide wide-access to vaccines in developing countries, but low vaccine uptake
      and delayed immunizations make infants and children more vulnerable to vaccine preventable
      diseases. The result of suboptimal immunization rates is the persistent existence of several
      vaccine preventable diseases. Many different strategies are being tested in these settings to
      increase immunization coverage, including out-reach services, health education, information
      dissemination, vaccination requirements for schools, conditional cash transfers and enhancing
      access to vaccination centers. This study proposes to investigate the use of SMS and
      interactive text reminders to improve timely immunization coverage. SMS reminders have the
      potential to increase immunization coverage and could prove to be a simple low cost
      intervention to improve timely immunization coverage.

      SMS reminders Although there is limited data, SMS has been successfully used in various
      health programs including raising preventive and clinical treatment compliance, increasing
      HIV testing,4 reducing missed primary care and dental visits etc. Kaewkungwal's study
      designed a maternal and child care module based on SMS reminders and increased EPI on-time
      vaccinations to 44% from 35% (p<0.001). Vilella's study showed 47% (95% Confidence Interval
      (CI): 41-54%) of the participants in SMS reminder intervention arm completed third dose of
      hepatitis A + B vaccine as compared to 27% (95% CI: 23-32%) in control arm (RR 1.75; 95% CI:
      1.41-2.17). SMS reminders have shown a potential simple cost-effective solution to remember
      the next vaccination date. With the growing use of mobile phones, SMS reminders can be quite
      useful in health communications. The cost of SMS in Pakistan is very low and use of SMS has
      broadened beyond the conventional use of peer-peer chat to include social networking, SMS
      banking, delivery tracking, advertising, business, disaster management, and identity
      verification etc. With such a low cost and varied use of SMS, it has a potential to be a
      frequent mode of health communications.

      Interactive reminders Interactive reminders are a variant of SMS reminders where recipients
      are asked to respond back to SMS with a specific/non-specific response. Our experience of
      pilot with interactive reminders to tuberculosis patients to comply with drug adherence has
      shown positive acceptability. The system can be potentially used for compliance to vaccine
      schedule. The pilot study will be carried out only in 2 EPI centers at Korangi. The pilot
      will determine whether automated text messages produce increased immunization coverage in the
      reminder groups compared to the control group over the 8 weeks follow-up. The results of
      proposed pilot will provide the basis for a large scale-up study in urban and rural settings
      in Pakistan.

      Study site & Participants:

      The study will be conducted in Korangi town, Karachi. Healthy infants 6-12 weeks of age
      visiting the Indus Hospital EPI center for first dose of pentavalent vaccine will be
      recruited for the study. Study will require parents/caregivers of infants to own a cell phone
      or have regular access to one. Parents/caregivers planning to go to a different center for
      next immunization will be excluded.

      Sample size:

      A sample of 522 participants would give 90% power (alpha= 0.05, 2-sided) to detect a
      difference of 15% over the baseline vaccine coverage rate of 70%. The final sample size of
      656 infants (164 in each arm) will allow for a potential dropout rate of 20% during the
      follow-up period.

      Randomization Enrolled subjects will be randomized to receive the SMS, interactive SMS or to
      serve as a control. The randomization sequence was created using SAS, version 9.3 (SAS
      Institute, Cary, NC), with a 1:1:1 allocation, using random block sizes of 3, 6, and 9.

      Vaccines:

      The vaccines will be administered as per routine EPI program in Pakistan which include
      Bacille Calmette-Guérin (BCG) at 0-6 weeks of age, pentavalent (DPT + Hepatitis B (HepB) +
      Hib) vaccine and oral polio vaccine at 6, 10 and 14 weeks of age, measles vaccine at 9 and 15
      months of age.

      Interventions:

      The two interventions include SMS and interactive reminders. Infants will be randomized to
      either of the interventions or control groups. All participants will receive the routine EPI
      immunizations.

      Study procedures & Recruitment:

      Children will be recruited at the EPI center when they arrived for the Penta-1 vaccine. Field
      workers will screen and obtain consent from the child's caregiver. Once the caregiver agrees
      to be a part of the study the infant will be randomised to one of the study arms and the name
      and age of the child will be recorded along with the immunization received on the visit. Each
      infant will be provided with a unique EPI number by the EPI staff and the same identifier
      (ID) will be used throughout the study to update and maintain the immunization record for all
      follow up visits. The child will be followed up to the measles 2 vaccine after which their
      immunization status will be marked as complete.

      The parents of infants in SMS and interactive reminder groups will received 3-5 reminders for
      all scheduled follow-up immunization visits until the measles 2 vaccine. The infants in the
      control group will carry out routine follow up without any added intervention.

      After the completion of follow-up duration a phone interview will be conducted to collect
      data on experiences of study participants with the SMS and interactive reminders. This will
      be a brief 3-5 minute interview to confirm if they received the messages and if there were
      any suggestions to improve the reminder system.

      Statistical Analysis An intention to treat analysis will be conducted using STATA'13. Summary
      statistics and percentages will be calculated to establish coverage and timeliness rates
      within the three study arms. Fisher's Exact test with an alpha of 0.05 will be conducted to
      test differences in proportions for coverage and timelines

      Additionally to determine factors associated with measles-2 completion at 24 months of age, a
      bivariate analysis will be conducted.Variables previously examined for association with
      measles 2 completion at 24 months via a bivariate analysis will then be selected for
      determining final multivariate model. All the variables will first be used in the model and
      the coefficients and the vif will be examined. Next, forward selection and step wise
      selection will be carried out in STATA to determine final model for a logistic regression.
    

Intervention name(s): SMS Reminder; Interactive Reminder
Intervention type(s): Other; Other
Intervention description(s): A text message sent as a reminder for immunization on the registered phone number; A text message sent as a reminder for immunization on the registered phone number which requires the receiver to respond back
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an individually randomized, three-arm parallel group design randomized control trial with equal allocation in the two treatment groups and control group. The parents of infants in SMS and interactive reminder groups will receive 3-5 reminders for scheduled follow-up immunization visits. The difference in between SMS and interactive reminders is that parents in SMS reminders are not asked to respond back to SMS reminders. The infants in control group will carry out routine follow-ups without any added intervention.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: SMS Reminder; Two-way Reminder