Effect of Mobile Phone Text Message Reminders on Routine Immunization Uptake in Pakistan: Randomized Controlled Trial

Background Improved routine immunization (RI) coverage is recommended as the priority public health strategy to decrease vaccine-preventable diseases and eradicate polio in Pakistan and worldwide. Objective The objective of this study was to ascertain whether customized, automated, one-way text messaging (short message service, SMS) reminders delivered to caregivers via mobile phones when a child is due for an RI visit can improve vaccination uptake and timelines in Pakistan. Methods This was a randomized controlled trial, conducted in an urban squatter settlement area of Karachi, Pakistan. Infants less than 2 weeks of age with at least one family member who had a valid mobile phone connection and was comfortable receiving and reading SMS text messages were included. Participants were randomized to the intervention (standard care + one-way SMS reminder) or control (standard care) groups. The primary outcome was to compare the proportion of children immunized up to date at 18 weeks of age. Vaccine given at 6, 10, and 14 weeks schedule includes DPT-Hep-B-Hib vaccine (ie, diphtheria, pertussis, and tetanus; hepatitis B; and Haemophilus influenza type b) and oral poliovirus vaccine (OPV). Data were analyzed using chi-square tests of independence and tested for both per protocol (PP) and intention-to-treat (ITT) analyses. Results Out of those approached, 84.3% (300/356) of the participants were eligible for enrollment and 94.1% (318/338) of the participants had a working mobile phone. Only children in the PP analyses, who received an SMS reminder for vaccine uptake at 6 weeks visit, showed a statistically significant difference (96.0%, 86/90 vs 86.4%, 102/118; P=.03).The immunization coverage was consistently higher in the intervention group according to ITT analyses at the 6 weeks scheduled visit (76.0% vs 71.3%, P=.36). The 10 weeks scheduled visit (58.7% vs 52.7%, P=.30) and the 14 weeks scheduled visit (31.3% vs 26.0%, P=.31), however, were not statistically significant. Conclusions Automated simple one-way SMS reminders in local languages might be feasible for improving routine vaccination coverage. Whether one-way SMS reminders alone can have a strong impact on parental attitudes and behavior for improvement of RI coverage and timeliness needs to be further evaluated by better-powered studies and by comparing different types and content of text messages in low-and middle-income countries (LMICs). Trial Registration ClinicalTrials.gov NCT01859546; https://clinicaltrials.gov/ct2/show/NCT01859546 (Archived by WebCite at http://www.webcitation.org/6xFr57AOc)


2a-i) Problem and the type of system/solution
Despite all the Expanded Program of Immunization (EPI) scheduled vaccines being free of cost, the coverage rate in Pakistan is well under 90% as recommended for RI programs in low-middle income countries (LMICs). A major reason for poor coverage is the lack of awareness among parents and caregivers regarding the need for immunization and the importance of completing the entire series of vaccines. There is an immense need for enhancement in the leverage between care seeker and the health care provider in order to improve vaccine uptake and complete all doses according to the schedule. New innovative and cost-effective techniques are required for improvement in vaccination uptake and coverage. 2a-ii) Scientific background, rationale: What is known about the (type of) system There has been a rapid increase in mobile phone use with around 7 billion mobile phone subscribers globally with the majority living in developing countries. SMS messages have also shown the considerable impact on disease prevention efforts in LMICs and have particularly been quite effective for changing behavior in treatment adherence, smoke cessation, and health care appointment attendance. Pakistan has also seen a drastic rise in the use of mobile phones in the last decade, with more than 133 million current subscribers of the mobile phone in the country with mobile penetration density being 71%. In addition, there has been a major increase in the use of SMS texting, with 237.58 billion person-to-person SMS generated in 2011. Given the mobile phone access and acceptability in Pakistan, there is great potential for SMS based interventions to improve immunization coverage. Available data suggests mHealth as a great potential in connecting health care services to women and caregivers who can now be directly connected through this mode of communication; bypassing different hurdles encountered during physical visits or contact Does your paper address CONSORT subitem 2b?
In this study, we evaluated the role of automated one-way SMS texts reminders for improvement in uptake of childhood vaccines included in the RI at 6, 10 and 14 weeks of EPI schedule in Pakistan.

3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio
The study staff after obtaining the information from the surveillance team visited the homes of newborns in the surveillance catchment area and offered enrollment to the parents in the study area. After informed consent eligible infants were allocated to 1:1 ratio into two groups using randomly generated computer assignments with a block of 6 children, allocated in sealed opaque envelopes which were opened at the time of enrollment. The study staff administered the baseline questionnaire at the household level; however, the participants could not be blinded due to overt participation and nature of the intervention.

3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons
The study inclusion criteria were: child less than 2 weeks of age; parent/guardian or at least one person in the household has a valid mobile phone connection; ability to use and read SMS text messages and parent/guardian providing consent. Study exclusion criteria were a child from outside HDSS area or family plans to stay in the catchment area for less than 6 months.

3b-i) Bug fixes, Downtimes, Content Changes NO 4a) CONSORT: Eligibility criteria for participants
The study inclusion criteria were: child less than 2 weeks of age; parent/guardian or at least one person in the household has a valid mobile phone connection; ability to use and read SMS text messages and parent/guardian providing consent. Study exclusion criteria were a child from outside HDSS area or family plans to stay in the catchment area for less than 6 months. 4a-i) Computer / Internet literacy NOT RELEVANT 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: NOT RELEVANT 4a-iii) Information giving during recruitment 4b) CONSORT: Settings and locations where the data were collected This study was conducted in an urban-squatter settlement area, Ibrahim Haidry (IH) union council in Karachi where the Aga Khan University's Department of Paediatrics and Child Health is conducting a health demographic surveillance system (HDSS) on maternal and child health since 2008 4b-i) Report if outcomes were (self-)assessed through online questionnaires GIVEN IN ARTICLE 4b-ii) Report how institutional affiliations are displayed 5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners 5-ii) Describe the history/development process 5-iii) Revisions and updating 5-iv) Quality assurance methods 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used

5-xi) Report any prompts/reminders used
The intervention group, in addition to this standard counseling, received four SMS reminders in the week that the enrolled child was due for the EPI vaccines according to the RI schedule. Four one-way SMS text reminders according to the language preference as captured in the baseline survey were sent in the week child was due for EPI vaccine according to EPI schedule. The content of the text message was "Child name" is due for 6-week vaccination immediately take your child to the nearest EPI center". Same message was sent when the child was 6,10 and 14 weeks of age.

5-xii) Describe any co-interventions (incl. training/support)
NO 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed YES 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons This study was conducted in an urban-squatter settlement area, Ibrahim Haidry (IH) union council in Karachi where the Aga Khan University's Department of Paediatrics and Child Health is conducting a health demographic surveillance system (HDSS) on maternal and child health since 2008 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size 7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines YES 8a) CONSORT: Method used to generate the random allocation sequence MENTIONED IN ARTICLE 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) YES MENTIONED 9) CONSORT: Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned MENTIONED IN METHODS 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions MENTIONED IN METHODS 11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't MENTIONED 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator"