title: MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial.
abstract: BACKGROUND
  Recent studies have revealed a low measles vaccination (MV) rate in the Republic of Guinea-Bissau (West Africa) that has not increased in accordance with the increasing coverage of other vaccinations. Measles is the deadliest of all childhood rash/fever illnesses and spreads easily, implying that if the vaccination coverage is declining there is a significant risk of new measles outbreaks [27]. Meanwhile, mobile health (mHealth; the use of mobile phones for health interventions) has generated much enthusiasm, and shown potential in improving health service delivery in other contexts.
  
  
  OBJECTIVE
  The aim of this study is to evaluate the efficiency of mHealth as a tool for improving MV coverage while contributing to the mHealth evidence base.
  
  
  METHODS
  This study will take place at three health centers in different regions of Guinea-Bissau. Participants, defined as mothers of the children receiving the MV, will be enrolled when they arrive with their children at the health center to receive the Bacillus Calmette-Guérin vaccination, usually within one month of the child's birth. Enrolment will continue until a study population of 990 children has been reached. The participants will be randomly assigned to a control arm or one of two intervention arms. Each of the three groups will have 330 participants, distributed equally between health centers. Participants in the first intervention arm will receive a scheduled short message service (SMS) text message reminding them of the MV. Participants in the second intervention arm will receive a voice call in addition to the SMS message, while the control arm will receive no interventions. The MV is scheduled to be administered at 9 months of age. Although the vaccine would still be effective after 12 months, local policy in Guinea-Bissau prevents children aged >12 months from receiving the vaccination, and thus the study will follow-up with participants after the children reach 12 months of age. Children who have not yet received the MV will be offered vaccination by the project group.
  
  
  RESULTS
  The study will analyze the efficiency of the intervention by determining its overall effect on MV coverage and timeliness when children reach 12 months of age. The main analysis will be stratified by intervention group, health center, level of education, ethnic group, and role of the person receiving the text messages (eg, mother, father, other family member). Secondary outcomes include the average number of health center visits (with intention to obtain the MV) required before successful administration.
  
  
  CONCLUSIONS
  Despite the rapid proliferation of mHealth projects, only a small number have been evaluated in terms of direct links to health outcomes. This gap in knowledge requires solid evidence on which policy-makers can base decisions. This study aims to produce significant knowledge about mHealth implementation within a Sub-Saharan context while creating data-supported evidence.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT02662595; https://clinicaltrials.gov/ct2/show/NCT02662595 (Archived by WebCite at http://www.webcitation.org/6jH8YiSjY).
authors.affiliation: OPEN, Odense Patient data Explorative Network, Odense University Hospital, Department of Clinical Research, University of Southern Denmark, Odense C, Denmark. emro@ssi.dk.
authors.forename: Emil
authors.identifier: http://orcid.org/0000-0003-2940-7296
authors.initials: E
authors.lastname: Rossing
authors.forename: Henrik
authors.identifier: http://orcid.org/0000-0002-1387-2022
authors.initials: H
authors.lastname: Ravn
authors.forename: Celso Soares Pereira
authors.identifier: http://orcid.org/0000-0001-9277-414X
authors.initials: CS
authors.lastname: Batista
authors.forename: Amabelia
authors.identifier: http://orcid.org/0000-0002-7976-1157
authors.initials: A
authors.lastname: Rodrigues
keywords: Africa; Guinea-Bissau, ODK; RapidSMS; SMS reminders; eHealth; health systems strengthening; immunization; mHealth; measles; randomized controlled trial; voice reminders