Nisha is a second year MSPH (master of science in public health) student at the Johns Hopkins Bloomberg School of Public Health in the Department of International Health. Nisha worked on the m-SIMU trial as a graduate research assistant in the Epidemiology team at IVAC.
September 12, 2013 was no ordinary day for me as a graduate research assistant working on the mobile solutions for immunization (m-SIMU) trial. Instead of going out to the field to visit a health facility or working on our SMS appointment reminder system, I found myself in a room with live music, laughter, dancing, and over 100 community advisory board members and village chiefs. This was the scene of the m-SIMU public randomization ceremony, a true moment of “public health in practice". It was an amazing sight to witness, as several months of preparation and hard work had gone into ensuring the successful execution of this event. For me, it was a gratifying experience to see the community so excited for the start of the m-SIMU trial.
The community approval of the public randomization ceremony meant that the m-SIMU trial was ready to begin. m-SIMU is a village-randomized controlled trial to assess the impact of short message services (SMS) reminders and cash incentives to improve childhood immunization coverage rates and timeliness in Siaya County, Western Kenya. It will add to the existing evidence base for mHealth and conditional cash transfers, two novel strategies in the field of public health.
The project will aim to enroll about 2,000 infants under the age of four weeks across 152 villages in Western Kenya. These children will be followed over 12 months during which time their vaccination status for routine EPI immunizations will be documented. The 152 villages are assigned to one of four arms:
- SMS reminders
- SMS reminders + 75 Kenyan Shillings (Ksh), which is just under USD 1, for every vaccine dose received on time
- SMS reminder + 200 Ksh (approximately USD 2.50) for every vaccine dose received on time.
The trial is a collaboration between IVAC and Kenya Medical Research Institute/Centers for Disease Control and Prevention (KEMRI/CDC).
The public randomization ceremony was held to assign 152 villages to the four study arms. We chose to do the randomization publicly to assure the community that the process for allocating villages to study arms was fair. We also saw the ceremony as an important way to boost community morale and raise excitement and acceptance of the m-SIMU trial.
Dustin Gibson, m-SIMU co-investigator and PhD candidate at the Johns Hopkins Bloomberg School of Public Health, with the community advisory board members after selecting villages for each trial arm
Preparation for the randomization ceremony involved using our epidemiologic toolbox and some creative thinking. We worked with Dr. Larry Moulton, Professor and Biostatistician at Johns Hopkins Bloomberg School of Public Health, to identify randomization sequences that adjusted for confounders. The next two steps necessary for assigning villages to the study arms were to randomly pick one of the sequences and then randomly assign each of the groups to a study arm. These steps were to occur during the public randomization ceremony and the selection would be done by community members themselves. During the ceremony, the community members enjoyed the suspense and excitement that came along with selecting the sequences, as they had to draw balls out of a cloth sack.
The randomization ceremony was a unique approach to engage the community and really helped to make the m-SIMU trial “come alive”. While we had previously attended meetings to inform the community members about the m-SIMU trial, in some ways, it felt as though we were just another KEMRI/CDC study to them. The ceremony made a memorable impression on the community and the m-SIMU trial had distinguished itself in a positive light. One of my favorite memories from that day was when a community advisory board member approached and thanked us for including her community in the trial and for holding the ceremony.
Nisha and the field supervisor, Jully Odhiambo, at the public randomization ceremony
As a student and a young public health professional, being able to be part of the community mobilization process and the randomization ceremony was an extremely important learning experience. Gaining community approval and investing the time to inform and engage community members are crucial to the success of any intervention or trial. The effort involved here should not be underestimated. From debating over the right size of the cloth sack to rehearsing the explanation of the randomization process – we contemplated and planned every detail in advance. I will definitely stick to these principles as I begin my career in public health.
The m-SIMU trial officially started on October 14, 2013 and has now enrolled over 900 children.