Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04001322 |
| Other study ID # |
IRB00008732 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2019 |
| Est. completion date |
November 29, 2020 |
Study information
| Verified date |
July 2020 |
| Source |
Johns Hopkins Bloomberg School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In 2016, only 33% of Nigerian children aged 12-23 months had been vaccinated with the 3rd
dose of the pentavalent vaccine. Lack of knowledge was the leading reason for
non-vaccination. To overcome this knowledge gap, this project, "Tunatar da ni", will deliver
targeted text messages to community leaders and individualized text messages to parents and
caregivers in Kebbi state, Northwest Nigeria, a state with very low coverage of immunization
(19% penta 3 coverage in 2018).
These text messages, also known as Short Messaging System (SMS) messages will be managed,
scheduled and sent from a purpose-built, cloud-based Immunization Reminder and Information
SMS System (IRISS). The messages will be deployed in three ways, as:
1. General broadcast of messages on the importance of immunization to all active mobile
phone subscribers in the intervention area.
2. Targeted educational, informational, normative and motivational messages on
immunization, and reminders on the local immunization clinic schedules, to community
members who voluntarily registered into IRISS for these messages, and to traditional and
religious leaders who then share these information with their communities.
3. Individualized reminders of a child's immunization due dates and local clinic schedule
to parents who voluntarily registered their child's information on IRISS in order to
receive these reminders.
Study investigators hypothesize that providing community leaders with positive and actionable
messages on immunization services will improve their understanding of the value of vaccines
and provide them facts to drive discussions, build positive norms and increase acceptance of
vaccination. Providing targeted reminders to parents about their child's vaccination due date
and the schedule of their local vaccination clinics will motivate their timely action to seek
vaccination services for their children.
Intervention will be evaluated using a two-arm cluster randomized controlled trial design.
All 21 Local Government Areas (LGAs) in Kebbi state will be involved. Based on a 2:1 ratio,
14 LGAs will be randomly assigned to receive the SMS intervention while 7 LGAs will serve as
controls.
The primary outcome measure will be the proportion of children aged 0-11 months who are
appropriately vaccinated for age. The data to compare this outcome between the intervention
and control arms, will be obtained from the quarterly lot quality assurance surveys done by
the Nigerian government.
Description:
Background and rationale:
Vaccines are one of the most effective and cost-effective interventions available to public
health today. But the benefits of vaccines are not getting to all children, particularly in
Nigeria. The 2016 National Immunization Coverage Survey (NICS) reports that only 33% of
children aged 12-23 months received the third dose of the pentavalent vaccine nationally. In
addition, as much as 40% of children had zero dose of vaccines from the routine immunization
(RI) program by the age of two years, having been left out of the "service grid". Even among
children that have access, retention and utilization is poor; as much as 31% of children who
received their first pentavalent vaccine dose, drop out. They do not return to complete the
third dose in the series.
In the 2016 NICS, barriers related to lack of knowledge were the most frequently cited
barriers by parents of under-vaccinated children. In Nigeria, RI is delivered through fixed
sessions at health clinics and outreach sessions in the communities. To complete the RI
schedule, caregivers are required to proactively take their infants to the service sites a
total of 5 times in the child's first year of life. As much as 42% of parents cited
knowledge-deficits such as, not appreciating the importance of vaccines, not knowing the
schedule or not recognizing the need to seek out vaccination services as reasons for not
vaccinating their children. The complacency to seek RI services may be linked to some
parent's erroneous belief that the door-to-door vaccination of their children during polio
eradication campaigns (with oral polio vaccine) provides their children with all the vaccines
they need. Low confidence, inconvenient clinic schedules and location may also underline the
poor demand for RI services.
The health belief model and theory of planned behavior provides an organizing framework to
articulate how knowledge, perceptions, subjective norms, self-efficacy and cues to action
influence behavioral intention and action. Based on this theory, the team identified that
Short Messaging System (SMS) messages and reminders could serve the three-fold purpose of
providing information, shaping subjective norms and cueing caregivers to action.
Study investigators hypothesize that providing community leaders with positive and actionable
messages on immunization services will improve their understanding of the value of vaccines
and provide them facts to drive discussions about vaccination in the community. These
discussions about vaccination will result in a common understanding of its importance,
increase support for it and build greater positive norms about it in the community.
Furthermore, if vaccination schedules for local clinics are sent to the community leaders
through SMS, and they, in turn, ask their town announcers to announce the session times in
the community, this may serve as cues to action for parents of vaccine age children. In the
same vein, providing targeted reminders to parents about their child's vaccination due date
and the schedule of their health center will motivate their timely action to seek vaccination
services for their children.
The evidence that SMS reminders improve vaccine uptake and coverage is strong, however, most
of these studies come from small research settings with tightly controlled and well-resourced
program infrastructure. The feasibility of implementing an SMS messaging and reminder
intervention like this, at scale, and in a rural and low coverage setting like Kebbi, will be
tested by integrating the intervention into RI services, using existing government
immunization providers and managers.
This is a mixed methods study comprising a qualitative component (formative study) to
understand the context, test the messages and refine intervention strategies, and a
quantitative component (evaluative studies) to evaluate the impact of the intervention on
immunization uptake, with a cluster randomized controlled trial (CRCT), covering all LGAs,
and a complementary before-and-after study, in one sentinel LGA. A costing of the program
will also be done to evaluate affordability by the government. Only the CRCT is described
here.
The objective of the CRCT is to: assess the impact of the SMS interventions on the
age-appropriate rates of routine vaccination among children 0-11 months of age.
Methods. The intervention.
The setting: Kebbi state, is one of the 37 states in Nigeria, with an estimated population of
4.4 million and 180,000 newborns every year. Located in the Northwest of the country, Kebbi
has 21 LGAs further divided into 225 wards. Each ward 1 to 3 health facilities.
The system: The project will develop the SMS platform, The Immunization Reminder and
Information SMS System (IRISS), to register contacts, manage the contact database and
coordinate, schedule and send the messages, as well as track messages sent. The SMS messages
will be sent in three ways:
The message targets: As described above in the summary, the project will send out a general
SMS broadcast to active phone users in the intervention LGAs, targeted messages to community
leaders and other community members who opt-in for the messages, and individualized reminders
of a child's vaccination dates and clinic schedule to parents of infants who opt-in for the
messages. The SMS messages will be deployed over a period of 9 months between June 2019 to
March 2020.
All individuals, including Leads, community gatekeepers, community volunteers, health
workers, and caregivers living in the intervention LGAs will be eligible for enrollment into
the IRISS e-registry without limitations if they meet the following criteria: for the public
broadcast - have an active phone; for the targeted messages to traditional (Mai-unguwas) and
religious leaders (Imams) at the community level - have a phone or access to one; for
caregivers - have a vaccine-age child (less than 12 months of age), have a phone or access to
one, and currently reside in the intervention area.
Based on the number of community leaders in the 14 intervention LGAs, the phone ownership
rate, and an assumption of the level of uptake, the projection is that about 7,000
traditional leaders, 1,000 Leads, and 72,000 parents will be enrolled in IRISS making it a
total of 80,000 enrollees. The projected enrollment of 72,000 parents of newborns is based on
an assumption that 20% of the parents of the 360,000 babies born annually in the intervention
LGAs will uptake the service.
The messages. Four types of messages will be sent: normative, educational, informative and
motivational. Vaccination schedule reminders will also be sent.
Advertising IRISS: To sensitize community leaders about IRISS and build capacity of RI
providers to assist caregivers with opting in, when needed, the study will leverage a
community engagement strategy (CES) being rolled out by the government. This strategy aims to
involve traditional leaders in the registration of newborns, reconciliation of the data on
children vaccinated, comparing community and health facility records, and the follow up of
children who missed their vaccine doses. The state immunization officers will conduct cascade
of sensitization meetings from the Emirs at the top of the traditional leadership ladder to
the Mai-unguwas at the lowest rung. This CES will be implemented in both intervention and
control LGAs by government officials, the difference is that IRISS sensitization module will
be presented only in the intervention areas. It is likely that advert for enrollment into
IRISS for health information may spill over to control LGAs, particularly if information is
shared by the public on social media in ways beyond the project's control. If this happens
and individuals from control LGAs register into IRISS expecting a message, they will receive
a general message about the importance of hand-washing. This is to avoid people losing trust
in the program, if they feel SMS messages were advertised but not sent.
Evaluation - CRCT Clusters were defined as the LGAs, the next lower administrative unit below
the state. In line with the goal of implementing at scale, all 21 LGAs in Kebbi state were
eligible to participate. The 21 clusters (LGAs) were randomly assigned in a 2:1 ratio to
maximize the number of LGAs receiving the intervention while maintaining sufficient power to
detect meaningful difference between the two parallel arms. The intervention arm (14 LGAs)
are to receive both the scheduled and responsive SMS messages on immunization. The control
arm (7 LGAs) is designed to receive no SMS intervention, unless some individuals erroneously
registered in IRISS, then only those individuals received a one-time message on hand-washing.
Randomization will be accomplished with un-stratified covariate-constrained randomization
using a macro accessible from: https://github.com/ejgreene/ccr-sas to generate multiple
allocations of each LGA into one of three groups. The covariates are: phone ownership/access
(continuous variable) - % of population with mobile phones; target population (continuous
variable) - number of children 0-11 months; immunization coverage (continuous variable) - %
of children 0-11 months appropriately vaccinated for age; emirate (4 binary variables for
each emirate where the variable equals 1 if the LGA is in that emirate and 0 otherwise).
Each LGA will be allocated to one of three groups, and the process is repeated 100,000 times.
To achieve the 2:1 ratio, two groups will be combined later to form the intervention arm,
while the third becomes the control arm. For each of the 100,000 allocations, the
within-group mean for each covariate will be calculated and compared to the overall state
covariate mean. The allocations where the groups' covariates means fall with 30% of the state
covariate mean, will be kept, otherwise, they will be discarded. The criteria used for the
emirate variables is that the groups could not differ in size by more than 1 LGA.
Once the qualifying allocations are generated, the next step is to conduct a transparent and
public draw. At a meeting of stakeholders from the state primary health care development
agency, a volunteer will be asked to randomly select one allocation out of those that
qualified. For example, if 200 allocations met the criteria, a random number from 1 to 200
will be generated from www.numbergenerator.org. The allocation corresponding to the generated
number is then taken. Next, the groups in the selected allocation are assigned to either
intervention or control by having three volunteers draw three balls labelled - intervention
1, intervention 2 and control from an opaque black bag. The groups assigned intervention 1
and 2 will be collapsed into one intervention arm.
Sample size: In a CRCT, sample size depends on both the number of clusters and of respondents
within each cluster. In this study, the number of clusters is 21 LGAs with 14 intervention
and 7 control LGAs. Similarly, the number of respondents per LGA in the Lot Quality Assurance
Surveys (LQAS) that study team plans to leverage to assess impact, is fixed at 60. The LQAS
are conducted by the government quarterly. Given a fixed sample size, the power of the study
to detect a meaningful difference in the primary outcome at the cluster level was calculated
as follows:
A total of 60 households will be sampled from each LGA. One infant per household will be
interviewed through their caregivers. Total no. of respondents is 21*60 =1,260. Based on the
2:1 allocation ratio of the 21 clusters, a baseline rate of 12% of infants appropriately
vaccinated for age in the state, assumed increase to 30% in intervention arm after 9 months
of intervention, a design effect of 3, type 1 error of 5%, a one-sided test; the study has
99% power to detect a difference of 18% percent between the intervention and control LGAs.
