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Evaluation of Mobile Health App Aiming to Increase Immunization Coverage in Northern Uganda
Last registered on August 18, 2017

Pre-Trial

Trial Information
General Information
Title
Evaluation of Mobile Health App Aiming to Increase Immunization Coverage in Northern Uganda
RCT ID
AEARCTR-0001089
Initial registration date
August 15, 2017
Last updated
August 18, 2017 5:10 PM EDT
Location(s)
Region
Primary Investigator
Affiliation
London School of Hygiene and Tropical Medicine
Other Primary Investigator(s)
PI Affiliation
Investigator
PI Affiliation
Investigator
Additional Trial Information
Status
On going
Start date
2016-06-01
End date
2018-04-30
Secondary IDs
Abstract
Uganda is one of the 35/194 WHO Member States which have not succeeded in reaching the Global Vaccine Action Plan’s (GVAP) intermediate goal of reaching 90% national coverage with three doses of diphtheria-tetanus-pertussis containing vaccines by 2015 (WHO, 2015). In the search for novel ways to address low and stagnating vaccination rates and improve access to and utilisation of immunisation services increased attention is being paid to the role of communities, and community engagement (CE) strategies (Sabarwal et al., 2015). Contextual factors and the degree to which community members understand and trust the immunisation process affect vaccination coverage rates (Rainey et al., 2011, Favin et al., 2012, Streefland et al., 1999). The effectiveness of CE strategies in addressing vaccine supply and demand factors and improving vaccine coverage is less well known. Evidence suggests that vaccine interventions that are designed and co-managed with community members are more likely to be successful, however more attention needs to be paid to evaluating and developing current CE practice (Sabarwal et al., 2015).

The 'Fifth Child' project, implemented by the International Rescue Committee (IRC), is a community engagement strategy which utilizes an immunisation status data management and tracking system with two objectives: 1) To improve access to quality data on immunization status through a user-friendly data platform; and 2) to utilise community engagement to trace defaulters and optimize outreaches through collaboration between Community Health Workers, village leaders and health centre staff.

The evaluation of this intervention is led by the London School of Hygiene and Tropical Medicine (LSHTM) and Innovations for Poverty Action (IPA) Uganda and aims to contribute to the emerging evidence base through a cluster randomised controlled trial (cRCT) with an embedded process evaluation and cost effectiveness analysis (undertaken by the IRC). Data collection will consist of household and health centre surveys during a baseline and endline, as well as a qualitative process evaluation component.
Registration Citation
Citation
Bruce, Jane, Tracey Chantler and Jayne Webster. 2017. "Evaluation of Mobile Health App Aiming to Increase Immunization Coverage in Northern Uganda ." AEA RCT Registry. August 18. https://doi.org/10.1257/rct.1089-1.0.
Former Citation
Bruce, Jane et al. 2017. "Evaluation of Mobile Health App Aiming to Increase Immunization Coverage in Northern Uganda ." AEA RCT Registry. August 18. http://www.socialscienceregistry.org/trials/1089/history/20608.
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Experimental Details
Interventions
Intervention(s)
The ‘fifth child’ intervention has two objectives, which are 1) to improve access to quality data on immunization status, and 2) to utilise community engagement to trace defaulters and optimize outreaches.

Objective 1: to improve access to quality data on immunisation status by producing and integrating improved data on the number of infants in the catchment area and data from immunisation services at both fixed and outreach sites to create a user-friendly data platform on immunisation status.

The Fifth Child intervention starts in the community. Guided by IRC staff, Village Health Team members (VHTs) work with village leaders (e.g. local councillors and religious leaders) to register all children, 0-12 months, and continually add newborns to the cohort. Villages included in the intervention arm health facility catchment areas are clearly delineated and all the community-generated data on individual infant immunisation status is entered by the healthcare worker (HCW) into the mHealth tool containing the following programmatic applications:

• Comprehensive immunization register: when an infant is immunised either at the facility or an outreach session, data on the updated status of that child is easily uploaded into the single CommCare platform, (rather than relying on facility-based registers and outreach tally sheets that are rarely consolidated). Healthcare workers are encouraged to routinely review child immunisation cards at contact opportunities and update the mHealth tool since some infants may receive immunisations outside of the catchment area.
• Facilitated vaccine reminder and defaulter identification: Infants are registered by birth date and health facility staff can easily open the ‘Vaccine Reminder’ tab in the application that flags those infants in their catchment area with immunizations due in the next 5 days. A separate tab, maintains an up-to-date list of defaulting children, defined as having missed an immunisation by >14 days, (either based on their birth date or when the previous antigen was administered). This list can be easily sorted by parish, village, or VHTs responsible.

Objective 2: to utilise community engagement strategies to trace defaulters and optimize outreaches and thereby decrease the number of defaulters through systematic engagement with community leaders and other key community groups in outreach planning, mobilisation, and implementation, based on coverage data, and performance monitoring of defaulter-tracing.

The intervention aims to equip VHTs with the tools and techniques necessary to encourage caregivers to seek immunisation services. It hypothesizes that data informed defaulter tracing, VHT home visits and active engagement of community leaders e.g. local councillors will promote linkages between community members and health facilities that organise immunisation services and outreaches.

Community leaders, are most often local counsellors (LCs), but could also include religious leaders, women leaders, of villages where there are more than 5 defaulting children that month, are supported to review coverage data for their village and. actively participate in planning meetings and to help design and schedule the outreaches alongside VHTs and HCWs. This meeting for the planning of ‘smarter outreaches’ is held at the facility level and is conducted with the assumption that if outreaches are convenient, and based on the data showing where the most defaulters are, it is more likely that infants will be brought. This pathway also postulates that community co-management leads to strengthened linkages between the community and facility and increased community ownership and accountability of HCWs. An intended positive outcome in the short-term could be creation of community demand for other maternal and child health services and more referrals from community to facilities. Another possible intended outcome may be community participation in other last mile health services.

During monthly meetings, HCWs inform VHTs which infants in their villages are due for immunisation and share the list of defaulters. Based on the number of infants/village and estimated dropout rate, it is expected that each VHT will visit approximately 2-3 infants due for immunisation and 1-2 defaulters per month.

VHTs are trained on administering key immunisation messages, addressing myths and misconceptions and improved interpersonal communication skills for counselling that focuses on reasons why the child missed their immunisations. Home visits are intended to be interactive where VHTs facilitate caregivers and other household decision-makers to develop an action plan for catch-up immunisation. They inform caregivers the date, time, and location of the next outreaches in the catchment area and provide a referral ticket for immunization services either at facilities or outreaches. As defaulters present referral tickets, the infants are vaccinated and updates are entered into the data platform, the HCW and the project team are then able to examine the timeliness and rates of catch-up vaccination post home visits.

Formative findings suggest that VHTs are motivated for defaulter visits and outreach mobilisation because with improved data, their efforts target households most in need. Their community leaders are more aware of defaulters, more systematically involved in mobilisation and play a role in monitoring VHT efforts. This pathway assumes that if community leaders have individualised data on defaulters, this will capture their interest and they will become supportive co-managers aiming to protect their communities against vaccine-preventable disease.
Intervention Start Date
2016-09-20
Intervention End Date
2017-09-30
Primary Outcomes
Primary Outcomes (end points)
Primary outcome:
1.Increase in DPT3, Measles Containing Vaccines(MCV) immunization coverage in 9-23 month old children
Secondary outcomes:
1. Reduction in drop-out rates for DPT 1 & 2 and OPV 1, 2, 3
2. Improvements in the timely uptake of other Expanded Programme on Immunization(EPI) immunizations
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The study is a cluster randomized controlled trial (cRCT). Non-neighboring Health Facility Catchment Areas (HFCAs) in three districts in northern Uganda will be randomly allocated to the intervention and control arms of the trial. The intervention HFCAs will receive the package of interventions comprising the mHealth and and Community Engagement activities. Both intervention and control health facility catchment areas will receive supportive activities as defined by the Ministry of Health UNEPI standard of care for immunization.
Experimental Design Details
Randomization Method
A list of potential trial clusters defined as the catchment area of a health facility was compiled using 2014 census boundaries as used by district health teams (DHTs) and Quantum Geographic Information System (QGIS) shape files provided by UBOS. Inclusion criteria for the health centres was level II or III, rural, funded by the Uganda Ministry of Health (MoH) and functional. A total of 64 health facilities met these criteria, and from these 64 corresponding HFCA, 32 were selected to be included in the trial. HFCAs that were non-neighboring were visually selected to minimize instances in which villages in one or more HFCA were adjacent to one another. Half of the selected HFCAs were randomly assigned to the intervention group.

The evaluation method is a cross-sectional household survey linked to a health facility survey in all of the 32 trial clusters, 1 month before the start of the implementation, and an endline one year later.

A two-stage cluster random sample will be used for the household survey. At the first stage 7 villages within each of the 32 catchment areas were selected using probability proportional to size (pps) based on village population sizes from the 2014 census data. For the second stage, 8 households with at least one child aged 9-23 months were randomly selected per village.
Randomization Unit
Health facility catchment areas
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
32 health facility catchment areas (16 intervention/16 control)
Sample size: planned number of observations
1,760 households with children of immunisation age
Sample size (or number of clusters) by treatment arms
16 clusters per arm, each including 7 randomly selected villages from within the HFCA, where 8 households were randomly selected to be surveyed, totaling 55-56 households with children of immunisation age (9 – 23 months) per cluster giving a total of approximately 1,760 children.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
London School of Hygiene and Tropical Medicine
IRB Approval Date
2016-04-26
IRB Approval Number
10591
IRB Name
Uganda National Council for Science and Technology (UNCST)
IRB Approval Date
2016-06-14
IRB Approval Number
SS 4091
IRB Name
Mildmay Uganda Research Ethics Committee (MUREC)
IRB Approval Date
2016-05-23
IRB Approval Number
REC REF 0504 - 2016
Analysis Plan

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Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS