Demand Side Incentives Project (DSI)
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 100,000
- Locations
- 4
- Primary Endpoint
- proportion of identified stakeholders routinely engaged during implementation
Study Overview
Brief Summary
The goal of this cluster Randomised Controlled Trial (cRCT) is to evaluate the impact and effectiveness of demand-side incentives (DSIs) in improving immunisation coverage and reducing the burden of zero-dose children between the age of 12-23months in Nigeria.
The study seeks to answer the following questions
- What is the impact of demand-side incentives on increasing immunization coverage in the selected subnational regions of Nigeria?
- What is the effect of demand-side incentives on reducing the zero-dose burden in selected subnational regions in Nigeria?
- What is the effect of various demand-side incentive schemes on improving the timeliness of vaccination among children aged 0 to 23 months in the selected subnational regions of Nigeria?
- What is the impact of different demand-side incentive schemes on enhancing the immunization knowledge and perception of caregivers with children aged 0 to 23 months in the selected subnational regions Nigeria by December 2025.
Detailed Description
Background Immunisation coverage is a critical aspect of public health, as it protects children from vaccine-preventable diseases and deaths. However, according to World Health Organisations and United Nations Children's Education Fund, WHO/UNICEF Estimates of National Immunisation Coverage (WUENIC) data, approximately 25 million children worldwide missed out on life-saving vaccines in 2021, an increase of 6 million compared to 2019. This included 18.2 million zero-dose children, with more than 60% of them living in ten countries, including Nigeria. The global coverage of the third dose of diphtheria-tetanus-pertussis (DTP3) also declined from 86% in 2019 to 81% in 2021 according to the same WUENIC reports, the lowest level since 2008. Several factors have been identified as potentially contributing to this decline, such as increased conflict and fragile settings, misinformation, and disruptions caused by the Corona Virus Disease 2019 (COVID-19) pandemic, including service and supply chain disruptions and resource diversion to pandemic response efforts. The 2022 WUENIC results however show that vaccination coverage has started to improve following on from the decline in the preceding years.
Each year, nearly 2.5 million children living in Nigeria do not receive DTP1, and in 2020, an additional 500,000 children were unvaccinated because of the COVID-19 pandemic. In Nigeria, DTP1 coverage was reported in the 2022 Multiple Indicator Cluster Survey (MICS) to be 68%. The 2021 WHO/UNICEF estimates of national immunisation coverage (WUENIC) report a DTP1 coverage of 70%. Data from the District Health Information System 2 (DHIS 2) for 2022 shows cumulative DTP1 national coverage at 90.95%. These differences in coverage contribute to the challenges of visibility into where and why zero dose children exist.
The Equity Reference Group for Immunisation (ERG) has emphasised and called for a greater focus on four key areas to reach Zero dose children, namely conflict-affected, urban poor, and remote rural areas as well as gender-related barriers. Factors that have been reported to drive the existence of zero dose children in Nigeria include maternal education, fears and misconceptions, and access to health facilities, many of which are intricately linked to the four key areas identified by the ERG. Approximately 55% of zero-dose children in Nigeria however are concentrated in seven states - Kano, Sokoto, Bauchi, Katsina, Niger, Zamfara and Kaduna and are at greater risk of becoming sick or dying from preventable diseases. Sub-national variations in coverage exist, with Lagos and Kano states contributing the largest burden of zero-dose children despite significant differences between the state level coverages.
Inequities in immunisation coverage are reportedly common in urban areas affecting the urban poor, who often live in urban slums. Cumulative DTP1 coverages higher than 100% are unfortunately not uncommon on the DHIS 2, appearing to be reported more often among urban LGAs than among rural LGAs. In-country stakeholders largely attribute this data quality issue to the denominator used to calculate the coverage, as this denominator is based on the projected growth rates from the 2006 population census. The factors around geographical location however run deeper than the level of the LGA with administrative data on the DHIS 2 also showing disparities in DTP1 coverage between health facilities. Nigeria also has communities that have or are still experiencing conflicts, contributing to limited access to immunisation services in these communities and increased number of zero-dose children.
To improve immunisation coverage, Nigeria adopted the Reach Every Ward (REW) strategy in 2005, the REW strategy focuses on routine immunisation in health facilities and outreaches, including components such as improved access for under-served and hard-to-reach areas; supportive supervision; monitoring and use of data for action; community mobilisation and improving community links with service delivery. The National Emergency RI Coordination Centre (NERICC) implements the Optimised Integrated Routine Immunisation Sessions (OIRIS) approach with five key pillars: optimised Routine Immunisation (RI) sessions, integration with other services, intensified supportive supervision, ownership, and accountability. OIRIS aims to enhance RI service access by removing barriers through improved microplan development and implementation in states and Local Government Areas (LGAs). OIRIS also drives the implementation of the revised community engagement strategy, with community level line-listing of newborns to support connection to immunisation services, as a complement to other communications and demand generation activities and strategies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
No masking
Eligibility Criteria
- Ages
- 0 Days to 23 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Caregivers of children who are aged 0-23 months whose eligible child/children slept in the household the night before the survey will be interviewed
Exclusion Criteria
- •Caregivers of children who are aged above 23 months
Outcomes
Primary Outcomes
proportion of identified stakeholders routinely engaged during implementation
Time Frame: 3 months
Number of identified stakeholders mapped out from inception divided by the Number of identified stakeholders engaged on a routine basis during implementation
Proportion of planned stakeholders engagement meetings conducted
Time Frame: 3 months
Number of Planned stakeholders engagement meetings planned divided by the Number of planned engagement meetings conducted
Number of households enrolled and receiving DSI's
Time Frame: 6 months
Number of households successfully enrolled and benefitting from DSI's
Proportions of Health facilities in intervention communities with updated microplans developed with the communities
Time Frame: 3 months
Number of Health facilities in intervention communities with an updated micro plan co-developed with the participation of the host divided by the Total number of health facilities within the Intervention communities
Proportion of Health facilities in intervention areas conducting vaccination sessions for all catchment areas
Time Frame: 3 months
Number of Health facilities in intervention areas conducting vaccination sessions for all catchment areas divided by the Total number of Health facilities in intervention Communities implementing DSI's
Secondary Outcomes
- Cost per individual for enrolment and provision of DSI's(6-12 months)
- Cost per percentage point increase in coverage(6-12 months)
- Proportion of household receiving DSI who feel more accepting of vaccines(3 months)
- Proportion of Households in intervention communities who identify non-cash DSI as a source of Vaccine information(3 months)
- Proportion of households in intervention communities identifying lack of knowledge as a reason for under-immunization or zero dose(3 months)
- Number of households in intervention communities identifying lack of trust as a reason for under-immunization or zero dose(3 months)
- Proportion of households in intervention communities identifying lack of motivation as a reason for under-immunization or zero dose(3 months)
- Proportion of households in intervention communities with children receiving Vaccines appropriately/timely(3 months)
- DTP1 Coverage in Intervention Districts(3 months)
- DTP3 coverage in intervention districts(3 months)
- DTP1-DTP3 drop out rate in intervention districts(3 months)
