Evaluating the Impact of Demand-Side Incentives (DSI) on Zero Dose Burden and Immunisation Coverage in Nigeria

NCT06676787 | Recruiting Early Phase 1 DMC

• 1 other identifier: NHREC/01/01/2007-13/09/2023
• Study Type: interventional
• Target: 100,000
• Locations: 1 country
• Sites: 2

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

1. 1.What is the impact of demand-side incentives on increasing immunization coverage in the selected subnational regions of Nigeria?
2. 2.What is the effect of demand-side incentives on reducing the zero-dose burden in selected subnational regions in Nigeria?
3. 3.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?
4. 4.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.

Conditions

Incentives

Keywords

Nigeria; Immunisation; Incentives; Caregivers

Outcome Measures

Primary Outcomes (5)

• proportion of identified stakeholders routinely engaged during implementation

  Number of identified stakeholders mapped out from inception divided by the Number of identified stakeholders engaged on a routine basis during implementation

  3 months

• Proportion of planned stakeholders engagement meetings conducted

  Number of Planned stakeholders engagement meetings planned divided by the Number of planned engagement meetings conducted

  3 months

• Number of households enrolled and receiving DSI's

  Number of households successfully enrolled and benefitting from DSI's

  6 months

• Proportions of Health facilities in intervention communities with updated microplans developed with the communities

  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

  3 months

• Proportion of Health facilities in intervention areas conducting vaccination sessions for all catchment areas

  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

  3 months

Secondary Outcomes (11)

• 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

Study Arms (4)

Arm 1

EXPERIMENTAL

Wards in Kwara and Oyo states, where the DSI project provides transportation vouchers to children after vaccination, provided they are aged 0-23 months and reside in communities within the ward.

Other: Transportation Voucher, Comunity engagement and microplannnig support

Arm 2

EXPERIMENTAL

Wards in Kwara and Oyo states, where the DSI project provides monthly financing to routine immunisation primary healthcare facilities to support immunisation and other health services, provided these health facilities are located within the ward.

Other: Direct Facility Funding, Community Engagement, and Microplaning Support

Arm 3

EXPERIMENTAL

Wards in Kwara and Oyo states, where the DSI project provides transportation vouchers to children after vaccination, provided they are aged 0-23 months and reside in communities within the ward and also provides monthly financing to routine immunisation primary healthcare facilities to support immunisation and other health services, provided these health facilities are located within these wards.

Other: Transportation Voucher, Direct Facility Funding, Community engagement and Microplanning support

Control

NO INTERVENTION

No intervention in these wards

Interventions

Transportation Voucher, Comunity engagement and microplannnig support OTHER

Transportation vouchers will be provided to caregivers of eligible children after vaccination at designated routine immunisation health facilities. This is in addition to support for microplaning (technical assistance) for these routine immunisation health facilities and comunity engagement at their catchment areas.

Arm 1

Direct Facility Funding, Community Engagement, and Microplaning Support OTHER

Direct funding will be provided to designated routine immunisation health facilities monthly, in addition to weekly performance monitoring and quarterly financial capacity building. Also, there will be support for microplaning (technical assistance) for these routine immunisation health facilities and comunity engagement at their catchment areas.

Arm 2

Transportation Voucher, Direct Facility Funding, Community engagement and Microplanning support OTHER

Transportation vouchers will be provided to caregivers of eligible children after vaccination at designated routine immunisation health facilities. Direct funding will be provided to designated routine immunisation health facilities monthly, in addition to weekly oerformance monitoring and quarterly financial capacity building. Also, there will be support for microplaning (technical assistance) for these routine immunisation health facilities and comunity engagement at their catchment areas.

Arm 3

Eligibility Criteria

• Age: 0 Days - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Caregivers of children who are aged above 23 months

Sponsors & Collaborators

• Corona Management Systems: lead
• Kwara State Primary Healthcare Development Agency: collaborator
• Oyo State Primary Healthcare Board: collaborator

Study Sites (2)

Kwara State Prmary Healthcare Development Agency

Ilorin, Kwara State, 240281, Nigeria

RECRUITING

Oyo State Primary Healthcare Board

Ibadan, Oyo State, 110115, Nigeria

RECRUITING

Related Publications (10)

• Mahachi K, Kessels J, Boateng K, Jean Baptiste AE, Mitula P, Ekeman E, Nic Lochlainn L, Rosewell A, Sodha SV, Abela-Ridder B, Gabrielli AF. Zero- or missed-dose children in Nigeria: Contributing factors and interventions to overcome immunization service delivery challenges. Vaccine. 2022 Sep 2;40(37):5433-5444. doi: 10.1016/j.vaccine.2022.07.058. Epub 2022 Aug 13.

  PMID: 35973864 BACKGROUND

• Equity Reference Group. 2023. ERG Advocacy Brief. Accessed March 06, 2023. https://drive.google.com/file/d/1VpuVX85RWd_vq6FJ4lcmCnPOYJp1AhuM/view

  BACKGROUND

• District Health Information Systems version 2 (DHIS 2). Federal Ministry of Health. 2023

  BACKGROUND

• Diphtheria tetanus toxoid and pertussis (DTP) vaccination coverage; https://immunisationdata.who.int/pages/coverage/DTP.html?CODE=NGA&ANTIGEN=DTPCV1&YEAR

  BACKGROUND

• 2021 Multiple Indicator Cluster Survey (Mics) & National Immunisation Coverage Survey (NICS): Survey Findings Report https://www.unicef.org/nigeria/media/6316/file/2021%20MICS%20full%20report%20.pdf 2022 Aug

  BACKGROUND

• MOMENTUM. (2021). MOMENTUM Nigeria Country Profile - Immunisation - JSI. https://www.jsi.com/resource/nigeria-country-profile-immunisation/

  BACKGROUND

• MEDIA FACTSHEET: Takeaways from the 2022 WUENIC estimates for 57 lower-income countries supported by Gavi https://www.gavi.org/news/media-room/media-factsheet-takeaways-2022-wuenic-estimates-57-lower-income-countries-supported

  BACKGROUND

• United Nations (2022), COVID-19 fuels slowest rate of childhood vaccination in three decades, leaving millions at risk, Health https://news.un.org/en/story/2022/07/1122592

  BACKGROUND

• UNICEF (2022), Immunisation https://data.unicef.org/topic/child-health/immunisation/

  BACKGROUND

• WHO (2022), Progress and challenges with Achieving Universal Immunisation Coverage https://www.who.int/publications/m/item/progress-and-challenges

  BACKGROUND

Study Officials

• Obinna Ebirim, MSc

  Corona Management Systems

  STUDY DIRECTOR

• Chijioke Kaduru, MPH

  Corona Management Systems

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olamide Akeboi, MSc

CONTACT

+234 7034986118; Olamide.akeboi@coronams.com

Uche F Ibe, Msc

CONTACT

+2348060-541489; ibe.uche@coronams.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The interventions for each arm were selected based on findings from a feasibility evaluation conducted with national and sub-national stakeholders. This evaluation considered the local context of immunisation challenges and identified incentives that have broad stakeholder support across the Expanded Programme on Immunization (EPI) and the community.

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 6, 2024
• Study Start: August 29, 2024
• Primary Completion: October 4, 2025
• Study Completion: December 31, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NG (2)