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. 2022 Jan 31;23(1):95.
doi: 10.1186/s13063-021-05859-5.

Integrated Sustainable childhood Pneumonia and Infectious disease Reduction in Nigeria (INSPIRING) through whole system strengthening in Jigawa, Nigeria: study protocol for a cluster randomised controlled trial

Carina King  1   2 , Rochelle Ann Burgess  3 , Ayobami A Bakare  4   5 , Funmilayo Shittu  6 , Julius Salako  6 , Damola Bakare  6 , Obioma C Uchendu  5   7 , Agnese Iuliano  3 , Adamu Isah  8 , Osebi Adams  8 , Ibrahim Haruna  8 , Abdullahi Magama  8 , Tahlil Ahmed  9 , Samy Ahmar  9 , Christine Cassar  9 , Paula Valentine  9 , Temitayo Folorunso Olowookere  10 , Matthew MacCalla  11 , Hamish R Graham  12   13 , Eric D McCollum  14 , Adegoke G Falade  6   12 , Tim Colbourn  3 ; INSPIRING Project Consortium
Collaborators, Affiliations

Integrated Sustainable childhood Pneumonia and Infectious disease Reduction in Nigeria (INSPIRING) through whole system strengthening in Jigawa, Nigeria: study protocol for a cluster randomised controlled trial

Carina King et al. Trials. .

Abstract

Background: Child mortality remains unacceptably high, with Northern Nigeria reporting some of the highest rates globally (e.g. 192/1000 live births in Jigawa State). Coverage of key protect and prevent interventions, such as vaccination and clean cooking fuel use, is low. Additionally, knowledge, care-seeking and health system factors are poor. Therefore, a whole systems approach is needed for sustainable reductions in child mortality.

Methods: This is a cluster randomised controlled trial, with integrated process and economic evaluations, conducted from January 2021 to September 2022. The trial will be conducted in Kiyawa Local Government Area, Jigawa State, Nigeria, with an estimated population of 230,000. Clusters are defined as primary government health facility catchment areas (n = 33). The 33 clusters will be randomly allocated (1:1) in a public ceremony, and 32 clusters included in the impact evaluation. The trial will evaluate a locally adapted 'whole systems strengthening' package of three evidence-based methods: community men's and women's groups, Partnership Defined Quality Scorecard and healthcare worker training, mentorship and provision of basic essential equipment and commodities. The primary outcome is mortality of children aged 7 days to 59 months. Mortality will be recorded prospectively using a cohort design, and secondary outcomes measured through baseline and endline cross-sectional surveys. Assuming the following, we will have a minimum detectable effect size of 30%: (a) baseline mortality of 100 per 1000 livebirths, (b) 4480 compounds with 3 eligible children per compound, (c) 80% power, (d) 5% significance, (e) intra-cluster correlation of 0.007 and (f) coefficient of variance of cluster size of 0.74. Analysis will be by intention-to-treat, comparing intervention and control clusters, adjusting for compound and trial clustering.

Discussion: This study will provide robust evidence of the effectiveness and cost-effectiveness of community-based participatory learning and action, with integrated health system strengthening and accountability mechanisms, to reduce child mortality. The ethnographic process evaluation will allow for a rich understanding of how the intervention works in this context. However, we encountered a key challenge in calculating the sample size, given the lack of timely and reliable mortality data and the uncertain impacts of the COVID-19 pandemic.

Trial registration: ISRCTN 39213655 . Registered on 11 December 2019.

Keywords: Child mortality; Cluster randomised controlled trial; Community; Nigeria; Participatory learning and action; Pneumonia.

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Conflict of interest statement

HG, EM and CK are advisors to Lifebox Foundation on pulse oximetry. AAB, AGF and HG are board members for Oxygen for Life Initiative (OLI), a private non-profit that has provided services to the INSPIRING project. SA, TA, PV and CC are employed by Save the Children UK who are part of the partnership funding the research. TFO and MM are employees of and stockholders in GSK, a multinational for-profit pharmaceutical company that produces pharmaceutical products for childhood pneumonia, including a SARS-CoV2 vaccine.

Figures

Fig. 1
Fig. 1
SPIRIT trial schematic
Fig. 2
Fig. 2
Map of Kiyawa LGA with study clusters
Fig. 3
Fig. 3
Women’s and men’s group PLA cycle
See this image and copyright information in PMC

References

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