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

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

Perceptions of child death in Jigawa State, Nigeria: a mixed-methods study on how sociocultural nuances shape paediatric mortality reporting

“…Data sources included process data from verbal autopsies (VA, n = 42; personal level), community focus group discussions with women (n = 4; interpersonal level), and key informant interviews with Imams (n = 6; community level). This study was conducted as part of the formative research phase of the INSPIRING Jigawa randomised controlled trial (ISRCTN: 39,213,655), between November 2019 and April 2021 [ 16 ].…”

Using participatory action research to reimagine community mental health services in Colombia: a mixed-method study protocol

“…For example, their use has contributed to improved health outcomes for diabetes in Bangladesh, 29 and maternal and child health in India, 30 and are currently being evaluated for improvement in under-5 pneumonia in Nigeria. 31 Crucially, our adaptation seeks to enhance links across groups that are historically opposed and limited by unequal access to power: community service providers, ex-combatants, internally displaced people and host community members. The value of these types of linking interventions for health systems improvement is well documented elsewhere.…”

Prevalence of pneumonia and malnutrition among children in Jigawa state, Nigeria: a community-based clinical screening study

“…We conducted a cross-sectional household survey, January–June 2021, in Kiyawa Local Government Authority (LGA), Jigawa state, as part of the larger INSPIRING Project cluster randomised controlled trial (ISRCTN: 39213655). 14 …”

“…The target sample size was 4480 compounds, based on the primary outcome of under-5 mortality reduction for the INSPIRING trial. 14 …”

“…We conducted simple random sampling, proportional to cluster size (with a minimum of 50 compounds in each of the 32 study clusters), to generate a numbered list of compounds for recruitment. The target sample size was 4480 compounds, based on the primary outcome of under-5 mortality reduction for the INSPIRING trial 14…”