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

BackgroundChild 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, are low. Additionally, knowledge, care-seeking and health system factors are poor. Therefore, a whole systems approach is needed for sustainable reductions in child mortality.MethodsThis is a cluster randomised controlled trial, with integrated process and economic evaluations, conducted from January 2021 – 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; 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) 4,480 compounds with 3 eligible children per compound; c) 80% power; d) 5% significance; e) intra-cluster correlation of 0.007; 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. DiscussionThis 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 registrationISRCTN 39213655, registered 11th December 2019

Background Vital statistics are critical for effective public health and monitoring progress towards child survival. Nigeria has the highest global under-five mortality rate; however, deaths are often under- or misreported. Objective We explored perceptions of child deaths and socio-cultural factors influencing the reporting of child deaths in Jigawa State, Nigeria. Methods We conducted a triangulation mixed-methods study in Kiyawa local government area, Jigawa, including: four focus group discussions (FGDs) with 8–12 women, six key informant interviews (KII) with Imams, and process data from 42 verbal autopsies (VAs) conducted with caregivers of deceased children. Data was collected between November 2019-April 2021. Purposive sampling was used to recruit FDG and KII participants and two-stage systematic and simple random sampling was employed to recruit VA participants. Qualitative data was analysed using content analysis; VA data was described with proportions. Results Five categories emerged from FGDs: culturally grounded perceptions of child death, etiquette in mourning and offering condolence, formal procedures surrounding child death, the improving relationship between hospital and community, and reporting practices. Women expressed that talking or crying about a death was not culturally accepted, and that prayer is the most acceptable form of coping and offering condolence. Many women expressed that death was God’s will. These findings correlated with VAs, in which visible signs of emotional distress were recorded in 31% of the interviews. Three categories emerged from KIIs: religion as part of formal procedures surrounding child death, communities support the bereaved, and multilayered reasons for unreported deaths. Imams serve a key role as community leaders, involved in both the logistical and religious aspects of their community, though they are not involved in mortality reporting. Conclusion Religion plays a central role in burial practices, community mourning rituals, and expression of grief, but does not extend to reporting of child deaths. Imams could provide an opportunity for improving vital registration.

Background Current debates in Global Health call for expanding methodologies to allow typically silenced voices to contribute to processes of knowledge production and intervention design. Within trial research, this has typically involved small-scale qualitative work, with limited opportunities for citizens to contribute to the structure and nature of the trial. This paper reports on efforts to move past typical formative trial work, through adaptation of community conversations (CCs) methodology, an action-oriented approach that engages large numbers of community members in dialogue. We applied the CC method to explore community perspectives about pneumonia and managing the health of children under-5 in Northern Nigeria to inform our pragmatic cluster randomised controlled trial evaluating a complex intervention to reduce under-5 mortality in Nigeria. Methods We conducted 12 rounds of community conversations with a total of 320 participants, in six administrative wards in Kiyawa Local Government Area, Jigawa state, our intervention site. Participants were male and female caregivers of children under five. Conversations were structured around participatory learning and action activities, using drawings and discussion to reduce barriers to entry. During activities participants were placed in subgroups: younger women (18–30 years of age), older women (31–49 years) and men (18 years above). Discussions were conducted over three 2-h sessions, facilitated by community researchers. Following an initial analysis to extract priority issues and perspectives on intervention structure, smaller focus group discussions were completed with participants in five new sites to ensure all 11 administrative wards in our study site contributed to the design. Results We identified enabling and limiting factors which could shape the future trial implementation, including complex power relationships within households and wider communities shaping women’s health decision-making, and the gendered use of space. We also noted the positive engagement of participants during the CC process, with many participants valuing the opportunity to express themselves in ways they have not been able to in the past. Conclusions CCs provide a structured approach to deep meaningful engagement of everyday citizens in intervention and trial designs, but require appropriate resources, and commitment to qualitative research in trials. Trial registration ISRCTN39213655. Registered on 11 December 2019.