Authors
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King, Carina, Colbourn, Tim -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2019
INTERVENTION: Cluster randomized controlled trial, that will run from January 2020 to December 2021, with a subsequent scale‐up to control clusters from January 2022 to October 2022 Clusters will be populations living within 39 primary health centre catchment areas, with a 1:1 allocation into intervention and control. Clusters will be assigned using a random number sequence, and due to the nature of the intervention, participants will not be blinded to their allocation. The intervention is a whole systems approach to capacity building and empowerment, consisting of three elements: 1. Community women’s and men’s groups 2. An adapted community‐score card process which links men's and women's groups with health facility committees 3. Integrated management of childhood illnesses (IMCI) training and mentorship for primary healthcare providers. In addition, one secondary government health facility, outside of the study area, will be supported to ensure that medical oxygen is always available for children who are referred there as part of improved case management. The intervention will be delivered by Save the Children Nigeria, independently of the evaluation team. The main outcome will be the reduction in under‐five mortality, between intervention and control clusters after two years of intervention delivery. This will be measured through three cross‐sectional household surveys, conducted at the start of the trial, in the middle and at the end. The household surveys will be done in a random sub‐set of 3900 households in each survey, covering all villages in Kiyawa LGA. A concurrent process and economic evaluation will also be conducted. CONDITION: Under‐five mortality, with a specific focus on the prevention of pneumonia morbidity and mortality in children under‐five ; Not Applicable PRIMARY OUTCOME: Under‐five mortality after two years of intervention implementation. This will be calculated as the number of children aged 0‐59 months reported to have died in the previous 12 months who resided in sampled households (numerator), divided by the total number of children age 0‐59 months who reside in sampled households (denominator). These data will be collected from women aged 15‐49 years old during household surveys, in a random sample of households from all villages within study clusters. Households will be selected using stratified random sampling. Data will be collected at three timepoints, a baseline survey (January‐March 2020), midline survey (January‐March 2021) and endline survey (January‐March 2022). SECONDARY OUTCOME: ; 1. Suspected‐pneumonia under‐five mortality rate; 2. Caregiver knowledge of pneumonia symptoms; 3. Clinical pneumonia point prevalence; 4. Care‐seeking behaviours for pneumonia; 5. Vaccination coverage; ; These data will be collected from women aged 15‐49 years old during household surveys and from clinical screening of children under‐five by a study nurse, in a random sample of households from all villages within study clusters. Households will be selected using stratified random sampling. Data will be collected at three timepoints, a baseline survey (January‐March 2020), midline survey (January‐March 2021) and endline survey (January‐March 2022).; INCLUSION CRITERIA: 1. Resident in Kiyawa local government area, Jigawa State, Nigeria 2. A child aged 0‐59 months is resident in the household
Epistemonikos ID: ff63714f16fe7361d9c50d27a2ec02ef01be2804
First added on: Nov 11, 2020