Universal vs. Conditional 3-day follow up visit for children with unclassified fever at the community level: a cluster-randomized, community-based non-inferiority trial in Kalemie, Democratic Republic of Congo

Our group conducted a community-based non-inferiority trial in rural Democratic Republic of Congo to examine whether or not simplified approaches to following up children with uncomplicated fever would result in similar clinical failure rates as currently recommended more intensive follow up regimens. Between 2014 and 2016, we enrolled >4,000 children with uncomplicated fever from 28 communities in and around Kalemie, DRC. Eligible children were enrolled, provided either the current recommended universal follow-up advice (i.e. all return to CHW regardless of progression of illness) or the proposed simpler conditional follow-up advice (i.e. return to CHW only if illness continues or worsens). The primary outcome of the study was clinical failure, based on a range of clinical criteria assessed by CHWs at a home-based visit 7 days after enrollment