Abstract
BackgroundThe current recommendation within integrated Community Case Management guidelines that all children presenting with uncomplicated fever and no danger signs be followed up after three days may not be necessary. Such fevers often resolve rapidly (usually within 48–96 h), and previous studies suggest that expectant home care for uncomplicated fever can be safely recommended. We aim to determine the non-inferiority of a conditional versus a universal follow-up visit for these children.MethodsWe are conducting a cluster-randomized, community-based, non-inferiority trial enrolling ~4300 children (ages 2–59 months) presenting to community health workers (CHWs) with uncomplicated fever in Tanganyika Province, Democratic Republic of the Congo. Clusters (n = 28) of CHWs are randomized to advise caretakers of such children to either 1) return for a follow-up visit on Day 3 following the initial consultation (Day 1), regardless of illness resolution (as per current guidelines) or 2) return for a follow-up visit on Day 3 only if the child’s signs have not resolved. Enrolled children are followed up at Day 7 for a repeat assessment and recording of the primary outcome of the study, “failure”, which is defined as having fever, diarrhea, pneumonia or decline of health status (e.g. hospitalization, presenting danger signs, or death).DiscussionThe results of this trial will be interpreted in conjunction with a similarly designed trial currently ongoing in Ethiopia. If a follow-up visit conditional on continued illness is shown to be non-inferior to current guidelines stipulating universal follow-up, appropriate updating of such guidelines could reduce time and human resource pressures on both providers and caregivers throughout communities of sub-Saharan Africa and South Asia.Trial registrationThis trial was registered at ClinicalTrials.gov (NCT02595827) on November 2nd, 2015
Highlights
The current recommendation within integrated Community Case Management guidelines that all children presenting with uncomplicated fever and no danger signs be followed up after three days may not be necessary
Current World Health Organization (WHO) integrated community case management (iCCM) guidelines prescribe that a febrile child presenting to a Community health worker (CHW) be assessed for malaria, pneumonia, and diarrhea, and for general danger signs
A randomized controlled cross-over study in Tanzania supported the safety of withholding artemisinin-based combination therapy (ACT) to Malaria Rapid Diagnostic Test (mRDT) negative patients receiving care in the community [8] and a study in Zambia found that only 8.2% of mRDT-negative children treated in the community with an antipyretic alone continued to have fever or were reported by the caregiver to be unwell at the time of the follow-up visit [9]
Summary
Aims The primary aim of this study is to determine if the likelihood of clinical deterioration (“failure”) among children between 2–59 months of age in Tanganyika Province, DRC that present with an uncomplicated fever to CHWs is similar between those advised universally to be followed up on Day 3 and those advised for follow up only if illness does not resolve. Follow up of sick children If the caregiver reports that the child has a fever, or if the CHW determines that the child has any danger signs, or has to be treated for malaria, diarrhea, or pneumonia during the follow up visit on Day 7 (i.e. child meets the primary outcome definition), an additional follow up visit is planned on Day 14 for the child At this second home visit, the CHW and data collector again conduct the same health assessment as described above and the outcome of the visit is recorded. We will assess characteristics of enrolled children to determine the extent to which our randomization procedure at the health area level achieved balance across the study arms; these characteristics will include infant, maternal/paternal, household, Discussion This study, expected to be completed by the end of 2016, is a cluster-randomized, community-based noninferiority trial evaluating conditional follow up versus a universal follow up of children who present uncomplicated fever and seek care at a CHW site.
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