Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo
Condition: Fever
MeSH terms: Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      Providers in integrated Community Case Management (iCCM) programs in low resource settings
      often see children without any danger signs, presenting with fever but not having pneumonia,
      malaria, or diarrhea. These children are sent home (often with analgesic only), and
      caretakers are advised to return in 2 or 3 days. In this study, we are evaluating if
      conditional return advice (i.e. return in 2 or 3 day only if your child is still sick")
      results in the same proportion of children remaining with fever one week after
      identification, as the current universal return advice.
    

Detailed description: 
      Fevers in childhood are common and usually self resolve. In rural Democratic Republic of
      Congo (and many other settings), when a febrile child presents to a community health worker
      (CHW), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs,
      according to World Health Organization (WHO) guidelines for integrated Community Case
      Management (iCCM) of childhood illnesses. In the cases where 1) there are no danger signs
      present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the CHW provides an
      antipyretic only, sends the child home, and advises all such cases to come back in 3 days. We
      hypothesize, however, that health outcomes for these cases will be equivalent if the CHW
      advises to come back in 3 days, only if symptoms have not resolved.

      To test this hypothesis, we are conducting a cluster-randomized, community-based
      non-inferiority trial in two zones of Kalemie, Katanga Province, Democratic Republic of
      Congo. In this area, the International Rescue Committee (IRC) has been supporting the
      training, scale-up, and rollout of community health workers who conduct iCCM as per WHO
      guidelines and with Ministry of Health oversight. CHWs have unique non-overlapping catchment
      areas, and groups of CHWs (average 5-7) are associated with health clinics. We will utilize
      this group structure as the unit of randomization; health clinics (and thereby, groups of
      CHWs) will be randomly allocated to one of two groups in terms of the advice given to
      caretakers of children who have no danger signs, have neither malaria, pneumonia, nor
      diarrhea, and are thus classified as having fever of non-identified origin.

        -  Group 1 (Universal follow-up): CHWs in this group will advise caretakers to follow up in
           3 days

        -  Group 2 (Conditional follow-up): CHWs in this group will advise caretakers to follow up
           in 3 days if symptoms/signs remain the same (or worsen).
    

Intervention name(s): Conditional Advice
Intervention type(s): Other
Intervention description(s): Caretakers are told to return in 2-3 only (Conditional Advice) if the child's symptoms continue.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pediatrics; Epidemiology; Fever; Democratic Republic of the Congo; Randomized Controlled Trial