A Phase 3 interventional study of Conditional Advice in Fever, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Congo, The Democratic Republic of the. Open to participants aged 2 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 3, Interventional, and Health services research
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.
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.
601 studies on the registry are indexed under Fever; 101 are open to participants now.
This study's enrollment of 4,451 is above the median of 100 across 382 interventional studies indexed under Fever.
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Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
In this group, caretakers of children will receive the standard advice under current iCCM guidelines in DRC. Specifically, the CHW will advise that the child come back in 2-3 days.
In this Conditional Advice group, caretakers will be given advice that is modified from the current iCCM guidelines. Specifically, the CHW will advise that the child come back in 2-3 days if the child's symptoms continue.
Other: Conditional Advice
Caretakers are told to return in 2-3 only (Conditional Advice) if the child's symptoms continue.
Clinical failure at 7 days
If the child has fever, has a CHW-treatable condition (pneumonia, malaria, or diarrhea), or is referred for care at the Day 7 visit, the child has met the definition of the primary outcome
Time frame: 1 week
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health