NCT02595827

Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo

Universal Versus Conditional Follow Up for Children With Unclassified Fever at the Community Level: A Cluster-Randomized, Community-based, Non-Inferiority Trial in Kalemie, Democratic Republic of Congo (DRC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,451 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 2 Months – 60 Months
• Healthy volunteers: Accepted

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).

Conditions

• Fever

Interventions

Type	Name	Description
OTHER	Conditional Advice	Caretakers are told to return in 2-3 only (Conditional Advice) if the child's symptoms continue.

Timeline

• Start date: 2015-10-09
• Primary completion: 2016-12-05
• Completion: 2016-12-05
• First posted: 2015-11-03
• Last updated: 2017-02-23

Locations

1 site across 1 country: Democratic Republic of the Congo