Clinical trial NCT02595827: Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fever
Keywords: Pediatrics
Epidemiology
Fever
Democratic Republic of the Congo
Randomized Controlled Trial
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: International Rescue Committee
name: University Research Co, LLC
name: Centers for Disease Control and Prevention
First posted: 2015-11-03
Enrollment: 4451
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Agree to recruitment script provided by CHWs at the time of identification of eligible

Exclusion Criteria:

* None

Primary outcomes:
measure: Clinical failure at 7 days
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kalemie
country: Congo, The Democratic Republic of the
facility: International Rescue Committee, Kalemie Office
state: Katanga
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Luke C Mullany, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mullany LC, van Boetzelaer EW, Gutman JR, Steinhardt LC, Ngoy P, Barbera Lainez Y, Wittcoff A, Harvey SA, Ho LS. Universal versus conditional day 3 follow-up for children with non-severe unclassified fever at the community level in the Democratic Republic of the Congo: A cluster-randomized, community-based non-inferiority trial. PLoS Med. 2018 Apr 17;15(4):e1002552. doi: 10.1371/journal.pmed.1002552. eCollection 2018 Apr.
citation: van Boetzelaer E, Ho LS, Gutman JR, Steinhardt LC, Wittcoff A, Barbera Y, Ngoy P, Harvey SA, Mullany LC. Universal versus conditional three-day follow up visit for children with uncomplicated fever at the community level: design of a cluster-randomized, community-based, non-inferiority trial in Tanganyika, Democratic Republic of Congo. BMC Pediatr. 2017 Jan 26;17(1):36. doi: 10.1186/s12887-017-0792-1.