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

NCT ID: NCT02595827

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4451 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-09
• Study Completion Date: 2016-12-05

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).

Conditions

Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Universal

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Conditional

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.

Group Type: ACTIVE_COMPARATOR

Conditional Advice

Intervention Type: OTHER

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

Interventions

Conditional Advice

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Rescue Committee

OTHER

Sponsor Role: collaborator

University Research Co, LLC

INDUSTRY

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luke C Mullany, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

International Rescue Committee, Kalemie Office

Kalemie, Katanga, Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

References

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.

Reference Type: DERIVED

PMID: 29664951 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28122542 (View on PubMed)

Other Identifiers

68295

Identifier Type: -

Identifier Source: org_study_id