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

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.

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

International Rescue Committee, Kalemie Office

Kalemie, Katanga, Democratic Republic of the Congo

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Conditional Advice

Other

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

Primary outcomes

Clinical failure at 7 days

Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

Centers for Disease Control and Prevention
International Rescue Committee
University Research Co, LLC

Registry information

Official study 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)

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 3, 2015
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed