Home Management of Malaria and Pneumonia (HMM/P)

Home and Community Management of Fevers/Malaria and Pneumonia in Children Under-five: a Cluster Randomised Controlled Trial of an Integrated Approach in a Rural District of Burkina Faso

A well-implemented community-based program of early and appropriate treatment of fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction of the less than five mortality rate.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Malaria
• Intervention / Treatment: Other: home/community case management

Detailed Description

An integrated approach of home and community management of malaria and pneumonia may increase the proportion of children receiving prompt treatment; improve child survival as measured by a reduction of the under five mortality rate. To test this hypothesis, a cluster randomised controlled trial will be performed, involving children less than 5 years of age, in Burkina Faso using a community-based supplying community health workers (CHWs), a core group of mothers (KOLs) with Coartem and cotrimoxazole specially packed in age-specific blisters containing a full course of treatment. The study will be carried out in 111 clusters of a rural district in Burkina Faso where malaria and pneumonia are two major mortality causes in under five mortality.

• Study Type: Interventional
• Enrollment (Actual): 11500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Burkina Faso
  • Kadiogo
    • Ouagadougou, Kadiogo, Burkina Faso
      • Groupe de Recherche Action en Sante (GRAS sarl)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• living in one of the study cluster (villages)
• no story of allergy to any of the study drugs
• history of fever or body temperature >= 38.5°C

Exclusion Criteria:

• signs of severity/complications like impaired consciousness, convulsions, fast breathing etc

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: nothing at home level; No intervention at community level. The study drugs (arthemeter/Lumefantrine and Cotrimoxazole) available at the health facility drug stores level and prescribed exclusively to sick children attending to the health facility for care seeking. No Community Heath Worker /Key Opinion leader (CHWs/KOLs) selected in those clusters
Experimental: Home management of malaria; At the community level, the Community health workers/ keay opinion leader (HWs/KOLs) trained and equipped to provide the antimalarial drug (arthemeter/Lumefantrine ) to any child with fever ("hot body") without any other signs of complications like impaired consciousness, convulsions, etc	Other: home/community case management
Experimental: Home management of malaria and pneumonia; At the community level, the Community health workers/ key opinion leader (HWs/KOLs) trained and equipped to provide the antimalarial drug (arthemeter/Lumefantrine ) or antibiotic (Cotrimoxazole) to any child with fever ("hot body") without any other signs of complications like impaired consciousness, convulsions, etc. The treatment decision making for the CHWs/KOLs based on the algorithm	Other: home/community case management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of death in children aged 6 to 59 months	annual crude mortality rate in children aged 0 to 6 months in the different study arms	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
- specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level	12 months

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events at community level consecutive to the administration of the cotrimoxazole and arthemeter/lumefantrine	7 days after the administration of the drug

Collaborators and Investigators

• Sponsor: World Health Organization
• Investigators: Principal Investigator: Sodiomon Bienvenu SIRIMA, MD, PhD, Groupe de Recherche Action en santé (GRAS), 06 BP 10248 Ouagadougou 06, Burkina Faso

Publications and helpful links

General Publications

• Oliphant NP, Manda S, Daniels K, Odendaal WA, Besada D, Kinney M, White Johansson E, Doherty T. Integrated community case management of childhood illness in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Feb 10;2(2):CD012882. doi: 10.1002/14651858.CD012882.pub2.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): May 30, 2014
• Last Update Submitted That Met QC Criteria: May 29, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Impact of home management of malaria and pneumonia on child mortality; home management of malaria and pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Pneumonia; Malaria
• Other Study ID Numbers: HMMP001; A70210 (Other Identifier: WHO-TDR)