Integrated Community Case Management Study in Eastern Province, Zambia

Overview

This study will provide important evidence to the Ministry of Community Development, Mother and Child Health (MCDMCH) and the Ministry of Health (MOH) on how to effectively implement iCCM with a focus on improving both the flow of supplies to CHWs as well as the quality of their supervision and mentorship. The overall aim will be to determine whether improvements in supplies for community health workers (CHWs) and strengthened supervision result in improved early and appropriate treatment for children with malaria, pneumonia, and diarrhea in rural Zambia when compared to CHWs offering iCCM without this logistics and supervision support.

Full Title of Study: “Strengthening the Delivery of Integrated Community Case Management (iCCM) in Two Districts of Eastern Province, Zambia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2016

Detailed Description

The main objective of this study is to strengthen the delivery of integrated community case management (iCCM) of malaria, diarrhea, and pneumonia in Chadiza and Chipata Districts of Eastern Province, through mHealth supported improved supply chain management of iCCM commodities and enhanced supportive supervision of iCCM-trained CHWs.

Interventions

  • Other: mHealth inventory management
    • Improved stock management of iCCM commodities using the DHIS2 mHealth platform
  • Other: Supportive supervision
    • Strengthening of supportive supervision using DHIS2
  • Other: ICCM current standard of care
    • ICCM implementation as per current practice without mHealth interventions

Arms, Groups and Cohorts

  • Experimental: Intervention
    • mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy
  • Placebo Comparator: Control
    • ICCM current standard of care with CHWs operating under standard conditions without enhanced inventory management or supportive supervision by mHealth

Clinical Trial Outcome Measures

Primary Measures

  • Composite percentage of children appropriately treated for malaria, diarrhea, and pneumonia.
    • Time Frame: Through study completion, up to six months
    • Defined as percentage of sick children under five years of age presenting with an i-CCM condition to an i-CCM trained health worker (CHW or a CHA) who received appropriate treatment for an iCCM condition (composite indicator): Appropriate treatment for malaria: received artemisinin-based combination therapy (ACT) for malaria for at least three days or Appropriate treatment for pneumonia: received amoxicillin for pneumonia for at least five days or Appropriate treatment for diarrhea: received zinc in addition to fluid from ORS packet or oral rehydration solution (ORS) liquid or homemade fluid for diarrhea

Secondary Measures

  • a) Medicine availability (artemether-lumefantrine)
    • Time Frame: Through study completion, up to six months
    • Defined as percentage of iCCM sites with artemether-lumefantrine in stock during the monthly assessments
  • b) Clinical supervision coverage
    • Time Frame: Through study completion, up to six months
    • Defined as proportion of CHWs who received at least one supervisory contact (in person) every 3 months during which a sick child visit or scenario was assessed and coaching provided.
  • c) Virtual supervision coverage (via mobile technology)
    • Time Frame: Through study completion, up to six months
    • Defined as proportion of CHWs who received at least SMS per month from their supervisor reinforcing the appropriate use of the iCCM algorithm for classification and treatment.
  • d) Average cost per iCCM contact
    • Time Frame: Through study completion, up to six months
    • Defined as average expenditure per iCCM contact by type of condition
  • e) Diagnostic availability
    • Time Frame: Through study completion, up to six months
    • Defined as percentage of iCCM sites with all iCCM diagnostics (malaria rapid diagnostic tests) in stock during the monthly assessments
  • f) Medicine availability (amoxicillin)
    • Time Frame: Through study completion, up to six months
    • Defined as percentage of iCCM sites with amoxicillin in stock during the monthly assessments
  • g) Medicine availability (ORS)
    • Time Frame: Through study completion, up to six months
    • Defined as percentage of iCCM sites with ORS in stock during the monthly assessments
  • h) Medicine availability (Zinc)
    • Time Frame: Through study completion, up to six months
    • Defined as percentage of iCCM sites with Zinc in stock during the monthly assessments

Participating in This Clinical Trial

Inclusion Criteria

  • Age <5 years – Treatment for an iCCM condition (malaria, pneumonia, or diarrhea) by a CHW – Willingness of the child's caregiver to provide informed consent Exclusion Criteria:

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zambia Center for Applied Health Research and Development
  • Collaborator
    • UNICEF
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Godfrey Biemba, MBChB, M.Sc, Principal Investigator, ZCAHRD and Boston University
    • David Hamer, MD, Principal Investigator, Boston University
    • Boniface M Chiluba, B.Sc, M.Sc, Study Director, Zambia Center for Applied Health Research and Development
  • Overall Contact(s)
    • Godfrey Biemba, MBChB, M.Sc, 260974770293, biemba@bu.edu

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