Integrated Community Case Management Study in Eastern Province, Zambia

Sponsor
Zambia Center for Applied Health Research and Development (Other)
Overall Status
Unknown status
CT.gov ID
NCT02866097
Collaborator
UNICEF (Other), Bill and Melinda Gates Foundation (Other), Boston University (Other), Ministry of Health, Zambia (Other), Ministry of Community Development, Mother and Child Health (Other)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mHealth inventory management
  • Other: Supportive supervision
  • Other: ICCM current standard of care
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3840 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Strengthening the Delivery of Integrated Community Case Management (iCCM) in Two Districts of Eastern Province, Zambia
Study Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2016
Anticipated Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy

Other: mHealth inventory management
Improved stock management of iCCM commodities using the DHIS2 mHealth platform
Other Names:
  • intervention
  • Other: Supportive supervision
    Strengthening of supportive supervision using DHIS2
    Other Names:
  • intervention
  • Placebo Comparator: Control

    ICCM current standard of care with CHWs operating under standard conditions without enhanced inventory management or supportive supervision by mHealth

    Other: ICCM current standard of care
    ICCM implementation as per current practice without mHealth interventions
    Other Names:
  • Control
  • Outcome Measures

    Primary Outcome Measures

    1. Composite percentage of children appropriately treated for malaria, diarrhea, and pneumonia. [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 Outcome Measures

    1. a) Medicine availability (artemether-lumefantrine) [Through study completion, up to six months]

      Defined as percentage of iCCM sites with artemether-lumefantrine in stock during the monthly assessments

    2. b) Clinical supervision coverage [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.

    3. c) Virtual supervision coverage (via mobile technology) [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.

    4. d) Average cost per iCCM contact [Through study completion, up to six months]

      Defined as average expenditure per iCCM contact by type of condition

    5. e) Diagnostic availability [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

    6. f) Medicine availability (amoxicillin) [Through study completion, up to six months]

      Defined as percentage of iCCM sites with amoxicillin in stock during the monthly assessments

    7. g) Medicine availability (ORS) [Through study completion, up to six months]

      Defined as percentage of iCCM sites with ORS in stock during the monthly assessments

    8. h) Medicine availability (Zinc) [Through study completion, up to six months]

      Defined as percentage of iCCM sites with Zinc in stock during the monthly assessments

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chadiza and Chipata Districts Chipata Eastern Province Zambia

    Sponsors and Collaborators

    • Zambia Center for Applied Health Research and Development
    • UNICEF
    • Bill and Melinda Gates Foundation
    • Boston University
    • Ministry of Health, Zambia
    • Ministry of Community Development, Mother and Child Health

    Investigators

    • Principal Investigator: Godfrey Biemba, MBChB, M.Sc, ZCAHRD and Boston University
    • Principal Investigator: David Hamer, MD, Boston University
    • Study Director: Boniface M Chiluba, B.Sc, M.Sc, Zambia Center for Applied Health Research and Development

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zambia Center for Applied Health Research and Development
    ClinicalTrials.gov Identifier:
    NCT02866097
    Other Study ID Numbers:
    • 4980/A0/04/001/010
    First Posted:
    Aug 15, 2016
    Last Update Posted:
    Aug 15, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Zambia Center for Applied Health Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 15, 2016