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Integrated Community Case Management Study in Eastern Province, Zambia

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ClinicalTrials.gov Identifier: NCT02866097
Recruitment Status : Unknown
Verified August 2016 by Zambia Center for Applied Health Research and Development.
Recruitment status was:  Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborators:
UNICEF
Bill and Melinda Gates Foundation
Boston University
Ministry of Health, Zambia
Ministry of Community Development, Mother and Child Health
Information provided by (Responsible Party):
Zambia Center for Applied Health Research and Development

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
Malaria Diarrhea Pneumonia Other: mHealth inventory management Other: Supportive supervision Other: ICCM current standard of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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 Name: intervention

Other: Supportive supervision
Strengthening of supportive supervision using DHIS2
Other Name: 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 Name: Control




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



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

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866097


Contacts
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Contact: Godfrey Biemba, MBChB, M.Sc 260974770293 biemba@bu.edu
Contact: Boniface M Chiluba, B.Sc, M.Sc 260977820763 chiluboni@yahoo.com

Locations
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Zambia
Chadiza and Chipata Districts Recruiting
Chipata, Eastern Province, Zambia
Contact: Boniface Chiluba, MSc    260-96782073    chiluboni@yahoo.com   
Contact: Godfrey Biemba, Mb ChB, MPH    260-97470293    gbiemba@gmail.com   
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
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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

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Responsible Party: Zambia Center for Applied Health Research and Development
ClinicalTrials.gov Identifier: NCT02866097     History of Changes
Other Study ID Numbers: 4980/A0/04/001/010
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will make the data available to outside parties upon receipt of an appropriate request detailing specific aims and an acceptable analysis plan.

Keywords provided by Zambia Center for Applied Health Research and Development:
integrated community case management
Mobile Health (mHealth)
rapid diagnostic test
artemether-lumefantrine
amoxicillin
zinc
oral rehydration solution (ORS)
District Health Information System 2 (DHIS2)
iCCM-DHIS2
ZCAHRD

Additional relevant MeSH terms:
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Pneumonia
Diarrhea
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms