Integrated Community Case Management Study in Eastern Province, Zambia
Primary Purpose
Malaria, Diarrhea, Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
mHealth inventory management
Supportive supervision
ICCM current standard of care
Sponsored by
About this trial
This is an interventional health services research trial for Malaria focused on measuring 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
Eligibility 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:
Sites / Locations
- Chadiza and Chipata DistrictsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy
ICCM current standard of care with CHWs operating under standard conditions without enhanced inventory management or supportive supervision by mHealth
Outcomes
Primary Outcome Measures
Composite percentage of children appropriately treated for malaria, diarrhea, and pneumonia.
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
a) Medicine availability (artemether-lumefantrine)
Defined as percentage of iCCM sites with artemether-lumefantrine in stock during the monthly assessments
b) Clinical supervision coverage
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)
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
Defined as average expenditure per iCCM contact by type of condition
e) Diagnostic availability
Defined as percentage of iCCM sites with all iCCM diagnostics (malaria rapid diagnostic tests) in stock during the monthly assessments
f) Medicine availability (amoxicillin)
Defined as percentage of iCCM sites with amoxicillin in stock during the monthly assessments
g) Medicine availability (ORS)
Defined as percentage of iCCM sites with ORS in stock during the monthly assessments
h) Medicine availability (Zinc)
Defined as percentage of iCCM sites with Zinc in stock during the monthly assessments
Full Information
NCT ID
NCT02866097
First Posted
December 10, 2015
Last Updated
August 9, 2016
Sponsor
Zambia Center for Applied Health Research and Development
Collaborators
UNICEF, Bill and Melinda Gates Foundation, Boston University, Ministry of Health, Zambia, Ministry of Community Development, Mother and Child Health
1. Study Identification
Unique Protocol Identification Number
NCT02866097
Brief Title
Integrated Community Case Management Study in Eastern Province, Zambia
Official Title
Strengthening the Delivery of Integrated Community Case Management (iCCM) in Two Districts of Eastern Province, Zambia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zambia Center for Applied Health Research and Development
Collaborators
UNICEF, Bill and Melinda Gates Foundation, Boston University, Ministry of Health, Zambia, Ministry of Community Development, Mother and Child Health
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Diarrhea, Pneumonia
Keywords
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3840 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
ICCM current standard of care with CHWs operating under standard conditions without enhanced inventory management or supportive supervision by mHealth
Intervention Type
Other
Intervention Name(s)
mHealth inventory management
Other Intervention Name(s)
intervention
Intervention Description
Improved stock management of iCCM commodities using the DHIS2 mHealth platform
Intervention Type
Other
Intervention Name(s)
Supportive supervision
Other Intervention Name(s)
intervention
Intervention Description
Strengthening of supportive supervision using DHIS2
Intervention Type
Other
Intervention Name(s)
ICCM current standard of care
Other Intervention Name(s)
Control
Intervention Description
ICCM implementation as per current practice without mHealth interventions
Primary Outcome Measure Information:
Title
Composite percentage of children appropriately treated for malaria, diarrhea, and pneumonia.
Description
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
Time Frame
Through study completion, up to six months
Secondary Outcome Measure Information:
Title
a) Medicine availability (artemether-lumefantrine)
Description
Defined as percentage of iCCM sites with artemether-lumefantrine in stock during the monthly assessments
Time Frame
Through study completion, up to six months
Title
b) Clinical supervision coverage
Description
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.
Time Frame
Through study completion, up to six months
Title
c) Virtual supervision coverage (via mobile technology)
Description
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.
Time Frame
Through study completion, up to six months
Title
d) Average cost per iCCM contact
Description
Defined as average expenditure per iCCM contact by type of condition
Time Frame
Through study completion, up to six months
Title
e) Diagnostic availability
Description
Defined as percentage of iCCM sites with all iCCM diagnostics (malaria rapid diagnostic tests) in stock during the monthly assessments
Time Frame
Through study completion, up to six months
Title
f) Medicine availability (amoxicillin)
Description
Defined as percentage of iCCM sites with amoxicillin in stock during the monthly assessments
Time Frame
Through study completion, up to six months
Title
g) Medicine availability (ORS)
Description
Defined as percentage of iCCM sites with ORS in stock during the monthly assessments
Time Frame
Through study completion, up to six months
Title
h) Medicine availability (Zinc)
Description
Defined as percentage of iCCM sites with Zinc in stock during the monthly assessments
Time Frame
Through study completion, up to six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Godfrey Biemba, MBChB, M.Sc
Phone
260974770293
Email
biemba@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Boniface M Chiluba, B.Sc, M.Sc
Phone
260977820763
Email
chiluboni@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Godfrey Biemba, MBChB, M.Sc
Organizational Affiliation
ZCAHRD and Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Hamer, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Boniface M Chiluba, B.Sc, M.Sc
Organizational Affiliation
Zambia Center for Applied Health Research and Development
Official's Role
Study Director
Facility Information:
Facility Name
Chadiza and Chipata Districts
City
Chipata
State/Province
Eastern Province
Country
Zambia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boniface Chiluba, MSc
Phone
260-96782073
Email
chiluboni@yahoo.com
First Name & Middle Initial & Last Name & Degree
Godfrey Biemba, Mb ChB, MPH
Phone
260-97470293
Email
gbiemba@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
32509293
Citation
Biemba G, Chiluba B, Yeboah-Antwi K, Silavwe V, Lunze K, Mwale RK, Hamer DH, MacLeod WB. Impact of mobile health-enhanced supportive supervision and supply chain management on appropriate integrated community case management of malaria, diarrhoea, and pneumonia in children 2-59 months: A cluster randomised trial in Eastern Province, Zambia. J Glob Health. 2020 Jun;10(1):010425. doi: 10.7189/jogh.10.010425.
Results Reference
derived
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Integrated Community Case Management Study in Eastern Province, Zambia
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