Integrated Community Case Management Study in Eastern Province, Zambia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Strengthening the Delivery of Integrated Community Case Management (iCCM) in Two Districts of Eastern Province, Zambia

Conditions
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Malaria, Diarrhea, Pneumonia

Intervention / Treatment
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* Other: mHealth inventory management
* Other: Supportive supervision
* Other: ICCM current standard of care


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy | Other: mHealth inventory management<br>* Improved stock management of iCCM commodities using the DHIS2 mHealth platform<br>* Other names: intervention;Other: Supportive supervision<br>* Strengthening of supportive supervision using DHIS2<br>* Other names: intervention;|
| Placebo Comparator: Control<br>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<br>* ICCM implementation as per current practice without mHealth interventions<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a) Medicine availability (artemether-lumefantrine) | Defined as percentage of iCCM sites with artemether-lumefantrine in stock during the monthly assessments | Through study completion, up to six months | 
| 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. | Through study completion, up to six months | 
| 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. | Through study completion, up to six months | 
| d) Average cost per iCCM contact | Defined as average expenditure per iCCM contact by type of condition | Through study completion, up to six months | 
| e) Diagnostic availability | Defined as percentage of iCCM sites with all iCCM diagnostics (malaria rapid diagnostic tests) in stock during the monthly assessments | Through study completion, up to six months | 
| f) Medicine availability (amoxicillin) | Defined as percentage of iCCM sites with amoxicillin in stock during the monthly assessments | Through study completion, up to six months | 
| g) Medicine availability (ORS) | Defined as percentage of iCCM sites with ORS in stock during the monthly assessments | Through study completion, up to six months | 
| h) Medicine availability (Zinc) | Defined as percentage of iCCM sites with Zinc in stock during the monthly assessments | Through study completion, up to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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