Integrated Community Case Management Study in Eastern Province, Zambia

Not Applicable

• Conditions: Malaria; Diarrhea; Pneumonia
• Interventions: Other: ICCM current standard of care; Other: mHealth inventory management; Other: Supportive supervision

• Registration Number: NCT02866097
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-12-10
• Study Start: 2016-03
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study First Submitted QC: 2016-08-09
• Last Update Submitted: 2016-08-09
• Study First Posted: 2016-08-15
• Last Update Posted: 2016-08-15
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3840

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	ICCM current standard of care	ICCM current standard of care with CHWs operating under standard conditions without enhanced inventory management or supportive supervision by mHealth
Intervention	mHealth inventory management	mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy
Intervention	Supportive supervision	mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
d) Average cost per iCCM contact	Through study completion, up to six months	Defined as average expenditure per iCCM contact by type of condition
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
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.
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.
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
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
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

Trial Locations

Locations (1)

Chadiza and Chipata Districts; 🇿🇲 Chipata, Eastern Province, Zambia