Integrated Community Case Management Study in Eastern Province, Zambia

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02866097
• Other study ID #: 4980/A0/04/001/010
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2015
• Last updated: August 9, 2016
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: August 2016
• Source: Zambia Center for Applied Health Research and Development
• Contact: Godfrey Biemba, MBChB, M.Sc
• Phone: 260974770293
• Email: biemba[@]bu.edu
• Is FDA regulated: No
• Health authority: Zambia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3840
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 5 Years

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diarrhea
• Malaria
• Pneumonia

Intervention

Other:
• mHealth inventory management
Improved stock management of iCCM commodities using the DHIS2 mHealth platform
• Supportive supervision
Strengthening of supportive supervision using DHIS2
• ICCM current standard of care
ICCM implementation as per current practice without mHealth interventions

Locations

Country	Name	City	State
Zambia	Chadiza and Chipata Districts	Chipata	Eastern Province

Sponsors (6)

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

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	d) Average cost per iCCM contact	Defined as average expenditure per iCCM contact by type of condition	Through study completion, up to six months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No