Clinical trial NCT02866097: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Zambia Center for Applied Health Research and Development
Sponsor class: OTHER
Collaborators: name: UNICEF
name: Bill and Melinda Gates Foundation
name: Boston University
name: Ministry of Health, Zambia
name: Ministry of Community Development, Mother and Child Health
First posted: 2016-08-15
Enrollment: 3840
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

Primary outcomes:
measure: Composite percentage of children appropriately treated for malaria, diarrhea, and pneumonia.
timeFrame: Through study completion, up to six months
Secondary outcomes:
measure: a) Medicine availability (artemether-lumefantrine)
timeFrame: Through study completion, up to six months
measure: b) Clinical supervision coverage
timeFrame: Through study completion, up to six months
measure: c) Virtual supervision coverage (via mobile technology)
timeFrame: Through study completion, up to six months
measure: d) Average cost per iCCM contact
timeFrame: Through study completion, up to six months
measure: e) Diagnostic availability
timeFrame: Through study completion, up to six months
measure: f) Medicine availability (amoxicillin)
timeFrame: Through study completion, up to six months
measure: g) Medicine availability (ORS)
timeFrame: Through study completion, up to six months
measure: h) Medicine availability (Zinc)
timeFrame: Through study completion, up to six months
Other outcomes:
Locations:
city: Chipata
country: Zambia
facility: Chadiza and Chipata Districts
state: Eastern Province
Study officials:
affiliation: ZCAHRD and Boston University
name: Godfrey Biemba, MBChB, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: David Hamer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zambia Center for Applied Health Research and Development
name: Boniface M Chiluba, B.Sc, M.Sc
role: STUDY_DIRECTOR
References:
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.