Integrated Community Case Management Study in Eastern Province, Zambia
Strengthening the Delivery of Integrated Community Case Management (iCCM) in Two Districts of Eastern Province, Zambia
1 other identifier
interventional
3,840
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedAugust 15, 2016
August 1, 2016
5 months
December 10, 2015
August 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
a) Medicine availability (artemether-lumefantrine)
Through study completion, up to six months
b) Clinical supervision coverage
Through study completion, up to six months
c) Virtual supervision coverage (via mobile technology)
Through study completion, up to six months
d) Average cost per iCCM contact
Through study completion, up to six months
e) Diagnostic availability
Through study completion, up to six months
- +3 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALmHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy
Control
PLACEBO COMPARATORICCM current standard of care with CHWs operating under standard conditions without enhanced inventory management or supportive supervision by mHealth
Interventions
Improved stock management of iCCM commodities using the DHIS2 mHealth platform
Strengthening of supportive supervision using DHIS2
ICCM implementation as per current practice without mHealth interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zambia Center for Applied Health Research and Developmentlead
- UNICEFcollaborator
- Bill and Melinda Gates Foundationcollaborator
- Boston Universitycollaborator
- Ministry of Health, Zambiacollaborator
- Ministry of Community Development, Mother and Child Healthcollaborator
Study Sites (1)
Chadiza and Chipata Districts
Chipata, Eastern Province, Zambia
Related Publications (1)
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.
PMID: 32509293DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Godfrey Biemba, MBChB, M.Sc
ZCAHRD and Boston University
- PRINCIPAL INVESTIGATOR
David Hamer, MD
Boston University
- STUDY DIRECTOR
Boniface M Chiluba, B.Sc, M.Sc
Zambia Center for Applied Health Research and Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2015
First Posted
August 15, 2016
Study Start
March 1, 2016
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
August 15, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
The investigators will make the data available to outside parties upon receipt of an appropriate request detailing specific aims and an acceptable analysis plan.