Integrated Community Case Management Study in Eastern Province, Zambia

August 9, 2016 updated by: Zambia Center for Applied Health Research and Development

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
    • Eastern Province
      • Chipata, Eastern Province, Zambia
        • Recruiting
        • Chadiza and Chipata Districts
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy
Other: mHealth inventory management
Improved stock management of iCCM commodities using the DHIS2 mHealth platform
Other Names:
  • intervention
Other: Supportive supervision
Strengthening of supportive supervision using DHIS2
Other Names:
  • intervention
PLACEBO_COMPARATOR: Control
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
ICCM implementation as per current practice without mHealth interventions
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite percentage of children appropriately treated for malaria, diarrhea, and pneumonia.
Time Frame: 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
Through study completion, up to six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
a) Medicine availability (artemether-lumefantrine)
Time Frame: Through study completion, up to six months
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
Time Frame: 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.
Through study completion, up to six months
c) Virtual supervision coverage (via mobile technology)
Time Frame: 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.
Through study completion, up to six months
d) Average cost per iCCM contact
Time Frame: Through study completion, up to six months
Defined as average expenditure per iCCM contact by type of condition
Through study completion, up to six months
e) Diagnostic availability
Time Frame: 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
Through study completion, up to six months
f) Medicine availability (amoxicillin)
Time Frame: Through study completion, up to six months
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)
Time Frame: Through study completion, up to six months
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)
Time Frame: Through study completion, up to six months
Defined as percentage of iCCM sites with Zinc in stock during the monthly assessments
Through study completion, up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zambia Center for Applied Health Research and Development

Collaborators

Boston University
Bill and Melinda Gates Foundation
Ministry of Health, Zambia
UNICEF
Ministry of Community Development, Mother and Child Health

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2016

Study Completion (ANTICIPATED)

September 1, 2016

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

August 9, 2016

First Posted (ESTIMATE)

August 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4980/A0/04/001/010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will make the data available to outside parties upon receipt of an appropriate request detailing specific aims and an acceptable analysis plan.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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