Integrated Community Case Management Study in Eastern Province, Zambia

NCT ID: NCT02866097

Last Updated: 2016-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria Diarrhea Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy

Group Type EXPERIMENTAL

mHealth inventory management

Intervention Type OTHER

Improved stock management of iCCM commodities using the DHIS2 mHealth platform

Supportive supervision

Intervention Type OTHER

Strengthening of supportive supervision using DHIS2

Control

ICCM current standard of care with CHWs operating under standard conditions without enhanced inventory management or supportive supervision by mHealth

Group Type PLACEBO_COMPARATOR

ICCM current standard of care

Intervention Type OTHER

ICCM implementation as per current practice without mHealth interventions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mHealth inventory management

Improved stock management of iCCM commodities using the DHIS2 mHealth platform

Intervention Type OTHER

Supportive supervision

Strengthening of supportive supervision using DHIS2

Intervention Type OTHER

ICCM current standard of care

ICCM implementation as per current practice without mHealth interventions

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

intervention intervention Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UNICEF

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

Ministry of Health, Zambia

OTHER_GOV

Sponsor Role collaborator

Ministry of Community Development, Mother and Child Health

UNKNOWN

Sponsor Role collaborator

Zambia Center for Applied Health Research and Development

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Godfrey Biemba, MBChB, M.Sc

Role: PRINCIPAL_INVESTIGATOR

ZCAHRD and Boston University

David Hamer, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Boniface M Chiluba, B.Sc, M.Sc

Role: STUDY_DIRECTOR

Zambia Center for Applied Health Research and Development

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chadiza and Chipata Districts

Chipata, Eastern Province, Zambia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Zambia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Godfrey Biemba, MBChB, M.Sc

Role: CONTACT

260974770293

Boniface M Chiluba, B.Sc, M.Sc

Role: CONTACT

260977820763

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Boniface Chiluba, MSc

Role: primary

260-96782073

Godfrey Biemba, Mb ChB, MPH

Role: backup

260-97470293

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32509293 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4980/A0/04/001/010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.