MalariaNCT02866097
Integrated Community Case Management Study in Eastern Province, Zambia
A study testing mHealth inventory management and Supportive supervision in people with Malaria and Diarrhea, run by Zambia Center for Applied Health Research and Development at 1 site in Zambia.
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. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- What is being tested?
- mHealth inventory management and Supportive supervision
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,840 participants
- Where
- 1 siteZambia
- Study dates
- Mar 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Zambia1 site, 1 recruiting
- Recruiting
Chadiza and Chipata Districts
Chipata, Eastern Province
Boniface Chiluba, MSc, 260-96782073, chiluboni@yahoo.com
Godfrey Biemba, Mb ChB, MPH, 260-97470293, gbiemba@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- mHealth inventory management, Supportive supervision, ICCM current standard of care
- 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
- Medical subject headings
- Malaria, Diarrhea, Pneumonia, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth inventory managementOther
Also called intervention
Improved stock management of iCCM commodities using the DHIS2 mHealth platform
Supportive supervisionOther
Also called intervention
Strengthening of supportive supervision using DHIS2
ICCM current standard of careOther
Also called Control
ICCM implementation as per current practice without mHealth interventions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | mHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy Receives: Other: mHealth inventory management; Other: Supportive supervision |
| Control | Placebo comparator | ICCM current standard of care with CHWs operating under standard conditions without enhanced inventory management or supportive supervision by mHealth Receives: Other: ICCM current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, up to six months
Secondary outcomes (8)
a) Medicine availability (artemether-lumefantrine)
Defined as percentage of iCCM sites with artemether-lumefantrine in stock during the monthly assessments
Measured: Through study completion, up to six months
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.
Measured: Through study completion, up to six months
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.
Measured: Through study completion, up to six months
d) Average cost per iCCM contact
Defined as average expenditure per iCCM contact by type of condition
Measured: Through study completion, up to six months
e) Diagnostic availability
Defined as percentage of iCCM sites with all iCCM diagnostics (malaria rapid diagnostic tests) in stock during the monthly assessments
Measured: Through study completion, up to six months
f) Medicine availability (amoxicillin)
Defined as percentage of iCCM sites with amoxicillin in stock during the monthly assessments
Measured: Through study completion, up to six months
g) Medicine availability (ORS)
Defined as percentage of iCCM sites with ORS in stock during the monthly assessments
Measured: Through study completion, up to six months
h) Medicine availability (Zinc)
Defined as percentage of iCCM sites with Zinc in stock during the monthly assessments
Measured: Through study completion, up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zambia Center for Applied Health Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF, Bill and Melinda Gates Foundation, Boston University, Ministry of Health, Zambia, Ministry of Community Development, Mother and Child Health
- Responsible party
- Sponsor
- Investigators
- Godfrey Biemba, MBChB, M.Sc, Principal investigator, ZCAHRD and Boston UniversityDavid Hamer, MD, Principal investigator, Boston UniversityBoniface M Chiluba, B.Sc, M.Sc, Study director, Zambia Center for Applied Health Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866097
- Sponsor's protocol ID
- 4980/A0/04/001/010
- Status last verified
- Aug 2016
- First submitted
- 10 Dec 2015
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The investigators will make the data available to outside parties upon receipt of an appropriate request detailing specific aims and an acceptable analysis plan.
Publications
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.
PubMed 32509293
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening the Delivery of Integrated Community Case Management (iCCM) in Two Districts of Eastern Province, Zambia
- ClinicalTrials.gov ID
- NCT02866097
- Acronym / sponsor ID
- 4980/A0/04/001/010
- 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)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,840 participants (estimated)
- Lead sponsor
- Zambia Center for Applied Health Research and DevelopmentUniversity, hospital or other
- Collaborators
- UNICEF, Bill and Melinda Gates Foundation, Boston University, Ministry of Health, Zambia, Ministry of Community Development, Mother and Child Health
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: mHealth inventory management, Other: Supportive supervisionmHealth inventory management and referrals via text messaging plus supportive supervision of CHWs via an mHealth strategy |
| Control | Placebo comparator | Other: ICCM current standard of careICCM current standard of care with CHWs operating under standard conditions without enhanced inventory management or supportive supervision by mHealth |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth inventory managementAlso: interventionImproved stock management of iCCM commodities using the DHIS2 mHealth platform | Other | Intervention |
| Supportive supervisionAlso: interventionStrengthening of supportive supervision using DHIS2 | Other | Intervention |
| ICCM current standard of careAlso: ControlICCM implementation as per current practice without mHealth interventions | Other | Control |
Primary outcome
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
8 secondary outcomes
a) Medicine availability (artemether-lumefantrine)
Time frame: Through study completion, up to six months
b) Clinical supervision coverage
Time frame: Through study completion, up to six months
c) Virtual supervision coverage (via mobile technology)
Time frame: Through study completion, up to six months
d) Average cost per iCCM contact
Time frame: Through study completion, up to six months
e) Diagnostic availability
Time frame: Through study completion, up to six months
f) Medicine availability (amoxicillin)
Time frame: Through study completion, up to six months
g) Medicine availability (ORS)
Time frame: Through study completion, up to six months
h) Medicine availability (Zinc)
Time frame: Through study completion, up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
- Derived from this study: PubMed 32509293Biemba 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.
- Individual participant dataSharing planned: Yes. The investigators will make the data available to outside parties upon receipt of an appropriate request detailing specific aims and an acceptable analysis plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Godfrey Biemba, MBChB, M.Sc principal investigator
ZCAHRD and Boston University
David Hamer, MD principal investigator
Boston University
Boniface M Chiluba, B.Sc, M.Sc study director
Zambia Center for Applied Health Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth inventory management and Supportive supervision in people with Malaria and Diarrhea, run by Zambia Center for Applied Health Research and Development at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Godfrey Biemba, MBChB, M.Sc (260974770293, biemba@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite percentage of children appropriately treated for malaria, diarrhea, and pneumonia. (time frame: Through study completion, up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02866097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2016; AzTrials last refreshed its copy on 2 Nov 2026.