DiarrhoeaHCU:VHV/ICCMNCT02072629
HCU: Can VHVs Trained in ICCM Improve Care for Children
A study testing Training of VHVs in iCCM in people with Diarrhoea and Pneumonia, run by University of Calgary.
Trial summary
This study will assess how the current VHV (VHV=CHW, community health worker) scope can be expanded to include iCCM and if such group interventions can provide improved access to treatment for children. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- What is being tested?
- Training of VHVs in iCCM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,071 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Dec 2012
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women living in intervention and comparison villages
- Mother to at least one child under 59 months old
Who cannot join
- -No living child
About this study
Official title: Healthy Child Uganda: Can Village Health Volunteers Trained in Integrated Community Case Management of Childhood Illness Improve Access to Care for Africa's Most Vulnerable Children?
This study will assess how the current VHV (VHV=CHW, community health worker) scope can be expanded to include iCCM and if such group interventions can provide improved access to treatment for children.
In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving anti-malarials?
- Being tested
- Training of VHVs in iCCM
- Keywords
- Antimalarials, Antibiotics, ORS Zn, Village Health Volunteers, Integrated Community Case Management
- Medical subject headings
- Diarrhea, Pneumonia, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training of VHVs in iCCMOther
Village Health Volunteers will be trained in Integrated Community Case Management (iCCM) of childhood illness
| Study group | Role | What they receive |
|---|---|---|
| Training of VHVs in iCCM | Experimental | In these villages VHVs will be provided with iCCM training and equipped to support iCCM in their villages Receives: Other: Training of VHVs in iCCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia
Measured: pre- (Dec 2010) post- (Dec 2012) intervention (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionDec 2012
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 DiarrhoeaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Responsible party
- Principal investigator, Jennifer L. Brenner, University of Calgary
- Investigators
- Samuel Maling, MD, Principal investigator, Mbarara University of Science and Technologyjenn Brenner, MD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072629
- Sponsor's protocol ID
- E-22746
- Acronym
- HCU:VHV/ICCM
- Status last verified
- Feb 2014
- First submitted
- 21 Feb 2014
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oliphant NP, Manda S, Daniels K, Odendaal WA, Besada D, Kinney M, White Johansson E, Doherty T. Integrated community case management of childhood illness in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Feb 10;2(2):CD012882. doi: 10.1002/14651858.CD012882.pub2.
PubMed 33565123
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Child Uganda: Can Village Health Volunteers Trained in Integrated Community Case Management of Childhood Illness Improve Access to Care for Africa's Most Vulnerable Children?
- ClinicalTrials.gov ID
- NCT02072629
- Acronym / sponsor ID
- HCU:VHV/ICCM / E-22746
- Keywords
- Antimalarials, Antibiotics, ORS Zn, Village Health Volunteers, Integrated Community Case Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,071 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Feb 2014 (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 assess how the current VHV (VHV=CHW, community health worker) scope can be expanded to include iCCM and if such group interventions can provide improved access to treatment for children.
In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving anti-malarials?
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training of VHVs in iCCM | Experimental | Other: Training of VHVs in iCCMIn these villages VHVs will be provided with iCCM training and equipped to support iCCM in their villages |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women living in intervention and comparison villages
- Mother to at least one child under 59 months old
Key exclusion criteria (1 listed)
- -No living child
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 |
|---|---|---|
| Training of VHVs in iCCMVillage Health Volunteers will be trained in Integrated Community Case Management (iCCM) of childhood illness | Other | Training of VHVs in iCCM |
Primary outcome
Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia
Time frame: pre- (Dec 2010) post- (Dec 2012) intervention (2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Derived from this study: PubMed 33565123Oliphant NP, Manda S, Daniels K, Odendaal WA, Besada D, Kinney M, White Johansson E, Doherty T. Integrated community case management of childhood illness in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Feb 10;2(2):CD012882. doi: 10.1002/14651858.CD012882.pub2.
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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.
Samuel Maling, MD principal investigator
Mbarara University of Science and Technology
jenn Brenner, MD study director
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Training of VHVs in iCCM in people with Diarrhoea and Pneumonia, run by University of Calgary.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia (time frame: pre- (Dec 2010) post- (Dec 2012) intervention (2 years)). 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 NCT02072629, 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 26 Feb 2014.