Maternal and Child HealthNCT02046018
Integrated Community Case Management (ICCM) Delivered by Village Health Teams in Bushenyi District in Uganda
A study testing ICCM delivered by VHT and ICCM delivered by VHT with Cell Phone in people with Maternal and Child Health, run by Healthy Child Uganda.
Trial summary
In Sub-Saharan Africa (SSA), many children die from diarrhoea, acute respiratory illness (ARI) and malaria, despite well- recognized, inexpensive and highly effective treatments, since health access and human resources are limited. Read more about this study
- Who is it for?
- Ages Up to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Maternal and Child Health
- What is being tested?
- ICCM delivered by VHT and ICCM delivered by VHT with Cell Phone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to May 2013
- 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 Up to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children under five (< or =59 months)
Who cannot join
- Children over five years (> 59 Months)
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?
In Sub-Saharan Africa (SSA), many children die from diarrhoea, acute respiratory illness (ARI) and malaria, despite well- recognized, inexpensive and highly effective treatments, since health access and human resources are limited. Healthy Child Uganda (HCU) is a Ugandan-Canadian partnership that since 2003, has developed, implemented and evaluated a Village Health Volunteer (VHV) program in 175 rural villages. Volunteers, selected by peers, provide health education and refer sick children. Volunteer retention (94%) and significant decreases in child deaths are remarkable. Now, HCU wonders whether VHV scope can extend to provide treatment for sick children using Oral Rehydration Salts (ORS)/Zinc, antibiotics, and antimalarials. Use of lay providers in this capacity, called integrated community case management (iCCM), has been proposed as a potential inexpensive solution to SSA's human health resource crisis.
PRIMARY QUESTION: In rural southwest Uganda, can iCCM provided by lay volunteers, improve the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving antibiotics, and fever/malaria receiving antimalarials? Secondary study questions consider VHV capacity to prescribe appropriate drug, dose, duration; iCCM acceptance by family, and VHV; VHV retention/motivation; program cost. Selected VHV will be iCCM trained then receive treatments for distribution. Qualitative and quantitative methods including household surveys, and focus groups will consider pre/post intervention differences and differences in control and intervention populations. A research short course and micro research grants (~ $3000 to multidisciplinary groups pursuing relevant questions) will promote health system evaluation capacity. Lessons learned are critical as SSA countries move forward in planning for increased iCCM programming.
- Conditions
- Maternal and Child Health
- Being tested
- ICCM delivered by VHT, ICCM delivered by VHT with Cell Phone, No intervention
- Keywords
- Maternal and Child Health, Rural Uganda
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICCM delivered by VHTOther
VHT's deliver ICCM to children under five in their communities
ICCM delivered by VHT with Cell PhoneOther
ICCM delivered to children under 5 by VHT trained in ICCM and given cell phones
No interventionOther
VHT's selected by no ICCM training given and no drugs or cell phones.
| Study group | Role | What they receive |
|---|---|---|
| ICCM delivered by VHT | Active comparator | Health Outcomes in Communities where VHT's were trained in ICCM and given drugs. Receives: Other: ICCM delivered by VHT |
| ICCM delivered by VHT with cell phone | Active comparator | Health Outcomes in communities with VHT's who were trained in ICCM and given cell phones Receives: Other: ICCM delivered by VHT; Other: ICCM delivered by VHT with Cell Phone |
| Health outcomes in communities with no ICCM | Active comparator | Health outcomes in communities with VHT's who were not trained in ICCM Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for presumed pneumonia.
Children diagnosed by a Community Health Worker with presumed pneumonia (fast breathing and cough) treated with Amoxicillin.
Measured: March 2013 - November 2014 (8 months)
Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for diarrhea
Children diagnosed with diarrhea will be treated with ORS and zinc.
Measured: March 2013 - November 2014 (8 months)
Percentage of change in number of children under five in intervention area who receive Integrated Community Case Management Treatment from a Community Health Worker for fever.
Children diagnosed with fever are presumed to have malaria, as per government treatment guidelines, and are treated with Coartem.
Measured: March 2013 - November 2014 (8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startOct 2009
- Primary completionNov 2012
- Study completionMay 2013
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 Maternal and Child HealthStudies 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
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthy Child Uganda
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jenn Brenner, Healthy Child Uganda
- Investigators
- Samuel Maling, Principal investigator, MUSTCelestine Barigye, Principal investigator, MUSTJerome Kabakyenga, Principal investigator, MUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046018
- Sponsor's protocol ID
- HCU_AHSI
- Status last verified
- Jul 2014
- First submitted
- 21 Jan 2014
- Last updated
- 11 Jul 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 11 Jul 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
- NCT02046018
- Acronym / sponsor ID
- HCU_AHSI
- Conditions
- Maternal and Child Health
- Keywords
- Maternal and Child Health, Rural Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Healthy Child UgandaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Jan 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.
In Sub-Saharan Africa (SSA), many children die from diarrhoea, acute respiratory illness (ARI) and malaria, despite well- recognized, inexpensive and highly effective treatments, since health access and human resources are limited. Healthy Child Uganda (HCU) is a Ugandan-Canadian partnership that since 2003, has developed, implemented and evaluated a Village Health Volunteer (VHV) program in 175 rural villages. Volunteers, selected by peers, provide health education and refer sick children. Volunteer retention (94%) and significant decreases in child deaths are remarkable. Now, HCU wonders whether VHV scope can extend to provide treatment for sick children using Oral Rehydration Salts (ORS)/Zinc, antibiotics, and antimalarials. Use of lay providers in this capacity, called integrated community case management (iCCM), has been proposed as a potential inexpensive solution to SSA's human health resource crisis.
PRIMARY QUESTION: In rural southwest Uganda, can iCCM provided by lay volunteers, improve the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving antibiotics, and fever/malaria receiving antimalarials? Secondary study questions consider VHV capacity to prescribe appropriate drug, dose, duration; iCCM acceptance by family, and VHV; VHV retention/motivation; program cost. Selected VHV will be iCCM trained then receive treatments for distribution. Qualitative and quantitative methods including household surveys, and focus groups will consider pre/post intervention differences and differences in control and intervention populations. A research short course and micro research grants (~ $3000 to multidisciplinary groups pursuing relevant questions) will promote health system evaluation capacity. Lessons learned are critical as SSA countries move forward in planning for increased iCCM programming.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICCM delivered by VHT | Active comparator | Other: ICCM delivered by VHTHealth Outcomes in Communities where VHT's were trained in ICCM and given drugs. |
| ICCM delivered by VHT with cell phone | Active comparator | Other: ICCM delivered by VHT, Other: ICCM delivered by VHT with Cell PhoneHealth Outcomes in communities with VHT's who were trained in ICCM and given cell phones |
| Health outcomes in communities with no ICCM | Active comparator | Other: No interventionHealth outcomes in communities with VHT's who were not trained in ICCM |
Who may qualify
- Ages
- Up to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children under five (< or =59 months)
Key exclusion criteria (1 listed)
- Children over five years (> 59 Months)
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 |
|---|---|---|
| ICCM delivered by VHTVHT's deliver ICCM to children under five in their communities | Other | ICCM delivered by VHT, ICCM delivered by VHT with cell phone |
| ICCM delivered by VHT with Cell PhoneICCM delivered to children under 5 by VHT trained in ICCM and given cell phones | Other | ICCM delivered by VHT with cell phone |
| No interventionVHT's selected by no ICCM training given and no drugs or cell phones. | Other | Health outcomes in communities with no ICCM |
Primary outcome
Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for presumed pneumonia.
Time frame: March 2013 - November 2014 (8 months)
Children diagnosed by a Community Health Worker with presumed pneumonia (fast breathing and cough) treated with Amoxicillin.
Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for diarrhea
Time frame: March 2013 - November 2014 (8 months)
Children diagnosed with diarrhea will be treated with ORS and zinc.
Percentage of change in number of children under five in intervention area who receive Integrated Community Case Management Treatment from a Community Health Worker for fever.
Time frame: March 2013 - November 2014 (8 months)
Children diagnosed with fever are presumed to have malaria, as per government treatment guidelines, and are treated with Coartem.
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 11 Jul 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 principal investigator
MUST
Celestine Barigye principal investigator
MUST
Jerome Kabakyenga principal investigator
MUST
Questions about this trial
What is this clinical trial studying?
A study testing ICCM delivered by VHT and ICCM delivered by VHT with Cell Phone in people with Maternal and Child Health, run by Healthy Child Uganda.
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 1 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 11 Jul 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?
Percentage of change in number of children under five in intervention area who receive appropriate Integrated Community Case Management Treatment from a Community Health Worker for presumed pneumonia. (time frame: March 2013 - November 2014 (8 months)). The study lists 3 primary outcomes in all. 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 NCT02046018, 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 11 Jul 2014.