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Trial registered on ANZCTR


Registration number
ACTRN12614000208606
Ethics application status
Approved
Date submitted
7/02/2014
Date registered
26/02/2014
Date last updated
26/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrated community case management (iCCM) of pneumonia, malaria and diarrhea among children under 5years in Homabay County, Kenya
Scientific title
Impact of integrated community case management of pneumonia, malaria and diarrhea in sick children under 5 years in Homabay County, Kenya
Secondary ID [1] 284048 0
Nil Known
Universal Trial Number (UTN)
U1111-1152-2805
Trial acronym
HBICCM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 290934 0
malaria 290935 0
diarrhoea 290936 0
Condition category
Condition code
Infection 291290 291290 0 0
Other infectious diseases
Public Health 291291 291291 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention that will be carried out in this research is integrated community case management (iCCM) of pneumonia, malaria and diarrhoea. However, because zinc and Oral Rehydration Solution (ORS), Rapid Diagnostic Test (RDTs) and anti-malarials have been ratified for use in the community by the Kenya Ministry of health, our focus shall be on pneumonia home case management primarily and on diarrhoea secondarily. Community Health Workers (CHWs) will be trained to diagnose and treat these three ailments as described below
1. Giving antibiotic to a child with fast breathing and or chest indrawing
2. Giving an antimalarial to a child with a positive RDT
3. Giving Oral Rehydration Solution (ORS) and Zinc to a child with diarrhea

Training of community health workers
The CHWs will be trained to classify and treat children with diarrhoea, pneumonia or malaria and also manage stock of appropriate drugs and supplies. The CHWs will also be trained to perform RDTs for malaria diagnosis. They will also require skills to be able to accurately complete the relevant registers and data collection forms as well as counseling of caregivers and general health education. The training will last for 6 days. The training manual that will be used has already been developed by the Kenya iCCM taskforce. This manual was adapted from the WHO’s Community Health Workers’ Handbook. The training will be conducted by a training team experienced in Integrated Management of Childhood illnesses skills with support from the County and district iCCM CHW trainers of trainers. The training will be conducted in groups of 30 at link health facilities.

The training will use a variety of methodologies including lectures, presentations, discussions, case studies, demonstrations, practice, role-plays, and video shows. The CHWs will take quality time to go through and practice the use of a diagnostic tool that will be developed to assist them to classify cases. The trainer/supervisors will follow up the CHWs one month after the initial training to ensure that they acquired the necessary skills. There will be refresher courses at approximately week 6 and week 10 after the first training and subsequently every six months. This will be hands on 1-2 day trainings.

Children aged 2–59 months with cough, fever, and difficult breathing during regular home visitation schedule, or whose mothers seek care from the CHW will be assessed and classified children according to the WHO classification for pneumonia as below.

1. No pneumonia: cough or cold
a. No signs of pneumonia or severe pneumonia

2. Pneumonia
Fast breathing:
a. Greater than or equal to 50 breaths/min in a child aged 2–11 months
b. Greater than or equal to 40 breaths/min in a child aged 1–5 years

3. Severe pneumonia (Pneumonia with danger signs)
Cough or difficulty in breathing with
a. Severe respiratory distress (e.g. grunting, very severe chest indrawing)
b. Signs of pneumonia with a general danger sign (inability to breastfeed or drink, lethargy or reduced level of consciousness, convulsions)

CHWs will provide oral amoxicillin 80–90 mg/kg per day twice a day to infants aged 2–11 months and twice a day for those aged 12–59 months) for 5 days to children with pneumonia (includes both chest in drawing pneumonia and fast breathing pneumonia) and give the mother specific guidance about its use. This dosage has been found to be safe and efficacious for treatment of even severe pneumonia in community settings. Children will be seen by the CHW either in the patient's home or at the CHW’s house on day 4. This day 4 visit is recommended by the WHO. At this visit, adherence to the oral antibiotic will be assessed, as well as the child's clinical status and the presence of any danger sign and adverse events. The child will be regarded as lost to follow-up if contact cannot be made on day 4.
CHWs will also be trained as follows:-
If child has fever (less than 7 days)
1. If RDT is positive, give oral antimalarial i.e. Artemether-Lumefantrine (AL). One tablet of AL contains 20mg Artemether and 120mg Lumefantrine).
It is to be given twice daily for 3 days as follows
Age 2 months up to 5 months -1/2 tablet (total 3 tabs)
Age 5 months up to 3 years—1 tablet (total 6 tabs)
Age 3 years up to 5 years—2 tablets (total 12 tabs)
2. Help caregiver give first dose. Advise to give 2nd dose after 8 hours, and to give dose twice daily for 2 more days.

If child has diarrhoea less than 14 days

Give ORS. Help caregiver give child ORS solution in front of you until child is no longer thirsty. The ORS being utilized is low osmolar ORS (245mmol/l) and contains approximately 2.6g/l of sodium chloride, 13.5g/l of anhydrous glucose, 1.5g/l of potassium chloride and 2.9g/l of trisodium citrate, dehydrate. The ORS come in Sachets of powder for dilution in 500 ml and 1 liter.

Instructions:
Give caregiver 4 ORS packets to take home. Advise to give as much as child wants, but at least
50-100 ml (or a quarter to half a large cup of fluid) for children under 2 years and 100-200 ml (one half to one large cup of fluid) for children ages 2-5 years after each loose stool until diarrhea stops.

In addition to the ORS, CHWs will be trained to give Zinc supplementation. The zinc formulation to be used in this study is the dispersible formulation. Each dispersible tablet contains 10 mg or 20 mg of elemental zinc only. It does not contain any other vitamins or chemicals. The Zinc is packaged in blister packs of 10 tablets. The 20mg tablets of elemental zinc are scored. The CHW will be trained as follows

Give zinc supplement (20mg tablet). Give 1 dose daily for 10 days:
Age 2 months up to 6 months—1/2 tablet (total 5 tabs)
Age 6 months up to 5 years—1 tablet (total 10 tabs)
Help caregiver to give first dose

Children will be referred if they have pneumonia with danger signs or very severe disease, have diarrhoea with severe dehydration, are severely malnourished, their caregiver refuses home case or are already on antibiotics for more than 48hrs with no improvement.

CHWs will also be trained to administer Vitamin A supplementation described as vitamin A capsules for the right child age as defined in the Kenya government vitamin A guidelines i.e. giving a vitamin A capsule of 100,000 IU to children aged 6 to 11 months and 200,000 IU capsules to children aged 12 to 59 months. Vitamin A will be given to all children who have not received supplementation in the last 6 months regardless of what health condition except if the child has bilateral pitting edema as per the training manual.

ESTIMATED TIMELINE
This study will be completed in a period of 24 months. Start up activities will take place during the first 3 months during which ethical approval will be sought, all stakeholders sensitized. During the 4th to 6th month, the community health units will be mapped and the baseline surveys at the household level and with the community health workers conducted. From the 7th to the 9th month, iCCM will be set up, CHWs trained and the interventions piloted. The ensuing 12 months (month 10-21) will involve the actual implementation of the interventions as well as a midline survey during month 16. The final three months (22-24) of the study period will be used for data management, data cleaning, analyses, and write-up of study results.
Intervention code [1] 288620 0
Treatment: Other
Comparator / control treatment
Compared to baseline where CHWs only diagnose and refer to the health centers
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291430 0
Proportion of children under 5 years with pneumonia who receive appropriate antibiotic treatment

a household survey with interviews of mothers/caretakers of children who have experienced cough in the previous four weeks.
Timepoint [1] 291430 0
Baseline (month 0)

End line (month 12)
Primary outcome [2] 291431 0
Proportion of CHWs who are able to rationally use antibiotics for treatment of pneumonia

source of data:
CHW sick child recording forms
CHW treatment register
Research nurse treatment report

Each time a CHW sees a suspected pneumonia case, s/he sends a please call me text to a hotline number. The information on his sick child recording form is then entered into a web based application which is able to determine if the right diagnosis has been made and correct treatment given and generate a report. In addition, a trained nurse will go and independently verify each pneumonia case within 24 hrs and enter the information into a mobile phone based sick child recording form. This will generate a report comparing the CHW to the computer system and the nurse.
Timepoint [2] 291431 0
Endline (month 12)
Primary outcome [3] 291432 0
Proportion of CHWs who appropriately account for supplied commodities

Source of data:
CHW inventory control card, CHEW stock control card, CHEW requisition, issue and order voucher, CHEW supply register

These tools are logistics and supply tools which allow the CHW and CHEW to keep track of the medicinal and diagnostic products they are using on sick children on a monthly basis

Furthermore we will conduct interviews with CHW at end line asking them whether in the last three months they experienced stock outs. We will identify the point in time and the duration of the stock out period
Timepoint [3] 291432 0
Endline (month 12)
Secondary outcome [1] 306754 0
Proportion of CHWs who are able to rationally use antimalarials

source of data: sick child recording forms
CHW treatment and tracking register

We will evaluate if children whose caregivers mentioned fever less than 7 days, were tested for Malaria using an RDT. Correct management entails giving an antimalarial for a child with a positive RDT and not giving if the RDT is negative

From this tools, we will be able to determine the CHWs’ performance in classification and treatment. For classification, we will calculate the “percentage of misclassification” (number misclassified based on the complaints out of the total number classified multiply by 100). For treatment, we will calculate the “percentage of inappropriate treatment” (number inappropriately treated based on classification out of the total number classified multiply by 100).
Timepoint [1] 306754 0
Endline (month 12)
Secondary outcome [2] 306755 0
Proportion of CHWs who are able to rationally use ORS and zinc

source of data: sick child recording forms
CHW treatment and tracking register

We will evaluate if children whose caregivers mentioned diarrhea
less than 14 days. Correct management entails giving an Zinc and ORS for a child with diarrhea and not giving for a child who has no diarrhea

From this tools, we will be able to determine the CHWs’ performance in classification and treatment. For classification, we will calculate the “percentage of misclassification” (number misclassified based on the complaints out of the total number classified multiply by 100). For treatment, we will calculate the “percentage of inappropriate treatment” (number inappropriately treated based on classification out of the total number classified multiply by 100).
Timepoint [2] 306755 0
Endline (month 12)
Secondary outcome [3] 306756 0
Proportion of mothers of children under 5 years who have symptoms of pneumonia or malaria who seek care from an appropriate provider

A household survey with mothers/caretakers of children who have experienced fever in the previous four weeks
Timepoint [3] 306756 0
Baseline (month 0)

Endline (month 12)
Secondary outcome [4] 306757 0
Proportion of children treated for pneumonia who do not respond to treatment (experience treatment failure or relapse)

The children with pneumonia seen by the CHWs will be followed up at home by trained nurses on day 4 to assess the outcome of the treatment given or recommended. For children with severe pneumonia, a follow up visit will be done on day 4 and day 6. Treatment failure is defined in this study as appearance of any of the following:-
a) Appearance of any signs of pneumonia with any danger signs such as inability to breastfeed or drink, or vomiting everything, convulsions, lethargy or unconsciousness, severe respiratory distress e.g. head nodding
b) Change of antibiotic treatment or use of additional antibiotics beyond those prescribed and dispensed by the CHW
c) Persistence of fever greater than 38 degrees Celsius with lower chest indrawing and or fast breathing on day 4 (after 3 days of initiation of treatment)
d) Either fever greater than 38 degrees Celsius or lower chest indrawing or fast breathing alone at day 6
e) Death
Timepoint [4] 306757 0
Endline (month 12)
Secondary outcome [5] 306758 0
Proportion of CHWs who are able to correctly administer VAS, defined as giving vitamin A supplementation to children aged 6 to 59 months on a semi-annual basis in the County

source of data
CHW Treatment and tracking register
Household surveys with children under 5 who have received vitamin A supplementation in the last 6 months
Timepoint [5] 306758 0
Endline (month 12)
Secondary outcome [6] 306759 0
Proportion of children aged 6 to 59 months who received VAS on a semi-annual basis.

Source of data: Household survey (immunization module)
Timepoint [6] 306759 0
Endline (month 12)

Eligibility
Key inclusion criteria
Children between two months and five years from within Homabay County who present to a CHW with diarrhoea, fever and/or cough/difficult breathing
Minimum age
2 Months
Maximum age
59 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children less than 2 months or greater than 59 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
888
Accrual to date
Final
Recruitment outside Australia
Country [1] 5810 0
Kenya
State/province [1] 5810 0
Homabay County

Funding & Sponsors
Funding source category [1] 288676 0
Other
Name [1] 288676 0
The United Nations Children's Fund (UNICEF)
Country [1] 288676 0
Kenya
Funding source category [2] 288677 0
Other
Name [2] 288677 0
World Health Organization(WHO)
Country [2] 288677 0
Malaysia
Primary sponsor type
Other
Name
The United Nations Children's Fund (UNICEF)
Address
United Nations Complex, Gigiri, Block D
UNICEF Kenya Country Office
P.O. Pox 44145-00100
Nairobi, Kenya
Country
Kenya
Secondary sponsor category [1] 287386 0
Other
Name [1] 287386 0
World Health Organization (WHO)
Address [1] 287386 0
WHO/GSC/GPL
BLOCK 3510
JALAN TEKNOKRAT 6
CYBERJAYA 63000
MALAYSIA
Country [1] 287386 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290525 0
Kenya Ethical Review Committee
Ethics committee address [1] 290525 0
Ethics committee country [1] 290525 0
Kenya
Date submitted for ethics approval [1] 290525 0
Approval date [1] 290525 0
21/05/2013
Ethics approval number [1] 290525 0
FWA00002066
Ethics committee name [2] 290526 0
World Health Organization
Ethics committee address [2] 290526 0
Ethics committee country [2] 290526 0
Switzerland
Date submitted for ethics approval [2] 290526 0
Approval date [2] 290526 0
06/01/2014
Ethics approval number [2] 290526 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45666 0
Dr Maricianah Onono
Address 45666 0
Kenya Medical Research Institute
Center for Microbiology Research
PO BOX 614-40100
Kisumu, Kenya
Country 45666 0
Kenya
Phone 45666 0
+254732390992
Fax 45666 0
Email 45666 0
monono@kemri.org
Contact person for public queries
Name 45667 0
Elizabeth Bukusi
Address 45667 0
Kenya Medical Research Institute
Center for Microbiology Research
Box 19464, post code 00202, Nairobi
Country 45667 0
Kenya
Phone 45667 0
+254733617503
Fax 45667 0
Email 45667 0
ebukusi@kemri.org
Contact person for scientific queries
Name 45668 0
Maricianah Onono
Address 45668 0
Kenya Medical Research Institute
Center for Microbiology Research
PO BOX 614-40100
Kisumu, Kenya
Country 45668 0
Kenya
Phone 45668 0
+254732390992
Fax 45668 0
Email 45668 0
monono@kemri-ucsf.org

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No Supporting Document Provided



Results publications and other study-related documents

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