Integrated Community Case Management (ICCM) Delivered by Village Health Teams in Bushenyi District in Uganda

Study Overview
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Brief Summary
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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.

Official Title
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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?

Conditions
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Maternal and Child Health

Intervention / Treatment
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* Other: ICCM delivered by VHT
* Other: ICCM delivered by VHT with Cell Phone
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children under five (< or =59 months) Exclusion Criteria: Children over five years (> 59 Months)

Ages Eligible for Study
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Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICCM delivered by VHT<br>Health Outcomes in Communities where VHT's were trained in ICCM and given drugs. | Other: ICCM delivered by VHT<br>* VHT's deliver ICCM to children under five in their communities<br>|
| Active Comparator: ICCM delivered by VHT with cell phone<br>Health Outcomes in communities with VHT's who were trained in ICCM and given cell phones | Other: ICCM delivered by VHT<br>* VHT's deliver ICCM to children under five in their communities<br>Other: ICCM delivered by VHT with Cell Phone<br>* ICCM delivered to children under 5 by VHT trained in ICCM and given cell phones<br>|
| Active Comparator: Health outcomes in communities with no ICCM<br>Health outcomes in communities with VHT's who were not trained in ICCM | Other: No intervention<br>* VHT's selected by no ICCM training given and no drugs or cell phones.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | March 2013 - November 2014 (8 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal and Child Health, Rural Uganda