- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02046018
Integrated Community Case Management (ICCM) Delivered by Village Health Teams in Bushenyi District in Uganda
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children under five (< or =59 months)
Exclusion Criteria:
- Children over five years (> 59 Months)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ICCM delivered by VHT
Health Outcomes in Communities where VHT's were trained in ICCM and given drugs.
|
VHT's deliver ICCM to children under five in their communities
|
Active Comparator: ICCM delivered by VHT with cell phone
Health Outcomes in communities with VHT's who were trained in ICCM and given cell phones
|
VHT's deliver ICCM to children under five in their communities
ICCM delivered to children under 5 by VHT trained in ICCM and given cell phones
|
Active Comparator: Health outcomes in communities with no ICCM
Health outcomes in communities with VHT's who were not trained in ICCM
|
VHT's selected by no ICCM training given and no drugs or cell phones.
|
What is the study measuring?
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.
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.
|
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
Time Frame: March 2013 - November 2014 (8 months)
|
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.
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.
|
March 2013 - November 2014 (8 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samuel Maling, MUST
- Principal Investigator: Celestine Barigye, MUST
- Principal Investigator: Jerome Kabakyenga, MUST
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HCU_AHSI
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