Clinical trial NCT02046018: Integrated Community Case Management (ICCM) Delivered by Village Health Teams in Bushenyi District in Uganda
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal and Child Health
Keywords: Maternal and Child Health
Rural Uganda
Lead sponsor: Healthy Child Uganda
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 5000
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Children under five (\< or =59 months)

Exclusion Criteria:

* Children over five years (\> 59 Months)

Primary outcomes:
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.
timeFrame: March 2013 - November 2014 (8 months)
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 diarrhea
timeFrame: March 2013 - November 2014 (8 months)
measure: 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.
timeFrame: March 2013 - November 2014 (8 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MUST
name: Samuel Maling
role: PRINCIPAL_INVESTIGATOR
affiliation: MUST
name: Celestine Barigye
role: PRINCIPAL_INVESTIGATOR
affiliation: MUST
name: Jerome Kabakyenga
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.