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

Maternal and Child Health Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046018
• Other study ID #: HCU_AHSI
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: July 9, 2014
• Start date: October 2009
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: Healthy Child Uganda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 59 Months

Eligibility

Inclusion Criteria:

• Children under five (< or =59 months)

Exclusion Criteria:

• Children over five years (> 59 Months)

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Maternal and Child Health

Intervention

Other:
• ICCM delivered by VHT
VHT's deliver ICCM to children under five in their communities
• ICCM delivered by VHT with Cell Phone
ICCM delivered to children under 5 by VHT trained in ICCM and given cell phones
• No intervention
VHT's selected by no ICCM training given and no drugs or cell phones.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Healthy Child Uganda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No