Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT02046018
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2014-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrated Community Case Management (ICCM) Delivered by Village Health Teams in Bushenyi District in Uganda
Sponsor:
Healthy Child Uganda
Organization:
Study Overview
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?
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: