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

• Sponsor: Healthy Child Uganda (Other)
• Overall Status: Completed
• CT.gov ID: NCT02046018
• Collaborator: (none)
• Enrollment: 5,000
• Arms: 3
• Duration (Months): 43

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal and Child Health	Other: ICCM delivered by VHT; Other: ICCM delivered by VHT with Cell Phone; Other: No intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5000 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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 Start Date: Oct 1, 2009
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ICCM delivered by VHT Health Outcomes in Communities where VHT's were trained in ICCM and given drugs.	Other: ICCM delivered by VHT; 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	Other: ICCM delivered by VHT; VHT's deliver ICCM to children under five in their communities; Other: ICCM delivered by VHT with Cell Phone; 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	Other: No intervention; VHT's selected by no ICCM training given and no drugs or cell phones.

Outcome Measures

Primary Outcome Measures

1. 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. [March 2013 - November 2014 (8 months)]

   Children diagnosed by a Community Health Worker with presumed pneumonia (fast breathing and cough) treated with Amoxicillin.

2. 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 [March 2013 - November 2014 (8 months)]

   Children diagnosed with diarrhea will be treated with ORS and zinc.

3. 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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 59 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Children under five (< or =59 months)

Exclusion Criteria:

• Children over five years (> 59 Months)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Healthy Child Uganda

Investigators

• Principal Investigator: Samuel Maling, MUST
• Principal Investigator: Celestine Barigye, MUST
• Principal Investigator: Jerome Kabakyenga, MUST

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Jenn Brenner, Clinical Associate Professor, Healthy Child Uganda
• ClinicalTrials.gov Identifier: NCT02046018
• Other Study ID Numbers: HCU_AHSI
• First Posted: Jan 27, 2014
• Last Update Posted: Jul 11, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Dr. Jenn Brenner, Clinical Associate Professor, Healthy Child Uganda: Maternal and Child Health; Rural Uganda

Study Results

No Results Posted as of Jul 11, 2014