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

NCT02046018 | Completed DMC

• 1 other identifier: HCU_AHSI
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maternal and Child Health

Keywords

Maternal and Child Health; Rural Uganda

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (3)

ICCM delivered by VHT

ACTIVE COMPARATOR

Health Outcomes in Communities where VHT's were trained in ICCM and given drugs.

Other: ICCM delivered by VHT

ICCM delivered by VHT with cell phone

ACTIVE COMPARATOR

Health Outcomes in communities with VHT's who were trained in ICCM and given cell phones

Other: ICCM delivered by VHT; Other: ICCM delivered by VHT with Cell Phone

Health outcomes in communities with no ICCM

ACTIVE COMPARATOR

Health outcomes in communities with VHT's who were not trained in ICCM

Other: No intervention

Interventions

ICCM delivered by VHT OTHER

VHT's deliver ICCM to children under five in their communities

ICCM delivered by VHT; ICCM delivered by VHT with cell phone

ICCM delivered by VHT with Cell Phone OTHER

ICCM delivered to children under 5 by VHT trained in ICCM and given cell phones

ICCM delivered by VHT with cell phone

No intervention OTHER

VHT's selected by no ICCM training given and no drugs or cell phones.

Health outcomes in communities with no ICCM

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children over five years (\> 59 Months)

Sponsors & Collaborators

• Healthy Child Uganda: lead

Related Publications (1)

• 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.

  PMID: 33565123 DERIVED

Study Officials

• Samuel Maling

  MUST

  PRINCIPAL INVESTIGATOR

• Celestine Barigye

  MUST

  PRINCIPAL INVESTIGATOR

• Jerome Kabakyenga

  MUST

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 27, 2014
• Study Start: October 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 11, 2014

Record last verified: 2014-07