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

NCT ID: NCT02046018

Last Updated: 2014-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

ICCM delivered by VHT

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

Group Type: ACTIVE_COMPARATOR

ICCM delivered by VHT

Intervention Type: OTHER

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

ICCM delivered by VHT with cell phone

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

Group Type: ACTIVE_COMPARATOR

ICCM delivered by VHT

Intervention Type: OTHER

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

ICCM delivered by VHT with Cell Phone

Intervention Type: OTHER

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

Health outcomes in communities with no ICCM

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

Group Type: ACTIVE_COMPARATOR

No intervention

Intervention Type: OTHER

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

Interventions

ICCM delivered by VHT

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

Intervention Type: OTHER

ICCM delivered by VHT with Cell Phone

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

Intervention Type: OTHER

No intervention

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children under five (< or =59 months)

Exclusion Criteria

• Children over five years (> 59 Months)

• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Healthy Child Uganda

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jenn Brenner

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Maling

Role: PRINCIPAL_INVESTIGATOR

MUST

Celestine Barigye

Role: PRINCIPAL_INVESTIGATOR

MUST

Jerome Kabakyenga

Role: PRINCIPAL_INVESTIGATOR

MUST

References

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.

Reference Type: DERIVED

PMID: 33565123 (View on PubMed)

Other Identifiers

HCU_AHSI

Identifier Type: -

Identifier Source: org_study_id