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Completed

NCT Number: NCT02046018

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

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.

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Key information

Age range

Up to 59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children under five (< or =59 months)

Exclusion criteria

  • Children over five years (> 59 Months)

Treatment and study plan

ICCM delivered by VHT

Other

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

ICCM delivered by VHT with Cell Phone

Other

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

No intervention

Other

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

Primary outcomes

  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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Healthy Child Uganda

Other

Registry information

Official study 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?

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jan 27, 2014
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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