Plain English Summary
Background and study aims
Pneumonia and diarrhea are leading killers of children. Although a number of effective treatments exist, levels of preventive and treatment are virtually unchanged over the past decade and remain unacceptably low. As a result, few African countries, which have a substantial burden of these two diseases, will reach the Millennium Development Goal 4 of a two-thirds reduction in child mortality by 2015. UNICEF and the World Health Organization published the “Global Action Plan for the Prevention and Control of Pneumonia” in 2007 and “Diarrhea: Why Children Are Still Dying and What Can Be Done,” in 2009, which contained a comprehensive set of preventive, promotive and treatment interventions that capture exciting new advances for these two diseases. While countries have incorporated many of the key interventions into national policy and planning, and donors have contributed additional resources to implement some of these interventions, resources are insufficient and implementation has been limited, particularly among the poor and under served that experience the greatest mortality burden from both pneumonia and diarrhea. Previous studies have demonstrated that the failure to successfully scale up of interventions such as those proposed to decrease pneumonia and diarrhea deaths are essentially due to four factors: the lack of supportive policies, failure to prioritize those interventions that are most likely to prevent deaths, problems with the essential commodities for vaccination services and treatment of illnesses, and the absence of community-based health promotion activities (e.g., breastfeeding) and care (Bryce et al, 2010). While considerable gains have been made in the policy arena, the other three remain problematic. Furthermore, difficulties with prioritization, commodities, and community care for pneumonia and diarrhea have been compounded by an increasing decentralization of services, and a major challenge has been the support of implementation at the decentralized, district level. Analyses demonstrate that the root of many of these problems is poor management capacity, including the lack of local abilities and local data to prioritize and contextualize interventions, insufficient emphasis on results, the lack of identification of bottlenecks and of financial leeway to carry out context-specific managerial solutions, as well as failure to involve communities as active proponents in helping overcome obstacles to high coverage. New approaches are urgently needed to resolve the many obstacles to scaling up lifesaving interventions to prevent pneumonia and diarrhea deaths, which together account for more than a third of child deaths. We are therefore proposing an innovative new approach that will focus on identifying local needs, the obstacles to overcome them, and what evidence-based strategies are most likely to work in a given context, focused on results. It will simultaneously focus on both demand- and supply side bottlenecks, and is designed to optimize learning. An approach consisting of a cycle of assessment, action, accountability, and analysis/re-analysis will be used to improve coverage for priority pneumonia and diarrhea interventions. Uganda, which has one of the highest child mortality rates in Africa and a highly decentralized health system, will be the case study for this approach. This project aims to demonstrate that a management strategy based on
1. Improved targeting of interventions to match disease burden, and better allocation of resources.
2. Regular review and improvement of district health team performance, and use of evidence-based management tools and focal funding to overcome management bottlenecks.
3. Community oversight and inputs will lead to improvements both coverage and quality of key interventions to reduce child deaths from diarrhea and pneumonia.
Who can participate?
All members of the district health teams in the intervention and control districts and local and political leaders.
What does the study involve?
This project consists of a 6 month preparatory period to identify participating districts, develop contracts with partners, and conduct an initial survey, followed by a two year initial implementation in a small number of districts, an additional two years of scale up in a larger number of districts if specific benchmarks are met in the first two years, and a 6 month period to conduct further advocacy and broadly share lessons learned. It represents a different and far more focused way of approaching two of the major causes of child death in Africa. If successful, this project has potential far-reaching applications in resource-limited settings and could be further scaled up in Uganda and other countries characterized by high pneumonia and diarrhea mortality and decentralized management. Led by UNICEF, the proposal will involve Uganda Ministry of Health supported by strong local implementing organizations, with monitoring and evaluation jointly by Makerere University, Uganda and Karolinska Institutet, Sweden.
What are the possible benefits and risks of participating?
There are no direct benefits to the individual respondents that will take part in this study. However the study will provide information to the district managers and other health partners on how to improve management for better service delivery. We hope that through this process districts will provide higher coverage and quality of care for the benefit of individuals. Since the study is a district management strengthening intervention, we don’t anticipate any risk that will be attributed to an individual for taking part in this study.
Where is the study run from?
UNICEF (Uganda Country Office)
When is the study starting and how long is it expected to run for?
October 2013 to September 2016
Who is funding the study?
Bill and Melinda Gates Foundation (USA)
Who is the main contact?
1. Dr Flavia Mpanga (public)
fmpanga@unicef.org
2. Dr Peter Waiswa (scientific)
pwaiswa2001@yahoo.com
Study website
http://ki.se/en/phs/codes-community-and-district-empowerment-for-scale-up
Contact information
Type
Public
Contact name
Dr Flavia Mpanga
ORCID ID
Contact details
UNICEF (Uganda Country office)
Plot 9 George Street
Kampala
Box 7047
Uganda
+256 717171 407 , +256 772244345
fmpanga@unicef.org
Type
Scientific
Contact name
Dr Peter Waiswa
ORCID ID
Contact details
Dept of Health Policy
Planning and Management
Makerere University School of Public Health
Kampala
Box 7072
Uganda
Tel (mobile). 256772405357, 256414534258 (office)
pwaiswa2001@yahoo.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PBA SC/2011/0258
Study information
Scientific title
Community and District Empowerment for Scale-up (CODES): A complex district level intervention to improve child survival in Uganda-study protocol for a cluster randomized controlled trial
Acronym
CODES
Study hypothesis
Areas receiving CODES intervention will perform “better” and show accelerated “improvement” on the key protective, preventive, and curative quality coverage indicators for pneumonia, diarrhea and malaria compared to those that have not received the CODES intervention.
Ethics approval(s)
Uganda National council for science and technology, 23/06/2011, ref: SS 2548
Study design
This is a single centre cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
Community
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Child health with special focus on pneumonia, diarrhoea and malaria
Intervention
The CODES intervention package, which combines implementation of district-level diagnostic, management and evaluation tools, is evaluated for effect via a cluster randomized trial with eight districts as intervention and eight as comparison. Differences at a 2 year endline survey and changes between baseline and endline surveys in key child survival quality coverage indicators amongst target populations in the overall intervention and control districts will be compared. Implementation of the CODES intervention and all data collection is by the responsible local districts teams and/or local CBO who are supported in the supply and demand side implementation by two local NGOs. Additional information related to level of implementation of the CODES package and contextual factors in each district is obtained based on reports from the local NGOs supporting the districts in the implementation activities as well as the from qualitative information solicited from the district. Analytical evaluation of the trial, the associated contextual factors and lessons learned is conducted by Makaerere University and Karolinka Institutet
Intervention type
Other
Primary outcome measure
The status of the key protective, preventive and curative quality coverage indicators for pneumonia, diarrhea, and malaria
Measurements will be made in intervention and comparison districts at baseline and at endpoint two years (24 months) later
Secondary outcome measures
Prevalence of pneumonia, diarrhea, and malaria
Measurements will be made in intervention and comparison districts at baseline and at endpoint two years (24 months) later
Overall study start date
16/09/2010
Overall study end date
30/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All members of the district health teams in the intervention and control districts
2. District local and political leaders
3. We have no specific age limit so long as they are within the considered districts
Participant type(s)
Health professional
Age group
Adult
Sex
Both
Target number of participants
21 districts
Total final enrolment
16
Participant exclusion criteria
All districts outside the intervention and control arms
Recruitment start date
01/10/2013
Recruitment end date
30/09/2016
Locations
Countries of recruitment
Uganda
Study participating centre
UNICEF (Uganda Country Office)
Plot 9 George Street
P.O.Box 7047
Kampala
256
Uganda
Sponsor information
Organisation
UNICEF (Uganda Country office)
Sponsor details
Plot 9 George Street
Kampala
Box 7047
Uganda
+256 4 1717 1000
kampala@unicef.org
Sponsor type
Charity
Website
ROR
Funders
Funder type
Research organisation
Funder name
Bill and Melinda Gates Foundation
Alternative name(s)
Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United States of America
Results and Publications
Publication and dissemination plan
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/03/2016 | Yes | No | |
| Results article | 01/06/2021 | 10/06/2021 | Yes | No |