Condition category
Infections and Infestations
Date applied
14/12/2017
Date assigned
19/12/2017
Last edited
18/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Ethiopia has significantly reduced under-five mortality, but utilisation of primary maternal, newborn and child health services is still low. Concerted efforts are needed for continued improvements in maternal, newborn and child health and survival. UNICEF and PATH in collaboration with the Federal Ministry of Health have developed a complex intervention based on an analysis of barriers to the utilization of primary maternal, newborn and child health services. The intervention includes components to engage the community, strengthen the capacity of primary care workers, and reinforce the local ownership and accountability of the primary maternal, newborn and child health services. The evaluation has a pragmatic trial design with intervention and comparison areas across four Ethiopian regions. The primary outcomes are increased care seeking and appropriate treatment for probable pneumonia and diarrhea in children below the age of five years, and neonatal sepsis. Baseline and end line surveys covering household, facility, and health worker modules will be performed in intervention and comparison areas across Amhara, Southern Nations Nationalities and Peoples, Oromia, and Tigray regions. The effectiveness of the intervention will be assessed by difference-indifferences analysis, controlling for cluster design and relevant confounders. A process
evaluation follows the guidelines of the UK Medical Research Council. It will describe and
analyze the activities, the recipient, cost, and fidelity of the intervention, dose, reach, and
contextual factors. The results will form the basis for possible scale-up in Ethiopia, and inform policy and efforts in other settings to engage communities and improve ownership and accountability for increased primary care service utilization.

Who can participate?
Children aged 0-59 months and their caretakers.

What does the study involve?
Areas are randomly allocated to either being an intervention or comparison area. Intervention areas engage with the community in the primary care services, strengthening the capacity of the primary care workers, and increasing the ownership and accountability of the health system stakeholders in the programs for newborn and child health care and treatment. Participating caretakers are randomly selected to fill out a questionnaire about the utilization of services, and quality of services for newborn serious infections, probable pneumonia, and diarrheal diseases (the three main killers). The results from those in the intervention areas are compared to those in the comparison areas.

What are the possible benefits and risks of participating?
The potential benefits for the participants in intervention areas are increased care utilization and improved quality of care. If the result is promising, the intention by the Federal Ministry of Health is to scale-up the interventions to increase the demand for care and improved quality of care to other parts of the country. Neither those engaged in the interventions, nor the participants (children) in the evaluation of outcome are exposed to any risk by this study.

Where is the study run from?
This study is being run by the London School of Hygiene & Tropical Medicine (UK) and takes place in partnership with universities in Ethiopa.

When is the study starting and how long is it expected to run for?
October 2015 to October 2020

Who is funding the study?
Bill and Melinda Gates Foundation (USA)

Who is the main contact?
1. Professor Joanna Schellenberg (Scientific)
joanna.schellenberg@lshtm.ac.uk
2. Professor Lars Åke Persson (Scientific)
lars.persson@lshtm.ac.uk

Trial website

https://dagu.lshtm.ac.uk

Contact information

Type

Scientific

Primary contact

Prof Joanna Schellenberg

ORCID ID

http://orcid.org/0000-0002-0708-3676

Contact details

London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 207 927 2358
joanna.schellenberg@lshtm.ac.uk

Type

Scientific

Additional contact

Prof Lars Åke Persson

ORCID ID

http://orcid.org/0000-0003-0710-7954

Contact details

London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+46 702 870 357
lars.persson@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OPP1132551

Study information

Scientific title

Evaluation of a complex intervention aiming at increased utilisation of primary maternal, newborn, and child health services in Ethiopia

Acronym

Dagu

Study hypothesis

An increased demand of primary maternal, newborn, and child health services, improved availability and quality of integrated community case management and community-based newborn care services, and improved ownership and accountability of these services would lead to an increased and sustained use of these services, which ultimately would further reduce neonatal and under-five mortality.

Ethics approval

1. The Ethiopian Scientific and Ethical Review Committee
2. The London School of Hygiene & Tropical Medicine Ethical Review Committee, 06/06/2016, ref: 11235

Study design

Pragmatic trial design with intervention and comparison districts in four regions in Ethiopia.

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

The focus of the study is primary care utilization for the main causes of under-five mortality in Ethiopia, i.e., neonatal conditions, pneumonia, and diarrheal diseases

Intervention

A complex intervention including activities aiming at community engagement in primary care services, capacity building of health extension
workers and "Women's Development Army" members (a type of community health volunteers), and efforts to increase ownership and accountability within the health system for community-based newborn care and integrated community case management of childhood diseases. The total duration of these interventions is 24 months. These interventions are only performed in intervention areas in four regions of Ethiopia, not in comparison areas.

The interventions are performed in the community, and in the primary care services. The study unit for the evaluation of effect of this intervention is the child below the age of five years in intervention areas and comparison areas. All children aged 0-59 months and their caretakers in randomly selected households in these areas are invited to participate in baseline and endline surveys.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Care seeking and provision of appropriate treatment for probable pneumonia and diarrheal diseases in children below the age of five years, and neonatal sepsis. This is measured through baseline (before) and endline (after) surveys in interventions and comparison areas in four regions in Ethiopia by
household interviews and interviews and observations in health posts in these areas. The estimation of effectiveness will be performed by the difference-in-differences methodology, with adjustments for the cluster design and confounding factors.

Secondary outcome measures

Coverage of antenatal visits, institutional delivery, postnatal first week home visit, quality of care provided by health extension worker (observation, re-examination), use of prevention (bed-nets, immunization). This will be assessed through baseline and endline surveys in intervention and comparison areas in four regions in Ethiopia.

Overall trial start date

22/10/2015

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All community members, invited to the different engagement activities
2. Health extension workers and women's development army members participating in capacity building activities
3. Stakeholders within the district health services who are invited to ownership and accountability creation activities

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

In intervention as well as in comparison areas 3000 households will be included (total 6000). Most of the households will have children below the age of five years, who will be included in the sample. In the observations of quality of care provided a total sample of 800 sick children will be included.

Participant exclusion criteria

Participants outside the intervention areas.

Recruitment start date

01/12/2016

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Ethiopia

Trial participating centre

London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Trial participating centre

Ethiopian Public Health Institute
Addis Ababa
n/a
Ethiopia

Trial participating centre

University of Gondar
Gondar
n/a
Ethiopia

Trial participating centre

Mekelle University
Mekelle
n/a
Ethiopia

Trial participating centre

Jimma University
Jimma
n/a
Ethiopia

Trial participating centre

Hawassa University
Hawassa
n/a
Ethiopia

Sponsor information

Organisation

Bill and Melina Gates Foundation

Sponsor details

PO Box 23350
Seattle
WA 98102
United States of America
+1 206 709 3140
media@gatesfoundation.org

Sponsor type

Charity

Website

https://www.gatesfoundation.org

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation

Alternative name(s)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

The baseline report is available: Community-based child care: household and health facility perspectives.
https://www.slideshare.net/DaguProject/dagu-baseline-survey-report-ethiopia-december-2016-february-2017.

We plan a number of papers in high-impact journals. These are some of the planned publications with
tentative dates of submission to journals:
The study protocol will be submitted to journal around 01/03/2018
The process evaluation report will be submitted around 31/01/2019
The effectiveness report will be submitted around 01/07/2019

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/07/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes