Pneumonia Clinical Trial
Official title:
Independent Prospective Evaluation of Integrated Community Case Management and Development and Implementation of a Method for Real-time Mortality Monitoring in the Oromia Region, Ethiopia
The purpose of this study is to to measure the effect of the HEP+ICCM program relative to routine HEP approach in rural Ethiopia on changes in coverage of case management of common childhood illnesses and severe acute malnutrition, reductions in mortality among children under the age of five, and improvements in nutritional status using a rigorous evaluation design.
STUDY BACKGROUND AND RATIONAL Most low-income countries are making slow progress in
addressing childhood mortality - too slow to achieve the fourth Millennium Development Goal
by 2015. Countries, donors and development agencies are responding to the situation by
redoubling efforts to stimulate and support child survival activities in countries,
particularly in Africa. The Catalytic Initiative to Save a Million Lives (CI) is a
partnership between donor agencies committed to accelerate progress toward MDGs 4 and 5
through support of scale-up of proven high impact interventions. UNICEF and the Canadian
International Development Agency (CIDA), as part of the CI, are undertaking a major
initiative to reduce mortality among children less than five years of age in several
countries in sub-Saharan Africa, including Ethiopia.
Ethiopia has a high under-five mortality rate, estimated at 123 per 1000 live births by the
2005 Demographic and Health Survey. The country has made a commitment to achieve the MDG 4
target of a two-thirds reduction in mortality by 2015 as reflected through the launching of
the national Health Extension Program (HEP) in 2004, with continued support from UNICEF and
CI funding. The key program strategy is to train and support approximately 30,000 Health
Extension Workers (HEWs) to provide promotive, preventive, and selected curative health care
services at the community level. Previously, the HEWs treated diarrhea with ORS and malaria
with rapid diagnostic kits and ACTs; pneumonia cases were referred to health centers.
Ethiopia has recently adopted a policy to expand management of pneumonia among children
under-five with antibiotics to communities through HEWs. This provides a unique opportunity
to accelerate increases in coverage of treatment of pneumonia, which is one of the greatest
killers of children under-five in Ethiopia. This expansion, when combined with the existing
community management of malaria, diarrhea and severe acute malnutrition, is referred to as
integrated community case management (HEP+ICCM) and is largely supported through the
Catalytic Initiative by CIDA and UNICEF and will focus on its first stage on five regions of
the country: Amhara, Benishangul-Gumaz, Oromia, SNNP and Tigray. The leading strategy of the
HEP+ICCM initiative is to increase the capacity of the HEWs to effectively assess, classify,
and manage the leading causes of preventable child mortality including pneumonia, malaria,
diarrhea, and severe acute malnutrition. In the focus regions, plans have been developed to
introduce CCM of childhood pneumonia with cotrimoxazole and diarrhea with ORS and zinc,
malaria with ACTs, and malnutrition with therapeutic feeding. The program plans to conduct
refresher trainings of HEWs and their supervisors, strengthen supervision, logistical support
and the ICCM system overall. The initial implementation will start in August 2010 and to be
phased in Oromia region.
The effectiveness of the ICCM varies across specific country contexts and depends on the
strength of implementation. It is therefore essential to evaluate the effectiveness of the
scale-up strategy to provide a basis for future program improvement and global evidence on
effective strategies for accelerating reductions in under-five mortality.
OBJECTIVES The Institute for International Programs at the Johns Hopkins University Bloomberg
School of Public Health (IIP-JHU) has been commissioned by CIDA and UNICEF to conduct an
independent prospective evaluation of the HEP+ICCM.
This study objective is to conduct a full prospective evaluation of the impact of the
Ethiopian HEP+ICCM of common childhood illnesses implemented through HEWs on mortality and
nutritional status of children under the age of five.
The specific objectives of the study are:
i. To measure the effect of the HEP+ICCM program relative to routine HEP approach in the
country over an 18 month period on changes in coverage of case management of common childhood
illnesses and severe acute malnutrition, reductions in mortality among children under the age
of five, and improvements in nutritional status using a rigorous evaluation design; ii. To
track program implementation inputs, processes, outputs and contextual factors; and iii. To
measure implementation strength and assess the quality of child health care.
METHODOLOGY In Oromia region, implementation of the HEP+ICCM program will be phased allowing
the possibility to identify comparison areas for the evaluation. The prospective evaluation
will use a cluster randomized design with stratification by zone, within which woredas are
randomly assigned to intervention and comparison arms using a restricted randomization
procedure. Coverage of childhood interventions will be measured at baseline and end-line with
a midterm "quality of care implementation snapshot" to assess the strength of implementation.
Mortality estimates for both the intervention and comparison woredas will be generated
retrospectively through the end-line household survey. Program implementation and contextual
factors will be documented throughout the evaluation period.
The evaluation will be focused the Jimma and West Hararge zones. Woredas within the two
evaluation zones will be randomly assigned to intervention and comparison areas. Intervention
areas are referred to as phase 1 area and comparison areas referred to as phase 2 areas. The
phase 1 and 2 woredas will be randomly assigned through an adapted, restricted randomization
process, balanced by the presence of malaria, food security and the zone. Urban areas were
excluded since the urban HEP is a recent addition and implemented differently. In Jimma zone,
the seventeen woredas will be divided into nine phase 1 woredas and eight phase 2 woredas. In
West Haraghe zone, there will be seven woredas in phase 1 and phase 2 areas.
The ORHB has committed to at least an 18-month phase-in between the identified intervention
and comparison areas in these two areas. Phase 1 woredas will implement HEP+ICCM while the
Phase 2 woredas will continue to offer services included in the routine HEP. Phase 1
implementation in the two evaluation zones will begin in February 2011, following the
baseline coverage survey.
DATA SOURCES Household Surveys: The primary data for the evaluation will come from baseline
and end-line household surveys. The baseline survey was conducted in January - February 2011
and the end-line survey will be conducted 18 months following the end of the HEW training as
part of phase one. These surveys will measure coverage of the child health interventions of
interest and nutritional status among children under five. The end-line survey will include,
in addition to coverage measures, a full birth history for women 15-49 years old to measure
retrospectively mortality among children under five. Partners report that phase one
implementation was completed in July 2011; therefore the end-line survey is planned for
January 2013.
For the baseline survey, we estimate that 3,700 households (1850 in each arm) are required to
detect a change in coverage indicators between baseline and end-line. For the end-line
survey, sample size of households is calculated to detect a difference in differences of 20
percentage point in under-five mortality between intervention and comparison areas with 80%
power. We estimate a conservative sample of about 15,157 households in each arm of the study
will be required, making a total sample size of 30,314 households.
Measurement of implementation strength and assessment of quality of child health care data: A
community-level survey of HEWs is planned to provide a "snapshot" of HEP +ICCM implementation
strength in the two evaluation zones. The data collected will comprise core indicators of
implementation strength, as well as indicators on demand-generation activities, utilization
and the quality of services provided by HEWs.
The study will sample functional 104 health posts in the intervention areas and 46 in the
comparison areas. Study participants will include: 1) HEWs performing case management of
childhood illnesses, 2) sick children 2-59 months of age presenting at health posts for
consultations and their caretakers and 3) sick children 2-59 months in the communities
surrounding health posts.
ANALYSIS The main analysis of the data will involve comparison of trends in coverage and
impact indicators between intervention and comparison arms, using appropriate statistical
models that adjust for clustering at cluster level. Adequacy of implementation in each arm of
the evaluation will be determined using data from baseline surveys, process documentation
data and the implementation snapshot survey.
Using data from the end-line survey, under-five mortality will be computed on 18-month period
before the baseline survey (which will represent the baseline under-five mortality) and on
18-month period after full implementation (the end-line under-five mortality). Precaution
will be taken to measure the end-line mortality only on period starting from time when full
implementation (training and deployment of HEWs with drugs) has been completed. Full
implementation in intervention woredas was achieved in July 2011, six months after the
completion of the baseline survey.
The first level of analysis will assess "intention to treat", which consists of analyzing the
data from the intervention and comparison arms as per the start-up design. This analysis will
compare changes between baseline and end-line in under-five mortality rates as well as
nutritional status among children under-five in the intervention and comparison areas.
Difference in differences analysis will be conducted to estimate the impact of the ICCM on
mortality. Proportion hazard models will also be applied to control for possible differences
in baseline characteristics and contextual factors.
An important secondary objective of the HEP+ICCM is to increase equity in access to high
impact, cost-effective preventative and curative interventions. The evaluation team will
assess changes in inequalities associated with the implementation of the HEP+ICCM program
interventions by examining project outcomes and impact across socioeconomic and demographic
subgroups.
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