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PROJECT INFORMATION DOCUMENT (PID)
CONCEPT STAGE
Project Name
Region
Sector
Project ID
Borrower(s)
Implementing Agency
Environment Category
Date PID Prepared
Estimated Date of
Appraisal Authorization
Estimated Date of Board
Approval
Report No.: 46673
Africa Regional Health and TB Support Project
AFRICA
Health (100%)
P111556
REGIONAL PROJECT SEVERAL BORROWERS
Ministries of Health in participating countries
[ ] A [X ] B [] C [ ] FI [ ] TBD (to be determined)
November 18, 2008
June 15, 2009
September 3, 2009
1. Key development issues and rationale for Bank involvement
A major public health problem
Sub-Saharan Africa has the highest rates of tuberculosis and the worst treatment outcomes,
with the continent contributing significantly to the global rise in TB. While other regions have
shown a steady decline in the TB burden, the numbers of new cases and mortality rates have
been on the rise in Africa since 1990, fuelled by the HIV/AIDS epidemic. Of the 22 high burden
countries worldwide nine are in Africa (DR Congo, Ethiopia, Kenya, Mozambique, Nigeria,
South Africa, Tanzania, Uganda and Zimbabwe). About a dozen countries on the continent are
afflicted with the highest incidence rates in the world, including Swaziland, Lesotho, Botswana,
Zambia, and Malawi. Tuberculosis is a preventable and treatable infectious disease that hits
hardest working age adults, and imposes heavy costs, particularly among the poor.
A dual epidemic
TB control in Africa is distinguished from other continents by the high prevalence of TB/HIV
co-infection, with each disease accelerating the other’s progression. Tuberculosis is the most
common opportunistic infection of people living with HIV/AIDS who have compromised
immune systems and the leading killer of HIV infected patients. While the lifetime risk of
developing active tuberculosis for a HIV negative person is 5-10 percent, an HIV positive patient
has an annual risk of 5-10 percent to develop TB. For infected individuals there is a need for
rapid diagnosis, as infectiousness and risk of TB transmission is most serious before people are
placed on treatment.
The HIV epidemic poses new challenges to the traditional approach of combating TB based
on the DOTS strategy. While the DOTS strategy is essential it is not sufficient. The DOTS
(Directly Observed Therapy Short-Course) strategy for TB control-- comprising of diagnosis by
sputum-smear microscopy, short course chemotherapy with rifampicin and isoniazid, and
systematic monitoring of each patient to evaluate outcomes-- has worked well historically in
countries with low rates of HIV infection. Experience from Africa suggests that even well
managed TB programs can not easily control the rise in tuberculosis in high HIV prevalence
settings. Countries with high rates of HIV infection and drug resistance need to adopt a DOTS-
plus approach, including greater attention to TB/HIV integrated care and greater focus on
appropriate diagnostics for early identification and treatment of co-infected patients and those
suffering from drug resistant strains.
An emerging drug resistance problem
Multi-drug resistant tuberculosis in Southern Africa is becoming an increasing threat to the
health and development gains in the region. Multi-drug resistance stems from weak TB control
systems, unstable supply of quality first-line drugs, and poor program management. Drugs for
treatment of resistant forms of tuberculosis have higher levels of toxicity, case fatality, and
treatment failure and are much more expensive.
In high HIV settings the emergence of multi-drug resistant forms of TB is having devastating
effects, threatening to compromise the gains made in HIV/AIDS investments. Recent
experience has shown that people living with HIV/AIDS are not only more susceptible to TB but
those on antiretroviral therapy (ART) are no more protected from death due to extensively drug
resistant TB than those who are not on ART. The emergence of drug resistant strains
underscores the importance of strengthening the quality of basic DOTS programs, as well as
introducing appropriate technology for early and efficient diagnosis and treatment of those coinfected with TB and HIV and to strengthen surveillance efforts to respond more efficiently to
future epidemics.
Health systems challenges
The effective response for disease detection and monitoring remains constrained by systemic
health systems weaknesses. The barriers that limit laboratory capacity are largely those which
limit health service provision in general, namely human resources, financing, procurement and
supply chain management, regulatory environment, and information systems. Each of these
systemic constraints needs to be strengthened, thereby reinforcing regional capacity for diagnosis
and management of multiple diseases.
Laboratories are among the weakest aspects of health systems, hindering patient management
and disease surveillance. Allocation of resources for diagnostic laboratory testing has not been
a priority for either governments or donors. The gross underfunding of laboratories has resulted
in unreliable and inaccurate testing and misdiagnosis, which in turn leads to higher costs and
compromised patient care. Building laboratory capacity to provide rapid, accurate, affordable,
and reliable diagnostic tests will enable health care workers to deliver more effective treatment,
enhance efficiency in use of resources, and improve quality of care.
It is broadly recognized that lack of diagnostic capacity is a crucial barrier preventing an
effective response to the challenge of HIV associated tuberculosis as well as multi-drug
resistant forms. The accuracy of sputum smear microscopy, the standard method for diagnosing
TB, is reduced by the presence of HIV infection. Most countries in the Africa region have
limited or no capacity to diagnose HIV related tuberculosis which requires diagnostic techniques
(e.g. liquid culture) that are more efficacious but also more costly, and more complex. The
majority of countries in the region do not have capacity to do drug-sensitivity testing (DST) and
to conduct drug resistance surveys. National laboratories are often in need of physical
upgrading, as demand for their services has outstripped capacities, and as new technologies and
diagnostics require physical modifications, such as improvements in bio-safety and infection
control standards.
In spite of the increasingly regional nature of TB in Africa, the region has virtually no
diagnostic or surveillance capacity at the supranational level. Currently, there is only one
supranational reference laboratory in South Africa which is stretched beyond capacity,
supporting drug resistance tuberculosis surveillance activities and not able to expand routine
diagnostic services, external laboratory quality assurance, and regional training. There is a huge
need to establish additional supranational reference laboratories to boost diagnostic and quality
assurance functions in the region.
Human resources are another major weakness. Human resources capacity at national reference
laboratories is a particularly serious issue, as numbers are far below critical mass, there is limited
training, inadequate pay, lack of structured career paths, and non-recognition of the importance
of diagnostic services. Given the highly infectious nature of TB, particular measures need to be
introduced to protect health workers and laboratory technicians from being infected and priority
treatment needs to be provided for staff that is infected.
Rationale for Bank Involvement
Tuberculosis prevention and control is a regional and global public good, with high positive
externalities, as benefits accrue to non infected individuals within and across countries. The
risks of transmitting drug resistant forms of TB, particularly in Southern Africa, are enormous
and individual countries do not always have the resources and incentives to make the necessary
investments which would have spillover effects for other countries. Investments in lab
strengthening have potential spillover effects for other diseases, as upgraded labs will ultimately
benefit other patients. The proposed project is consistent with the Bank’s institutional focus on
global public goods and with the 2007 Bank Health Nutrition and Population Strategy which
focuses on health systems strengthening.
Tuberculosis Control in Sub-Saharan Africa
Why TB?
 High burden of TB; highest levels of infection; disproportionate share of global burden
 Rise in drug resistant TB, which poses major public health risks regionally and globally
 Preventable and treatable disease associated with poverty which hits primarily working-age adults
 High expected rate of return, highly cost-effective, strong public good nature of TB control
Why Labs?
 Gross underfunding has resulted in misdiagnosis, higher costs, and compromised patient care
 Accuracy of standard method for diagnosing TB is reduced by presence of HIV infection
 Virtually no capacity in the region to diagnose and treat drug-resistant forms of TB
 Introduction of modern diagnostics will result in reduced diagnostic delays and improved quality of
care
Why a Regional Approach?
 Potential to reap economies of scale, lowering costs, and achieving higher quality diagnostic services
 Dearth of capacity at regional level to deal with a regional public good
 Inherent market failures which imply that services may not otherwise be provided by individual
countries
Why Bank support?
 Investments in TB are in line with the institutional commitment to global public goods
 Comparative advantage to address systemic health systems issues hindering TB programs
 Funding gaps persist and key role for the Bank as donor of last resort
 Bank’s traditional comparative advantages (analytic capacity, convening power) can be brought to bear
2. Proposed objective(s)
The project development objective is to improve access, quality, and efficiency of TB diagnostic
services using an integrated approach to laboratory strengthening. The specific objectives would
be to: (i) establish additional Supranational Reference Laboratories to provide quality assurance,
training, and capacity building; (ii) introduce modern techniques for diagnosis of HIV related
TB, and increase capacity for drug resistance diagnosis and surveillance in a group of national
reference and public health laboratories in priority countries; and (iii) develop and test alternative
service delivery models to promote private sector involvement. The project would also facilitate
learning and knowledge sharing across the network of participating laboratories and countries.
3. Preliminary description
Country Selection All countries will be eligible to participate. Selection and prioritization will
be based on several criteria: (i) epidemiological situation (i.e. burden of TB, HIV, and drug
resistant TB; (ii) existing laboratory capacity to address HIV related and drug resistance
tuberculosis, (iii) presence of other partners and projected funding gaps; and (iv) country interest
to participate in this regional operation and willingness to contribute one-third to the total cost
from the respective IDA country allocations.
Project Components
The proposed US$140 Million Regional Health and TB Support Project includes three
components. Project components are described below.
Supranational Laboratory Capacity Enhancement (US$30 million) This component will
finance the establishment of regional capacity to: (i) conduct external quality assessments of
national reference laboratories, (ii) provide training and capacity building across the region to
develop a new cadre of laboratory experts, and (iii) provide a regional forum for knowledge
sharing and research on new diagnostics. This would be accomplished by financing the
upgrading, rehabilitation, and equipping of regional laboratories with modern diagnostics,
ensuring the availability of well trained personnel, assisting with operational and logistical costs,
and providing funds for conducting research and organizing knowledge sharing workshops.
Operational research activities will be financed to document and learn from this regional lab
initiative. The project would fund operational research on suitability and cost effectiveness of
new diagnostic technologies in resource constrained settings, and share emerging good practices.
Laboratories targeted for becoming supranational facilities will be selected in consultation with
countries and through the Global Lab Initiative with support of technical partners. The facilities
would be accredited to function at the regional level, ensuring equity in geographical access and
coverage.
National Reference and Public Health Laboratory Network Strengthening (US$90 million)
This component would support the modernization of national reference laboratories with an
initial focus on tuberculosis control. The goal is to assist national reference and other public
health laboratories to rapidly detect drug resistance, strengthen supervision and quality
assurance, boost the volume, quality and efficiency of diagnostic services, and provide outreach
and support services to district and rural clinical laboratories. This would be done by upgrading
and expanding existing national laboratories; ensuring biosafety and appropriate infection
control; introducing modern diagnostics; supporting drug susceptibility testing; providing
logistical means to transport infectious samples promptly and safely; expanding training in
laboratory methods, quality management, and biosafety; and providing technical support to build
and sustain capacity. The project would also support the development of a Laboratory Quality
Management System which would address systemic barriers that limit laboratory capacity. The
Quality Management System will extend out of the National Reference Laboratory to build and
monitor upstream (supranational) and downstream (regional and service level) linkages. The
possibility of leveraging World Bank funds to mobilize financial support for drugs and
diagnostics from UNITAID would be explored during project preparation.
Public Private Partnerships in TB Control (US$20 million) This component aims to support
the financing of partnerships with the private sector and the testing of alternative service delivery
models to engage the private sector in achieving public health goals in TB control. While
recognizing that some TB related services (e.g. control of disease vectors) are pure public goods
because of the inherent market failures, other services (e.g. laboratory testing) may be provided
by both the public and private sectors. Building on the significant private sector involvement in
health in Sub-Saharan Africa the project would support different ways to harness the private
sector in improving efficiency, promoting innovation, and ensuring sustainability. To this end,
the project would finance a combination of the following activities, depending on individual
country interests and circumstances:
 Knowledge Stocktaking, including the following activities: (i) a study of private sector
involvement in laboratory services (with a particular focus on TB control) globally with
applications for sub-Saharan Africa; (ii) consultations with policy makers and partners to
discuss findings and their relevance to the regional initiative to bolster laboratory and
diagnostic services and to reach agreement on the main elements of a public private
partnership for strengthening laboratory services and TB control.
 Public-Private Partnerships: The project would fund contracts with private laboratories using
a public/partnership model, with possible support from IFC. The partnerships may also be
coupled with IFC loans to interested private sector groups who may wish to collaborate on a
larger scale. The number and types of partnerships to be funded would depend on the
findings of the study mentioned above, so maximum flexibility would need to be maintained.
 Operational Research: The project would support operational research to test alternative
public private partnerships, such as management contracts, leases, structured leases or full
concessions, for delivering these services in the most cost effective manner.
Framework for Scale-up The preparation and design of the proposed operation will be done in
close collaboration with key partners involved in strengthening diagnostics in sub-Saharan
Africa. This will minimize the risk of duplication and ensure that participating countries take
advantage on a priority basis of the grant financing available from the Global Fund, bilateral
agencies, and foundations. This coordinated approach will ensure that the Bank’s comparative
advantage in providing flexible financing will be coupled with the technical know-how of the
Stop TB partnership, and top notch technical expertise, including from the network of laboratory
specialists established under the Global Laboratory Initiative with its secretariat in the Stop TB
Department of WHO, which is our key partner in this initiative.
The Global Laboratory Initiative network aims to expand access to diagnostic services through
associated laboratory infrastructure, financial, and human resources are mobilized. GLI provides
a good framework for this operation with its mandate to work on: (i) global policy guidance on
appropriate laboratory technology and best practices; (ii) laboratory advocacy and resource
mobilization; (iii) laboratory capacity development and coordination; (iii) interface design with
other laboratory networks to ensure appropriate integration; (iv) standardized laboratory quality
assurance; (v) coordination of technical assistance; and (vi) effective knowledge sharing.
4. Safeguard policies that might apply
The IDA-funded operation is expected to be classified as category B
5. Tentative financing
Source:
BORROWER/RECIPIENT
International Development Association (IDA)
Total
6. Contact point
Contact: Miriam Schneidman
Title: Sr Health Spec.
Tel: (202) 473-9391
Fax:
Email: [email protected]
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