Report No. PID8039 Project Name RUSSIAN FEDERATION-TUBERCULOSIS AND @... AIDS CONTROL PROJECT Region Europe and Central Asia Region Sector Health (100%) Project ID P064237 Borrower(s) GOVERNMENT OF RUSSIA Implementing Agency Address MINISTRY OF HEALTH AND MINISTRY OF JUSTICE Environment Category C Date PID Prepared October 17, 2002 Auth Appr/Negs Date June 6, 2000 Bank Approval Date April 23, 2003 1. Country and Sector Background Summary The main sector issue is the gap between needs and current practices regarding the control of TB and HIV/AIDS/STIs. The factors contributing to this gap include the following: (i) inadequate response, both in scale and in technical quality, to tackle the large burden of TB and HIV/AIDS/STIs; (ii) the need for stronger management and institutional capacity for rapid implementation of large-scale programs, based on scientific evidence, across Russia; and (iii) financial constraints. The Russian Government is addressing this range of issues with increasing commitment. However, there is room for substantial improvement in the technical content, geographic scale and population coverage, beyond the current pilot efforts. This need is particularly urgent, in view of the potential for human and economic devastation due to HIV/AIDS in the Russian Federation. A detailed description of main sector issues follows. TUBERCULOSIS According to the WHO, Russia is one of the 22 high-burden countries for TB in the world (WHO, Global Tuberculosis Control: Surveillance, Planning, Financing. Geneva, 2002). The reported incidence of TB increased throughout the 1990's. This was due to a combination of factors, including: (i) increased poverty, (ii) underfunding of the TB services and health services in general, (iii) diagnostic and therapeutic approaches that were designed for a very centralized command-and-control system but unable to cope with the social mobility and relative freedoms of the post-Soviet era, as well as (iv) technical inadequacies and outdated equipment. In addition, migration of populations from ex-Soviet Republics with high TB burdens to the Russian Federation also increased the problem. Prevalence rates were many times higher in the prison system than in the general population. A shrinking health budget resulted in an erratic supply of anti-TB drugs and laboratory supplies, reduced quality control in TB dispensaries and laboratories, and has resulted in inadequate treatment and increasing drug resistance. The social conditions favoring the spread of TB, combined with inadequate systems for diagnosis, treatment and surveillance, produce a serious public health problem. Data on TB incidence and prevalence during the Soviet era are not considered reliable either by local or international experts. However, it is evident that after a gradual decline in the TB incidence rate in the decades before 1990, the trend has reversed and the TB incidence rate more than doubled from 34.2 (in 1990) to 90.7 (in 2000) per 100,000 population or more than 130,000 new cases in 2001. There has been a major increase in the TB mortality rate, which has nearly tripled to reach 20.4 per 100,000 in 2000. At the present time, the Russian Federation has one of the highest TB mortality rates in Europe. TB is first among causes of death from infectious diseases in Russia. The incidence rate of TB among children has also doubled in the past ten years, from 7.9 (in 1990) to 17.8 (in 2000) per 100,000 population or more than 4,500 children with TB in 2001. The TB situation is even more complex in correctional institutions and in prisons, where case rates and death rates among prisoners are ten times higher than in the civilian sector. Case-notification rate in the penitentiary system in 2000 was 3,118/100,000 convicts and persons under criminal investigation. This is a potential problem for TB control in the civilian sector as there is a growing number of prisoners with TB that are being released. The prison system serves as one of the epidemiological pumps for the TB epidemic; the prisons help to breed a pool of infected persons who are then released into the general population without a guarantee of follow-up and adequate treatment. In addition, the incidence of Multi-Drug Resistant TB (MDR-TB) is also increasing and is of great concern to the Russian Government. High rates of MDR-TB have been observed in many oblasts, in both the civilian and prison sectors. MDR-TB converts a disease that can be reliably cured into one which is often fatal and costly to treat. Lastly, it is essential to note that the current increase in TB and drug resistance could become significantly worse if HIV became much more prevalent in the society. Government response The approach taken by Government is characterized by increasing commitment (but with persistent resource gaps), increasing technical collaboration with WHO and other partner agencies (but with persistent absence of a clear agreement on evidence-based technical guidelines for diagnosis, treatment and surveillance to be used across the country). The Government's 5-year plan on "Prevention and Control of Social Diseases, 2002-2006" has the following main components: (i) Development of documents defining the strategy and tactics of TB control at the federal level (ii) Monitoring and control at the federal level (iii) Training and education at the federal level (iv) Improvement of TB case detection and diagnosis (v) Improvement of TB patient treatment Important steps taken by the Government include the approval of the Federal Law (#77 ) on June 18, 2001 "On Preventing TB Dissemination in the -2 - Russian Federation", increased Federal budget to address TB, and ongoing work to revise, in consultation with WHO, the current regulations for TB control. However, there is still much work to be done for reaching consensus in the main principles of TB control, i.e. the role of case-finding, distribution of anti-TB drugs, setting priorities, etc. HIV/AIDS Russia is experiencing one of the fastest-growing epidemics of HIV/AIDS in the world. Almost 83,000 new HIV-positive diagnoses were reported in 2001, raising the total number of HIV infections reported since the epidemic began to more than 173,000 in 2001, up from the 10,993 reported at the end of 1998. The estimated number of persons now living with HIV/AIDS in Russia is thought to be around four times higher than these reported figures and, according to the Russian AIDS Center, it could be even higher. Efforts to address HIV/AIDS by the Russian Government have been patchy for several reasons. First, despite the steep increase, HIV/AIDS prevalence rates remain very low, below 1 of the adult population, compared to the worst affected regions in Saharan Africa, Asia and the Caribbean. Second, the epidemic is driven mainly by transmission among the high-risk core group of injecting drug users (IDUs), hence there is a perception that HIV/AIDS is a problem of "social deviants". Third, political advocacy has not been linked to the evidence base, with limited results from exhortations and rights-based advocacy. As such, it has been politically difficult to mobilize effective programs on a large scale for a problem that is perceived to be confined to a group with limited political clout. Principal Risk Factors Russia demonstrates the features of an epidemic that was initially concentrated among the high-risk, core transmitters (IDUs and commercial sex workers (CSWs)) and is now starting to spread into the bridge population (such as the sex partners of the high-risk core transmitters). Although precise predictions are impossible, it is reasonable to expect that, without effective efforts to control the trend, the epidemic would likely spread from this "bridge population" into the general population. Federal level response In 1995, the Russian Government adopted the Federal Law on the "Prevention of the Spread of Disease caused by the Human Immunodeficiency Virus (HIV)" in Russia. The law has been implemented through the Federal Anti-HIV/AIDS Program, which ran from 1996 to 2001. The Federal Anti-HIV/AIDS Program is funded directly from the Federal budget and by MOH. The main actors implementing the Federal anti-HIV/AIDS Program are federal, territorial and regional AIDS Centers, which are the public health institutions under the authority of the HIV/AIDS Prevention Division of the MOH of the Russian Federation. Building on the 1996-2001 Program, the Federal Government has introduced another Anti-HIV/AIDS Program which will last from 2002-2007. Its main components include the following: development and enforcement of legal and normative acts necessary for the implementation of the Program; expanded provision of information on HIV prevention; development of the surveillance system; -3- safety of medical/surgical procedures, blood and blood products, bodily fluids and tissues; development of HIV diagnosis and treatment services; human resource development in HIV diagnostics, clinical management, care, epidemiology and prevention; social protection of HIV-infected individuals and their families, and social protection of personnel exposed to risk of contracting HIV. According to the Federal Ministry of Health, the budget for the Federal Targeted Anti-HIV/AIDS Program increased from RUR123 million in 2001 to RUR162 million in 2002. Recent official decisions indicate a shift in thinking about HIV/AIDS in the MOH, per Ordinance # 28, dated September 9, 2002, entitled "Re: Intensified HIV control action in RF". It is the first high-level document to emphasize the need to concentrate on the high-risk groups of IDUs, sex workers and prisoners, promoting harm reduction as effective interventions. 2. Objectives The project would assist the Russian Federation to protect its population and economy from uncontrolled epidemics of tuberculosis (TB), HIV/AIDS and other epidemiologically important sexually transmitted infections (STIs). It would do so by using evidence-based approaches to support the following on a large-scale: (i) the control of TB through enhanced policies, surveillance, diagnosis, treatment and effective management; (ii) HIV/AIDS surveillance, policies, program development and interventions for prevention and care; and (iii) the surveillance, diagnosis and treatment of STIs. Russia is unique in its combination of a strong legacy of health services in the socialist model, long-established institutions, membership of the G-8 and a fast-growing epidemic of HIV/AIDS as well as a large burden of TB. Promoting change in this context is therefore more complex than in many other settings. As a result, the project concept and design stress the local development of Russian strategies and programs, not pre-packaged protocols, with the understanding that those Russian strategies and standards would be based on credible scientific evidence as documented in the international literature and WHO guidelines. This combination of substance and process would help to ensure project effectiveness while securing Russian ownership of the process. The project would support the Government's Federal Target Program, "Prevention and Control of Social Diseases, 2002-2006". With reference to the control of TB, the technical aspects of components to be supported by this Project would be based on the outcomes of ongoing consultations between the Ministry of Health (MOH) of the Russian Federation and the World Health Organization (WHO) on a set of evidence-based guidelines for diagnosis, treatment and surveillance. The project objectives are consistent with the Millennium Development Goals, with attention to the specific needs in Russia. Target Number 7 is to have halted and begun to reverse by 2015 the spread of HIV/AIDS (http://sima.worldbank.org/mdg/NewFrame/goal-6.htm). - 4 - 3. Rationale for Bank's Involvement Together with WHO and large bilateral organizations such as DFID and USAID, the Bank serves as a co-convenor of major discussions on sustainable approaches to the control of TB and HIV/AIDS/STIs in Russia. In addition to these discussions on program contents, the World Bank would provide US$150 million to ensure a major progression from small-scale pilots to a large-scale program. This scaling up is crucial to ensure measurable progress towards the objectives of TB and HIV/AIDS/STIs control at the general population level. The Bank brings to the proposed project an unusually strong combination of international experience as an institution, substantive policy dialogue with many of the sectors involved in the TB and HIV/AIDS/STIs control, knowledge of Russia's health system from three earlier projects, as well as know-how in designing and supporting the implementation of large-scale programs. The Bank's portfolio includes over 50 projects throughout the world aimed at prevention and control of HIV/AIDS and other infectious diseases. 4. Description The project would support the development and large-scale implementation of interventions that are based on up-to-date scientific evidence. In that context, the major project inputs would be directed at (i) updating and/or dissemination of strategies, guidelines and protocols; (ii) assessment of needs as a basis for effective planning, design, implementation, monitoring and evaluation; (iii) training and on-the-job learning to improve the local capacity for effective implementation; (iv) supply of equipment and consumables required to improve the technical quality of diagnostic and therapeutic activities, based on explicit needs assessments carried out prior to any procurement actions; (v) procurement of drugs; and (vi) close attention to project monitoring and evaluation. The project includes three main components whose indicative costs are as follows: Component I. Control of Tuberculosis 1.1.) Policies, Strategies and Protocols for TB Control 1.2.) Strengthening Surveillance, Monitoring, Quality Control and Quality Assurance 1.3.) Improvement of TB Case Detection and Diagnosis 1.4.) Improvement of TB Treatment Component II. Control of HIV/AIDS 2.1.) Policies, Strategies and Public Information for HIV/AIDS Control 2.2.) Strengthening Surveillance & Monitoring 2.3.) Laboratory Service and Blood Safety Improvement 2.4.) Prevention and Control of STIs 2.5.) Targeted Prevention of HIV/AIDS and STIs in High Risk Groups 2.6.) Prevention of Mother-to-Child Transmission Component III. Project Management, Monitoring and Evaluation 3.1.) Project Preparation and Implementation Unit 3.2.) Training and Study Tours for Staff 3.3.) Project Audits 3.4.) Monitoring and Evaluation -5- 5. Financing Total ( US$m) BORROWER $116.64 IBRD $150.00 IDA WORLD HEALTH ORGANIZATION $2.07 Total Project Cost $268.72 6. Implementation The project would be implemented over a five year period and all implementation arrangements would be governed by the guidelines and procedures set out in the Project Operational Manual (POM) and in accordance with the Project Implementation Plan (PIP). Given the intentional and inherent flexibility of project design, the PIP would be an evolving document aimed at supporting the overall achievement of project objectives. Any major changes to either the POM or the PIP would be preceded by technical consultations between the project implementing agencies and the Bank and would require Bank final review and approval. The overall responsibility for project implementation would reside in the two implementing agencies, the MOH and MOJ. It is therefore critical that the project receives strong and continuous technical, operational and logistical support throughout the project implementation period from both implementing agencies as well as from the Ministry of Finance (MOF) and Ministry of Economy (MOE) and other relevant agencies in the Russian Government, and particularly at the regional and local levels. To ensure overall interagency coordination, the project would be supported by a technical team within an Interministerial Working Group (IWG). The IWG would meet regularly to review project progress against agreed timetables and stated project objectives, take necessary decisions with respect to pending implementation issues, and report to both ministries and to the Russian Government at large on the overall project implementation. 7. Sustainability The project hinges on three main elements without which its sustainability would be in jeopardy, including: (i) continued strong and broad political commitment to control the TB and HIV/AIDS/STIs epidemics, both on federal and regional levels; (ii) the provision of adequate financial resources, on federal and regional levels, for prevention, diagnostics and treatment of these diseases, including allocating sufficient resources for consumables, operation and maintenance of diagnostic centers and laboratories as well as adequate and stable supply of drugs; and (iii) strong capacity, both in government and non-government sectors, to continue to implement measures to control the epidemics after project completion. 8. Lessons learned from past operations in the country/sector Scientific evidence and principles to guide infectious disease control underpin the design of this project: TB. There is a large and growing body of literature on the most effective methods for TB control. The literature covers bacteriology, epidemiology, surveillance and screening, diagnosis and treatment. The published evidence forms the basis for the WHO-recommended strategy for drug-sensitive TB and for MDR-TB. - 6- HIV/AIDS/STIs. At a relatively early stage such as Russia's, the published evidence strongly favors a combination of (i) preventing generalized epidemics through targeted interventions for high-risk and bridge-populations, based on good virological, epidemiological and behavioral surveillance, and (ii) broader public information efforts to enable a supportive social environment, making it possible to develop and implement effective programs. A critical lesson incorporated in the design of all project components is support to be provided for surveillance, monitoring and evaluation, - all of which are essential elements for a successful disease control program. The above-mentioned key elements of an effective operation will be largely dependent on continued high commiment to TB and HIV/AIDS/STIs control of the different levels of the Russian Government, both on the federal and regional levels, including the representatives of the MOH and the MOJ, but also other related sectors which would need to be involved to achieve a comprehensive response to the control of the epidemics. In addition, it is critical that NGOs and other members of the civil society, as well as the main stakeholders, are involved in all aspects of policy, design and implementation of effective programs, particularly at the regional and local levels. These are both important lessons from similar operations which have proven successful in other countries. 9. Environment Aspects (including any public consultation) Issues : None 10. Contact Point: Task Manager Olusoji 0. Adeyi The World Bank 1818 H Street, NW Washington D.C. 20433 Telephone: 202-458-1988 Fax: 202-477-3387 11. For information on other project related documents contact: The InfoShop The World Bank 1818 H Street, NW Washington, D.C. 20433 Telephone: (202) 458-5454 Fax: (202) 522-1500 Web: http:// www.worldbank.org/infoshop Note: This is information on an evolving project. Certain components may not be necessarily included in the final project. This PID was processed by the InfoShop during the week ending October 25, 2002. -7-