Report No. PID11512 Project Name BRAZIL-BR-AIDS & STD Control III Region Latin America and Caribbean Region Sector Health (100%) Project ID P080400 Borrower(s) GOVERNMENT OF BRAZIL Implementing Agency MINISTRY OF HEALTH Address: National AIDS & STD Coordination Unit, SEPN Quadra 511, Bloco C, 2ndo andar Brasilia, DF 70750-543 Contact Person: Paulo R. Teixeira, Coordinator Tel: 55-61-448-8000-6 Email: Pteixeira@Aids.Gov.Br Environment Category B Date PID Prepared November 15, 2002 Auth Appr/Negs Date January 15, 2003 Bank Approval Date April 15, 2003 1. Country and Sector Background Background: This loan would be the third STD/AIDS Control project to be financed in Brazil. Brazil has the highest number of AIDS cases in the region (just under the U.S.). Since the first cases appeared in 1980, the Brazilian Government has put HIV/AIDS prevention and treatment high on its agenda. The Epidemiology of HIV/AIDS: AIDS first appeared in Brazil in 1980. The number of AIDS cases reported has risen from 550 in 1985, to close to 240,000 in mid-2002. The number of individuals infected by HIV is currently estimated at 600,000, or 0.65% of the population aged 15-49 (this estimate includes about 120,000 persons who have AIDS that are alive). Prevalence of HIV has ranged from 0.5 to 0.8 since end of 1997 showing a trend towards stabilization. In the case of AIDS, the number of cases reported per year has been stabilizing as well. Given the existence of free antiretroviral therapy (ARV) mortality from AIDS has declined from 9.6 per 100,000 in 1996 to 6.3 per 100,000 in 2000. The availability of ARV will lead to increases in prevalence of HIV, at least as long as the number of new infections is greater than the number deaths from AIDS. Although the epidemic appears to be stabilizing, its mode of transmission and demographics have changed significantly. While in 1985 85% of all cases were among men who have sex with men, they now account for 26.6% of all AIDS cases reported. Heterosexual transmission has increased, increasing from 16.4 in 1990 to 39% by 2001, and women now account for one third of all new cases. In addition to the feminization of the epidemic (which is occurring all over Latin America), new cases are less educated and a broader group of municipalities. The proportion of AIDS cases derived from blood transfusion has declined over time, while the proportion transmitted through intravenous drug-use has remained the same. However, the proportion infected through vertical transmission has almost doubled. Overall incidence of AIDS was estimated at 12.4 per 100,000 in 2000, declining to 8.1 in 2001. However, there are important regional disparities. Incidence rates for AIDS however, have been declining amongst men in the southeast and center west. They remain high in the south and in all regions amongst women. The National Response: The First AIDS & STD Control Project (1994-1998, becoming effective June 1, 1994) for a total of US$250 million (US$160 million IBRD) accounted for one-third of Brazil's spending on AIDS. Its objectives were to reduce the spread of the epidemic and to strengthen public and private institutions engaged in AIDS and STD control. The project left in place a solid institutional framework for HIV/AIDS & STD control that is strongly supported by partnerships with state and local governments and a wide range of NGOs. The ICR noted two important shortcomings of AIDS I: (a) the project evaluation unit was not adequately staffed nor equipped, making it impossible to quantify the achievements of the project; and (b) inadequate supervision (by both Borrower and Bank) of procurement activities subcontracted to UNDP. Mention was also made of the need for greater integration of activities in prevention, surveillance, diagnosis, treatment, training and evaluation. That said, the achievements of the project are substantial, and the lessons learned have proven key to the sustainability and effectiveness of project activities: (a) building a constituency for the project very early on among states, municipalities and NGOs proving valuable in a rapid and smooth start-up and buy-in; and, (b) the involvement of NGOs proved critical to reaching high risk groups. The Second AIDS & STD Control Project (1998-2002) which is financing activities for a total of US$296.5 million (of which US$161.5 is IBRD financed) became effective February 9, 1999. The Government requested a six-month extension (to June 30 2003) in order to complete its implementation which was slightly delayed due to the late approval of supplementary budget. The objectives of AIDS II are to reduce the incidence of HIV and STD infection, and to expand and improve diagnosis, treatment and care for persons with STD, HIV and AIDS. The rationale for the second project was to extend coverage of preventive activities (while maintaining a focus on high-risk groups), strengthen evaluation capacity, and work toward the sustainability of the project through the devolution of some responsibilities to the state and the definition of more cost-effective interventions. Accomplishments of AIDS II to date: The project expanded prevention services significantly through increased participation of NGOs and partnerships with states and municipalities, increasing accessibility to condoms (male and female), doubling the number of testing and counseling sites and HIV testing (to how much). However, although prevention activities expanded (while maintaining a focus on high-risk groups), expansion continues to be insufficient. Moreover, the enthusiasm for prevention seems to have been overshadowed by that of treatment and care -2 - (in part due to the international visibility they have acquired in bringing down ARV prices internationally). With regards to treatment, it increased specialized ambulatory facilities five-fold, almost doubled day hospitals and accredited 50 additional conventional hospitals. It also strengthened provision of prevention services in testing, treatment and care facilities. Moreover, the sentinel surveillance system was greatly improved. The use alternative care options such as day hospitals and specialized ambulatory facilities have reduced the number of hospitalizations per AIDS patient from 0.8 in 1997 to 0.3 in 2001, yielding some important savings, in addition to those derived from the reduction in the incidence of opportunistic infections resulting from the use of ARV. While not financed by the project, all the training, development of protocols, and studies conducted to ensure adequate provision of ARV treatment and follow-up services were financed by the project. The project has continued to build strong alliances with NGOs, the private sector, associations of people living with HIV/AIDS, and state and municipal stakeholders, fostering participation in project preparation and implementation. Remaining Challenges: Coverage and quality need to be improved: While expansion of services has been significant in the last four years, the team acknowledges that coverage still needs to be expanded and quality of care needs to be addressed. Further emphasis of prevention efforts with high-risk groups needs to be a high priority Coverage of intravenous drug users is only 10%. Coverage of men who have sex with men is estimated at 52% but the size of the target population seems underestimated, and coverage of commercial sex workers is unknown due to the difficulty in estimating the target population. However, there are more NGO subprojects with sex workers than the other groups. And, with regards to prevention of mother-to-child transmission, only 40% of pregnant women are currently tested and only one third of those testing positive receive treatment. STD diagnosis and treatment continues to be weak given that states, who are responsible for the provision of medications for treatment of STDs, have not made available the necessary supplies. Coverage of HIV testing for pregnant women and treatment for those infected also continues to be low (only 409 tested and only 32% testing positive are receiving treatment). And, despite free treatment, only one-third of all estimated HIV positive cases have been reached. A monitoring and evaluation system of the program needs to be implemented: Regarding monitoring and evaluation of the epidemic and the program, some advances have been made although they are still inadequate for a program of this magnitude and stature (and given the fact that this was to be an important focus of AIDS II). AIDS/HIV surveillance has improved but STD surveillance continues to be inadequate. Although the project has developed numerous independent data sets developed for specific purposes (other than project monitoring and management), and has conducted some studies to assess project outcomes and impact, they have not been conducted systematically and often fail to use comparable methodologies. Thus, as such, the project has studies and data but no evaluation strategy nor system, resulting in a lack of systematic information on project outcomes and impacts in various areas. They have never hired M&E staff with the appropriate background and do not have a culture of using data for decision-making. As part of the agreement to extend the project -3 - closing date by six months, the project team will prepare a detailed M&E operational plan and develop indicators to assess performance of municipalities financed under the fund-to-fund transfer in 2003 before the 6-month extension period is over. Program sustainability needs to be addressed: The project needs to decentralize financing and decision-making to the states and municipalities (and thus be in line with current health sector reforms in Brazil), and reduce its operational costs at the center. AIDS II only contemplated the decentralization of the supervision of its NGO-implemented subprojects to the states. The project went further than what AIDS II required, by transferring the bidding and selection processes for the NGO subprojects to 8 states. Bidding for all other 19 states and financing of subprojects remained centralized. Given the decentralization of financing that currently prevails in the health sector, it is crucial that the AIDS program align its implementation strategy to be coherent with the rest of the health sector. The project took some steps in this direction in the last 6 months. In order to align the AIDS program with financing mechanisms currently employed in the health sector to allocate federal funds to state and municipal programs, the project has prepared a draft law that establishes a fund-to-fund transfer mechanism (federal level to state or municipal level health fund) for qualifying states and municipalities. At present a total of 411 municipal and 27 state health programs are eligible in terms of their epidemiological profile. They still need to qualify in terms of management capacity. This is an important advance in the process of decentralization and coherence with current reforms, and ensures funding for AIDS activities as part of the regular program of states and municipalities. However, a clear plan and procedures need to be developed to ensure the transfer works as an incentive and not merely as an entitlement. 2. Objectives The project would have the following objectives: fn Reduce the incidence of STDs, and HIV n Improve the quality of life for people living with HIV/AIDS (PLWHA) n Strengthen the sustainability of the national response To achieve the first objective, the focus would be on prevention activities targeting high risk populations (behavior change, condom use, needle exchange), extending Voluntary Counseling and Testing (VCT), Prevention of Mother to Child Transmission (PMTCT), prevention and treatment of STDs and in all of the above, improving the quality of services provided. To achieve the second objective, the project would provide treatment for opportunistic infections, protection of human rights, social/psychological support, and extending laboratory support for testing for HIV, and for following up patients under ARV. To achieve the third objective, the focus would be on: (a) increased decentralization of project management and implementation activities (NGO subprojects, fund-to-fund transfers) (b) strengthened management (strong M&E capacity centrally and state level, performance based management tools and processes, computerized monitoring system, improved surveillance); (c) - 4 - focus on more cost-effective interventions; and (d) identification of alternative preventive and curative strategies. 3. Rationale for Bank's Involvement The project is an important investment for the Bank, not just because AIDS prevention is a high priority for the Bank, but because of the high visibility of the program worldwide. It has been the leader in many respects, and despite the fact in some areas their coverage is not as great as it could be, they tend to do a better job than anyone else. Lessons learned will be applicable to parts of the majority of AIDS prevention programs currently supported by the Bank. Moreover, any gains in containing the epidemic in Brazil are bound to have spillover effects in other countries. 4. Description COMPONENT I: Improving the Quality and Coverage of Services (the response) Subcomponent 1: Improving Quality and Expanding Service Delivery (for those in fund-to-fund financing): Activities financed under this subcomponent are the same as subcomponent 2 but are financed through a different modality, and are managed at the state and municipal levels. Originally, the project team requested that this subcomponent be financed exclusively with counterpart funds. However, it seems likely that funds for NGOs in qualified states, for a total of US$12.8 million for the life of the project may be included in the transfers. Ten percent of resources transferred to each state will be earmarked for NGO subprojects, bringing the overall total allocated to the transfer to US$72.8 million. This would ensure Bank participation in the transfer mechanism. Services to be financed include both prevention and treatment and care activities. In Prevention and Promotion, the following services will be financed: behavior change to prevent STDs and HIV with a strong focus on high risk groups, mother to child transmission, condom promotion, risk reduction among IV drug users (needle exchange programs), IEC (information, education and communication), and the protection of human rights to encourage more people to test themselves. Services in Diagnosis, Treatment and Care include the expansion of voluntary counseling and testing services, expanded diagnosis and treatment for STDs, Opportunistic Infections, HIV (ARV not included in the project), home-based social/psychological care, palliative care, and strengthening instruments to guarantee protection of human rights, training on rights, advocacy targeting legislative and judicial branches of government. The laboratory network will be strengthened and some facilities will be upgraded. Subcomponent 2: Improving Quality and Expanding Service Delivery: Municipalities and States not in Fund-to-Fund Financing, and Strategic Projects/Investments. This subcomponent includes the same activities as above but will be financed via annual implementation plans with the states/municipalities rather than through fund-to-fund transfers. This will include all municipalities that have not qualified to receive financing via the - 5 - fund-to-fund transfer mechanism. This component also includes regional initiatives and areas which acquire strategic importance throughout implementation, giving the team some flexibility to address emerging issues. COMPONENT II: Scientific and Technological Development. This component will finance preparatory studies and infrastructure for clinical trials for vaccines to prevent HIV infection and microbicides, and improve effectiveness of treatment. Subcomponent 1: Readiness for clinical research. Establish GMP excellence centers, clinical support for participation in phase I, II and III clinical trials for the development of AIDS prevention vaccines and microbicides, bioinformatic support for clinical trials, and activities to prepare and promote civil society participation in clinical trials. The component would finance training of national institutions in international settings such as NIH, UNAIDS, ANRS, workshops for participants in trials, laboratory equipment and supplies for the implementation and monitoring of clinical trials, and computer equipment. Subcomponent 2: Implementation of studies. The contents of the studies are under discussion as many are not areas the Bank generally finances. The Carta Consulta was vague, but did mention research on new forms of treatment, side-effects of medications, and the development of new algorithms for treatment and testing, development of new rapid tests for HIV testing. They also want to pilot test new national products. COMPONENT III: Strengthening Program Management Subcomponent 1: Strengthening of Project/Program Monitoring and Evaluation. This subcomponent includes the establishment and operation of a Monitoring, Evaluation and Planning Unit at the federal level that will utilize performance based management to assess program progress in meeting specified targets (by region/target group/priority interventions), the resources dedicated to reach them, and utilize this information to redirect program activities for the following funding cycle (strategic planning). Similar, smaller units will be established in each state. States will analyze their own information and send a subset of information to the National Program for overall program direction and policy formulation. Emphasis will be made on training staff to use information for decision-making and setting the right incentives for them to use it. It also includes activities designed to strengthen HIV/AIDS and STD surveillance at all three levels of government. The current strength of surveillance is on AIDS. The focus of AIDS III will be to strengthen STD and HIV surveillance, particularly of high-risk groups. In addition, periodic behavioral surveillance surveys will be conducted. Thus, the subcomponent would finance the following activities at federal, and state levels: the establishment of M&E systems: (staffing, training on M&E, computerized management tools (hardware and software)); and, in the case of the federal level, this subcomponent would finance the operation of the M&E system, including consulting services to conduct quantitative and qualitative evaluations on a periodic basis, planning and evaluation meetings to discuss results, and specific operations research studies to - 6 - assess adequacy and quality of service delivery and to identify improved ways of delivering services, and beneficiary assessments to improve quality. The project would finance technical assistance to ensure adequate monitoring capacity and the opportune use of information for management and setting priorities. In the case of surveillance, the project will finance data collection and analysis, training at state level (municipal), assessment of quality of data, methods to improve data collection and reduce underreporting. Most of the funds for evaluation would go to the national and state levels. Activities for monitoring the meeting of agreed targets associated with the fund transfers to states and eligible municipalities would also be financed. Subcomponent 2: Strengthening Management Practices. This subcomponent will finance management training for the federal, state and municipal levels, and NGOs. In the case of NGOs training will also include: training on income generation and promotion of their services and to find other sources of financing. NGO forums will be established where non-existent, and strengthened elsewhere to strengthen their negotiation capacity vis-a-vis the states/municipal governments, providing them with political, institutional and financial sustainability. This component will also include the development and application of management tools, including such tools as logistics for supplies, software for inventory management and follow-up of individuals under HAART. Subcomponent 3: Strengthening Institutional Development of the PCU. This will include funds for the preparation of joint ventures/studies with other countries to improve program performance, to conduct studies included in Component 2, participation in international forums to exchange ideas and information, and to provide guidance in such important initiatives as the Global Fund to Fight AIDS, TB and Malaria. 5. Financing Total ( US$m) BORROWER $100.00 IBRD $100.00 IDA Total Project Cost $200.00 6. Implementation The project will be executed by the Ministry of Health through the National Coordination Program for AIDS and STD and by states and participatory municipal health secretariats. In addition, NGOs will be providing prevention and care services in all states. At least 10t of funds transferred to states will be executed by NGOs. 7. Sustainability The project needs to decentralize financing and decision-making to the states and municipalities (and thus be in line with current health sector reforms in Brazil), and reduce its operational costs at the center. AIDS II only contemplated the decentralization of the supervision of its NGO-implemented subprojects to the states. The project went further than what AIDS II required, by transferring the bidding and selection processes for the NGO subprojects to 8 states. Bidding for all other 19 states and financing of subprojects remained centralized. Given the decentralization of financing that currently prevails in the health sector, it is crucial - 7 - that the AIDS program align its implementation strategy to be coherent with the rest of the health sector. The project took some steps in this direction in the last 6 months. In order to align the AIDS program with financing mechanisms currently employed in the health sector to allocate federal funds to state and municipal programs, the project has prepared a draft law that establishes a fund-to-fund transfer mechanism (federal level to state or municipal level health fund) for qualifying states and municipalities. At present a total of 411 municipal and 27 state health programs are eligible in terms of their epidemiological profile. They still need to qualify in terms of management capacity. This is an important advance in the process of decentralization and coherence with current reforms, and ensures funding for AIDS activities as part of the regular program of states and municipalities. However, a clear plan and procedures need to be developed to ensure the transfer works as an incentive and not merely as an entitlement. With regards to operational/administrative costs, the project more than likely doubled its staff instead of than reducing it. There were as many as 470 people working in the unit up to June 2002. Although the Bank has been informed that about 200 staff left since, the project unit needs to downsize and decentralize if they are serious about sustainability and decentralization. 8. Lessons learned from past operations in the country/sector These are the lessons learned from the first AID & STD Control Project: Building a Constituency for the Project. Building support for the project at the local level before project implementation is labor intensive, especially for projects that are broad in geographic scope. Such an effort, however, can help to accelerate start up and promote timely implementation. NGO Participation and Effective Outreach to High Risk Groups. The implementation of HIV/AIDS and STD control efforts among specific high risk groups can be most effectively carried out by societal organizations that have formed a relationship of trust with members of certain high risk groups. The individuals being targeted often belong to marginalized segments of society with which governments may have little experience. NGOs can often bring more of the specialized knowledge needed and often have an established credibility with the target group. This is especially true for work with homosexuals, commercial sex workers, street people, and indigenous peoples. Greater Focus on Evaluation. Although the SAR included a long list of monitoring and impact indicators, the project still failed to track changes in high risk behaviors in key target populations. An effective evaluation plan should specifically define what survey instruments will be used, when they will be tested and applied, and by whom. A plan to execute these evaluation instruments should accompany the implementation plan to help ensure that appropriate baseline data are collected in a timely fashion. Appropriate Staffing of the Evaluation Unit. In order to ensure adequate evaluation of program activities, the project management unit should maintain sufficient qualified staff exclusively dedicated to the task of evaluation. -8- Cost-Effectiveness Analysis. A variety of disease control interventions are being carried out among a variety of targeted high risk groups. Optimally, the program should gather the necessary pre-and post-intervention data to determine the relative cost-effectiveness of these various interventions. This kind of analytical information would help the program to set priorities, especially when resources are scarce. Integration of Program Activities. There are many opportunities for integrating the program's various activities in prevention, surveillance, diagnosis, treatment, training and evaluation. To provide just one example, the counseling expertise in CTAs could be made use of in nearby day hospitals, in specialized ambulatory care units, or by local NGOs working with specific risk groups. Procurement. More intensive supervision, by project management and by the Bank, of the procurement process is necessary when procurement activities are contracted out to third parties. 9. Environment Aspects (including any public consultation) Issues Special or hazardous waste streams may be generated as a result of implementation of studies under component II. Therefore the project will be taking the necessary steps to ensure protection and safety training for workers that will be performing such services and to develop an adequate plan to manage resulting waste streams. 10. Contact Point: Task Manager Sandra Rosenhouse The World Bank 1818 H Street, NW Washington D.C. 20433 Telephone: (202) 473-2747 Fax: (202) 522-1102 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. Cleared by: Madalena Dos Santos, Sector Leader, LCC5C This PID was processed by the InfoShop during the week ending November 22, 2002. 9