Document of The World Bank FOR OFFICIAL USE ONLY MICROFICHE COPY Report No. 10165-IN Type: (SAR) Report No. 10165-IN HABAYEB, SI X80314 / D10025/ SA2PH STAFF APPRAISAL REPORT INDIA NATIONAL AIDS CONTROL PROJECT MARCH 9, 1992 South Asia Country Department II (India) Population and Human Resources Operations Division This document hlas a restricted distrbution and may be used by reciplents only in the performance of their officiu?. duties.o Its contents maiy not otherwise be disclosed without World Bank authorization. CURRENCY EOUIVALENTS (As of October 1, 1991) Currency Unit - Rupee Rupee 25.50 = US$ 1.00 Rupee 1.00 - US$ 0.04 METRIC EOUIVALENTS 1 Meter (m) = 3.28 Feet (ft) 1 Kilometer (km) 0.62 Miles FISCAL YEAR April 1 - March 31 ABBREVIATIONS AND ACRONYMS AIDS Acquired Immunodeficiency Syndrome ARC AIDS Related Complex CHEB Central Health Education Bureau CNB Central Narcotic Bureau DGHS Directorate General of Health Services ELISA Enzyme-linked Immunosorbent Assay GOI Government of India GPA Global Program on AIDS/WHO HIV Human Immunodeficiency Virus IEC Information, Education and Communication ICMR Indian Council of Medical Research IVDU Intravenous Drug User NH)HFW Ministry of Health & Family Welfare, GOI NACP National AIDS Control Program NACA National AIDS Control Authority NGO Non-governmental Organization NPCT National Program Coordination Team PCT Program Coordination Team PSI Population Services International PRAD Physician Responsible for reporting AIDS Diagnosis PVO Private Voluntary Organization SHEB State Health Education Bureau SPCT State Program Coordination Team STD Sexually Transmitted Disease TAC Technical Advisory Committee WB Western Blot WHO World Health Organization ZBTC Zonal Blood Testing Center FOR OFFICIAL USE ONLY AIDS Acquired Immunodeficiency Syndrome (AIDS) is a severe life-threatening condition which represents the late clinical stage of infection with the Human Immunodeficiency Retroviruses (HIV). This most often results in progressive damage to the immune, organ and central nervous systems. HIV invades the body's defense system, exposing the infected person over time to a range of lung disease, cancers, fungal infections, wasting, rashes, sores and other debilitating conditions until death. There is as yet no cure or vaccine. Anonymous HIV Testing HIV testing performed on blood samples without personal identity information which would enable the laboratory or arn official unit/agency to trace the results to the individual. There are two types of anonymous HIV testing: in the first, the individual voluntarily decides to have an anonymous test and in the second, the test is made anonymous by those carrying it out (unlinked). Counselling Process of dialogue and mutual interaction aimed to discuss problems, facilitate understanding, and increase motivation. In counselling, the psychosocial needs of the individual are taken into account together with, medical and legal needs. Counselling is designed to provide support at times of crisis, to promote it when change is required, to propose realistic action in the context of different life situations, and to assist individuals in accepting information on health and well-being and adapting to its implications. Counselling can be a process of advice-giving or of eduction, or it can respond to individual psychosocial needs. In practice, these different forms of counselling overlap. This document has a restricted distribution and may be used by recipients only in the performance of their official duties. Its contents may not otherwise be disclosed without World Bank authorization. - ii - HIV Screening The systematic application of HIV testing to any or all of the entire population, selected target population, donors of blood and blood products and cells, tissues and organs. UIV Testing Voluntary serological procedure for HIV infection markers for an individual person, whether recommended by a health care provider or requested by the individual. Savo-positivity Test results indicating infection based on serological testing. Latent, subclinical infections and carrier states can thus be detected, in addition to clinically overt cases. Surveillance Systematic, regular collection of information on the incidence, distribution, and trends of a specific disease used to plan effective control of the disease. Surveillance within the framework of the AIDS control program includes two components: surveillance on HIV infection and surveillance on AIDS cases. The AIDS case surveillance is carried out as a routine procedure by all medical institutions serving in- and out- patients. HIV surveillance comprises a series of surveys. Sentinel surveys, initial point prevalence surveys and repeated (periodically) point prevalence surveys in various groups of behavior are designed to meet various objectives of the HIV surveillance. Surveillance does not include mandatory testing. v iii - Unlinked anonymous screening When blood has been collected for a purpose other than HIV testing, it can be used for unlinked anonymous screening by removing personal identity information, (but not demographic data). Each blood specimen is given a number and the same number replaces the personal identity information on the forms. Thus, the results cannot be linked with information which would identify a specific individual. In this system, people cannot know the result of their test. Voluntary anonymous testing HIV test requested by an individual can be made anonymous when the individual does not provide a name or other information which would reveal his or her identity. However, general demographic data and HIV risk behaviors or factors can be collected. If voluntary anonymous testing approach is selected, counselling resources would be required, along with a clear plan for management of people who after being informed of a positive result, come forward for counselling and other services. - iv - IVDI NATIONAL_AIDS CONTROL PROJECT Table. of Cnte_nts -Page NO. SI-__ATA . . . . . . . . . . . . . . . . . . . . I . . . . . . . . vi GRE DITANDPROJECA_YI . .. . . . . . . . . viii I. MlV/'II_ l,lru ND SI A. The Issue of the Epidemic in India: Background and Dimensions . . . . . . . . . . . . . . . . 1 B. Development of HIV/AIDS Control Activities . . . . . . . . 2 C. Current Constraints on HIV/AIDS Control . . . . . . . . . 4 D. Past Experience . . . . . . . . . . . . . . . . . . . . . 9 E. Rationale for IDA Involvement . . . . . . . . . . . . . . 10 II. THE P JECT A. Project OriSins . . . . . . . . . . . . . . . . . . . . . 10 B. Project Objectives . . . . . . . . . . . . . . . . . . . . 10 C. Project Scope . . . . . . . . . . . . . . . . . . . . . . 11 D. Project Description . . . . . . . . . . . . . . . . . . . 11 III. PROJECT COSTS. FINANCING, IMPLEMENTATION AND MONITORING A. Costs. . . . . . . . . . . . . . . . . . . . . . . 23 B. Financing Plan . . . . . . . . . . . . . . . . . . . . . . 25 C. Recurrent Costs and Sustainability . . . . . . . . . . . . 25 D. Implementation . . . . . . . . . . . . . . . . . . . . . . 26 E. Monitoring and Evaluation . . . . . . . . . . . . . . . 28 F. Disbursements . . . . . . . . . . . . . . . . . . . . . . 30 C. Procurement . . . . . . . . . . . . ... . . . . . . . . . 31 H. Accounting and Auditing . . . . . . . . . . . . . . . . . 32 IV. BENEFITS Ag _RISKS A. Benefits . . . . . . . . . . . . . . . . . . . . . . . . . 32 B. Risks . . . . . . . . . . . . . . . . . . . . . . . . . . 34 V. AGREEMENTS REACHED AND RECQMENDATIONS . . . . . . . . . . . 35 This report Is based on an appralsal mission that visited India In October/November 1991, and consisted of: World Sank Stf: Salim Habayeb (mission leader and senior public health physiolan), Damianos Odeh (senlor economist, John Middloton (senior operations officer and back-up mission ooordinator), A. A. Contractor (publio health specialist) and Suzanne Morris (senior disbursement offlicer). Rlhard Skolnik (Chief SA2PM) participated In an advisory capaciy. World Health Organization: Karin Edstrom (Chief, CNPIGlobal Program on AIDS), Olavi Elo (VHO Representative to India), Lv Khodakovich (WHO medical offloe, Mikal Stampke (technical offioer) and Carol Larivee (health education speclall). Consultants: Joyce Lyons (Chief Technical Advisor, Asia and Pacific Reglonal Project, UNDP), William Smith (Executive Vice President, Academy for Eduoational Development, Washington), Eld Dlb (architeot and implementaton speolaillt, John Narkunas (Assistant Chief for Operations, Epidemolology Branch, Division of HIV/AIDS, US Centers for Dieasoe Control, and Sevg' Aral (researoh solentist, Divislon of STD/HIV Provention, US Centers for Disease Control). At Headauarters: David Dunlop (Ad). Prof. of Community and Family Medicine, Dartmouth Medical School and Jlan Mel Gan (financial analyst) assisted In Impact analysis. General Coordination and Supoer: Edward Davis assisted In preparing the document, graphics and annoxes. Vivian Mendoza assisted In mission arrangements and cost tables. Marilyn ChatterjI, Janet Nader and Jasvir Shasin assisted In the mission's preparation. Aruna Chandran assisted In data preparation. Peer.Reviewers: JowLuis Bobadlila (PHRHN), Mead Over (PHRHIl, James Greene (ASTPH, Michael Porter (ASTPH), Jlil Armstrong (AF2PIt) and Kerin Edetrom (Chief CNP, WHO, Global Program on AIDS, Genev). The project was endorsed by Richard Skoinik, Division Chlef, India Population and Human Resources Divsion) and Heinz Vergin, Director, South Asia Country Dopaitment Z -V Page No. ANNEXES 1. Profile of Sero-Positive Indians detected through September 1991. . . . . . . . . . . . . . . . . . . . . . . . . 37 2. Global Distribution, Projections and Dimensions of HIV/AIDS , 38 3. Projected AIDS Cases without and with the Project and Analysis of Return on Investment . . . . . . . . . . . . . 44 4. Impact of HIV/AIDS .4.7............. . . . .... 47 5. Budget and Finance . . . . . . . . . . . . . . . . . . . . . . 52 Budget Provision for AIDS . . . . . . . . . . . . . . . . . . 52 Pattern of Five-Year Plan Outlays . . . . . . . . . . . . . . 53 Strategic Plan for AIDS Control . . 54 External Assistance . . . . . . . . . . . . . . . . . . . . . 55 6. Organizational Structure . . . . . . . . . . . . . . . . . . . 56 7. Terms of Reference . . . . . . . . . . . . . . . . . . . . . . 57 8. Training Plans for the AIDS Control Project . . . . . . . . . . 62 9. Social Mobilization/NGO Collaboration: Implementation Matrix . 63 10. Collaborating Ministries . . . . . . . . . . . . . . . . . . . 64 11. Blood Banking Screening Facilities . . . . . . . . . . . . . . 65 12. Surveillance: Applications and Techniques . . . . . . . . . . 72 13. Operational Studies . . . . . . . . . . . . . . . . . . . . . . 77 14. Detailed Project Costs . . . . . . . . . . . . . . . . . . . . 83 Summary Accounts by Year . . . . . . . . . . . . . . . . . . 83 Financing Plan by Disbursement Category (US$) . . . . . . . 84 Summary Account by Project Components (Rs) . . . . . . . . . 85 Project Components by Year (Rs) . . . . . . . . . . . . . . 86 Financing Plan by Project Components (US$) . . . . . . . . . 87 15. Schematic Implementation Levels .88 16. Implementation Schadule . . . . . . . . . . . . . . . . . . . . 89 17. Distribution Network/Medical Store Depots . . . . . . . . . . . 90 18. Important Indicators Proposed by WHO for Evaluating the Global HIV/AIDS Prevention Strategies . . . . . . . . . . . 94 19. Reporting System Outline . . . . . . . . . . . . . . . . . . . 95 20. Supervision Plan . . . . . . . . . . . . . . . . . . . . . . . 96 21. Forecasts of Expenditures and Disbursements . . . . . . . . . . 97 22. Selected Working Papers and Documents Available in the Project File . . . . . . . . . . . . . . . . . . . . . . 98 - vi - INDIA iATXONAL-AIDS CONTRL PROJECT BASIC DATA A. general a Total Area ('000 sq. km) 3,288 Density per sq. km 259 1990 GNP per capita (US$) 340 1988 Population below absolute poverty level (&) - urban 28 1988 - rural 40 1988 Allocation of central govt. expenditure (%) - health 2 1988 - education 3 1988 Population urbanized (%) 27 1989 B. Population. Heialth. Nutrition and WID Total population (millions) 850 1990 Population annual growth rate (%) 2.1 1989 Crude death rate 11 1989 Crude birth rate 31 1989 Life expectancy 59 1989 Total fertility rate 3.9 1989 Current Contraceptive Prevalence Rate 40 1988 Infant mortality rate (under 1) 96 1989 Under 5 mortality rate 145 1989 Annual no. of births (thousands) 26071 1989 Annual no. of under 5 deaths (thousands) 3780 1989 Population per physician 2,610 1983 Population per midwife/nurse 2,251 1983 Population with access to safe water (%) - total 57 1988 - urban 76 1988 - rural 50 1988 Oral Rehydration Therapy (ORT) usage rate 21 1988 Infants with low birth-weight (%) 30 1985 Malnourishment (%) - pregnant women 50 1985 - preschool children 50 1985 Pregnant women immunized against tetanus 69 1989 Births attended by trained health personnel (%) 33 1988 Maternal mortality ratio (maternal deaths 400 1988 per 100,000 live births) v vii - C. du'catin Total adult literacy rate 44 1985 Male adult literacy rate 58 1985 Female adult literacy rate 29 1985 Primary school enrolment ratio (gross) - male 113 1988 - female 81 1988 Secondary school enrolment ratio (gross) 27 1988 Enrolment ratios: females as a % of males - primary school 72 1988 - secondary school 54 1988 Sources; World Development Report, 1991; Operations Research Group Survey; The State of the World's Children, UNICEF, 1991; Social Indicators of Development, 1990; and Safe Motherhood in South Asia, the World Bank and Family Care International, 1990. viii. INDIA RA_TIONAL AIDS CON4TROL X&O-JECT CREDIT -AND PROJCT UMR Bo,rover: India, acting by its President. Ban iciaresk: States and Union Territories of India. Amount: SDR 59.8 million (US$84.0 million equivalent). Telma: Standard, with 35 years maturity. On..lendin terms: Government of India to the States and Union Territories: in accordance with standard arrangements for development assistance to States and Union Territories. Descriptio: The project would support the Government's efforts in controlling the HIV/AIDS epidemic in order to preserve human capital development and to minimize the reversal of health improvements. The project would constitute a start-up investment to launch expanded preventive activities in t:he control of HIV transmission. The ultimate objective of the project would be to slow the spread of HIV in India so as to reduce future morbidity, mortality and impact of AIDS. The project would have a multi-pronged strategy and would comprise the following components: (a) promoting public awareness and communigy suRgort with a primary focus on sexual transmission, behavioral change and condom promotion through mass media communications nationally; private advertising agencies; NGOs to reach risk behavior groups in 12 States and Union Territories; and the existing health system countrywide; (b) improving blood safety from a current 30 percent to 90 percent of the blood supply, and enhancing the rational use of blood and the share of voluntary donations; (c) building surveillance and clinical management canacity to monitor the spread of the epidemic and to strengthen the skills of health staff and social workers in managing and counselling HIV/AIDS persons; (d) controlling sexually transmitted diseases by improving clinical services and case management in the country's STD centers and training private practitioners In metropolitan areas; and (e) strengthgening the management canacitv for HIV/AIDS control through the formation and support of organizational structures at the national and State level. i x i heiefi.ts: The project's interventions would help slow the spread of the HIV epidemic and would alleviate the burden of HIV/AIDS on individuals and their household, and subsequently on the sectoral and national levels. The project would contribute to preserving health status and previous investments in health. The project would have a significantly high return in terms of healthy life years saved. Externalities would be high and the project benefits would accrue to the society at large. Most importantly, responding to this priority now would cost only a fraction of what would be required at a later stage when the disease is allowed to become more widespread. It is estimated that at least 300,000 AIDS cases would be avoided on account of the project by the year 2000. Direct and indirect returns would be significant. The project would have a favocable WID impact by reducing women's mortality due to AIDS an6 STD morbidity affecting their reproductive health and would benefit poor segments of the population and migrant labor. Also, by enhancing prevention, the project would limit the shifting of health resources to additional curative care. By enacting higher standards for condom quality, the project would benefit not only HIV/STD control, but also family planning programs. Risks: There are several risks to the project. First, changing people's behavior is a difficult and prolonged undertaking and AIDS control has no quick solution. This would be addressed by making the project well focused on key actions through a multi-pronged approach, by using NGOs to reach risk behavior groups and by extensive participation of television and radio stations and the private sector in mass communication efforts. In addition, this project would be used to set the basis for more extensive AIDS prevention and control activities. Second, there are the usual risks of poor implementation of project investments by a Borrower whose implementation record is mixed. These would be addressed by the careful preparation of the project in those areas that have constrained previous social sector projects in India, by paying special attention to project management and implementation responsibilities, and by making good use during implementation of WHO technical assistance. Local Foreign Total US$ Million stmted Projle_L Cost Yg Strengthening Program Management Capacity 5.5 1.5 7.0 Promoting Public Awareness and Community Support 27.2 1.8 29.0 Improving Blood Safety and Rational Use 12.3 17.4 29.7 Controlling Sexually Transmitted Diseases 4.4 5.6 10.0 Building Surveillance and Clinical Management Capacity 11.S 2 1 13.4 TOTAL BASE COST 60.7 28.4 89.1 Contingencies 4.8 5.7 10.5 TOTAL PROJECT COST 65.5 ALL 99,6 /-a Including taxes and duties equivalent to US$3.6 million. Financing Plan GovernmeT . 14.1 - 14.1 WHO 0.4 1.1 1.5 IDA 51.0 33.0Q A_L TOTAL PROJECT COSTS _5,5 34.1 9. Estimated Disbursements DA PY MFY93 FY94 FY95 FY96 FYLFY98 Annual 12.2 20.1 20.3 16.3 14.6 0.5 Cumulative 12.2 32.3 52.6 68.9 83.5 84.0 Economic Rate of Return: Please see Annex 3. NATIONAL AIDS CONTROL PROJECT I. Ey/JAIDS SITUATION IN INDA A. The Issue of the Epidemic in India: Background and Dimensions 1.U1 The first person in India recognized to be sero-positive for the human immunodeficiency virus (HIV) was identified in 1986 among the prostitutes of Madras. Since then, surveillance activities have been gradually expanded to include males and females who practiced multipartner sex, intravenous drug users, pregnant women, blood donors and recipients of blood and blood products. The nationwide average HIV prevalence rate in the surveys has grown from 0.2 percent in 1986 to 1.3 percent in 1990. This represents a seven-fold increase within five years, which is alarming. HIV infected persons have been identified in every State and Union Territory where HIV testing facilities are available. The highest sero-positivity rates and number of AIDS cases have been reported from Maharashtra State, mainly from Bombay and Pune. Sexually Transmitted Diseases (STD) patients and prostitutes constituted two thirds of the HIV carriers. Out of 5,841 intravenous drug users (IVDUs) tested in Manipur by January 1991, 1135 were found sero- positive. It is expected that, with the stepping up of surveillance, more sero-positive cases will come to light. 1.02 The first case of acquired immune deficiency syndrome (AIDS) in India was also reported in 1986. Up to September 1991, 96 clinically overt cases of AIDS have been reported to the Directorate General of Health Services (DGHS) of the Ministry of Health and Family Welfare (MOHFW), and most have succumbed to the disease. 1.03 Heterosexual transmission is predominant. In addition, transmission is facilitated by a high incidence of STDs, especially among prostitutes and their clients. Infection is also being spread through intravenous drug use, especially in the Northeastern States. The blood supply is unsafe, partly since it depends on professional donors, many of whom are sero-positive. The distrLbution of 5,706 sere-positive Indians detected through September 1991 is shown in Annex 1. The vast majority of affected individuals are young adults in their most productive years. 1.04 Current estimates of HIV prevalence in India vary between 300,000 and 500,000 people, with some estimates twice these figures. Worldwide, HIV infections are estimated at 10 million people, almost half of whom are women, and to date about one million children are estimated to have been born infected. The HIV pandemic is composed of multiple epidemics throughout the world. The projected annual HIV infections in Asia, Africa, Latin America, North America and Europe as well as the current and future dimensions of the pandemic are summarized in Annex 2. A dramatic increase is anticipated in Asia and, if transmission continues at the same pace as it is now, annual infections in Asia alone would exceed one million new cases every year by the year 2000. -2- 1.05 The potential for HIV spread is high and the epidemic in India, described as a "silent volcano", may turn out to be the largest in the region. Prostitution is prevalent in all major urban centers in India. The problem of intravenous drug abuse is sizeable in the northeast. In addition, police records indicate heroin use and needle sharing by XVDUs in slum areas, industrial pockets, commercial and tourist centers, and some universities. There is a large homosexual population in Bombay. Skin pier'eing practices are prevalent in the community at large. It is estimated that about 30 percent of injections performed in public health facilities and by private physicians are unnecessary and could be easily replaced by oral medication. B. Develonment of HIVZAIDS Control Activities in India 1.06 HIV/AIDS control programs are in their initial stages and just beginning (paras. 1.15-1.16). The availability of related services is limited. The sections below describe what has been initiated so far. 1.07 Institutional Arrangements. An AIDS task force was established by the Indian Council of Medical Research (ICMR) in 1985 and screening of risk behavior groups started at the National Institute of Virology, Pune, and the Christian Medical College, Vellore, that same year. The ICMR, in collaboration with DGHS, also initiated sero-surveillance activities in 1985. The National AIDS Committee was formed in 1986 under the chairmanship of the Secretary, MOHFW, and included the Director General of Health Services, GOI; Director General of ICMR; senior officers of GOI's MOHFW; representatives from other concerned organizations as members; and the Administrator of the Voluntary Health Association of India. 1.08 The main function of the National AIDS Committee was to advise MOHFW on major policy issues and strategies. Representatives from States with high reported incidence were also invites to participate in the committee meetings. Several State Governments have assigned staff to AIDS control on a part-time basis. 1.09 N_ational AIDS Control Prgram. The Control Program was formulated In 1987 and included surveillance, screening of blood and blood products, health education and information. As discussed later, however, present program activities are limited in scope. The Directorate General of Health Services within MOHFW is responsible for AIDS control activities in the country. The DGHS provides the necessary logistics, HIV test kits, spare- parts and ELISA readers to surveillance centers and training facilities. 1.10 Sero-surveillance. The activities undertaken during Phase-I of sero-surveillance, in 1985-1986, confirmed the presence of HIV infection in India. In 1986-1987, during Phase-II, infection among multipartner heterosexual males, pregnant women, blood donors and recipients was detected. This phase concluded that multipartner sex played a major role in the transmission of HIV infection. During the first part of Phase-Ill, from November 1987 to October 1988, It was concluded that there was a need to: initiate routine screening of blood transfusions; provide health education to high risk groups; establish clinical faci'ities for care and counselling; -3- develop hospital policies; expand diagnostic capabilities; and initiate sentinel surveillance. The second part of Phase III, from November 1988 onwards, focused on screening blood donors, blood products, blood recipients, diagnostic screening and training of personnel. Regarding clinical surveillance, GOI has sent a group of physicians and nurses abroad for training in clinical, laboratory and hospital management aspects of the disease. They have become trainers and conducted courses in the medical colleges. 1.11 Screeing ofBlood an Blogd Products. This is a significant preventive tool since the probability of transmission of HIV infection through infected blood e,xceeds 90 percent. Testing of blood donors was started in the Christian lMedical College, Vellore; Madras Medical College; National Institute of Communicable Diseases, Delhi; and All India Institute of Medical Sciences, Delhi. Currently, about one third of the blood supply in the country is being screened. The zonal referral system has been designed with the idea that a group of blood banks are attached to a zonal center for testing by the Enzyme- linked Immunosorbent Assay (ELISA) test. There are 1,018 blood banks in the country handling an estimated two million blood units per annum. The following is the profile of the blood banks in the country: Government blood banks 608 Private hospital blood banks 151 Private commercial blood banks 203 Voluntary blood banks 56 1.12 The Drug Controller 'of India issued guidelines for manufacturers for rigorous prec&utions regarding the safety of blood products in March 1989. There are nine manufacturing units in the country: six in Bombay, two in Madras and one in Faridabad. The following major blood products are produced locally: ANTI-D Rh Immunoglobulin; Human Normal Immunoglobulin; Anti- hemophiliac factor VIII; Histaglobulin; Placental extracts; Tetanus Immunoglobulin; and Albumin. Relevant agencies of GOI including ICMR and four Referral Centers collaborate in the evaluation of HIV tests available on the market. 1.13 H&aJ,th Educatoln and Information. The Central Health Education Bureau (CHEB) subordinated to DOllS is responsible for promoting public awareness. To date, the activities of the Central Bureau have included: press advertisement in important newspapers; display boards; printed material prepared for different categories of persons including health care workers, medical colleges, hospitals and State Governments; bus panels developed and displayed on Delhi buses; and cinema slides released to cinema halls in New Delhi. Similar efforts have been initiated in the larger cities. Also, several NGOs have become involved in health promotion activities in the metropolitan areas. 1.14 With the collaboration of the United Nations Fund for Drug Abuse Control, GOI has initiated measures to reduce drug abuse. These include legislation, communication, preventive education as well as early identification, treatment and rehabilitation of drug dependents. The CHEB is -4- planning to collaborate with the Narcotic Control Bureau to include HIV related messages in its educational work. C. Current Constraints on RIV/AIDS Control 1.15 Institutional Arrangements and Scope of Coverage. Since the HIV epidemic is relatively recent in India, initial responses and control activities have been limited in geographic range, population coverage, resource allocations, and mobilization of other sectors. Access to communities at risk is lacking. The public sector does not have the capacity and the resources to effectively reach risk behavior groups. Developing the administrative structure and capability to manage the program is needed. Continuous monitoring of the epidemic is vital and surveillance needs to be broadened. Screening of blood transfusions is now limited to 30 percent of the blood supply. Mobilization of other Ministries needs to be developed. 1.16 State authorities need to enhance their involvement in health promotion activities and to develop a better understanding of the options for community based support for HIV sero-positive persons. Limited capacity of the State health institutions necessitates wider cooperation with NGOs, the private sector and other sectors in order to cope with the ensuing health and societal impact of AIDS. 1.17 Technical and Strategic Issues. The technical and operational skills of professional staff needed to deal with HIV control are weak. Information, education and communication (IEC) skills are required for linking audience research with strategy and materials development. Current public sector capabilities are not sufficient to carry out needed communication activities. The private sector capacity is extensive in India and GOI and State Governments will need to tap its resources to strengthen AIDS prevention and control activities. 1.18 Several condom utilization issues are related to the variable quality of condoms and to the need for promoting their use as a preventive device. Access to condoms has grown impressively in the country and sales of the NIROD condom brand have risen from 25 million in the 1960's to about 350 million in 1990. India is currently self-sufficient in condom production with an operating capacity of approximately 2 billion condoms per year from several manufacturing plants. However, condoms are seen largely as a family planning device. Repositioning condoms as an STD/HIV prevention tool with extramarital or premarital partners presents a significant problem for overcoming prevalent negative behavioral attitudes of men towards their use. 1.19 Adapting major preventive themes effectively to the cultural and linguistic variety in India is a challenge. Consumer research and appropriate integration of condom programming activities with the existing and expanded capacity of GOI's social marketing program for family planning could significantly accelerate STD/HIV prevention. Health education to date has stressed the basic facts of AIDS after using a forceful fear approach. There are risks of needless fear arousal, misinformation and stereotyping without offering hope or communicating across the many cultural barriers in the society. - 5- 1.20 Since quality control is an essential component for any laboratory test, strengthening is needed to support the network of laboratories performing HIV tests. This is of special significance in HIV testing because, at present, diagnosis is made solely on the basis of laboratory results. 1.21 Existing STD services are underfunded and lack basic resources such as diagnostic equipment and medical supplies. STD program management suffers from understaffing at the national level and at the municipal level in the largest cities. Staff skills require upgrading. Strengthening and reorientation of STD control constitute long term challenges, particularly for enhancing the involvement of peripheral health facilities and promoting the interest and role of the private sector in early diagnosis and treatment of STDs comblined with condom promotion. 1.22 Although no comprehensive data on the prevalence and incidence of STDs in India exists, the available information indicates that STDs represent a serious health problem in both urban and rural areastl. 1.23 STDs are associated with the same risk behaviors that put a person at risk for HIV infection, and ultimately AIDS. In addition, STDs are now recognized as an independent risk factor for HIV/AIDS, facilitating both the acquisition and transmission of HIV. Although STDs pose a serious public health threat in their own right, being responsible for considerable morbidity and long-term complications like pelvic inflammatory disease, infertility and neonatal infections, it is this relationship to HIV infection that renders STD control imperative in the prevention of HIV infection. First, STD control would remove these diseases as a risk factor and so reduce HIV transmission. Second, STD control programs, by providing good quality clinical services to STD patients, would also provide access to this heterogeneous and often elusive group. This would provide a unique opportunity for IEC and counselling. 1.24 agIs and Ethical Issues. HIV infection raises multiple social, legal and ethical issues worldwide. The following central questionall are often raised in various debates: (a) What is the best public health approach to people with HIV infection and AIDS and what rights should they have? (b) Whether testing should be mandatory. Who should be tested? (c) Who has the right to know if someone has the infection? Is there a duty to warn others? 3 Bang R., Baitule M. et al. High prevalence of gynecological diseases in rural Indian Women, Lancet, 1989, 85-89. 21 Connor S. Issues of the "Third Epidemic" in AIDS: Profile of an Epidemic, Pan American Health Organization, No. 514, Washington, D.C., 1989, 141- 158. -6 - (d) How can society be protected against people who irresponsibly infect others? 1.25 All of these questions involve essentially the same analysis. First, where do we draw the line between the rights of the individual and the rights of the society? aegond, how do we balance those interests? Thi what is the best way to protect individuals at risk and society as a whole against the spread of AIDS? And fourth, what relsvant scientific evidence exists regarding transmission, prognosis, treatment, testing, behavior modification, counselling, education and informacion? 1.26 These considerations are critical for HIV control, where the scientific evidence points to spread from intimate behavior censored by most societies such as multiple sexual contacts and intravenous drug abuse. The level of social tolerance or disapproval varies widely from country to country, and every nation also has different traditions governing the strength of individual rights versus those of the society at large. 1.27 The challenge is to elucidate the best way of protecting public health from a scientific standpoint without improper impairment of individual rights. In India, these issues should be viewed in the context of constitutional protection of individual rights through an independent judicial branch of government, as well as a constitutional framework within which public policy is developed and implemented. 1.28 Financial Impact of AIDS and related Issues. The costs of dealing with AIDS cases including medical treatment, counselling and care are significant. Under current epidemiological conditions in India, it is projected that about one million clinically overt AIDS cases would result by the year 2000 (Annex 3). Direct costs of medical care would escalate yearly to reach a total of about US$1.6 billion equivalent by the year 2000. The cost incurred by the Union and State Governments would exceed US$1.3 billion equivalent during the same period, while the remaining portion of other direct costs, mainly in the private sector, would amount to US$300 million. The indirect national income loss is estimated to be about US$1 billion equivalent for every 100,000 AIDS related deaths. 1.29 Based on available information and related international experience, the mission estimates that the total direct lifetime treatment costs per AIDS case in India to be about US$950 at present. This covers the cost of ambulatory treatment of illnesses related to AIDS (US$20011) and I, Assuming 30 illness episodes per case due to opportunistic infections and ARC/AIDS morbidity, of which only 20 episodes would be treated at a cost of Rs 250 (US$10) per episode. The cost per episode is derived from the Household Survey of Medical Care conducted in July 1990 by the National Council of Applied Economic Research and is adjusted to reflect the most common morbidity associated with AIDS. -7 - hospitalization costs (US$750J). Data also shows that 60% of the illness episodes are addressed in the private sector and that 90% of hospital costs are borne by the Government. When quantifying actual health care expenditures, it should be noted that persons with AIDS seek treatment for opportunistic infections, cancers and other ARC/AIDS morbidity and are not necessarily recognized as having AIDS. 1.30 Indirect costs are more complex to quantify. They cover economic, social and psychological costs both to the individual affected with AIDS as well as to the society at large. What is certain, however, is that indirect costs per AIDS case are much higher than the direct costs of US$950. International experience suggests a multiplier of no less than 20 times11. The potential socio-economic impact of AIDS will first be felt at the household and community level. When the disease disseminates, macro-level impacts will be observed at the sectoral level and finally at the national or economy-wide level. At the household and community level there are at least twelve impacts, from loss of economic security for the remaining members of the household or community to the additional costs of medical care devoted to parsons affected by the disease (Annex 4). The toll on family life, on women in their prime childbearing years, and on the generation of an increasing number of orphans is profound. Only two items will be quantified here as examples of the magnitude of such indirect costs; wages lost due to ARC/AIDS related morbidity prior to the death of an AIDS patient and the income lost due to early death: (a) Lost Wages. Based on reviews and discussions with health authorities in India, it is estimated that an AIDS patient would require about 250 - 300 days of care prior to death. Correcting for under-age, over-age, and unemployment, among others, about 15011 days of work would be lost due to infections and morbidity associated with AIDS. Assuming a daily wage of US$4.0, an AIDS patient would lose about US$600 in unearned wages. (b) Early Death. Approximately 75 percent of HIV infected persons in India are 20-35 years old. Another 15 percent are in the age group 35+ and only 10 percent are below 20 years of age. Conservative estimates imply that an a'-erage of 15 potential earning years would be lost by an infected person. Adjusting for unemployment and non-income earning individuals, an average AIDS AI The mission estimates that an AIDS patient would require about 250 days of care, of which 10% (25 days) would be hospital care at a cost of Rs 750 (US$30) per day. Al Over M. et. al. The direct and indirect cost of HIV infection in developing countries. The case of Zaire and Tanzania. The global impact of AIDS, pages 123-135, 1988, Alan R. Liss, Inc. 3/ 30% due to holidays and non-working days; 10% unemployment factor; and 10% for underage. -8- person would lose about eight income earning years. Applying an average income earned per working person of US$1,050 per year would mean that about US$8,400 of future income would be lost to the economy for every case of death of an AIDS patient. 1.31 Present levels of public expenditure on HIV/AIDS control are very low at about US$1.5-2.0 million per year and the initiation of a major start-up investment to launch expanded preventive activities is needed. 1.32 During 1986-1991, MOHFW allocated Rs 150 million (about US$6 million) to the National AIDS Control Program (Annex 5, Table 1). Two-thirds of this allocation was spent on HIV kits and ELISA readers, and the remaining one-third on health education and training. An additional Rs 85 million (US$3.4 million) were given to the States to improve blood safety programs during 1987/88-1991/92. 1.33 Primary health care and communicable disease control have been receiving a declining share of total health resources. Per capita annual government expenditure on health and family welfare programs amounts to US$4, of which the Center spends US$1 and the States about US$3. Public health expenditures remain extremely dependent on tax revenues. User fees and health insurance finance a negligible share (2%) of government expenditures. 1.34 India spends about four percent of its GNP on both health and family welfare programs. While this share compares favorably with the average for Asian countries (3.1%), it is less than half of the 8-11 percent spent bn health in industrialized countries. Excluding the family welfare program, less than two percent (1.9%) of the total public sector resources in India are devoted to health. This share of 1.9 percent of the total budget was stable during the last three 5-year plans, Fifth, Sixth and Seventh, and constitutes a marked decline from the first two 5-year plans during which, over three percent were allocated to health (Annex 5, Table 2). 1.35 The Government's Strategic Plan for the Control of AIDS for 1992- 1996 proposes a level of expenditure of US$192 million for the next five years and is detailed in Annex 5, Table 3. Over the long-term, India will require additional financial resources to cover the costs of HIV/AIDS prevention and control including health education, promotion and counselling, all labor intensive priorities. In addition, there will be an exceptional burden to deal with the cost of medical care and social support of AIDS patients. Attention will need to be paid to the sustainability of these efforts, especially in a period of fiscal retrenchment. 1.36 External Assistance. WHO has provided US$525,850 in 1990-91 from the collaborative program as well as US$1.3 million from the GPA/HQ budget for HIV/AIDS control activities in the States of Maharashtra, Manipur, Tamil Nadu, West Bengal and Delhi. SIDA has provided US$246,000 and USAID contributed US$1.3 million for blood screening. The Ford Foundation has pledged US$150,000 in support of condom promotion activities in the prostitution areas of Bombay. 9_ 1.37 WHO intends to grant about US$5.8 million over the next five years for HIV/AIDS activities including US$1.5 million earmarked to support the currently proposed project. EEC intends to contribute about US$700,000 for health education and training of medical staff in Maharashtra State; USAID is planning to provide about US$10 million to assist NGOs in Tamil Nadu uuring 1992-1997; and ODA is considering providing US$3.0 million to West Bengal over the next five years. Other potential contributors to the AIDS prevention program in India are UNDP, UNICEF, UNPDC and NORAD (Annex 5, Table 4). D. Past ExMergiene 1.38 There is no past Bank Group experience in financing AIDS control in India. However, the Bank Group to date has financed one free standing AIDS project in Zaire, and AIDS components in several projects. In addition, considerable international experience has been accumulated from both developed and developing countriesVl. The main conclusions to date include: (a) the need for speed because intervening at the initial stages of the epidemic's development has a greater impact and a higher benefit-cost ratio than intervening at a later stage; (b) the need for a multi-pronged approach while prioritizing among interventions and maintaining the complementarity of synergistic efforts; (c) the importance of targeting core groups for cost effective measures; (d) the importance of controlling STDs; (e) mass media is important for changing social norms, while targeting specific groups through direct contact interventions is important for affecting behavioral change within those groups; (f) socio-cultural determinants are critical for considering strategies for influencing risk behavior; (g) behavior change is not only cognitive dependent on perceived personal risk but also situation dependent; this argues for manipulation of opportunity structures which are favorable to risk behavior such as those encountered in employment and migration; and (h) there is a need to go beyond the formal health sector in multidisciplinary and multisectoral directions. 1.39 The seven World Bank-assisted population projects, one maternal and child health project, and two nutrition projects in India have generally been implemented satisfactorily, with modest delays in the early part of the project. The completed Tamil Nadu Nutrition Project had a very positive impact on the nutrition status of malnourished young children. The Fourth Population Project, the Fifth Population Project, and the Health Component of the Third Calcutta Urban Development Project are ongoing but are already showing positive results on morbidity and fertility. However, lessons of experience suggest that greater attention needs to be paid to: the financing and management of projects; the management and supervision of staff; the training of personnel, the planning of work routines; and the supply of needed goods and materials. 1I Over M and Piot P. HIV infection and sexually transmitted diseases. Forthcoming in Dean T. Jamison and W. Henry Mosley (editors), Dieagggsg ntrol Priorities in Developine Countries. New York: OxfErd University Press for the Yorld Bank. - 10 - E. Rationale for IDA involvement 1.40 There are several reasons for involvement, which underline IDA's strategy for enhancing human capital development in India through high return investments. They also go along with our emerging objective of assisting India in controlling major health problems, while simultaneously improving quality, effectiveness and efficiency of health systems in a sustainable manner. First, the country is witnessing the emergence of an epidemic whose potential negative consequences are enormous if left unrestrained. In this context, it is necessary to assist the Government in reducing the risks of jeopardizing and reversing health improvements and sectoral achievements with enormous human, social and financial implications. The detrimental impact on maternal and child health would be especially significant. Second, the level of assistance required to respond to the epidemic cannot be fulfilled by other donors. Finally, there are high direct and indirect economic returns to the proposed investments. II. THE PROJECT A. Project Qri&Lns 2.01 In 1990, the Government of India, in consultation with 'WHO, prepared a Medium-Term Plan for the prevention and control of AIDS with an estimated total cost of US$20 million for three years. Its focus was on the four metropolitan cities and the States of Maharashtra, Manipur, Tamil Nadu and West Bengal. The plan was solid and the major States participated in its design. More recently however, the Government decided to enlarge and accelerate national prevention efforts. With this in mind, GOI has now prepared an expanded five-year strategic plan for HIV/AIDS Control (para. 1.35) to cover a broader range of activities and has prepared the proposed project to cover the most critical interventions over a five-year period. B. Prolect Objectives 2.02 The proposed project would initiate a major effort in the prevention of HIV transmission and would constitute a start-up investment to launch expanded preventive activities. The ultimate objective of the project would be to slow the spread of HIV in India so as to reduce future morbidity, mortality and impact of AIDS. 2.03 Operationally, project interventions would seek to achieve the following: (a) involve all States and Union Territories in developing HIV/AIDS preventive activities with a special focus on the major epicenters of the epidemic; (b) attain a satisfactory level of public awareness on HIV transmission and prevention; - 11 (c) develop health promotion interventions among risk behavior groups; (d) screen the majority of blood units collected for blood transfusions; (e) decrease the practice of professional blood donations; (f) develop skills in clinical management, health education and counselling, and psycho-social support to HIV sero-positive persons, AIDS patients and their associates; (g) initiate the strengthening of STD control; and (h) monitor the development of the HIV/AIDS epidemic in the country. C. Prolect Sope 2.04 The project is based on a centrally sponsored scheme for which the Union Government would bear all costs. The scope of the project would vary with each intervention, taking into account need, absorptive capacity, feasibility and efficiency. The scope of major interventions is elucidated in the following matrix of main project interventions. Training and mass media would be national; blood safety interventions would include the majority of blood bank centers; targeted health promotion is expected to be undertaken in at least 12 States through NGOs. The enhancement of STD control would involve all the public health sector's STD centers and the training of private practitioners would be done mainly in the four largest metropolitan areas. D. Proiect Description and Strategv 2.05 The Project would take a multi-pronged approach that would focus on the most critical interventions to begin limiting HIV transmission today. It would also set a basis for more extensive HIV/AIDS control activities in the future. The proposed project would take account of currently available scientific information and the lessons of experience from AIDS control worldwide (para. 1.38). Project activities would be integrated to the maximum extent with the existing health infrastructure; they would also make extensive use of the private sector and NGOs in areas in which they have a comparative advantage. The project would consist of the following components: (a) Strengthening the Management Capacity for HIV Control; (b) Promoting Public Awareness and Community Support; (c) Improving Blood Safety and Rational Use; (d) Building Surveillance and Clinical Management Capacity; and (e) Controlling Sexually Transmitted Diseases. - 12 - 2.06 The matrix on pages 14 and 15 summarizes the constraints on existing HIV/AIDS prevention efforts, activities proposed to address them, and the outcomes that are sought. STRENGTHENING HIV_CON_TROL MAAGEMENT CAAIY U Z. Millign.L1 2.07 Institutional limitations are major constraints to the implemeutation of HIV control activities, as discussed earlier. While overall policy regarding AIDS control would be coordinated by GOI through an interministerial committee, GOI has designed the following structures (organization and terms of reference in Antnexes 6 and 7 respectively) in order to coordinate project implementation: (a) Gentrnl level: (i) Board for the Prevention and Control of AIDS acting as the executive body within MOHFW, vested with administrative and financial powers, chaired by the Secretary of Health, and includes a representative of the Ministry of Finance; (ii) National AIDS Control Authority (NACA) acting as an operational body for day-to-day implementation; and (iii) Technical Advisory Committees (TAC) for social, ethical and legal issues; IEC; condom programming; STD control; NGOs; blood safety; epidemiology and research; case management; and women & children's health. TAC would include representatives of leading institutions, the private sector and NGOs; and (b) State level: AIDS Control Cells and Empowered Committees. 2.08 Strengthening Central and State Management Canabli_ties. The project would strengthen and develop program planning, coordination, management and monitoring capabilities at the national and State levels to deal with HIV control, providing technical and operational support to organizations and staff who are implementing project activities. To achieve these aims, the project would provide consultant services, training, computers, typewriters, photocopiers, office equipment, MIS materials, IEC materials, vehicles, incremental salaries for additional staff, civil works, and operation and maintenance of vehicles and MIS office equipment. 2,09 Gentral Level. A National AIDS Control Authority (NACA) would be formed prior to credit effectiveness and would be headed by an administrator with adequate seniority and experience. He/she would act as Project Manager and would be assisted by two technical officers of the rank of Deputy Director General, responsible for implementing activities connected with surveillance, training, case management and blood safety. A Director (Media) would be appointed to coordinate lEC activities with Central/State Education Bureaus, the Ministry of Information and Broadcasting, private agencies with expertise in production of media software, and non-governmental organizations that would be involved in promoting IEC in groups practicing risk behavior. The staff would include a director for finance and accounts, a director for procurement, an administrative officer, field monitoring staff and support staff. - 13 - 2.10 The NACA would function as a Secretariat for national AIDS control, for the Board and the technical sub-committees. An office facility would be built at a site owned by MOHFW in New Delhi to house the NACA team and WHO resident technical assistance. The NACA team would be responsible for planning, coordinating, managing an-1 monitoring project activities. Ths central ooordinating staff of NACA are critical to the successful start-up and execution of the project. A condition of effectiveness would be that the Government shall establish and thereafter maintain a National AIDS Control Authority, with adequate full-time staff, other resources and terms of reference satisfactory to IDA, and that the designated staff shall have commenced work. 2.11 Stati' _leyel. The National AIDS Control Authoricy would operate through State AIDS Control Cells and Union Territory (UT) Cells that would be established in the Project States and Project UT's Ainistries of Health and financed by the project. Each AIDS Control Cell in the larger States would have an Additional/Joint Director assisted by two Deputy Directors and three support staff. Control Cells in smaller States would have one Deputy. The Cell would be responsible for planning, coordinating, implemenAing and monitoring project activities in each State. The terms of reference of the State AIDS Control Cells would be in line with those of NACA, and adapted as necessary according to conditions in each State. At negotiations, the Government provided assurances that, except as IDA may otherwise agree, it would cause project States and Union Territories to establish by a date agreed with IDA and maintain AIDS Control Cells in their respective Departments of Health, with appropriate staff and resources, for planning, coordinating, implementing and monitoring isplementation of the project in the concerned State or Union Territory. 2.12 In order to implement this institutional development componenc, the project would provide both NACA and the States with inputs listed in par%. 2.08 above and consultant services with terms of reference agreed with IDA. The Association reviewed at appraisal the schedule for staffing the national and State Cells. It is expected that 80 percent of the State/UT staff would be appointed 3 months after endorsement of the project by the Union Cabinet following negotiations; and 100 percent, six months later. A condition of disbursement for expenditures incurred by any State or Union Territory would be that the Borrower furnish IDA with a Letter of Undertaking satisfactory to IDA from that State or Union Territory. Those letters would outline how each State/UT would carry out its part of the project. Such letters will also refer to the considerations discussed in paras. 3.22-3.23. 2.13 Training. The project would finance training workshops to train 38 trainers, 168 high level officials from the Center and the States/UT, and 130 mid-level administrative officers. Training location and duration are shown in Annex 8. In order to coordinate AIDS control activities with other sectors, NACA would liaise and establish working relations with other A State - State/Union Territory - 14 - SUMMARY MATRIX OF MAIN PROJECT INTERVENTIONS AND THEIR SCOPE Project iS intervention Limited capacity to Develop organizational structurq manage and coordinate and skills; provide Information control activitles support and technkc'al assistance Lack of awareness on Informatlon, education and risk behavior communlatlon through mass medla, little medla, private advertising agencies, health education bureaus and through health staff Lack of access to Targeted health promotion risk behavior groups/ Interventions Including condom communities use through NGOs Lack of skills to manage Train',0g health staff and HIV/AIDS patients and to medilcal social workers provide counselling HIV transmisslon Develop blood screening through blood capabilities transfusions Increased risk of HIV IEC transmission through sold Expand voluntary donor base blood with NGO assistance Develop plan for phasing out sold blood In future strategic plan Insufficient supply of Establish component separation blood components capabilities In larger blood centers Inefficient management of Strengthen management tearis, blood transfusion services monitoring and Inspections Lack of quality control In Training and certification of private blood centers FDA Inspectors and enhanced monitoring Limited Information on the Develop capability for swreening, epidemic's development research and surveys Sexually transmitted - Strengthen STD servces through diseases catalyze HIV training and provision of transmission iaboratbry equipment, medical supplies, early diagnosi s and therapy, condom promotion - lEC - Training private practitioners In metropolitan areas - Develop plan for further expanslon of STD control In future Inadequate quality of condoms Enact higher standards for condom quality - 15 - Expected National AIDS Control Authority Institutional development In and States AIDS Control Celia HIVIAIDS control management NaSlonal Increased knowledge of risks Reduction In risk behavior 12 States increased condom use and tO0 NGOs capacity building for NGOs Natlonal Capacity building for better care, psychological support and fostering the spirit of understanding and compassion for HIV hfected people 608 blood banks including Increase blood safety from 30% 118 zonal centers, upgrading to 90% In 1996. 90 banks, 30 component separation and rapid dlagnostic tests In remaining banks National Safer and more adequate blood supply 30 Centers Rational use of blood and resources, reduction of of whole blood use National Improved management efficlency and quality control Private blood banks StandardizatIon and Improvod leveI 0f performance and safety Selected samples throughout Avallability of Information for the country the epidemic monitorin and measuring Interventions ffect All 372 SD clinics Reduction of morbidity associated of the pubilo health with STO and reductlon of HIV sector transmission National Metropolitan areas/ and red-light districts Natlonal Inc.ased effactiveness In the prevention of HIV/STD transmisslon - 16 - ministries, social institutions, religious organizations and NGOs, and would assist them in establishing their own AIDS coordination committees and designating a liaison officer. NACA would provide these sectors with the necessary technical advise for promoting HIV prevention end coping with AIDS. Overseas fellowships and study tours are planned by the Government, but would be sponsored by multilateral and bilateral grant funds. 2.14 taning: for ,thefuture. The project would be a first critical step in strengthening control interventions and institutional capacities for dealing withl HIV. During negotiations, the Government provided assurances that it would develop under terms of reference satisfactory to IDA and provide to IDA by June 30, l995, a strategic plan, for the next phase of the Goverrament's progl'am for HIV/AIDS control. The tentative outline of the strategic plan has been agreed at appraisal and the final terms of reference would be agreed with both IDA and WHO prior to drafting after the project's mid-term review planned around December 1994. The plan contents would be similar to the current strategic plan that was developed with the technical collaboration of WHO and would also include: the role of the private sector, the role of other ministries, sustainability of interventions, feasibility of cost recovery in blood testing, control of sexually transmitted diseases, phasing out of paid blood r!onations, feasibility of using disposable syringes and needles, medical waste disposal, expanding control interventions and surv kllance in semi-urban and rural areas, counselling and home care. The project would provide funds for the preparation of subsequent investments in AIDS control. Also, the proposed project would include funding for the preparation of health projects in other critical areas of priority in health. This would further strengthen institutional capacities to deal with key health issues. PLIOLAA- NES1 AND COMITY SUPPORT Q6SS1. Million! 3l.3% 2.15 In order to support the promotion of public awareness and social mobilization, the project would provide for IEC materials, consultant services and private advertising agencies, radio and television advertisement/publicity services, NGO services, audio-visual equipment, HIS materials, training, workshops and conferences. 2.16 GO is emphasizing three objectives for its mass awareness strategy within the national effort seeking to attain behavioral change that would contribute to the reduction of HIV transmission: (a) promotion of safe practices including safe sex, use of sterilized/disposable needles, use of uninfected blood and blood products, and upgrading the standards of health care; (b) Influencing sexual behavior patterns in the society; and (c) improving the knowledge of risk behavior groups, potentially vulnerable groups and health service providers about HIV and AIDS. Based on currently available information, It in clear that prevention of sexual transmisslon in urban centers throughout the country would be a major priority since sexual transmission can be reduced through informed and responsible behavior. The IEC strategy would depend on two components: - 17 - (a) Mass media: for creating a favorable environment towards prevention, providing critical information and facilitating adoption of safer practices in the community across the whole social fabric; and (b) Interpersonal communication and focused health promotion interventions largely to persons practicing risk behavior: face to face contact with: (i) commercial sex workers and their clients; and "madames" and 'supervisors" who influence decisions related to condom use; (ii) IV drug users and STD patients; (iii) vulnerable persons likely to engage in risk behavior practices such as migrant workers, truck drivers and adolescents; and (iv) persons at risk of acquiring the infection due to factors outside their control such as mothers, and patients in need of blood or blood products. 2.17 Although categorization of the target populations does not apply homogeneously throughout the country, GOI would follow three broad assumptions in project implementation: (a) Access to risk behavior groups through the existing government machinery is inadequate from the point of view of both resources atnd staff attitude. Since NGOs often have more effective access to the community thian governmental institutions, it is imperative to reach such groups through the channels and services of NGOs who can provide intensive interpersonal communication and promote condom use. (b) The role of NGOs and action groups in HIV control is currently marginal and requires motivation and stimulation by the States. So far, there has been no significant HIV/AIDS control interventions by NOOs as much of the current NGO movement is characterized by a heavy dependence on government aid. (c) Among the rural communities, it is the Government and not NGOs that would need to be the key actor, utilizing several formal and informal communication channels available; health workers, trained birth attendants, anganwadi workers, school teachers, village headmen, private medical practitioners, women's groups, and others. 2.18 Operationally, this has led GOI to adopt several approarhes under the project through the services of: (a) NGOs to reach risk behavior groups; (b) television, radio and private sector agencies for mass media; and (c) the existing health system infrastructure and resources. 2.19 Non-Governmental Organizagtjns. NGOs would be selected in urban areas for working among risk behavior groups and the services of about 100 NGOs would be engaged in at least 12 States. The NGOs would be selected through proposal assessment in accordance with criteria and procedures satisfactory to IDA. The process of collaborating with NGOs would be characterized by transparency in selection, flexibility of targets, and - 18 - accountability. The implementation matrix for NGO collaboration is shown in Annex 9. Funding levels would be set by the State Empowered Committees and State AIDS Control Cells. One autonomous institute of social sciences would be designated in each State as a nodal agency and would be assisted by the project to train, monitor and facilitate the work of NGOs. The nodal agency would liaise with the State AIDS Control Cell through an NGO adviser whose consultant services would be engaged on contract tG the Cell. During negotiations, the Government provided assurances that non-governmental organizations participating in the Project would be selected on the basis of criteria and procedures satisfactory to IDA. 2.20 The nodal agency would assist NGOs in developing their capacity to provide education and counsellinig services and to monitor performance. Its tasks would include identification and mapping of the NGO network; training in communication skills and counselling; project preparation and financial management; motivation of new NGOs through workshops; operational research; development of teaching materials for NGOs and associated software as required in their interaction with risk behavior groups and lastly, in regions lacking NGOs and public services, take up training of professional social workers for working in such areas. 2.21 The project would finance the nodal agency's consultant services and its inputs in NGO staff training, preparation of modules and IEC software. The project would also finance the establishment of a documentation center for reference use by NGO staff to obtain adequate information and to raise technical standards. Another advantage of collaborating with the nodal institutions is that, at the end of the project, a good resource center would remain with the required expertise and infrastructure to sustain related work. 2.22 The project would also finance workshops for twelve nodal agencies responsible for coordinating 100 NGOs involved in health promotion work with high risk behavior groups. A staff of three would be trained from each nodal agency, followed by the training of five persons from each of the 100 NGOs, aggregating to 500 trainees. The purpose would be raising NGOs capacity in preventive activities, program design and management skills. 2.23 The Pri_ate Sector. Services of private advertising agencies would be utilized for mass media interventions and development of media software. The primary targets would be the urban and semi-urban populations. During the first two years of the project, the development of uniting themes and messages and communication software would be centralized. Due to cultural and linguistic diversities, the States would be progressively assisted to develop materials targeted toward their own populations building upon the central messages. The Empowered Committee (para. 3.10) at the Center would include senior IEC officials of MOHFW, representatives of key departments having production capabilities or dissemination infrastructure, including the Ministries of Education and Information, and communication experts to help formulate the media strategy, identify communication needs, specify messages, identify agencies for the production of software, coordinate with the Ministry of Information in the production and dissemination of information, and -19- identify agencies capable of designing research protocols and carrying out operational research. 2.24 Software, including printed materials, audio-visuals and slides to be used in the mass media channels and by field workers would be developed by commercial advertising agencies. The agencies would design the media strategy, develop prototypes and arrange for the printing of the materials in regional languages to be supplied to the State AIDS Control Cells. Concurrently, creative talents existing in the Government line agencies would be identified and provided with training for taking up design and production of software. This would be valuable for: (a) institutionalizing and internalizing sensitized and trained human resources; and (b) ensuring coordination of project messages with family welfare and other health education programs to avoid the emanation of conflicting messages. 2.25 Radio and lTelvision Advertisement/Publicity Services. Such critical services for the dissemination of mass awareness would be procured directly from the Ministry of Information's radio and television stations in aecordance with procedures satisfactory to IDA. 2.26 The Existing Health Infrastructure. The resources in the existing network of the health system would be utilized to contribute on a sustained basis to the dissemination of information and health education to their clients in both urban and rural populations under their jurisdiction. This includes health personnel, training institutions, health education bureaus and health extension educators. 2.27 Training of primary health care workers would be implemented within the existing infrastructure. Health workers would receive training in communication skills, condom promotion and counselling. Since access to rural men and seasonal migrants, and the mobilization of community leaders constitute a continuous challenge, training would include not only skill upgrading but also understanding how to utilize available human resources - traditional birth attendants, private practitioners and other sectoral/village based functionaries. The Government intends to encourage the establishment of community groups with wide participation to facilitate the flow of information at the periphery, to promote safe practices and later to provide support services for the affected families. In order to orient health staff to meet the community's questions about the infection and to raise their skills in interpersonal communication primarily with risk behavior groups, the project would finance IEC in-service training for health staff (Annex 8) and counselling training of medical social workers in 130 medical colleges and social workers in STD clinics. 2.28 Intersectoral Coordination and Conferences for ORinion Leaders. A commonly encountered attitude towards AIDS is that it is "someone else's disease", which delays the development of timely interventions. Mobilizing political and so-ial leaders is critical in addressing this issue. Conferences for opinion leaders would be held annually at the Center and the States. Representatives of Union and State governments including members of parliament, ministries, social and religious authorities, industrial groups - 20 and senior administration and police officers would be invited. Participants would be briefed on the following subjects: (a) AIDS situation in the world, countries of South-East Asia, and India; (b) prospects on the epidemic's development; (c) major policies of GOI on HIV prevention and control; and (d) expected support to MOHFW from various sectors and social and non-governmental organizations. The project would finance these conferences, involving about 10,000 persons. 2.29 Ministries and Agencies (Annex 10) including Education, Women and Child Development, Labor, Youth, Police, Rural Development and Social Welfare would be prepared for their roles during the National and State workshops financed by the project. The purpose of training would be to increase knowledge about HIV transmission and its prevention and to develop program strategies which would integrate HIV/AIDS information into existing educational activities of the respective institutions. Training of Ministry cadre would be conducted by Core Training Teams which would be established at selected Government institutions: the National Institute of Health and Family Welfare in New Delhi and State Medical Colleges. BLOQD SAVETY.AND_RATIONAL USE (US=34,6 million: 34.8%) 2.30 Most of the blood donated in the country is handled in the urban areas of the country. In the four metropolitan cities of Bombay, Delhi, Madras and Calcutta, 29 zonal blood testing centers have already been established (Annex 11). Blood transfusion screening capabilities are also available in 37 other centers in the country. The objective of the project would be to expand coverage from a current 30 percent to about 90 percent of all blood donated in the country. The proposed project would: develop HIV testing capabilities in 52 zonal centers to reach an aggregate of 118 zonal centers; upgrade 90 blood banks, establish blood component separation capabilities in 30 centers; and provide the remaining peripheral banks mainly in district hospitals with rapid HIV tests. An aggregate of 608 blood banks would have HIV testing capabilities at the end of the project period. 2.31 In order to attain this objective, the project would finance the provision of laboratory, blood banking and component separation equipment and supplies, HIV and Hepatitis B tests, medical supplies, air conditioners, training and IEC. The project would also provide for computers at the State level, MIS materials, and incremetutal salaries for additional blood banking staff. In addition, the project would support 25 centers in order to perform Western Blot confirmatory HIV tests when medically warranted to individual sero-positive persons, and these facilities would be designated as reference centers. Each of these centers would be linked with 6-7 blood screening facilities for quality control. Selected reference centers would also collaborate with relevant GOI agencies including ICMR in the evaluation of HIV tests available on the market. 2.32 Training blood banking staff would be carried out by referral centers at their own laboratories. Training of reference laboratory staff would be undertaken in four advanced laboratories. The project would provide salaries of incremental staff at the reference centers which would be - 21 - reinforced by a post of deputy director or technical officer to monitor the laboratories subordinated to them. Local and international consultant services would be provided to NACA in order to improve reporting and quality control, referral, program monitoring, supplies management, maintenance, and training of personnel involved in the HIV screening network. 2.33 In order to protect laboratory and blood banking technical staff and medical staff from exposure to HIV infected blood, the project would finance protective clothing, gloves, and infection control medical supplies. Provisions would be made for safe disposal of HIV positive blood and serum samples and instruments by incineration, or disinfection by glutaraldehyde and sodium hypochlorite. BUIDIN CAACIY FR SRVILLANCE AND CLINICAL MANAGEMEN (US814.5 million: I4.6%) 2.34 Surveillance is synonymous with information gathering and analysis for disease monitoring purposes. It in the ongoing scrutiny using methods distinguished by their practicability, uniformity, and rapidity, rather than by complete accuracy. Its main purpose is to detect changes in trend or distribution in order to initiate investigative or control measures. 2.35 In order to support surveillance activities and raise clinical management skills, the project would finance training, provision of laboratory equipment, HIV tests, medical and laboratory supplies, audio-visual equipment, consultant services, surveys and operational studies, IEC materials, MIS materials and operation and maintenance of audio-visual and laboratory equipment. 2.36 As noted earlier, surveillance has been limited in scope and there are information gaps on the spread of HIV in India. Hence, this component is aimed at monitoring the development of the HIV/AIDS epidemic and acquiring information for programming control interventions. The network of facilities with HIV screening capabilities serves some or all of the following functions: sero-epidemiological surveilldnce, AIDS case surveillance, blood screening, confirmatory tests, specific research, and voluntary blood testing. HIV surveillance does not require identification of infected persons. Therefore unlinked anonymous screening would be used. Surveillance applications and techniques are described in Annex 12. For individual voluntary testing and referral cases, confidentiality we-ld be exercised and the training financed by the project would include learning about the legal and ethical responsibility to preserve confidential information. 2.37 HIV testing capabilities would be provided to 100 sites throughout the country. Sentinel surveillance sites would be selected where a predetermined number of persons from identified groups are routinely tested in a regular and consistent fashion, thus providing program management with an inexpensive and regular flow of data to monitor infection trends. Sentinel surveillance would include: (a) STD clinic attendants; persons practicing multipartner sex; and intravenous drug users; (b) inter-city bus and truck drivers; pulmonary tuberculosis patients; and (c) populations without - 22 - identified risk: out-patient attendants; antenatal clinics attendants; and voluntary/replacement blood donors. In addition, HIV point prevalence surveys would be conducted in 10 selected sites every year. Point prevalence surveys would be repeated at established intervals in order to evaluate the impact of interventions. The sites would be selected by the States in consultation with NACA on the basis of social, demographic and epidemiological indicators to represent various patterns of HIV transmission and stages of epidemic development. Technical and operational support for the surveys would be the responsibility of the State Program Manager in the AIDS Control Cell who would be assisted by the State epidemiologist on the methodology of sample selection and reporting. The State Program Manager would participate once a year at a national level review and training session. Cities with good performance in applying surveillance techniques would be selected for field demonstrations and training seminars. 2.38 In order to strengthen skills related to HIV control interventions and surveillance, and in order to manage the rising number of HIV carriers and the gradual development of manifest AIDS cases, training would largely involve medical, nursing and laboratory staff. A core training team from the 130 medical colleges would be designated and oriented as trainers. Administrators, medical social workers ansd private practitioners would also be included. Nursing staff would be trained on clinical management and counselling according to guidelines for counselling and psycho-social support developed by the national coordinating team. 2.39 Under the project. operational studies would be undertaken in order to improve action programs and services. They include two main groups: (a) socio-behavioral studies; and (b) epidemiological and intervention studies. A summary of proposed studies is shown in Annex 13. The project would finance the cost of these studies under terms of reference satisfactory to IDA and their results would be reviewed with IDA. The final objectives and design of the operational research would be determined by the requirements and stage of development of interventions. The studies would generate data quickly and provide information on the effectiveness of project interventions, socio-cultural information to increase the acceptability of interventions and information regarding the feasibility of new strategies. The objectives of this operational research would be to collect baseline information for planning and programming; measure changes in behavior relevant to HIV transmission, primarily regarding condom use in prostitutes and their clients; assess and allow for adaptations in control interventions before replicating in other areas; measure process and outcome indicators for evaluation purposes; assess mass awareness campaigns; and provide quality control. CONTROLLING SEKRUALLY TRANSMITTED DISEASES (USS1I.5 million: _11.61) 2.40 In order to address the issues raised in paras 1.21-1.23, the project would initiate the strengthening of STD control. The main objectives for this component would be to: initiate early and timely diagnosis and treatment; promote STD/HIV prevention knowledge and the use of condoms; and emphasize the importance of treating partners/contacts in the community. Toward these aims, the project would improve and strengthen clinical services - 23 - and case management in STD centers of 130 medical colleges and in 242 STD municipal clinics in the 13 largest cities and in all State capitals. These clinics cater for the urban population, to clients of the city's "red light" districts, and to referred patients from semi-urban and rural areas. While these clinics would target populations in the multiple epicenters of the Indian epidemic, this strengthening would also constitute a long-term investment by enhancing a nucleus network supporting the health care system at large and enabling further future strengthening at the primary health care level. 2.41 The project would finance training workshops for: (a) 75 key staff responsible for STD control at the national and State levels; (b) 25 trainers who would provide in-service training for 1,062 staff in 372 STD clinics throughout the country; and (c) 1,000 private practitioners involved in STD control practice in the four metropolitan cities of Bombay, Madras, Delhi and Calcutta. 2.42 As noted earlier, (para. 1.18), there are a. number of problems related to the use of condoms, including their quality. In conjunction with the project, the Government provided assurances at negotiations that it would by September 30, 1992, promulgate and thereafter maintain and enforce regulations requiring that all condoms manufactured or sold in India conform to quality standards established by WHO. Schedule R to the Drugs and Cosmetics Act, 1940, would be amended by GOI to establish revised minimum quality standards for condoms. A transitional period of about one year after amendment of the Act would be allowed before all condom manufacturing and sales would fully conform to the new standards. 2.43 The project would provide laboratory equipment and supplies for STD diagnosis; medicines for STDs; medical supplies; consultant services; training; operational studies; incremental salaries for additional staff; and equipment maintenance. STD educational messages would be integrated in HIV/AIDS educational materials. Also, as noted earlier, long term STD control would be addressed in the plan of action for the next phase of investments on AIDS prevention and control (para. 2.14). III. PROJECT COSTS. FINANCING. IMPLEMENTATION AND MONITORING A. Costs 3.01 Summary of Costs. The total cost of the project, including taxes and duties, is estimated at about Rs 2,912.8 million or US$99.6 million. Taxes and import duties would be about Rs 104.2 million or US$3.6 million equivalent and the net of tax cost of the project is US$96.0 million. The breakdown of costs of the proposed project by component and subcomponent and by categories of expenditure is summarized in Tables 3.1 and 3.2 respectively. Detailed costs of the project by component, categories of expenditure, and year are given in Annex 14. 24 . TLbWEao3: DM tsbv0omQonsnt Strengthening Proam Management CQ4a ty 1309.0 39.70 179.00 0.48 1.65 7.04 Promoting Publlo Awareness and Community Support 004.12 45.34 739.40 V7.22 1.78 20.00 Improving blod safety and Ratlonal Us 313.2* 445.10 7638 12.28 17.48 20.74 Controlling Sexually Transmitted DIlease 112.37 142.78 255.16 4.40 0.e0 10.00 Bullding SurveIllane and Clini Management Capaoity Z97.30 2 339.6n ,58 aa & iB Tatal Base Costs 1,540.1 725.33 2.272.24 00.06 28.44 09.10 PhyalOContIngenlos 97.05 70.38 108.30 3.64 2.78 0.60 Pce Contingenies 272.68 100.55 472.23 1.00 2.38 3.8a Total ConUngencies 370.63 200.00 e4O.83 4.84 5.04 10.43 Totl Proot0Coat. 1117.64 9-0523 2,C12.70 6560 3410 0906 -_ =S, Not tnclusiveol tXes and duties etmated at US$.o million equivent. Figures may not add due to rounding. Table 32: tbCateoies of Exendlture Ruosa (Milin U0 (Million)l Catl"oyofExpenditure Local Foreign TOtl _ Local Foreign Total 0vIsl Works 4.70 1.91 0.01 0.18 0.08 0.20 Professional ericee 1.03 0,19 1.27 0.04 0.01 0.05 FurnIture 2.32 0.23 265 0.00 0.01 0.10 Equipment 49.00 174.04 223.13 1.93 0.82 8.75 Vehicles 0.73 0.67 7.40 0.20 0.03 0." Medical end LaboratorySupplies 201.80 470.87 072.07 7.91 18.47 20.38 IEC MaterIs 85.80 8.07 44.83 1.41 0.35 1.70 M MedIcinns 39.83 7.04 48.02 1.60 0.28 1.84 Ml8 Materials 70.02 17.08 83n.7 27 0.s 3U8 Local Training ao.30 - 30.30 10.60 - 10.00 NSOServIces 198.41 - 194.60 7.70 - 7.70 Loo Consultant SerIces 147.90 - 147.00 0.80 - 6.80 Forelgn Consultants 0.05 23.20 33.15 49 4091 1.30 6tudies 33.30 - 33.30 1.31 - 1.31 Publiity OsMose 104.00 18.24 182.33 0.44 0.70 7.4 Workshope 4.1 0.45 4.5a 0.o 0.02 0.18 Subtotal 1,30.44 723.40 2.092.00 63.70 28.37 82.07 . AfB-Vnt ¢Ofe Salares o0f ddiIonal Staff 141.04 - 141.94 8.07 - 6.57 Opetlon and Maintenance 38.53 1.87 37.eO 1. 0.07 1.40 Subtotal 177.47 IA? 17M.34 0O 0.07 7.03 Yoal BasCode 7 2 L 2725.3 2 4 gLe.s UH 1o Contingenes 370.03 200.0 040.83 4.4 0.4 10.41 Totl Project code 107.5 905.23 2012.77 06.50 34.10 00.00 Nowt Inclu4si od taxes nd duties eaUmstsd at USS.S milon equivalent. FIgures may not add due to rounding. - 25 - 3.02 Baais of Co_st Etmateas. Estimated equipment and vehicle costs are based on lists developed by GOI and the States/UT and include import duties and taxes. Costs of medical supplies and materials and furniture are based on GOI and the States' estimates and reflect current prices. Estimated costs for incremental staff salaries and operation and maintenance are based on current pay scales and norms used by the Central Government and the States including standard allowances for social and other benefits applicable in the States. 3.03 Continencyv Allow nces. Project costs include physical contingencies (US$6.6 million) estimated at 104 for physical components and at 5% for technical assistance, salaries, and operation and maintenance costs. The estimated costs of the project also include price contingencies (US$3.9 million) to cover expected price escalation at the following rates: for goods, salaries and technical assistance, foreign costs 3.9% from PY92 through FY96; local costs 7.0% in FY93, 6.5% in FY94, 6.0% in FY95 and 5.5% in FY96 and FY97. 3.04 Foreian Exchange Com3onent. The estimated foreign exchange component of US$34.1 million is calculated on the basis of estimated foreign exchange proportions as follows: (a) civil works, 15% (b) furniture, 9%; (c) locally produced equipment, 35%; (d) locally produced vehicles, 9%; (e) imported equipment and goods, 90%; (f) foreign consultants, 70%; (g) locally produced IEC and MIS materials, 20%; and (h) operation and maintenance, 5%. B. Financing Plan 3.05 The financing plan by project component and by categories of expenditure is summarized in Annex 14. The estimated total project cost of US$99.6 million would be financed by an IDA credit of US$84.0 million equivalent, which would cover about 87.5% of costs net of duties and taxes, or 97% of the estimated foreign exchange cost and 83% of the local cost of the proposed project. The Government of India would finance 14% of the total project cost or US$14.1 million equivalent. This would include all taxes, estimated at US$3.6 million. 3.06 The remaining cost of US$1.5 million, or 1.5% of the total project cost, would be provided by parallel grant financing from WHO. The WHO grant of US$1.5 million would finance foreign consultants. A condition of credit effectiveness would be that all conditions precedent to the effectiveness of the WHO Grant would have been fulfilled. C. Re_current Costs.ad Sustainablitv 3.07 The project's interventions are largely preventive and recurrent costs generated by the project would be a negligible part of Union and State expenditures on health at thW.s time. Nonetheless, project-assisted activities wo'ld need to be sustained and to grow for some time within serious budgetary constraints. The project constitutes an integral core of the Government's plan to combat HIV/AIDS and the Government's commitment to this objective is very prominent. A more significant and consequential issue is the cost of - 26 - deali.ng with AIDS patients, which will escalate progressively during the decade and beyond. In this context, the Bank and MOHFW have initiated a collaborative study on health financing. This review will help identify gaps in the financing of sectoral interventions and how they can be effectively and efficiently met. Intermediate outputs will. be available by December 1992 and the final output by July 1993. This would include measures related to the prevention of HIV transmission. In addition, the sustainability of national control interventions would be further addressed in the strategic plan for the next phase of interventions (para. 2.14). D. Implementation 3.08 The project would be largely implemented and integrated through the existing health infrastructure, private sector agencies, NGOs, and the Ministry of Information's mass media institutions. The schematic implementation levels are shown in Annex 15 and the implementation schedule is shown in Annex 16. General implementation responsibilities would be as follows: (a) Central Components: GOI would coordinate the project, carry out major procurement, and develop policy and technical guidelines. IEC interventions would be implemented through the services of the Ministry of Information's television and radio stations, private advertising agencies, and the existing health system. GOI would pass to the States/UTs the goods procured and would bear the entire project costs borne by the States and Union Territories, including incremental salaries for additional staff. (b) State1l Components: the States would be responsible for the implementaticoi of project activities in the States or Union Territories through the State AIDS Control Cells as necessary according to State work plans that are in general conformity with the priorities and strategies defined by GOI. NGO services would be engaged at the State level. The State would pass to the Municipalities the required resources for STD control, IEC and training. The State and Union Territory AIDS Control Cells would report to NACA at the Center and their functions would be facilitated by the formation of Empowered Committees, as discussed below (para. 3.10). 3.09 Project ManaSgement. NACA headed by the Project Manager (para. 2.^4) would be responsible for the operational day-to-day implementation of the project and would liaise with IDA. NACA would allocate funds for implementing agencies and would maintain project accounts. NACA would work out/update annual work plans in consultation with State AIDS control staff who would review the plans and progress in implementation on a quarterly basis. It should be underlined here that several States participated with GOI and WHO during 1990 in the planning and development of the Medium-Term-Plan for AIDS I/State - State/Union Territory - 27 Control which provided an initial basis on which the proposed project was developed (para. 2.01). 3.10 'Emoowred CoMMitt£es. In order to expedite the release of funds and decision making at the State level, project States/UTs intend to establish Empowered Committees under the chairmanship of the Chief Secretary, or another senior official. The Health Secretary would be Member-Secretary of the Empowered Committee. Members would include the Secretaries of Finance, Planning, Welfare, Education, Labor, and Urban Development. NCO representatives would be included and/or invited. Such Empowered Committees would ensure that funds allocated by the Government of India for undertaking activities through the State Government Departments as well as through NGOs are released promptly. Such Empowered Committees would review progress in implementation and resolve administrative and financial bottlenecks. 3.11 The Role of WHO in the Project. WHO has played a pivotal role in collaborating with the Government in project design and preparation. It has been assisting the Government in HIV/AIDS control activities since 1986 and has assisted GOI in developing strategies and plans for AIDS Control. The general role of WHO in health programs and in the AIDS Control Program in the country is significant and the level of its assistance to AIDS Control is discussed in paras. 1.36-1.37. 3.12 During the proposed project, WHO would assist in: (a) provision of international technical assistance; (b) carrying out international procurement of blood bank and STD laboratory equipment, condom quality assurance equipment, HTV tests and medical supplies on behalf of the Government; and (c) provision of technical support and advice to GOI and State Governments in project management and evaluation. 3.13 Status of Preparation. A team of senior MOHFW officials led by a Joint Secretary of Health and the Director of International Health have been leading preparation activities since May 1991. The team is assisted by three resident WHO/GPA experts. In addition, WHO provided the services of six international consultants to assist MOHFW in the preparation of working plans for blood safety; surveillance; information, education and communication; condom programming and STD control. As noted earlier, a detailed project proposal has been prepared. In addition, action plans have been prepared for key states; remaining plans are under preparation. A planning and training workshop has been held with the participation of the States and UTs in addition to a coordination meeting with the States' Secretaries of Health. 3.14 Lists of equipment, medical and laboratory supplies have been prepared and were found to be satisfactory at appraisal. The proposed procurement of critical medical equipment and supplies from WHO is expected to facilitate and expedite implementation. Standard bid documents developed and approved under the Technician Edutcation Projects would be used by the Directorate General of Supply (DOS&D) for the procurement of much other equipment and goods. Training plans are adequate. In-service training of primary health care staff would be undertaken in the existing structures. A list of operational research topics has been prepared. MOHFW has identified - 28 - the general terms of reference for the participation of private advertising agencies for software development and distribution. 3.15 Lo istics and t adipal S o Or a ization. The provision of major project supplies including HIV tests would be undertaken on a regional basis by the Medical Stores Organization through its medical store depots located in Madras, Bombay, Calcutta and Delhi. This process is currently ongoing and the network's recent performance is satisfactory. Within MOHFW, the Medical Stores Organization is a wing of the Directorate General of Health Services and the network reports to the Center and not to the States. The distribution network is shown in Annex 17. GOI is also planr.ing to use its three other medical store depots in Hyderabad, Karnal and Guwahati. E. Monitoring and Evaluation 3.16 NACA would be responsible for all operational aspects of project implementation, and both NACA and the Board (para. 2.07) for project monitoring and evaluation. Progress would be reported quarterly by the State AIDS Control Cells to the National Program Manager. Annual progress reports would be submitted to the Board, National Committee and the Technical Advisory Committee. The project would finance annual review workshops. During negotiations, the Government provided assurances that it would review with IDA annually by December 31 each year the progress of project implementation over the preceding twelve months and an annual work plan for the next following twelve months. 3.17 Benchmarks for monitoring implementation of the project were included by GOI as input and process indicators for each project component in the detailed work plans of the project proposal. Operationally, assessing the attainment of project objectives would be based on indicators related to the eight topics listed in para. 2.03. In addition, impact indicators would be assessed by GOI in collaboration with WHO. Also, operational research findings would assist in evaluating and improving action programs and services. Research findings would be linked with further implementation and guidelines as necessary. Additional important indicators that are proposed by WHO for evaluating the global prevention strategies worldwide are shown in Annex 18. WHO resident staff in India would provide technical support to GOI in project monitoring as needed. 3.18 A comprehensive mid-term project review would be carried out at the end of the third year with the participation of international consultants. The mid-term review would examine operational, technical, managerial and financial aspects of the project. A protocol for the evaluation would be developed six months prior to the review in collaboration with WHO resident staff. The findings and recommendations of the evaluation would assist GOI in future programming and in drafting the strategic plan for the next phase of intervention (para. 2.14). The Government provided assurances during negotiations that it would carry out with IDA a mid-term review of project implementation, prior to March 31, 1995, and that it would take into account comments and suggestions made by IDA at such review during project implementation thereafter. - 29 - 3.19 At the State level, project administration and monitoring would be undertaken by the State AIDS Control Cells (para. 2.11). The State team would be responsible for ensuring coordinated planning with the Center, monitoring of implementing institutions in the State, providing technical support and funds to implementing institutions, and ensuring technical and financial reporting to NACA at the Center. 3.20 The reporting system for information and coordination of the project is outlined in Annex 19. MOHFW already collects information on current control efforts through the existing syst-em. Implementation progress would be reported quarterly by the State AIDS Cells to NACA who would then compile the reported information and issue it in the form of a quarterly newsletter to all concerned institutions and States. Quarterly and annual reports from the States and the Center would constitute a major cornerstone for the progress review. Annual progress would be reported to the National Committee, Board, Technical Advisory Committee, States and Union Territories. 3.21 The frequency of reporting would be as follows: AIDS case reports, monthly; HIV screening sentinel reports, quarterly; HIV time-limited project reports, on completion; research/studies, on completion; operational reports, quarterly/annually; and financial reports, quarterly/annually. 3.22 Ebkcal. Standards for Project Intervention Strate-gies. GOI has stated its unequivocal support for the policy of humane treatment of persons affected by HIV/AIDS as articulated in Resolution WHA41.24 of the World Health Assembly. This decision of GOI is consistent with worldwide recognition that programs for the prevention and control of AIDS should be planned and implemented in a manner that ensures the humane treatment of affected persons. Such humane treatment is an essential pre-requisite for an effective long-term policy for the prevention and control of AIDS. 3.23 The Government informed the Association that it intends to promulgate by December 31, 1992 policies and guidelines concerning legal and ethical issues consistent with internationally accepted principles and procedures in this regard including relevant resolutions of the World Health Assembly and recommendations of the WHO Global Programme on AIDS Nanagement Committee. 3.24 Accordingly, the project would assist the Government in creating a framework for the provision of heajith, psychological and social support to HIV infected persons and AIDS patients and would help in reducing the impact of AIDS in accordance with adopted resolutions WHA40.26, and WHA41.24 of the World Health Assembly. The aim would be to: foster the spirit of understanding and compassion for HIV infected persons; protect the rights and dignity of HIV infected persons; avoid discriminatory action agair-st, and stigmatization of HIV infected persons; ensure the confidentiality of HIV test results and case reports; and promote the availability of social services including confidential counselling. - 30 X 3.25 Counselling services would be available to the affected individuals and their families on their request and would not be imposed on them. The purpose of counselling support for persons with HIV and AIDS would be to: offer explanation and help the individual to understand the significance of having HIV or AIDS, motivate the in-rfected individual to minimize the risk of transmitting the infectior. through the use of condoms, and assist in preserving psychosocial needs of the individual and his/her family, including guidance on lifestyle, adjustment, and maintenance of good health for as long as possible. 3.26 At negotiations, the Government provided assurances that it would establbsh by October 31, 1992, and then maintain a Technical Advisory Sub- Committee on Social, Ethical and Legal Issues, according to terms of reference satisfactory to the Association. The sub-Committee would put in place and monitor the operation of effective procedures through which affected persons could express grievances and seek resolution of concerns. 3.27 IDA Proiect Sunervision Plan. The approach to supervision would be to focus on key project issues and on arising constraints to successful Implementation. Field visits would focus on selected sites for indepth assessment of implementation progress. Tripartite supervision with MOHFW, WHO and IDA would be undertaken and would be enriched by the local knowledge of issues identified by the project team, the technical advisory committee, and the WHO resident technical mission. The proposed schedule and quantitative inputs are outlined in Annex 20. However, the skills and resources required may vary over time since the epidemic is not a static event. F. Disburse_ents 3.28 Disbursement Percentages. The IDA Credit would be disbursed against 100% of foreign CIF and local ex-factory costs and 80% of other local costs of equipment, vehicles, furniture, IEC and MIS materials, laboratory and medical supplies, and STD medicines; 90% of civil works and 90% of local consultant services; 80% of NGO services and training; 95% of advertisement/publicity services; and an average of about 75% (90% until March 31, 1994 and 60% thereafter) of local incremental expenditures on salaries of additional staff and operation and maintenance of vehicles and office and laboratory equipment. 3.29 Reguired Documentation. Disbursements for goods, consultant services, NGO services and training under contracts valued less than US$100,000 equivalent, and for incremental operating costs, would be made against statements of expenditure (SOEs). Documentation in support of SOEs would be retained by the States for expenditures incurred by the States and by MOHFW for expenditures incurred by the Center. This do,umentation would be subject to annual audit and made available for review by IDA supervision missions. All other disbursements would be made against fully documented withdrawal applications. - 31 - 3.30 Special Account. In order to accelerate disbursements and to provide for direct payment of eligible expenditures, a Special Account would be maintained in the Reserve Bank of India with an authorized allocation of US$5.0 million, equivalent to four months of estimated disbursements through the Special Account. 3.31 Retroactive financing up to SDR 2.1 million (US$3.0 million equivalent), or 3.6% of the proposed credit, is provided to cover eligible expenditures after October 31, 1991. These expenditures would be incurred after appraisal. Procurement arrangements, as well as the purposes for which the items would be used, were reviewed and found appropriate. 3.32 Disbursement Profile. The proposed IDA credit would be disbursed over five and one half years (Annex 21). The standard profile for PHN projects is a seven-year average and such projects include a substantial amount of civil works. The proposed project aims to develop HIV prevention activities quickly in largely existing infrastructure and the standard profile does not appear to be appropriate for comparative purposes. In addition, the proposed project conforms with the Government's VIII Plan period. The project is expected to be completed on March 31, 1997 and the Credit closed on September 31, 1997. Annex 21 shows forecasts of expenditures and disbursements. 0. Procurement 3.33 Procurement arrangements are summarized in Table 3.3. The Directorate General of Supply (DGS&D) would handle all bulk procurement of equipment and other goods under ICB and LCB procedures acceptable to IDA. Major contracts for equipment and medical supplies would be procured partly through ICB mainly for blood component separation equipment and supplies (US$7.7 million) and partly through LCB procedures acceptable to IDA. Contracts for the purchase of items valued at below US$200,000 equivalent each may be awarded on the basis of LCB procedures acceptable to IDA up to an aggregate of US$8.0 million equivalent. Civil works of about US$0.3 million would be undertaken through LCB procedures acceptable to IDA. Other items or groups of items valued at less than US$50,000 equivalent each may be procured by the States, Union Territories and the Center up to an aggregate of US$14.4 million equivalent using local or international shopping. Medical and laboratory equipment and supplies (US$19.8 million) would be directly procured from WHO. 3.34 Procurement would be packaged and bulked to the maximum extent possible except for vehicles (US$0.3 million) needed by all States and Union Territories where services and maintenance would differ. For comparing foreign and local bids in ICB, qualifying domestic manufacturers would be allowed a margin of preference equal to the existing rate of customs duty applicable to competing Imports or 15% of CIF price, whichever is lower. 3.35 All items procured under lCB procedures, as well as the first three LCB contracts for equipment, laboratory and medical supplies, IEC and MIS materials, STD medicines, vehicles and civil works would be subject to - 32 - IDA's prior review, which would also be required for equipment and laboratory and medical supplies procured from WHO and valued at US$200,000 or more. Approximately 41% of the value of the IDA credit would require prior review, but this is acceptable given the above procurement arrangements with WHO, the nature of the project, and the very satisfactory performance of DGS&D in previous projects. 3.36 Contracts for the hiring of consultants would be awarded according to IDA Guidelines for the Use of Consultants. Consultant services and NGO services would be subject to prior review and approval by IDA for those contracts of US$100,000 equivalent and above. However, the terms of reference for such consultants would be subject to prior review by IDA. Advertisement/publicity services for mass awareness would be procured directly from the Ministry of Information's radio and television stations through procedures satisfactory to IDA. 3.37 The table on the following page summarizes the project elements and their estimated costs and proposed methods of procurement. H. Accounting and Auditing 3.38 The project expenditures incurred by the Center and by each participating State and Union Territory would be subject to the normal GOI and the participants' accounting and auditing procedures, with the added requirement that MOHFW would maintain a separate project account. At NACA and the State AIDS Control Cells, a record of all project transactions would be maintained with appropriate support documentation for the transactions. 3.39 Audits of Central and State accounts, the Special Account and financial statements of the project including a separate opinion on Statements of Expenditures (SOE), would be subject to normal GOI accounting and auditing procedures which are considered satisfactory to IDA. Documentation supporting SOEs would be maintained at least one year after the completion of the audit for the fiscal yoar in which the last withdrawal was made. The Special Account woultz show all withdrawal requests disbursed, amounts advanced and reimbursed by IDA, and balance at the end of each accounting period. The c'- lidated audit reports would be submitted to the Association not later than nine months after the end of each financial year. The audits will cover all project expenditures until such time as the credit has been closed. IV. BENEFITS AND RISKS A. Benefits 4.01 The project's interventions would help slow the spread of the HIV epidemic and its burden on individuals, families, and the society. It would alleviate the socio-economic impact on the household and subsequently at the sectoral and natlonal levels. The project would contribute to preserving health status and previous investments in health. The project would have a significantly high return in terms of healthy life years saved. The control of HIV infections would contribute to the containment of pulmonary - 33 - Table U3, SumMary of,Poosd_ Procurement Arag2m_en_ts (US$ million) Procurement Method Total Project Element IOB LOB Other N.B.F. costs 1. Works 1.1 Civil Works - 0.3 - - 0.3 (0.3) (0.3) 2. Goods 2.1 Equipment, 7.7 8.0 34.22/ - 49.9 Vehicles, MIS & (6-9) (7.2) (30.8) (44.9) IEC Materials, Medical & Laboratory Supplies, STD Medicines & Fumrture 3. TraininglTechnical Assistance 3.1 Local Training, - - 16.8 - 16.8 and Workshops (13.0) (13.0) 3.2 NGO Services - 8.3 - 8.3 (6.5) (6.5) 3.3 Local Consultants - - 7.6 - 7.6 and Studles (6.8) (6.8) 3.4 Foreign Consultants - - - 1.5w 1.5 (0.0) (0.0) 4. Publcifty Seivices - . 7.7 - 7.7 (6.9) - (6.9) S. Miscellaneous 5.1 Salaries of Additional - - 5.9 5.9 Staff (4.4) (4.4) 5.2 Incremental Operation - 1.6 - 1.6 and Maintenance of (1.2) (1.2) Equlpment and Vehicles TOTAL 7.7 8.3 82.1 1.5 99.6 (6.9) (7.6) (69.6) (0.0) (84.0) N.B.F.: Not Bank Financed. Note : Figures In parentheses are the respective amount financed by the IDA Credit. at Laboratozy and medical equipment and supplies estimated to cost US$19.8 millon would bo prooured from WHO. kl Cofnanced In prraiiel by WHO. 34 - tuberculosis, which is exacerbated by AIDS. Externalities are high and the project benefits would accrue to the society at large. Most importantly, responding to this priority now would cost only a fraction of what would be required at a later stage when the disease is allowed to become more widespread. 4.02 It is estimated that at least 300,000 AIDS cases would be avoided on account of the project by the year 2000 under a conservative scenario of effective prevention estimated at 30 percent. It has been estimated that the project would help avoid about US$489 million of direct health care costs between 1994 and 2000, of which about US$388 million;/ would be the Government's share (Annex 3). The project would, by the year 2000, also help avoid a loss to the national income ranging from US$2.5 billion to US$3.0 billion equivalent&i. Hence direct and indirect returns would be significant. 4.03 Program Objective Categories: Poverty Aspects. Poor segments of the population such as migrant labor and commercial sex workers are at high risk of HIV infection. The project would target these groups. It would slow the rise in the number of orphans. More importantly, by enhancing prevention, the project would limit the inevitable shifting of health resources to additional curative care often consumed by the middle and upper socio-economic classes. WID Asgects. The project would contribute to alleviating the number of infections transmitted to women. It would help mitigate conventional sexually transmitted diseases, largely affecting women's reproductive health and which are responsible for considerable morbidity and long-term complications like pelvic inflammatory disease and neonatal infections. In addition, enacting higher standards for condom quality would benefit not only HIV/STD control but also family planning programs. Private Sector Aspects. The project would support the development of both the private sector and NGOs role in HIV/AIDS/STD prevention and care activities. B. Risks. 4.04 There are several risks to the project. First, preventing AIDS depends largely on changes in people's behavior. There is no "quick" formula for achieving these changes and they may take a prolonged time to achieve. This would be addressed by making the project well focused on key actions in a multi-pronged approach, by using NGOs to reach risk behavior groups and by It ERR - 26.7 percent. The rate relates to the investment in the proposed project and the projected direct cost (to the Government) associated with AIDS cases that would be avoided if the project is launched. The rate is calculated using the Internal Rate of Return method (discount rate at which the present value of total Lnvestment equals the present value of total direct cost avoided). When the direct cost to the private sector is included, ERR is calculated at 31.1 percent. Should.indirect costs-re-lated to national income losses be included. ERR would incrase substantially, Also. significant benefits beyond the year 2000. related to the latency period between infection and clinically overt diseaue. are not included. LI At 1992 prices. Assumptions are listed in para. 1.30b. - 35 - extensive participation of the television and radio stations and the private sector in mass communication efforts. 4.05 Second, there are the usual risks of poor implementation of project investments by a Borrower whose implementation record is mixed. These would be addressed by the careful preparation of the project in those areas that have constrained previous social sector projects in India, by paying special attention to project management and implementation responsibilities, and by making good use during implementation of WHO resident technical assistance. V. AGREE REACHED AND RECOMMENDATION 5.01 During negotiations, the Government provided assurances that it would: (a) except as IDA may otherwise agree, cause project States and Union Territories to establish by dates agreed with IDA and thereafter maintain AIDS Control Cells in their respective Departments of Health, with appropriate staff and resources, for planning, coordinating, implementing and monitoring implementation of the project in the concerned State or Union Territory (para. 2.11); (b) develop under terms of reference satisfactory to IDA and provide to IDA by June 30, 1995, a strategic plan, for the next phase of the Government's program for HIV/AIDS control (para. 2.14); (c) select non-governmental organizations participating in the project on the basis of criteria and procedures satisfactory to IDA (para. 2.19); (d) promulgate by September 30, 1992, and thereafter maintain and enforce regulations requiring that condoms manufactured or sold in India conform to quality standards established by WHO (para. 2.42); (e) review with IDA annually by December 31 each year the progress of project implementation over the preceding twelve months and an annual work plan for the next following twelve months (-ara. 3.16); (f) carry out with IDA a mid-term review of project implementation, prior to March 1995, and take into account comments and suggestions made by IDA at such review during project implementation thereafter (para. 3.18); (g) establish by a October 31, 1992, and then maintain a Technical Advisory Sub-Committee on Social, Ethical and Legal Issues, according to terms of reference satisfactory to IDA (para. 3.26). v 36 - 5.02 There would be two conditions of effectiveness: (a) the Government shall by June 1, 1992, establish and thereafter maintain a National AIDS Control Authority, with adequate full- time staff, other resources and terms of reference satisfactory to IDA, and the designated staff shall have commenced work (para. 2.10); and (b) all conditions precedent to the effectiveness of the WHO Grant would have been fulfilled (para. 3.06). 5.03 One condition of disbursement for expenditures incurred by any State or Union Territory would be that the Government furnish IDA with a Letter of Undertaking satisfactory to IDA from that State or Union Territory. Those letters would outline how each State/UT would carry out its part of the project (para 2.12). 5.04 Subject to the above conditions, the proposed project constitutes a suitable basis for a credit of SDR 59.8 million (US$84.0 million equivalent) to India at standard IDA terms with 35 years maturity. -37- ANNEX 1 NTONAL AIDS C.ONTROL-PROJECT Profile of Sero-Positive Indians detected through September 1991 Table 1. Reported,Clinical AIDS cases in India (up to Sept. 30. 1991) Males Females Total Indians: 59 24 83 Foreigners: 10 3 13 TOTAL 69 27 96 Table 2. Composition of ReRorted Sero-Positive Cases Mlales Females Total Indians Multipartner Heterosexuals 1040 1808 2848 IV Drug Users 1236 40 1276 Blood donors 872 3 875 Recipients of blood/blood Products 84 27 111 Suspected ARC/AIDS 48 15 c 63 Relatives of HIV Carriers 18 27 45 Antenatal Women 0 22 22 Dialysis Patients 14 3 17 Homosexuals 8 0 8 Others 332 109 441 Sub Total 3652 2054 5706 Foreigners Students 102 18 120 Others 38 15 53 Sub Total 140 33 173 Total 3792 2087 5879 1/ Compilation of diverse purposeful samples since 1986. - 38 - Page I INDI NATIONAL AIDS CONTROL PROJCT Global DtAtribution_.Pro etions and Dimensions of EIV/ADS 9STIAATEOD/PROJECTED ANNUAL ADULT HIV INFECTIONS UIlIona MUlllons IllFth ............................ 1.2 I; Awrt . o.ra O.2 IN Amorice WE urope i - l0 19s80 82 84 866 66 0 92 040 98O2000 Year HIV Transmission Global Summary 1991 Tvne of sspoaure Ef/Slngf2 Exgosu ePt. of Glgbal Total Blood transfusion P90% 6 Perlnatal 30% 10 Sexual Intercourse 0.1-1.0% 80 (VagInal) 170) (Anal) (10) Injecting drug use 0.6-1.0% 10 sharing needles,to Health care '0.6% 40.01 - need^le-tloks. etc 8outce: WHO/OPA 39 - Page 2 Estimated Global Distribution of Adult HIV Infections 1991 ntmalle r11877?>Femae 1/1400 \$k<~V al*ei 1l/40 ornate II/Q a 6 I/ Source; WHO/GPA Estimated Global Distribution of Adult HIV Infections 1991 1 Milillo , ,,¢