Review of the HIV Strategic Plan in Kosovo (in accordance with United Nations Security Council Resolution 1244 (1999)): October 2014

Review of the HIV Strategic Plan in Kosovo (in accordance with United Nations Security Council Resolution 1244 (1999)) October 2014 Review of the HIV Strategic Plan in Kosovo (in accordance with United Nations Security Council Resolution 1244/1999) WHO Technical Assistance for concept note development under Cooperative Agreement with the Global Fund Prepared by: Dave Burrows, Aram Manukyan and Mirza Musa, APM Global Health, Sydney, Australia Address requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional Office for Europe UN City, Marmorvej 51 DK-2100 Copenhagen Ø, Denmark Alternatively, complete an online request form for documentation, health information, or for permission to quote or translate, on the Regional Office website (http://www.euro.who.int/pubrequest). Keywords AIDS DRUG ABUSERS HEALTH POLICY HIV KOSOVO HEALTH PROGRAMMES © World Health Organization 2015 All rights reserved. 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List of abbreviations AIDS Acquired immunodeficiency syndrome ANC Antenatal care ART Antiretroviral therapy ARV Antiretroviral (drugs) CCM Country Coordinating Mechanism CDF Community Development Fund CSGD Centre for Social Group Development DOTS Directly observed treatment strategy EU European Union FSW Female sex workers GARPR Global AIDS Response Progress Report GDP Gross domestic product GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria GIPA Greater involvement of People Living with HIV and AIDS HBV Hepatitis B virus HCV Hepatitis C virus HCCA Health Care Commissioning Agency HIV Human immunodeficiency virus HTC HIV Testing and Counselling IBBSS Integrated biological and behavioural surveillance surveys IPH Institute of Public Health KAC Kosovo AIDS Committee KAPHA Kosovo Association for people living with HIV/AIDS Kosovo Kosovo (in accordance with United Nations Security Council Resolution 1244 [1999]) KDRA Kosovo Drug Regulatory Agency KFSA Kosovo Food Safety Agency KOPF Kosovo Population Fund MCYS Ministry of Culture, Youth and Sports MEST Ministry of Education, Science and Technology MMT Methadone maintenance treatment MoH Ministry of Health MSM Men who have sex with men NGO Nongovernmental Organization OI Opportunistic infections OST Opioid substitution therapy PICT Provider Initiated Counselling and Testing PLHIV People living with HIV PrER Pre-exposure prophylaxis PSM Procurement & Supply Management PUCC Pristina University Clinical Centre PWID People who inject drugs SRH Sexual and Reproductive Health STI Sexually transmitted infection TB Tuberculosis UNAIDS The Joint United Nations Programme on HIV/AIDS UNFPA United Nations Population Fund UNODC The United Nations Office on Drug VCT Voluntary, counselling and testing WHO World Health Organization List of contents 1. Background ................................................................................................................................................................ 1 2. Overview of Kosovo Strategic Plan 2009-2013 ............................................................................................... 2 2.1 Strengthening the information and knowledge base for an evidence-informed response ............... 2 2.2 Strengthening of the institutional frameworks and organizational and technical capacity of government and civil society organizations to develop and implement effective HIV/AIDS policies, programmes and services in a coordinated manner ............................................................................ 3 2.3 Strengthening the legislative, policy and financial basis for effective implementation of the response ............................................................................................................................................. 3 2.4 Improving the comprehensiveness and quality of programmes and services, to meet the prevention, care, support and treatment needs of those at risk or affected by HIV/AIDS .................... 4 2.5 Scaling up coverage of key populations at risk and those affected by or vulnerable to HIV and AIDS with key programmes and services .............................................................................................. 4 3. Suggestions for Kosovo Strategic Plan on HIV/AIDS 2015-2019 ............................................................... 5 References ........................................................................................................................................................................ 16 Appendices ....................................................................................................................................................................... 17 Annex 1 - Terms of Reference ............................................................................................................ 17 Annex 2 –Review team members and list of informants .................................................................... 20 Page 1 1. Background A World Health Organization review of the Kosovo1 Strategic Plan on HIV/AIDS was undertaken in October 2014. As part of a mission to carry out a HIV Programme review, meetings were held with various stakeholders about the status of the Kosovo Strategic Plan. Through this process, the mission found that a well-designed Strategic Plan developed through wide consultation and carefully costed, had been developed for the period 2009-2013. While the duration of the Strategic Plan had ended, few of the strategies or interventions described in the Strategic Plan have been implemented. Recently, the Ministry of Health (MoH) has contracted with a group of clinical disease physicians to develop a new Strategic Plan for the period 2015-2019. While the mission was assured that work was well under way on this Strategic Plan, there was no evidence of a consultative process, nor of any clear, SMART2 objectives and strategies to achieve those objectives. As the Strategic Plan is the cornerstone on which Kosovo’s Concept Note will be built, completion of a new Strategic Plan that is inclusive, based on the known epidemiology and response to date, and working towards comprehensive goals and objectives, is vital and urgent. It was therefore proposed that the mission team should review the 2009-2013 Kosovo Strategic Plan to provide suggestions on how it could be quickly adapted for use as the 2015-2019 Strategic Plan: this will be provided to the Strategic Plan development team and other stakeholders in the hope that these suggestions will enable the Strategic Plan to be completed by mid-November 2014 (which will be needed for a CN submission date of 15 January). 1 For the purposes of this publication, all reference to “Kosovo” should be understood/read as “Kosovo (in accordance with UN Security Council Resolution 1244 (1999))” 2 The acronym SMART is used as a concept of basic criteria, which can be used to provide a more comprehensive definition for goal setting in strategic planning: S - specific; M - measurable; A - achievable; R – reasonable; T – timely. The principal advantage of SMART objectives is that they are easier to understand and to implement. Page 2 2. Overview of Kosovo Strategic Plan 2009-2013 The goal of the Kosovo Strategic Plan on HIV/AIDS 2009-2013 is “to maintain the current low HIV prevalence rates among key populations3 at higher HIV risk in Kosovo below 5% and prevent HIV from spreading into other groups of the general population; and mitigate the impact of HIV and AIDS on persons infected and affected, as well as on society as a whole”. Kosovo’s Strategic Plan on HIV/AIDS 2009-2013 developed in 2008 may comply with international standards as it seems like a good array of international approaches were used for developing the plan. The Strategic Plan aims to maintain HIV in Kosovo at very low levels - including among key populations at risk – and reduce the impact of HIV/AIDS on individuals and society as a whole. Although the Strategic Plan was envisioned to last until 2013, the goal, key strategic issues and specific strategic objectives are as relevant in 2014 as they were at the time they were written. The recent WHO HIV Programme Review mission (1) identified five key strategic areas which need to be addressed to achieve the overall 2009-2013 goal: 2.1 Strengthening the information and knowledge base for an evidence- informed response While a basic HIV case reporting system is in place, there is a lack of efforts to address the issue of under-reporting, especially by private clinics that carry out HIV tests. Although addressed through implementation of current programme activities, more efforts are needed to specifically target strong societal stigma and discrimination against key populations. Successful activities on reducing stigma and discrimination towards key populations should positively influence voluntary counselling and testing (VCT) services and provide improvements in linkage to treatment and care. As in the period 2009-13, further activities are needed in order to more strongly tie monitoring and evaluation (M&E) to programme implementation. Introduction of automated management information systems, as well as ongoing qualitative operational research is still recommended. Periodical integrated biological and behavioural surveillance surveys (IBBSS) among key populations in Kosovo have been carried out in 2006, 2011 and 2014 and are recommended to continue in order to ensure appropriate information for evidence-based response. The results of these surveys should be used to observe the epidemic trends and inform the design of interventions for the prevention and mitigation of HIV impact among these populations. A synthesis of findings from other surveys such as the sentinel HIV prevalence survey among women attending antenatal care (ANC) and population based studies could also be considered to assist in characterizing the determinants and deterrents of HIV epidemic in Kosovo. 3 The Strategic Plan lists key populations at highest risk as people who inject drugs (PWID), female sex workers (FSW), clients of FSW, men who have sex with men (MSM) and prisoners. Page 3 2.2 Strengthening of the institutional frameworks and organizational and technical capacity of government and civil society organizations to develop and implement effective HIV/AIDS policies, programmes and services in a coordinated manner The efficient scale-up of Kosovo HIV/AIDS response still relies on effective coordination, organizational and technical capacity. The MoH leads the efforts in coordinating health, government and non-government sectors in order to scale up coverage and quality of service delivery. The capacity of the MoH to perform the coordinating role in HIV response should be strengthened in terms of organizational development, including leadership, management, and governance to effectively address the challenges of the HIV and AIDS epidemic. Other stakeholders also have important roles to play in an effective response to HIV in Kosovo. The following are suggested ways of improving overall capacity of all stakeholders to actively participate in the HIV/AIDS response: • Build the capacity of government agencies at district and central levels to improve, coordinate, and deliver services for key populations and all citizens • Build the capacity of non-government organizations to improve the coordination of HIV- related services for key populations • Improve the skills of hospital and clinic-based health workers to continuously improve the quality of services they provide • Improve the functioning of the Global Fund Principal Recipient(s) by assisting them to establish sustainable structures, systems, and procedures • Collaborate with traditional, cultural, and religious leaders, to deliver evidence-based HIV prevention messages to their communities of influence • Develop and disseminate tools, best practices, and lessons learned • Ensure primary health care staff know the symptoms of HIV disease and test for HIV if any of these symptoms are present 2.3 Strengthening the legislative, policy and financial basis for effective implementation of the response Resource mobilisation strategies have not been developed to address the sustainability of the programme and to plan for a decrease in external funding. Leadership by the government needs to ensure the continuity of service provision for key populations and plan the budget accordingly. Legislation, policies and resource allocation need to support a sustainable response. Government ministries and institutions need to develop policies that support their involvement in providing services and programmes for HIV/AIDS prevention, treatment and care after a decrease in external funding. Page 4 The Kosovo Strategic Plan 2009-2013 addressed many issues to build up capacity of the health system to effectively respond to HIV, however certain service delivery barriers remain, such as: • weak procurement and supply management practices often results in shortages and/or stock outs of vitally important medical products and consumables; • legislative barriers to easy access to needed services, in particular HIV prevention for key populations whose behaviour is deemed criminal (sex workers and people who use drugs); • management and organizational barriers usually present in the form of inability to manage a complex system of vertical programs and projects that are in many cases planned, managed and reported on independently from each other; • stigmatization from primary health care providers. This could be partly attributed to a lack of knowledge about HIV and AIDS issues and limited access to HIV patients. Further trainings of family practitioners and practical classes could help reduce stigmatization; • while the Government provides support for the central response by way of manpower, staff salaries, buildings and operational costs, government spending on health is amongst the lowest. With supportive legislation and policies, Kosovo can maintain its status as having one of the smallest HIV epidemics in the world. 2.4 Improving the comprehensiveness and quality of programmes and services, to meet the prevention, care, support and treatment needs of those at risk or affected by HIV/AIDS The Strategic Plan emphasizes the need for effective programmes and services to be based on assessment of key population needs. It is important to reiterate the role of the public health sector in provision of comprehensive package of services. A Comprehensive Package of Services for PWID and MSM is close to being achieved, but substantial work is still required on developing a Comprehensive Package for FSW. 2.5 Scaling up coverage of key populations at risk and those affected by or vulnerable to HIV and AIDS with key programmes and services There are significant improvements in scaling up coverage of interventions in the period of implementation of Kosovo Strategic Plan 2009-2013. However, more efforts are needed to ensure planned interventions are targeted at hard to reach key population as recommended in WHO Consolidated Guidelines on HIV Prevention, Diagnosis, Treatment and Care for Key Populations (2). Achieving the following is crucial to ensuring the scale up coverage of key populations and that people from key populations attain higher rates of access to HIV prevention, treatment, care and support services: Page 5 • population-specific prevention services reach at least 80% of those most-at- risk of acquiring HIV infection; • after reaching these populations, trust must be built to ensure that all (or almost all) of those reached will agree to a HIV test; for marginalised populations, any interaction with mainstream health services can be perceived as dangerous, so outreach workers usually have to build trust over a number of meetings, encouraging a meaningful knowledge of HIV status that leads to improved health outcomes; • HIV testing (and an immediate result) is available, appropriate, affordable, accessible and attractive enough to at least 80% of people from key populations; • counselling and peer support with accompanied HIV testing to minimise loss to follow-up; • for those who test HIV positive, there is linkage to appropriate, affordable, accessible and user-friendly treatment, care and support options, including ART as needed; • for specific key populations including PWID, adherence support is provided to assist with ongoing engagement with HIV care and (in particular) with ART; • secure, effective, supportive pathways exist from HIV testing to ongoing treatment, care and support. 3. Suggestions for Kosovo Strategic Plan on HIV/AIDS 2015-2019 As the Kosovo Strategic Plan 2009-2013 is a comprehensive document which proved successful in guiding all HIV/AIDS response interventions, it is recommended that the Strategic Plan for the period 2015-2019 should be based on the same overall goal, key strategic issues and specific strategic objectives, amended in the light of the Programme Review Report (1). The Strategic Plan for 2015-2019 should be updated with the latest data available: the epidemiological analysis from the Programme Review Report can be used as a replacement for Section 2 of the Strategic Plan 2009-2013. Section 3 will need to be updated with results from the past five years, but can otherwise stay largely the same as in the Strategic Plan 2009-2013. Section 4, as noted above, contains a set of strategic priority areas which remain the most important issues to be addressed in the Strategic Plan 2015-2019 (with the additional information provided above). Section 5, the Strategic Framework itself, and Section 6 (on implementation) require substantial revision (see suggestions below). Page 6 Suggested Section 5: Strategic Framework 5.1 : Guiding principles and wider policy context The Strategic Plan 2015-2019 should aim to address the priority strategic issues identified during the strategic planning process which is carried out every five years. The approaches and strategies employed in the context of this Strategic Plan should be based on a number of guiding principles that provide overall direction to, and constitute the core philosophy underlying Kosovo's response to HIV and AIDS. In addition, the Strategic Plan would not be a stand-alone document, but would build on, and contribute to a wider context of global and Kosovo development policies and initiatives. Key guiding principles of the Kosovo response to HIV/AIDS Government leadership in multisectoral partnerships - the responsibility of government to protect and foster its citizens' health and human rights requires government sectors to take the lead in the response to HIVIAIDS. Leadership means working in close coordination and collaboration with different government sectors, as well as with civil society and the private sector. Government leadership is also crucial for ensuring sustainability of programmes in the long term, by ensuring HIV/AIDS is integrated in government policies, programmes and budgets. In this context, the Strategic Plan 2015-2019 should be based on the Three Ones principles - one agreed central action framework; one coordinating authority; and one central monitoring and evaluation system (3). Prevention is key to the HIV response – the focus of the Kosovo strategy for HIV/AIDS should rely on prevention through development of programmes that address factors that increase vulnerabilities of specific populations and reduce the spread of HIV. Prevention programmes would consider local circumstances, ethical and cultural values and be acceptable for communities. Promoting human rights - Kosovo's response to HIV/AIDS needs to build on the fundamental human rights of all Kosovo citizens, including the freedom from discrimination on account of race, sex and gender roles; the right to health; the right to participation; and the right to information. Protection of these human rights is particularly important in the context of HIV/AIDS, which disproportionately affects marginalized population groups such as PLHIV, MSM, PWID and FSW, who often face stigma, discrimination, social exclusion and denial of their human rights. In this context, a human-rights-based approach emphasizes the legal obligations of the state in realizing the rights of its citizens - including the right to health - as well as the importance of empowerment and active involvement of communities and individuals infected or affected by HIV/AIDS. A gender-based approach acknowledges that (young) women and men have different vulnerabilities to HIV-infection; and that HIV/AIDS affects them in different ways and degrees. This is shown by the predominant role that gender plays in HIV/AIDS-related risks and vulnerabilities: the key populations at risk are predominantly male injecting drug users; female sex workers; and men who have sex with men. Therefore, programmes and services for prevention, treatment and care need to address these gender differences and offer women and men services that are tailored to their needs and situation. Page 7 Greater involvement of People Living with HIV and AIDS (GIPA) - the number of persons known to be HIV-positive is very low in Kosovo: the majority of PLHIV do not know their status, have no access to services and no voice in policies and programmes that affect their lives. However, PLHIV understand their own situation better than anyone else, and their personal experiences should help to shape the response to HIV/AIDS. The GIPA principle was formally adopted as a principle at the Paris AIDS Summit in 1994, where 42 countries declared the Greater Involvement of People Living with HIV and AIDS (GIPA) to be critical to ethical and effective responses to the epidemic. The greater engagement of PLHIV is all the more urgent as Kosovo scales up its AIDS response to achieve the goal of universal access to prevention, treatment, care and support services. The Kosovo response to HIV/AIDS in a wider policy context The above principles are not unique to Kosovo's response to HIV/AIDS, but guide government priorities and actions in a wider range of areas. Hence, the Strategic Plan is part of a larger policy context with regard to health and social rights and development. The Strategic Plan should be in accordance with the vision of the MoH Strategy for the Health Sector (4), which aims for a healthier population throughout the territory of Kosovo. The Strategic Plan must support other international commitments by Kosovar institutions, including the 2001 UNGASS Declaration of Commitment (5); the 2004 Dublin Declaration on HIVIAIDS (6); as well as The Three Ones principles (3), and more recently the targets of Universal Access to HIV/AIDS prevention, care and treatment (7). 5.2 Kosovo Strategic Plan Goal and Strategic Objectives The proposed goal of Kosovo’s Strategic Plan on HIV/AIDS 2015-2019 would be: “To maintain the current low HIV-prevalence rates among key populations 4 at higher risk of acquiring HIV in Kosovo below 5% and prevent HIV from spreading into other groups of the general population; and mitigate the impact of HIV and AIDS on persons infected and affected, as well as on society as a whole”. This goal will be addressed by achieving five objectives. Objective 1: to maintain the current low HIV prevalence rates among key populations - PWID, FSW, MSM and prison inmates at below 5% by 2019, by scaling up a Comprehensive Package of Services for each of the key populations, and identifying and removing legal and policy barriers to access to services. Objective 2: to strengthen the HIV treatment and care programme to ensure that 90% of HIV diagnosed PLHIV are enrolled and retained in HIV treatment and care program, 90% of those in 4 The key populations at highest risk will continue to be people who inject drugs (PWID), female sex workers (FSW), clients of FSW, men who have sex with men (MSM) and prisoners. Page 8 need of ART, based on 2013 WHO CG criteria, receive it, 90% of those on ART have suppressed viral load by 2019, and there are 0% stock outs of ARVs in each year of the plan. Objective 3: To strengthen the availability and strategic use of up-to-date information for an evidence-informed central response to HIV/AIDS, by mapping and estimating the size of key populations, carrying out operational research as needed, to assure well targeted interventions and reach and test 90% of key populations by 2019. Objective 4: To reduce AIDS deaths by 90% (over 2013 baseline figures) by improving surveillance of HIV (including HIV testing) and improving the quality of life of PLHIV in Kosovo, promoting a supportive environment and increasing availability and access to client-friendly HIV/AIDS care, support and treatment services and programmes. Objective 5: To establish and strengthen effective institutional frameworks, among public, private and civil society organisations, based on clear mandates and adequate institutional and technical capacity, so that more than 90% of people diagnosed with HIV are linked to HIV care immediately and loss to follow-up is less than 10%. 5.3 Strategic Objectives and Activities Objective 1: To maintain the current low HIV prevalence rates among key populations - PWID, FSW, MSM and prison inmates at below 5% by 2019, by scaling up a Comprehensive Package of Services for each of the key populations, and identifying and removing legal and policy barriers to access to services. All policies and activities for key populations would be harmonised with international standards, particularly the WHO Consolidated Guidelines on HIV Prevention, Treatment, Care and Support for Key Populations5: Health Sector Interventions HIV Prevention 1 The correct and consistent use of condoms with condom-compatible lubricants is recommended for all key populations to prevent sexual transmission of HIV and sexually transmitted infections (STIs). 2 Among men who have sex with men, pre-exposure prophylaxis (PrEP) is recommended as an additional HIV prevention choice within a comprehensive HIV prevention package. NEW RECOMMENDATION 3 Where serodiscordant couples can be identified and where additional HIV prevention choices for them are needed, daily oral PrEP (specifically tenofovir or the combination of tenofovir and 5 World Health Organisation: Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations [Internet]. 2014 Jul. Available from: www.who.int/hiv/pub/guidelines/keypopulations/en/ Page 9 emtricitabine) may be considered as a possible additional intervention for the uninfected partner. 4 Post-exposure prophylaxis (PEP) should be available to all eligible people from key populations on a voluntary basis after possible exposure to HIV. Harm Reduction For People Who Use Drugs 6 All people from key populations who inject drugs should have access to sterile injecting equipment through needle and syringe programmes. 7 All people from key populations who are dependent on opioids should be offered and have access to opioid substitution therapy. 8 All people from key populations with harmful alcohol or other substance use should have access to evidence-based interventions, including brief psychosocial interventions involving assessment, specific feedback and advice. 9 People likely to witness an opioid overdose should have access to naloxone and be instructed in its use for emergency management of suspected opioid overdose. NEW RECOMMENDATION HIV Testing and Counselling (HTC) 10 Voluntary HTC should be routinely offered to all key populations both in the community and in clinical settings. Community-based HIV testing and counselling for key populations, linked to prevention, care and treatment services, is recommended, in addition to provider initiated testing and counselling. HIV Treatment and Care 11 Key populations living with HIV should have the same access to antiretroviral therapy (ART) and to ART management as other populations. 12 All pregnant women from key populations should have the same access to services for prevention of mother-to-child transmission (PMTCT) and follow the same recommendations as women in other populations. Prevention and Management Of Co-infections and Co-morbidities 13 Key populations should have the same access to tuberculosis (TB) prevention, screening and treatment services as other populations at risk of or living with HIV. 14 Key populations should have the same access to hepatitis B and C prevention, screening and treatment services as other populations at risk of or living with HIV. 15 Routine screening and management of mental health disorders (depression and psychosocial stress) should be provided for people from key populations living with HIV in order to optimize health outcomes and improve their adherence to ART. Management can range from co- counselling for HIV and depression to appropriate medical therapies. Sexual and Reproductive Health 16 Screening, diagnosis and treatment of sexually transmitted infections should be offered routinely as part of comprehensive HIV prevention and care for key populations. 17 People from key populations, including those living with HIV, should be able to experience full, pleasurable sex lives and have access to a range of reproductive options Page 10 18 Abortion laws and services should protect the health and human rights of all women, including those from key populations. 19 It is important to offer cervical cancer screening to all women from key populations. 20 It is important that all women from key populations have the same support and access to services related to conception and pregnancy care, as women from other groups. Scaled-up HIV prevention activities and testing among key populations would be the priority for Kosovo’s HIV response (including addressing the nascent MSM epidemic; risk factors for a possible explosive epidemic among PWID; and a potential epidemic among FSW). Mapping of key populations would determine which cities and districts have high concentrations of each key population. The Comprehensive Package of Services for PWID and MSM would be provided centrally in all areas of high concentration of these populations. Services for FSW have not to date been successful in reaching and providing a comprehensive package of services to this population. FSW prevention will need to be reconceptualised, based on research and discussions with FSW from major cities throughout Kosovo. As the process to bring current services towards comprehensive packages is consultative by nature, meetings of key populations to deal with gaps and barriers in services can also be used as community consultations for the development of future GFATM Concept Notes and for data collection for the CCM Oversight Committee. HIV prevention and testing among key populations would continue to be a combined effort between Nongovernmental Organizations (NGOs) and government health services. Linkages between these types of services would be enhanced both at the local level – to resolve access issues to specific services for key populations – and at the central level, where policy/ legislative change may be required. A scaled-up outreach and peer educator system is proposed to be implemented for all identified key populations. Based on recent population size estimates and reach figures provided for 2013 (8,9), a significant scale-up of services for key populations is required. Approaches to be used would include utilising salaried outreach workers and incentive based activities carried out by peer educators. Peer educators would be recruited from most-at-risk subpopulations of PWID such as MSM who also inject drugs; FSW who also inject drugs; pregnant women who inject drugs etc. Attractiveness of enrolment to and retention in MMT programmes should be increased, including ensuring that procurement and supply management (PSM) procedures are operating effectively to ensure access to methadone as needed during the scale-up. Appropriate training would be provided to all health care workers involved in MMT prescription, dosing and monitoring, including the proper health care approach in working with PWID. Page 11 Nongovernmental Organizations working with PLHIV would be adequately strengthened and provided with a clear role in the HIV response (e.g. as “expert patients”), to reduce currently observed loss to follow-up, to provide community-based services, as well as testing services ensuring linkages to HIV treatment and care. Research would be carried out to: a) understand the reasons for high MMT dropout and for low rates of MMT enrolment in health institutions and prison settings (1,10); b) determine the most effective way to reach and involve FSW in HIV prevention activities and testing service due to issues discovered in FSW coverage (1), including ways to work effectively in the current law enforcement / political environment; c) provide mapping of population sizes in the largest population centres in Kosovo, in order to assist effective program planning and monitoring; d) determine risk factors for Roma, Ashkali and Egyptian youth to develop prevention programs for these youth, if needed: youth workers in Kosovo have expressed concern that these groups may be at enhanced risk for acquiring HIV but little is known about their risk behaviours. These strategies would be supported by activities to facilitate an enabling environment for HIV prevention, treatment, care and support among key populations. WHO Consolidated Guidelines on HIV Prevention, Treatment, Care and Support for Key Populations (2) describes the following Critical Enablers: Critical Enablers 1 Laws, policies and practices should be reviewed and, where necessary, revised by policy makers and government leaders, with meaningful engagement of stakeholders from key population groups, to allow and support the implementation and scale-up of health-care services for key populations. 2 Countries should work towards implementing and enforcing antidiscrimination and protective laws, derived from human rights standards, to eliminate stigma, discrimination and violence against people from key populations. 3 Health services should be made available, accessible and acceptable to key populations, based on the principles of medical ethics, avoidance of stigma, non-discrimination and the right to health. 4 Programmes should work toward implementing a package of interventions to enhance community empowerment among key populations. 5 Violence against people from key populations should be prevented and addressed in partnership with key population-led organizations. All violence against people from key populations should be monitored and reported, and redress mechanisms should be established to provide justice. In 2011, the MoH developed and adopted an Administrative Instruction for HIV-AIDS which includes guidance on the activities, structure and functions of the HIV/AIDS response and related health services. This Instruction would be fully implemented through this Strategic Plan. This will require: • development and implementation of (sectoral) HIV/AIDS-related policy frameworks in key government ministries and institutions; and Page 12 • development and implementation of resource-mobilisation strategies to ensure sufficient funds are available for all strategies and activities. Objective 2: To strengthen the HIV treatment and care program to ensure that 90% of HIV diagnosed PLHIV are enrolled and retained in HIV treatment and care program, 90% of those in need of ART, based on 2013 WHO CG criteria, receive it, 90% of those on ART have suppressed viral load by 2019, and there are 0% stock outs of ARVs in each year of the plan. In Kosovo, all citizens are entitled to access to health care services (and essential medicines) and there is an obligation on the state to ensure access to such services and also to ensure that where services (or medicines) are available, they remain available. ARV stock outs have been observed each year since 2009 and the current buffer stock of 2 months is not sufficient for preventing stock outs in Kosovo. ARV stock outs and shortages lead to patients taking partial doses of their treatment, interrupting or defaulting treatment altogether. Many PLHIV are at risk of developing and transmitting drug resistance and ultimately at increased risk of illness and death. Recommendations formulated for the 2013 guidelines on HIV testing and counselling, antiretroviral therapy (ART) and HIV service (11), and subsequent supplements, should be considered the basis for future optimization of treatment and care. The recommendations include comprehensive and specific guidance on HIV testing and counselling (community-based testing, HIV testing and counselling of adolescents); when to start ART in PLHIV (when to start ART in adults and adolescents, when to start ART in adults and adolescents, ARVs and duration of breastfeeding, when to start ART in children); what ARV regimens to start with (1st line ARV regimens for adults, 1st line ART for pregnant and breastfeeding women and their infants, 1st line ART for children below and above 3 years of age); monitoring ART response and diagnosis of treatment failure (all populations); 2nd line ART: what ARV regimen to switch to (children, adults and adolescents); operations and service delivery (interventions to optimize adherence to ART, service integration and linkage, decentralization of treatment and care, task-shifting). These will form the basis of standard operating procedures and protocols to be used throughout Kosovo. The optimization of HIV treatment and care in the future needs to focus on: 1. drug regimens: Defining short, medium and long-term objectives for the development, availability and optimum use of improved ART first- and second-line drug regimens; 2. diagnostics and monitoring technologies: Development of rapid test technology recommendations, strengthened reference laboratories, defining a rational use of CD4 and viral load testing for treatment effectiveness monitoring, and expanded use of “easier to use” technologies (including dry blood spot viral load tests); 3. health care delivery systems: Implementation of expanded task shifting to nurse practitioners, greater use of community healthcare workers and peer support for adherence and treatment literacy, improved integration of treatment and prevention services and linkage from testing to care, and increased linkages with other relevant health priorities, including Tuberculosis, Hepatitis B, Hepatitis C, Prevention of Mother-To-Child Transmission, Maternal and Child Health & Sexual Reproduction Health, drug treatment settings, primary care settings and other specialized health care institutions; Page 13 4. there is an urgent need to establish a HIV patient tracking system in order to have a viable system for HIV patient enrolment and retention, due to the very high level of loss to follow- up (1). The draft Guidelines for STI surveillance, and Guidelines for STI Syndromic Management, should be adopted and used as the basis for scaling up STI services for key populations. Objective 3: To strengthen the availability and strategic use of up-to-date information for an evidence-informed central response to HIV/AIDS, by mapping and estimating the size of key populations, carrying out operational research as needed, to assure well targeted interventions and reach and test 90% of key populations by 2019. Health policymakers, international donors, program managers, service providers and other health system stakeholders need reliable data to make evidence-based decisions when planning for an effective HIV response. Key indicators and country-specific metrics to monitor HIV treatment, care and support need to be collected continuously. Improved data dissemination and use provides the opportunity for evidence-based decision-making, better prevention, treatment and care programs, improved service quality and ultimately better health outcomes. Kosovo Ministry of Health will ensure that strategic information related to treatment and care will be collected, analysed and used for future planning of treatment regimes, forecasting the adequate supply of ARVs and evaluating the effectiveness, etc. Coordination and reporting of HIV testing and counselling activities among central AIDS Coordinator at MoH, Public Health Institute, National Reference Laboratory, Blood Transfusion Centre, Infectious and TB clinics, Obstetrics Clinic, drug treatment settings, prisons, other clinics, private laboratories and NGOs will be strengthened in order to provide up-to-date epidemiological and patient data for planning and decision-making. Monitoring and Evaluation (M&E) activities would build and strengthen capacity to successfully and sustainably collect, analyse and use information to improve health outcomes. Further efforts will be implemented to strengthen the collection, analysis and use of health data. Developing monitoring and evaluation frameworks helps to more effectively monitor programs’ implementation and progress. To ensure the reporting and use of high quality HIV/AIDS data, regular data quality assessments will be undertaken. Further sentinel HIV prevalence surveys among key populations are recommended to be carried out every two years. This is the foundation for tracking the current epidemic situation and making best possible programming and strategic decisions. Objective 4: To reduce AIDS deaths by 90% (over 2013 baseline figures) by improving surveillance of HIV (including HIV testing) and improving the quality of life of PLHIV in Kosovo, promoting a supportive environment and increasing availability and access to client-friendly HIV/AIDS care, support and treatment services and programmes. Page 14 HIV testing and counselling (HTC) is the essential first step in enabling PLHIV to know their status and obtain HIV treatment and care services. For those who test negative, HTC is an important opportunity to put those at risk for HIV in contact with primary prevention programmes and to encourage later retesting. For maximum efficiency, HTC should target key populations and pregnant women in Kosovo. Like all testing and counselling, HTC for key populations and pregnant women would be based on WHO’s 5 Cs: consent, confidentiality, counselling, correct results and linkage to care. Kosovo would develop and implement a HIV testing and counselling strategy, introducing provider initiated HIV testing and counselling (PITC) to the health care system, as well as expanding and improving community-based HIV testing and counselling for key populations. PITC will be recommended in all health facilities for: • pregnant women • adults, adolescents or children who present in clinical settings with signs and symptoms or medical conditions that could indicate HIV infection, including TB; and • HIV-exposed children, children born to women living with HIV and symptomatic infants and children A range of methods would be used to develop new, attractive and effective programs to increase targeted HIV testing in Kosovo among key populations and pregnant women. HTC must be part of a comprehensive prevention, care and treatment programme. It is important that there be clear and robust links between testing and HIV prevention, treatment and care services for those who test positive and with prevention services for those who test negative: poor linkages prevent people from acting on their test results. HIV testing among key populations would follow validated testing algorithms, accord with WHO testing strategies and have appropriate quality assurance/quality improvement mechanisms in place. In addition, rapid HIV diagnostic kits would be used at point of care, and mechanisms would need to be in place to both ensure the quality of test kits and testing (at central, geographic, facility and community levels), and ensure a consistent supply of test kits and prevent stock-outs. HTC in prisons should be a part of an integrated approach at the central level. Nongovernmental Organizations working with PLHIV would be strengthened and provided with a clear role in the central HIV response (e.g. as “expert patients”), to reduce currently observed loss to follow-up, to provide community-based services, as well as testing services ensuring linkages to HIV treatment and care. Objective 5: To establish and strengthen effective institutional frameworks, among public, private and civil society organisations, based on clear mandates and adequate institutional and technical capacity, so that more than 90% of people diagnosed with HIV are linked to HIV care immediately and loss to follow-up is less than 10%. Page 15 Clear roles and responsibility need to be defined for all stakeholders in Kosovo’s HIV response, including lines of reporting and management between MoH, Institute of Public Health, Infectious Diseases Clinic, Blood Transfusion Service, NGOs, CDF, Kosovo AIDS Committee and CCM. Coordination of antiretroviral treatment activities by the MoH AIDS Coordinator should be strengthened in relation to the Public Health Institute, National Reference Laboratory, Infectious Diseases Clinic, Laboratory, PLHIV and NGOs in order to ensure provision and uninterrupted continuity of services for PLHIV. In addition, services integration needs to ensure coordination between TB and HIV care settings, inpatient settings that assure viral hepatitis treatment, drug treatment settings, and all other related institutions and primary care settings. This integration should ensure that appropriate prevention is carried out in each setting, and that those diagnosed with HIV are referred to specialized institutions. Page 16 References 1. WHO (2014) Review of the HIV Programme in Kosovo. Copenhagen (Currently being uploaded to WHO EURO site) 2. WHO (2014) Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations Geneva: http://www.who.int/hiv/pub/guidelines/keypopulations/en/ 3. UNAIDS (2005) The “Three Ones” in action: where we are and where we go from here Geneva: http://reliefweb.int/sites/reliefweb.int/files/resources/F8E5CCDE0C36AE5F8525722D00759BC7- unaids-3onesinaction-jan2005.pdf 4. Government of Kosovo (2009) Ministry of Health Sector Strategy 2010-2014 Pristina: http://www.nationalplanningcycles.org/sites/default/files/country_docs/Kosovo/health_sector_str ategy_2010-2014.pdf 5. UN General Assembly (2001) Declaration of Commitment on HIV/AIDS NY: http://www.unaids.org/sites/default/files/sub_landing/files/aidsdeclaration_en_0.pdf 6. Dublin Declaration on Partnership to Fight HIVIAIDS in Europe and Central Asia (2004) Dublin: http://www.unicef.org/ceecis/The_Dublin_Declaration.pdf 7. UNAIDS (2011) Universal access to HIV prevention, treatment, care and support Geneva: http://www.unaids.org/sites/default/files/sub_landing/files/2011_UA_roadmap_en.pdf 8. HIV Integrated Behavioral and Biological Surveillance Surveys – Kosovo, 2014: People who inject drugs in Pristina and Prizren; Men who have sex with men in Pristina (2014) Draft 9. HIV Integrated Behavioral and Biological Surveillance Surveys – Kosovo, 2014: Female Sex Workers in Ferizaj (2014) 10. Schardt S (2013) Assessment Report: Methadone Maintenance Treatment in Kosovo Realitaten Bureau 11. WHO (2013) Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (and subsequent supplements 2014 Mar and 2014 Jun) Geneva: http://www.who.int/hiv/pub/guidelines/arv2013/download/en/ Page 17 Appendices Annex 1 - Terms of Reference WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR EUROPE WELTGESUNDHEITSORGANISATION REGIONALBÜRO FÜR EUROPA ORGANISATION MONDIALE DE LA SANTÉ BUREAU RÉGIONAL DE L'EUROPE ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО Evaluation of the HIV programme review in Kosovo 26 September – 3 October, 2014 1. Background WHO and the Global Fund have Cooperative Agreement regarding the provision of WHO technical assistance to applicants to the Global Fund prior to submission of their concept notes. The contract is effective during period from 1 January 2014 until 31 December 2015. Technical assistance is organized through external consultants and based on discussions with the countries and the Global Fund Portfolio Managers and formal Country Requests. Kosovo is eligible for the Global Fund grant to support local programme on HIV/AIDS. The Kosovo counterparts requested the WHO Regional Office for Europe to provide technical assistance in evaluating situational analysis and reviewing Strategic Plan on HIV. 2. Programme review Programme review will include 4 key components: 7. Epidemiological analysis 8. HIV services for key populations, including prevention of HIV and access to care 9. Review of HIV treatment and care along cascade of services 10. Procurement and supply management of ARVs A. Epidemiological analysis will focus on: • Assessment the level of, and trends in, HIV disease burden (incidence, prevalence, mortality), including estimated data on HIV epidemic. • Assessment of whether trends in HIV burden are plausibly related to programmatic efforts or other factors. • Defining the investments needed to directly measure trends in HIV disease burden in future B. HIV services for key populations (PWID, SW, MSM) • Needle and syringe programme • Drug dependency treatment (OST) • Condoms • ART access Page 18 • Community outreach (HIV testing and linkage to HIV treatment and care services, ARV dispense, case management/social accompanying) Analysis of HIV services for key populations will focus on coverage, quality and integration with other health services within health system C. Review of HIV treatment and care programme along cascade of services • HIV testing: for general population and key populations, including community-based testing and linkage to HIV treatment and care services, CD4 count at time of diagnosis • Early HIV infant diagnosis, MTCT and paediatric ART • Enrolment and retention in HIV care, including general HIV care, management of co-infections and co-morbidities, integration of HIV/Viral hepatitis, HIV/TB, HIV/OST services • ART: estimated need and coverage, criteria for ART initiation, adherence • ART regimens (1st line, 2nd line and 3rd line) • Monitoring of ART response and diagnosis of treatment failure: VL, ARV toxicity, HIVDR • Patient tracking system • ART outcome: viral suppression Analysis of HIV treatment and care programme will also include review of treatment and care policy and clinical protocols. D. Procurement and supply management of ARVs (PSM) Analysis will be focused on: • PSM policy/strategy/plans appropriateness and sustainability • Selection of ARVs (acceptability of generics?) and forecasting • Planning and coordination of procurement, stock out risk management • Procurement methods, ARV prices, fixed dose combination of ARVs 3. Kosovo’s Strategic Plan on HIV The review of Strategic Plan should focus on the components of Strategic Plan and ensure that: • The Strategic Plan defines and determines priorities and strategic directions over a period of time (e.g.: five years and is aligned with the health plan) • The Strategic Plan provides a clear framework that specifies the appropriate strategic interventions to reach the country’s HIV/AIDS care and control goal(s), objectives and targets. • It guides decision making on allocating resources and on taking action to pursue strategies and set priorities. • Interventions and objectives are adequately and coherently linked. Moreover, activities and sub- activities inherent to each intervention are clearly specified, highlighting clear target(s) for each intervention and identifying where and when each activity or sub-activity should be implemented and who will implement it. • The Strategic Plan specifies the budget needed to implement interventions and activities. • It also clearly describes how the interventions and activities will be operationalized as well as how the implementation will be monitored and their effect will be evaluated • It provides information on the technical assistance needed to make this operationalization effective. 4. Participants Page 19 External consultants • Dave Burrows • Dr. Aram Manukyan • Mirza Musa 5. Methodology Preparation phase will include desk review and analysis of available documents (WHO guidelines, central policy/strategy/plans, clinical guidelines, publications, reports, etc.) During the country mission WHO experts will visit relevant institutions and facilities and discuss with key informants: policy makers, health care providers and beneficiaries, NGOs, other partners where appropriate. Together with local clinical experts they will also have access to medical records of PLHIV for a review clinical management. 6. Time, duration and geographical sites of the mission Programme review includes 6 days mission to Kosovo (September 26-October 3, 2014. 7. Deliverables As a result the key recommendations (including recommendations on the Strategic Plan) based on public health approach will be developed and presented to the stakeholders by the end of the mission for informing the Concept Note. Compliance of approaches and recommendations with the main WHO recommendations, e.g. ‘Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection’ 20136 and ‘Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations’ 20147 will be ensured. Final report with findings and recommendations will be prepared by Dave Burrows, director of AIDS Project Management Group and submitted to WHO regional office for Europe by the end of October 2014. 6http://www.who.int/hiv/pub/guidelines/arv2013/download/en/ 7http://www.who.int/hiv/pub/guidelines/keypopulations/en/ Page 20 Annex 2 –Review team members and list of informants Review team members Dave Burrows, Team Leader, APM Global Health, Australia Dr. Aram Manukyan, Clinician and Epidemiologist, APM Global Health, Armenia Mirza Musa, Prevention, Policy and Public Health expert, APM Global Health, Bosnia and Herzegovina List of informants Name Job title Organization Dr. Skender Syla Head of Office World Health Organization Dr Ardita Tahirukaj NPO World Health Organization Dr. Laura Shehu HIV Programme Coordinator Ministry of Health Arta Berisha HIV/AIDS M&E Officer Ministry of Health Safet Blakaj Director Labyrinth Brikena Krasniqi Manager / Psychologist Labyrinth Dafina Muqaj Psychologist Labyrinth Lindor Bexheti Social Worker Labyrinth Eroll Shporta Manager Labyrinth/ Prizren Rifat Batusha Director KOPF Ramiz Dukaj Project Assistant KOPF Dr.Pashk Buzhala Acting Director of DPH Ministry of Health Bekim Fusha Pharmaceutical Department Director Ministry of Health Ismet Hyseni Procurement Department Director Ministry of Health Dr. Milazim Gjocaj Prisons Health Services Director Ministry of Health Burbuqe Zatriqi Donation Department Chief Ministry of Health Dr. Bajram Maxhuni UN focal Foint UNFPA Dr. Edona Deva GFATM HIV/AIDS Programme Manager Community Development Fund Available upon request to Ministry of Health PLHIV Population Representative PLHIV Population Representative Kushtrim Koliqi Director Integra Dr. Mirushe Emini Ministry of Culture, Youth and Sports Dr. Naser Ramadani Director Public HealthInstitute Dr. Luljeta Gashi HIV/AIDS/STI Unit Chief Public HealthInstitute Dr. Xhevat Jakupi Microbiology Department Public HealthInstitute Page 21 Director Dr. Laura Luzha Epidemiologist Public HealthInstitute Dr. Dafina Gexha Epidemiologist Public HealthInstitute Dr. Murat Mehmeti Infectologist Clinic for Infectious Diseases Dr. Izet Sadiku Infectologist Head of Strategic Plan WG Clinic for Infectious Diseases Dr. Bukurije Raça- Zhubi Transfusion Centre Arber Nuhiu Director CSGD World Health Organization Regional Office for Europe UN City, Marmorvej 51 DK-2100 Copenhagen 0 Denmark Tel.: +45 45 33 70 00 Fax: +45 45 33 70 01 Email: aids@euro.who.int Web site: www.euro.who.inVaids