How do participatory methods shape policy? Applying a realist approach to the formulation of a new tuberculosis policy in Georgia.

OBJECTIVES: This paper presents the iterative process of participatory multistakeholder engagement that informed the development of a new national tuberculosis (TB) policy in Georgia, and the lessons learnt. METHODS: Guided by realist evaluation methods, a multistakeholder dialogue was organised to elicit stakeholders' assumptions on challenges and possible solutions for better TB control. Two participatory workshops were conducted with key actors, interspersed by reflection meetings within the research team and discussions with policymakers. Using concept mapping and causal mapping techniques, and drawing causal loop diagrams, we visualised how actors understood TB service provision challenges and the potential means by which a results-based financing (RBF) policy could address these. SETTING: The study was conducted in Tbilisi, Georgia. PARTICIPANTS: A total of 64 key actors from the Ministry of Labour, Health and Social Affairs, staff of the Global Fund to Fight AIDS, TB and Malaria Georgia Project, the National Centre for Disease Control and Public Health, the National TB programme, TB service providers and members of the research team were involved in the workshops. RESULTS: Findings showed that beyond provider incentives, additional policy components were necessary. These included broadening the incentive package to include institutional and organisational incentives, retraining service providers, clear redistribution of roles to support an integrated care model, and refinement of monitoring tools. Health system elements, such as effective referral systems and health information systems were highlighted as necessary for service improvement. CONCLUSIONS: Developing policies that address complex issues requires methods that facilitate linkages between multiple stakeholders and between theory and practice. Such participatory approaches can be informed by realist evaluation principles and visually facilitated by causal loop diagrams. This approach allowed us leverage stakeholders' knowledge and expertise on TB service delivery and RBF to codesign a new policy.

Addressing challenges in tuberculosis adherence via performance-based payments for integrated case management: protocol for a cluster randomized controlled trial in Georgia.

BACKGROUND: Tuberculosis is one of the greatest global health concerns and disease management is challenging particularly in low- and middle-income countries. Despite improvements in addressing this epidemic in Georgia, tuberculosis remains a significant public health concern due to sub-optimal patient management. Low remuneration for specialists, limited private-sector interest in provision of infectious disease care and incomplete integration in primary care are at the core of this problem. METHODS: This protocol sets out the methods of a two-arm cluster randomized control trial which aims to generate evidence on the effectiveness of a performance-based financing and integrated care intervention on tuberculosis loss to follow-up and treatment adherence. The trial will be implemented in health facilities (clusters) under-performing in tuberculosis management. Eligible and consenting facilities will be randomly assigned to either intervention or control (standard care). Health providers within intervention sites will form a case management team and be trained in the delivery of integrated tuberculosis care; performance-related payments based on monthly records of patients adhering to treatment and quality of care assessments will be disbursed to health providers in these facilities. The primary outcomes include loss to follow-up among adult pulmonary drug-sensitive and drug-resistant tuberculosis patients. Secondary outcomes are adherence to treatment among drug-sensitive and drug-resistant tuberculosis patients and treatment success among drug-sensitive tuberculosis patients. Data on socio-demographic characteristics, tuberculosis diagnosis and treatment regimen will also be collected. The required sample size to detect a 6% reduction in loss to follow-up among drug-sensitive tuberculosis patients and a 20% reduction in loss to follow-up among drug-resistant tuberculosis patients is 948 and 136 patients, respectively. DISCUSSION: The trial contributes to a limited body of rigorous evidence and literature on the effectiveness of supply-side performance-based financing interventions on tuberculosis patient outcomes. Realist and health economic evaluations will be conducted in parallel with the trial, and associated composite findings will serve as a resource for the Georgian and wider regional Ministries of Health in relation to future tuberculosis and wider health policies. The trial and complementing evaluations are part of Results4TB, a multidisciplinary collaboration engaging researchers and Georgian policy and practice stakeholders in the design and evaluation of a context-sensitive tuberculosis management intervention. TRIAL REGISTRATION: ISRCTN, ISRCTN14667607 . Registered on 14 January 2019.

The Challenges of Transition From Donor-Funded Programs: Results From a Theory-Driven Multi-Country Comparative Case Study of Programs in Eastern Europe and Central Asia Supported by the Global Fund.

INTRODUCTION: In the era of declining development assistance for health, transitioning externally funded programs to governments becomes a priority for donors. However, the process requires a careful approach not only to preserve the public health gains that have already been achieved but also to expand on them. In the Eastern Europe and Central Asia region, countries are expected to graduate from support from the Global Fund to Fight AIDS, Tuberculosis and Malaria in or before 2025. We aim to describe transition risks and identify possible means to address them. METHODS: Using a theory-based conceptual framework-Transition Preparedness Assessment of Tuberculosis and HIV/AIDS programs-we investigated transition-related challenges through a health systems lens in 10 countries of the Eastern Europe and Central Asia region during 2015-2017. Study findings were derived from systematic collection of quantitative data on socioeconomic indicators and disease epidemics as well as qualitative data from in-depth interviews with 264 stakeholders. These findings were then compared with other donor transition experiences documented elsewhere. RESULTS: We found numerous common transition challenges, such as poor monitoring of a country's macroeconomic performance along with weakness in estimating financial needs for successful transition; limited political will of governments to replace donor-funded programs; punitive legislation criminalizing certain behaviors and constraining the government's ability to allocate funds and contract civil society organizations essential to providing services for key populations; limited coordination function of governments and weak decision-making power of coordinating mechanisms obscuring the latter's future role; and inadequate function of national procurement and supply chain management systems undermining an uninterrupted supply of quality-assured drugs and commodities. These challenges are compounded by the risks related to health workforce management leading to specialist shortages and/or inadequately skilled and qualified professionals and by limited funding for critical surveillance activities. CONCLUSION: The complex and multidimensional transition process requires a multipronged approach through well-planned collective and coordinated responses from global, bilateral, and national partners in coming years. Other similar transition processes may provide guidance. Although no "one-size-fits-all" approach exists, previous experiences highlight a need for both early planning and monitoring of the transition along several key dimensions. Issues that could threaten the maintenance of health gains include ongoing stigma against key populations; continued heavy reliance on external funding in some countries, especially for preventive services; the institutional viability of the country coordinating mechanisms; and emerging difficulties with procurement of quality drugs at reasonable prices.

Designing and evaluating provider results-based financing for tuberculosis care in Georgia: a realist evaluation protocol.

INTRODUCTION: In 2016, Georgian researchers and policymakers were developing a policy to improve the performance of the national tuberculosis (TB) control programme. The research programme 'Designing and Evaluating Provider Results-Based Financing for Tuberculosis Care in Georgia: Understanding Costs, Mechanisms of Effect and Impact (Results4TB)' was initiated to inform the policy formulation phase, document the policy implementation and assess the effectiveness, cost-effectiveness and the processes of change. To achieve this, the research team intends to combine an impact evaluation, a cost-effectiveness study and a realist evaluation (RE) within an overarching theory-informed design. This protocol is the RE component of the programme. METHODS: A realist methodological approach will be adopted to guide the research design and evaluation. RE answers the question of 'what works in which conditions for whom?' and starts with the development of an initial programme theory (IPT). The IPT will feed into other phases of the realist research cycle (study design, data collection, data analysis and synthesis and theory refinement). Data will be collected in a multiple embedded case study design (five intervention and three control sites) through document reviews, in-depth interviews, non-participant observations and context mapping at facility and national levels. Additional data from other research components (cost-effectiveness and impact evaluation) will aid data triangulation. ETHICS AND DISSEMINATION: The Institutional Review Boards of the National Centre for Disease Control and Public Health in Georgia (ref. IRB # 2018-019) and the Institute of Tropical Medicine, Antwerp (ref. IRB #- 1240/18) have granted ethical approval to the study. TRIAL REGISTRATION NUMBER: ISRCTN14667607.

On the way to Hepatitis C elimination in the Republic of Georgia-Barriers and facilitators for people who inject drugs for engaging in the treatment program: A formative qualitative study.

Hepatitis C virus (HCV) infection is a significant public health concern worldwide. Georgia is among the countries with a high burden of HCV infection. People who inject drugs (PWID) have the highest burden of infection in Georgia. In 2015, the Government of Georgia, with partners' support, initiated one of the world's first Hepatitis C Elimination Programs. Despite notable progress, challenges to achieving targets persist. This qualitative study is aimed to better understand some of the barriers and facilitators to HCV testing and treatment services for PWID to inform HCV treatment policies and practices. The study instrument examined social, structural, and individual factors influencing HCV testing and treatment practices. We started with key informant interviews to guide the study instrument development and compare the study findings against health care planners' and health care providers' views. Forty PWID with various HCV testing and treatment experiences were recruited through the snowball method. The study found that along with structural factors such as political commitment, co-financing of diagnostic and monitoring tests, and friendly clinic environments, knowledge about HCV infection and elimination program benefits, and support from family and peers also play facilitating roles in accessing testing and treatment services. On the other hand, inability to co-pay for diagnostic tests, fear of side effects associated with treatment, poor knowledge about HCV infection, and lack of social support hampered testing and treatment practices among PWID. Findings from this study are important for increasing the effectiveness of this unique program that targets a population at high risk of HCV infection.

Barriers to delivering mental health services in Georgia with an economic and financial focus: informing policy and acting on evidence.

BACKGROUND: Whilst there is recognition that the global burden of disease associated with mental health disorders is significant, the economic resources available, especially in Low and Middle Income Countries, are particularly scarce. Identifying the economic (system) and financial (individual) barriers to delivering mental health services and assessing the opportunities for reform can support the development of strategies for change. METHODS: A mixed methods study was developed, which engaged with a range of stakeholders from mental health services, including key informants, service managers, healthcare professional and patients and their care-takers. Data generated from interviews and focus groups were analysed using an existing framework that outlines a range of economic and financial barriers to improving mental health practice. In addition, the study utilised health financing and programmatic data. RESULTS: The analysis identified a variety of local economic barriers, including: the inhibition of the diversification of the mental health workforce and services due to inflexible resources; the variable and limited provision of services across the country; and the absence of mechanisms to assess the delivery and quality of existing services. The main financial barriers identified were related to out-of pocket payments for purchasing high quality medications and transportation to access mental health services. CONCLUSIONS: Whilst scarcity of financial resources exists in Georgia, as in many other countries, there are clear opportunities to improve the effectiveness of the current mental health programme. Addressing system-wide barriers could enable the delivery of services that aim to meet the needs of patients. The use of existing data to assess the implementation of the mental health programme offers opportunities to benchmark and improve services and to support the appropriate commissioning and reconfiguration of services.