Working toward sustainability: Transitioning HIV programs from a USA-based organization to a local partner in Zimbabwe.

BACKGROUND: Despite the history of United States of America (USA)-based partners implementing global health programs in low- and middle-income countries (LMIC), future models for sustainable healthcare rely on local country ownership and leadership. Transition is the process of shifting programs towards country ownership, where local stakeholders plan, manage, and deliver health programs. Transition is not a singular event but a process which may include a phase where health programs are led and managed by local entities but still reliant on awards from international partners. This phase is scarcely described yet can impact long-term program sustainability if navigated poorly. This qualitative study examines the transition of Zimbabwe's voluntary medical male circumcision and HIV care and treatment services from management by a USA-based organization, the International Training and Education Center for Health (I-TECH), to management under a new Zimbabwean organization, the Zimbabwe Technical Assistance, Training and Education Centre for Health (Zim-TTECH). The primary objective of this paper is to explore challenges, successes, and lessons learned during this transition to inform other non-governmental organizations. METHODS: We conducted sixteen virtual, key informant interviews using purposeful sampling, identifying potential participants based on their role in the transition team (leadership, administrative, financial, or human resources) and willingness to consent to the study. We aimed for equal representation from USA-based, I-TECH headquarters staff and Zimbabwe-based, Zim-TTECH staff involved in the transition team. Data were analyzed in Atlas.Ti using deductive and inductive methods, followed by a thematic analysis guided by several frameworks for program transition and organizational change. RESULTS: Findings suggest five themes to guide transition: 1) Develop a vision and empower leadership for change by delegating clear roles and supporting local ownership; 2) Plan and strategize for transition in a manner that accounts for historical context; 3) Communicate with and inform stakeholders to understand transition perceptions, understand barriers to transition, and enable open communications related to risks and benefits; 4) Engage and mobilize staff by constructing necessary infrastructure and providing technical assistance as needed; and 5) Define short-term and long-term success. CONCLUSION: Transition processes were challenged by the local country context, compressed transition timelines, and all-or-nothing measures of transition success. Facilitators included strong staff capacity and a synergistic partnership model between Zim-TTECH and I-TECH. Global funders and international organizations should support local LMIC partners in their pathway to independence by removing restrictions on funding awards, including transitioning ownership mid-stream, and positioning leadership of international awards for in-country entities.

The rollout of Community ART Refill Groups in Zimbabwe: a qualitative evaluation.

INTRODUCTION: Community ART Refill Groups (CARGs) are an antiretroviral therapy (ART) delivery model where clients voluntarily form into groups, and a group member visits the clinic to collect ART for all group members. In late 2016, Zimbabwe began a nationwide rollout of the CARG model. We conducted a qualitative evaluation to assess the perceived effects of this new national service delivery model. METHODS: In March-June 2018, we visited ten clinics implementing the CARG model across five provinces of Zimbabwe and conducted a focus group discussion with healthcare workers and in-depth interviews with three ART clients per clinic. Clinics had implemented the CARG model for approximately one year. All discussions were audio recorded, transcribed, and translated into English, and thematic coding was performed by two independent analysts. RESULTS: In focus groups, healthcare workers described that CARGs made ART distribution faster and facilitated client tracking in the community. They explained that their reduced workload allowed them to provide better care to those clients who did visit the clinic, and they felt that the CARG model should be sustained in the future. CARG members reported that by decreasing the frequency of clinic visits, CARGs saved them time and money, reducing previous barriers to collecting ART and improving adherence. CARG members also valued the emotional and informational support that they received from other members of their CARG, further improving adherence. Multiple healthcare workers did express concern that CARG members with diseases that begin with minor symptoms, such as tuberculosis, may not seek treatment at the clinic until the disease has progressed. CONCLUSIONS: We found that healthcare workers and clients overwhelmingly perceive CARGs as beneficial. This evaluation demonstrates that the CARG model can be successfully implemented on a national scale. These early results suggest that CARGs may be able to simultaneously improve clinical outcomes and reduce the workload of healthcare workers distributing ART.

Strengthening provider-initiated testing and counselling in Zimbabwe by deploying supplemental providers: a time series analysis.

BACKGROUND: Expansion of provider-initiated testing and counselling (PITC) is one strategy to increase accessibility of HIV testing services. Insufficient human resources was identified as a primary barrier to increasing PITC coverage in Zimbabwe. We evaluated if deployment of supplemental PITC providers at public facilities in Zimbabwe was associated with increased numbers of individuals tested and diagnosed with HIV. METHODS: From July 2016 to May 2017, International Training and Education Center for Health (I-TECH) deployed 138 PITC providers to supplement existing ministry healthcare workers offering PITC at 249 facilities. These supplemental providers were assigned to facilities on a weekly basis. Each week, I-TECH providers reported the number of HIV tests and positive diagnoses they performed. Using routine reporting systems, we obtained from each facility the number of clients tested and diagnosed with HIV per month. Including data both before and during the intervention period, and utilizing the weekly variability in placement locations of the supplemental PITC providers, we employed generalized estimating equations to assess if the placement of supplemental PITC providers at a facility was associated with a change in facility outputs. RESULTS: Supplemental PITC providers performed an average of 62 (SD = 52) HIV tests per week and diagnosed 4.4 (SD = 4.9) individuals with HIV per week. However, using facility reports from the same period, we found that each person-week of PITC provider deployment at a facility was associated with an additional 16.7 (95% CI, 12.2-21.1) individuals tested and an additional 0.9 (95% CI, 0.5-1.2) individuals diagnosed with HIV. We also found that staff placement at clinics was associated with a larger increase in HIV testing than staff placement at polyclinics or hospitals (24.0 vs. 9.8; p < 0.001). CONCLUSIONS: This program resulted in increased numbers of individuals tested and diagnosed with HIV. The discrepancy between the average weekly HIV tests conducted by supplemental PITC providers (62) and the increase in facility-level HIV tests associated with one week of PITC provider deployment (16.7) suggests that supplemental PITC providers displaced existing staff who may have been reassigned to fulfil other duties at the facility.

Accelerating the elimination of viral hepatitis: a Lancet Gastroenterology & Hepatology Commission.

Viral hepatitis is a major public health threat and a leading cause of death worldwide. Annual mortality from viral hepatitis is similar to that of other major infectious diseases such as HIV and tuberculosis. Highly effective prevention measures and treatments have made the global elimination of viral hepatitis a realistic goal, endorsed by all WHO member states. Ambitious targets call for a global reduction in hepatitis-related mortality of 65% and a 90% reduction in new infections by 2030. This Commission draws together a wide range of expertise to appraise the current global situation and to identify priorities globally, regionally, and nationally needed to accelerate progress. We identify 20 heavily burdened countries that account for over 75% of the global burden of viral hepatitis. Key recommendations include a greater focus on national progress towards elimination with support given, if necessary, through innovative financing measures to ensure elimination programmes are fully funded by 2020. In addition to further measures to improve access to vaccination and treatment, greater attention needs to be paid to access to affordable, high-quality diagnostics if testing is to reach the levels needed to achieve elimination goals. Simplified, decentralised models of care removing requirements for specialised prescribing will be required to reach those in need, together with sustained efforts to tackle stigma and discrimination. We identify key examples of the progress that has already been made in many countries throughout the world, demonstrating that sustained and coordinated efforts can be successful in achieving the WHO elimination goals.

The Micro-Elimination Approach to Eliminating Hepatitis C: Strategic and Operational Considerations.

The introduction of efficacious new hepatitis C virus (HCV) treatments galvanized the World Health Organization to define ambitious targets for eliminating HCV as a public health threat by 2030. Formidable obstacles to reaching this goal can best be overcome through a micro-elimination approach, which entails pursuing elimination goals in discrete populations through multi-stakeholder initiatives that tailor interventions to the needs of these populations. Micro-elimination is less daunting, less complex, and less costly than full-scale, country-level initiatives to eliminate HCV, and it can build momentum by producing small victories that inspire more ambitious efforts. The micro-elimination approach encourages stakeholders who are most knowledgeable about specific populations to engage with each other and also promotes the uptake of new models of care. Examples of micro-elimination target populations include medical patients, people who inject drugs, migrants, and prisoners, although candidate populations can be expected to vary greatly in different countries and subnational areas.

Late presentation of chronic viral hepatitis for medical care: a consensus definition.

INTRODUCTION: We present two consensus definitions of advanced and late stage liver disease being used as epidemiological tools. These definitions can be applied to assess the morbidity caused by liver diseases in different health care systems. We focus is on hepatitis B and C virus infections, because effective and well tolerated treatments for both of these infections have greatly improved our ability to successfully treat and prevent advanced and late stage disease, especially if diagnosed early. A consensus definition of late presentation with viral hepatitis is important to create a homogenous, easy-to-use reference for public health authorities in Europe and elsewhere to better assess the clinical situation on a population basis. METHODS: A working group including viral hepatitis experts from the European Association for the Study of the Liver, experts from the HIV in Europe Initiative, and relevant stakeholders including patient advocacy groups, health policy-makers, international health organisations and surveillance experts, met in 2014 and 2015 to develop a draft consensus definition of late presentation with viral hepatitis for medical care. This was refined through subsequent consultations among the group. RESULTS: Two definitions were agreed upon. Presentation with advanced liver disease caused by chronic viral hepatitis for medical care is defined as a patient with chronic hepatitis B and C and significant fibrosis (≥ F3 assessed by either APRI score > 1.5, FIB-4 > 3.25, Fibrotest > 0.59 or alternatively transient elastography (FibroScan) > 9.5 kPa or liver biopsy ≥ METAVIR stage F3) with no previous antiviral treatment. Late stage liver disease caused by chronic viral hepatitis is clinically defined by the presence of decompensated cirrhosis (at least one symptom of the following: jaundice, hepatic encephalopathy, clinically detectable ascites, variceal bleeding) and/or hepatocellular carcinoma. CONCLUSION: These consensus definitions will help to improve epidemiological understanding of viral hepatitis and possibly other liver diseases, as well as testing policies and strategies.

Requirements for global elimination of hepatitis B: a modelling study.

BACKGROUND: Despite the existence of effective prevention and treatment interventions, hepatitis B virus (HBV) infection continues to cause nearly 1 million deaths each year. WHO aspires to global control and elimination of HBV infection. We aimed to evaluate the potential impact of public health interventions against HBV, propose targets for reducing incidence and mortality, and identify the key developments required to achieve them. METHODS: We developed a simulation model of the global HBV epidemic, incorporating data on the natural history of HBV, prevalence, mortality, vaccine coverage, treatment dynamics, and demographics. We estimate the impact of current interventions and scaling up of existing interventions for prevention of infection and introducing wide-scale population screening and treatment interventions on the worldwide epidemic. FINDINGS: Vaccination of infants and neonates is already driving a large decrease in new infections; vaccination has already prevented 210 million new chronic infections by 2015 and will have averted 1·1 million deaths by 2030. However, without scale-up of existing interventions, our model showed that there will be a cumulative 63 million new cases of chronic infection and 17 million HBV-related deaths between 2015 and 2030 because of ongoing transmission in some regions and poor access to treatment for people already infected. A target of a 90% reduction in new chronic infections and 65% reduction in mortality could be achieved by scaling up the coverage of infant vaccination (to 90% of infants), birth-dose vaccination (to 80% of neonates), use of peripartum antivirals (to 80% of hepatitis B e antigen-positive mothers), and population-wide testing and treatment (to 80% of eligible people). These interventions would avert 7·3 million deaths between 2015 and 2030, including 1·5 million cases of cancer deaths. An elimination threshold for incidence of new chronic infections would be reached by 2090 worldwide. The annual cost would peak at US$7·5 billion worldwide ($3·4 billion in low-income and lower-middle-income countries), but decrease rapidly and this would be accelerated if a cure is developed. INTERPRETATION: Scale-up of vaccination coverage, innovations in scalable options for prevention of mother-to-child transmission, and ambitious population-wide testing and treatment are needed to eliminate HBV as a major public health threat. Achievement of these targets could make a major contribution to one of the Sustainable Development Goals of combating hepatitis. FUNDING: Medical Research Council.

Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic Analysis.

INTRODUCTION: New hepatitis C virus (HCV) medicines have markedly improved treatment efficacy and regimen tolerability. However, their high prices have limited access, prompting wide debate about fair and affordable prices. This study systematically compared the price and affordability of sofosbuvir and ledipasvir/sofosbuvir across 30 countries to assess affordability to health systems and patients. METHODS AND FINDINGS: Published 2015 ex-factory prices for a 12-wk course of treatment were provided by the Pharma Price Information (PPI) service of the Austrian public health institute Gesundheit Österreich GmbH or were obtained from national government or drug reimbursement authorities and recent press releases, where necessary. Prices in Organisation for Economic Co-operation and Development (OECD) member countries and select low- and middle-income countries were converted to US dollars using period average exchange rates and were adjusted for purchasing power parity (PPP). We analysed prices compared to national economic performance and estimated market size and the cost of these drugs in terms of countries' annual total pharmaceutical expenditure (TPE) and in terms of the duration of time an individual would need to work to pay for treatment out of pocket. Patient affordability was calculated using 2014 OECD average annual wages, supplemented with International Labour Organization median wage data where necessary. All data were compiled between 17 July 2015 and 25 January 2016. For the base case analysis, we assumed a 23% rebate/discount on the published price in all countries, except for countries with special pricing arrangements or generic licensing agreements. The median nominal ex-factory price of a 12-wk course of sofosbuvir across 26 OECD countries was US$42,017, ranging from US$37,729 in Japan to US$64,680 in the US. Central and Eastern European countries had higher PPP-adjusted prices than other countries: prices of sofosbuvir in Poland and Turkey (PPP$101,063 and PPP$70,331) and of ledipasvir/sofosbuvir in Poland (PPP$118,754) were at least 1.09 and 1.63 times higher, respectively than in the US (PPP$64,680 and PPP$72,765). Based on PPP-adjusted TPE and without the cost of ribavirin and other treatment costs, treating the entire HCV viraemic population with these regimens at the PPP-adjusted prices with a 23% price reduction would amount to at least one-tenth of current TPE across the countries included in this study, ranging from 10.5% of TPE in the Netherlands to 190.5% of TPE in Poland. In 12 countries, the price of a course of sofosbuvir without other costs was equivalent to 1 y or more of the average annual wage of individuals, ranging from 0.21 y in Egypt to 5.28 y in Turkey. This analysis relies on the accuracy of price information and infection prevalence estimates. It does not include the costs of diagnostic testing, supplementary treatments, treatment for patients with reinfection or cirrhosis, or associated health service costs. CONCLUSIONS: Current prices of these medicines are variable and unaffordable globally. These prices threaten the sustainability of health systems in many countries and prevent large-scale provision of treatment. Stakeholders should implement a fairer pricing framework to deliver lower prices that take account of affordability. Without lower prices, countries are unlikely to be able to increase investment to minimise the burden of hepatitis C.

Roundtable discussion: how the World Hepatitis Summit 2015 strengthened stakeholders' efforts to combat viral hepatitis.

The inaugural World Hepatitis Summit was jointly convened by the World Health Organization (WHO) and the World Hepatitis Alliance and hosted by the Scottish Government and supported by Glasgow Caledonian University and Health Protection Scotland in September 2015. The three day event convened a broad range of stakeholders to meet and share ideas, experience and best practice in addressing the many facets of viral hepatitis prevention, diagnosis and treatment. With the next World Hepatitis Summit scheduled to take place from 1 to 3 November 2017, the World Hepatitis Alliance asked Hepatology, Medicine and Policy to commission a roundtable discussion article in order to encourage reflection on how the 2015 Summit was significant for stakeholders' efforts and why it is important to keep the momentum going ahead of the World Hepatitis Summit 2017 and in the light of the newly adopted first-ever Global Health Sector Strategy on Viral Hepatitis.

Hepatitis C virus treatment in the real world: optimising treatment and access to therapies.

Chronic HCV infections represent a major worldwide public health problem and are responsible for a large proportion of liver related deaths, mostly because of HCV-associated hepatocellular carcinoma and cirrhosis. The treatment of HCV has undergone a rapid and spectacular revolution. In the past 5 years, the launch of direct acting antiviral drugs has seen sustained virological response rates reach 90% and above for many patient groups. The new treatments are effective, well tolerated, allow for shorter treatment regimens and offer new opportunities for previously excluded groups. This therapeutic revolution has changed the rules for treatment of HCV, moving the field towards an interferon-free era and raising the prospect of HCV eradication. This manuscript addresses the new challenges regarding treatment optimisation in the real world, improvement of antiviral efficacy in 'hard-to-treat' groups, the management of patients whose direct acting antiviral drug treatment was unsuccessful, and access to diagnosis and treatment in different parts of the world.

Ten priorities for expanding access to HCV treatment for people who inject drugs in low- and middle-income countries.

Of the estimated 130-150 million people who are chronically infected with hepatitis C virus, around 90% reside in low- and middle-income countries. People who inject drugs are disproportionately affected by HCV, with a global estimated prevalence (based on serological reports of HCV antibodies) of 67%; world-wide over 10 million people who inject drugs are infected with HCV. Treatment for HCV has improved dramatically in recent years with the arrival of new direct acting antivirals (DAAs) and this is stimulating considerable efforts to scale up access to treatment. However, treatment coverage among the general population is less than 10% in most countries, and coverage for people who inject drugs is generally much lower. It is estimated that globally around 2 million people who inject drugs need treatment for HCV. The DAAs offer significant potential to rapidly expand access to treatment for HCV. While the ideal combination therapy remains to be established, key characteristics include high efficacy, tolerability, pan-genotypic activity, short treatment duration, oral therapy, affordability, limited drug-drug interactions, and availability as fixed-dose combinations and once daily treatments. This paper outlines 10 key priorities for improving access to HCV treatment for people who inject drugs: (1) affordable access to direct acting antivirals; (2) increased awareness and testing; (3) standardization of treatment; (4) simplification of service delivery; (5) integration of services; (6) peer support; (7) treatment within a framework of comprehensive prevention; (8) tracking progress; (9) dedicated funding; and (10) enabling policies.

Global policy and access to new hepatitis C therapies for people who inject drugs.

People who inject drugs (PWID) are disproportionately affected by hepatitis C virus (HCV). This review outlines policy recommendations made in the 2014 World Health Organisation (WHO) Guidelines on Screening, Care and Treatment of HCV and their relevance to PWID. It also canvasses issues that will affect translation of these global guidelines into practice. The first global HCV guidelines released by WHO have recently advocated targeted HCV testing for PWID, assessment of liver disease and support for alcohol reduction during care. They also strongly advocate treatment using currently licensed direct-acting antiviral agents for all individuals, in particular PWID as a key affected population. New HCV treatment regimens have the potential to cure more than 90% of treated individuals. Scaling-up treatment among PWID has the potential to improve individual and population health by reducing HCV transmission, improving quality of life and supporting behaviour modifications that lead to less risk-taking over time. PWID face several barriers to accessing HCV care and treatment that need to be overcome. Testing services need re-orientation toward PWID, individuals need to be informed of their results and provided with direct linkage to ongoing care. Health services need to provide care in the community using simpler, cheaper and more accessible modes of delivery. Healthcare costs and pharmaceutical costs need to be minimised so PWID, who are highly marginalised, can access HCV treatment. Sustained scale-up of treatment for PWID could simultaneously improve individual health and achieve the goal of eliminating HCV transmission among this high-risk and vulnerable group.