Which Strings Attached? Toward an Ethics Framework for Selecting Conditionalities in Conditional Cash Transfer Programs

Conditional Cash Transfer programs (CCTs) present a promising new strategy for promoting the uptake of healthy behaviors, particularly for populations that face economic obstacles to these practices. CCTs provide cash payments to households or individuals contingent upon the completion of certain behaviors (e.g. school attendance, vaccination) or achievement of pre-specified outcomes (e.g. nutritional outcomes, STI status). CCTs have quickly become a popular approach in low and middle-income countries worldwide, addressing a range of public health and development issues. However, to date, there is little guidance on how CCT program designers should assess the ethics of a particular CCT design approach. With a range of potential behaviors or outcomes to incentivize, how ought program designers consider the ethics of the various options on which they could condition the monetary reward? What conditionalities should be used for a given conditional cash transfer program, given the health aims and the context? This dissertation seeks to advance the current understanding of ethical considerations related to conditionality selection through three aims. Aim one seeks to identify and define the moral considerations relevant to conditionality selection to help assess which behaviors and outcomes are morally permissible and preferable for program designers to select as conditionalities. Manuscript 1 provides the findings of the conceptual analysis for this aim, which applied norms and principles from a number of frameworks for public health ethics and social justice, drawing upon the extensive literature on CCT program experiences. The second aim is to provide insight into the values, perspectives, and experiences of multiple actors involved in the design of conditional cash transfer programs, with a particular focus on their views surrounding the conditionalities attached to payment. Through qualitative, in-depth interviews, this empirical research explored how various CCT program designers made decisions about program conditionalities, the rationales they used to support their choice of conditionalities, and their views on what general qualities make certain behaviors or outcomes well suited for conditioning. The findings are presented in Manuscript 2. The third aim is to provide an evaluative framework to help policy makers and program designers critically assess the ethics of various conditionalities. Manuscript 3 puts forward an ethical framework to facilitate structured analysis and evaluation of the ethics of a particular CCT approach through an iterative approach of assessing, refining, and re-evaluating the program conditionalities at various periods in the design, implementation, and adjustment of the program. It provides a set of ethical considerations across the various stages of the CCT policy cycle to help program designers identify aspects of a conditionality that may be morally problematic and support the selection of optimal conditionalities for the program. Development of this framework was informed by the aforementioned conceptual and empirical aims. At the heart of the framework are six core categories of morally relevant features: effectiveness in producing desired health gains, associated risks and burdens, receptivity, attainability, indirect effects and externalities, and distributive considerations

Public participation in decision-making on the coverage of new antivirals for hepatitis C.

Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance considerations of innovation, clinical evidence, budget impact and equity in health priority-setting. The purpose of this paper is to examine the role of public participation in addressing these considerations. Design/methodology/approach - The paper employs a comparative case study approach. It explores the experience of four countries - Brazil, England, South Korea and the USA - in making coverage decisions about the antiviral sofosbuvir and involving the public and patients in these decision-making processes. Findings - Issues emerging from public participation ac tivities include the role of the universal right to health in Brazil, the balance between innovation and budget impact in England, the effect of unethical medical practices on public perception in South Korea and the legitimacy of priority-setting processes in the USA. Providing policymakers are receptive to these issues, public participation activities may be re-conceptualized as processes that illuminate policy problems relevant to a particular context, thereby promoting an agenda-setting role for the public. Originality/value - The paper offers an empirical analysis of public involvement in the case of sofosbuvir, where the relevant considerations that bear on priority-setting decisions have been particularly stark. The perspectives that emerge suggest that public participation contributes to raising attention to issues that need to be addressed by policymakers. Public participation activities can thus contribute to setting policy agendas, even if that is not their explicit purpose. However, the actualization of this contribution is contingent on the receptiveness of policymakers.This is the author accepted manuscript. It is currently under an indefinite embargo pending publication by Emerald

Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response

Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely – and at times uniquely – affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group – a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy – in consultation with a variety of external experts and stakeholders.Fil: Krubiner, Carleigh B.. University Johns Hopkins; Estados UnidosFil: Faden, Ruth R.. University Johns Hopkins; Estados UnidosFil: Karron, Ruth A.. University Johns Hopkins; Estados UnidosFil: Little, Margaret O.. University Of Georgetown; Estados UnidosFil: Lyerly, Anne D.. University of North Carolina; Estados UnidosFil: Abramson, Jon S.. University Wake Forest; Estados UnidosFil: Beigi, Richard H.. Magee-Womens Hospital of University of Pittsburgh Medical Center; Estados UnidosFil: Cravioto, Alejandro R.. Universidad Nacional Autónoma de México; MéxicoFil: Durbin, Anna P.. University Johns Hopkins; Estados UnidosFil: Gellin, Bruce G.. Sabin Vaccine Institute; Estados UnidosFil: Gupta, Swati B.. IAVI; Estados UnidosFil: Kaslow, David C.. PATH; Estados UnidosFil: Kochhar, Sonali. Global Healthcare Consulting; IndiaFil: Luna, Florencia. Facultad Latinoamericana de Ciencias Sociales; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Saenz, Carla. Pan American Health Organization; Estados UnidosFil: Sheffield, Jeanne S.. University Johns Hopkins; Estados UnidosFil: Tindana, Paulina O.. Navrongo Health Research Centre; GhanaFil: The Prevent Working Group. No especifíca

Conspiracy theories and misinformation about COVID-19 in Nigeria: Implications for vaccine demand generation communications.

INTRODUCTION: COVID-19 vaccine hesitancy is a worldwide phenomenon and a serious threat to pandemic control efforts. Until recently, COVID-19 vaccine hesitancy was not the cause of low vaccine coverage in Nigeria; vaccine scarcity was the problem. As the global supply of COVID-19 vaccines improves in the second half of 2021 and more doses are deployed in Nigeria, the supply/demand dynamic will switch. Vaccine acceptance will become a key driver of coverage; thus, amplifying the impact of vaccine hesitancy. Conspiracy theories and misinformation about COVID-19 are rampant and have been shown to drive vaccine hesitancy and refusal. This study systematically elicits the misinformation and conspiracy theories circulating about COVID-19 among the Nigerian public to understand relevant themes and potential message framing for communication efforts to improve vaccine uptake. METHODS: From February 1 to 8, 2021, we conducted 22 focus group discussions and 24 key informant interviews with 178 participants from six states representing the six geopolitical zones. Participants were purposively selected and included sub-national program managers, healthcare workers, and community members. All interviews were iteratively analyzed using a framework analysis approach. RESULTS: We elicited a total of 33 different conspiracy theories or misinformation that participants had heard about the COVID-19 virus, pandemic response, or vaccine. All participants had heard some misinformation. The leading claim was that COVID-19 was not real, and politicians took advantage of the situation and misused funds. People believed certain claims based on distrust of government, their understanding of Christian scripture, or their lack of personal experience with COVID-19. CONCLUSIONS: Our study is the first to report a thematic analysis of the range of circulating misinformation about COVID-19 in Nigeria. Our findings provide new insights into why people believe these theories, which could help the immunization program improve demand generation communication for COVID-19 vaccines by targeting unsubstantiated claims

Introducing an Ethics Framework for health priority-setting in South Africa on the path to universal health coverage

Background. South Africa (SA) has embarked on a process to implement universal health coverage (UHC) funded by National Health Insurance (NHI). The 2019 NHI Bill proposes creation of a health technology assessment (HTA) body to inform decisions about which interventions NHI funds will cover under UHC. In practice, HTA often relies mainly on economic evaluations of cost-effectiveness and budget impact, with less attention to the systematic, specific consideration of important social, organisational and ethical impacts of the health technology in question. In this context, the South African Values and Ethics for Universal Health Coverage (SAVE-UHC) research project recognised an opportunity to help shape the health priority-setting process by providing a way to take account of multiple, ethically relevant considerations that reflect SA values. The SAVE-UHC Research Team developed and tested an SA-specific Ethics Framework for HTA assessment and analysis.Objectives. To develop and test an Ethics Framework for use in the SA context for health priority-setting.Methods. The Framework was developed iteratively by the authors and a multidisciplinary panel (18 participants) over a period of 18 months, using the principles outlined in the 2015 NHI White Paper as a starting point. The provisional Ethics Framework was then tested with multi-stakeholder simulated appraisal committees (SACs) in three provinces. The membership of each SAC roughly reflected the composition of a potential SA HTA committee. The deliberations and dedicated focus group discussions after each SAC meeting were recorded, analysed and used to refine the Framework, which was presented to the Working Group for review, comment and final approval.Results. This article describes the 12 domains of the Framework. The first four (Burden of the Health Condition, Expected Health Benefits and Harms, Cost-Effectiveness Analysis, and Budget Impact) are commonly used in HTA assessments, and a further eight cover the other ethical domains. These are Equity, Respect and Dignity, Impacts on Personal Financial Situation, Forming and Maintaining Important Personal Relationships, Ease of Suffering, Impact on Safety and Security, Solidarity and Social Cohesion, and Systems Factors and Constraints. In each domain are questions and prompts to enable use of the Framework by both analysts and assessors. Issues that arose, such as weighting of the domains and the availability of SA evidence, were discussed by the SACs.Conclusions. The Ethics Framework is intended for use in priority-setting within an HTA process. The Framework was well accepted by a diverse group of stakeholders. The final version will be a useful tool not only for HTA and other priority-setting processes in SA, but also for future efforts to create HTA methods in SA and elsewhere

Advancing HIV research with pregnant women: navigating challenges and opportunities

Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research

Low HIV incidence in pregnant and postpartum women receiving a community-based combination HIV prevention intervention in a high HIV incidence setting in South Africa

BACKGROUND: Young Southern African women have the highest HIV incidence globally. Pregnancy doubles the risk of HIV acquisition further, and maternal HIV acquisition contributes significantly to the paediatric HIV burden. Little data on combination HIV prevention interventions during pregnancy and lactation are available. We measured HIV incidence amongst pregnant and postpartum women receiving a community-based combination HIV prevention intervention in a high HIV incidence setting in South Africa. METHODS: A cohort study that included HIV-uninfected pregnant women was performed. Lay community- based workers provided individualized HIV prevention counselling and performed three-monthly home and clinic-based individual and couples HIV testing. Male partners were referred for circumcision, sexually transmitted infections or HIV treatment as appropriate. Kaplan-Meier analyses and Cox's regression were used to estimate HIV incidence and factors associated with HIV acquisition. RESULTS The 1356 women included (median age 22.5 years) received 5289 HIV tests. Eleven new HIV infections were detected over 828.3 person-years (PY) of follow-up, with an HIV incidence rate of 1.33 infections/100 PY (95% CI: 0.74±2.40). Antenatally, the HIV incidence rate was 1.49 infections/100 PY (95% CI: 0.64±2.93) and postnatally the HIV incidence rate was 1.03 infections/100 PY (95% CI: 0.33±3.19). 53% of male partners received HIV testing and 66% of eligible partners received referral for circumcision. Women within known serodiscordant couples, and women with newly diagnosed HIV-infected partners, adjusted hazard ratio (aHR) = 32.7 (95% CI: 3.8±282.2) and aHR = 126.4 (95% CI: 33.8±472.2) had substantially increased HIV acquisition, respectively. Women with circumcised partners had a reduced risk of incident HIV infection, aHR = 0.22 (95% CI: 0.03±1.86). CONCLUSIONS: Maternal HIV incidence was substantially lower than previous regional studies. Community-based combination HIV prevention interventions may reduce high maternal HIV incidence in resource-poor settings. Expanded roll-out of home-based couples HIV testing and initiating pre-exposure prophylaxis for pregnant women within serodiscordant couples is needed in Southern Africa

Economic Returns to Investment in AIDS Treatment in Low and Middle Income Countries

Since the early 2000s, aid organizations and developing country governments have invested heavily in AIDS treatment. By 2010, more than five million people began receiving antiretroviral therapy (ART) – yet each year, 2.7 million people are becoming newly infected and another two million are dying without ever having received treatment. As the need for treatment grows without commensurate increase in the amount of available resources, it is critical to assess the health and economic gains being realized from increasingly large investments in ART. This study estimates total program costs and compares them with selected economic benefits of ART, for the current cohort of patients whose treatment is cofinanced by the Global Fund to Fight AIDS, Tuberculosis and Malaria. At end 2011, 3.5 million patients in low and middle income countries will be receiving ART through treatment programs cofinanced by the Global Fund. Using 2009 ART prices and program costs, we estimate that the discounted resource needs required for maintaining this cohort are $14.2 billion for the period 2011–2020. This investment is expected to save 18.5 million life-years and return$12 to $34 billion through increased labor productivity, averted orphan care, and deferred medical treatment for opportunistic infections and end-of-life care. Under alternative assumptions regarding the labor productivity effects of HIV infection, AIDS disease, and ART, the monetary benefits range from 81 percent to 287 percent of program costs over the same period. These results suggest that, in addition to the large health gains generated, the economic benefits of treatment will substantially offset, and likely exceed, program costs within 10 years of investment