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[eng] The core argument of the present work is articulated in four points. First, social- science knowledge is crucial to understand and combat HIV/AIDS; second, integrated and engaged social-science is especially vital for such endeavor; third, integrated and engaged scholarship of HIV/AIDS has been prominent in Brazil (since 1990s) and South Africa (since 2000s); Fourth, Brazil's earlier use of social- science knowledge in HIV/AIDS policy accounts for its success in tackling the epidemic, and South Africa has only recently started making effort in this direction. The theoretical background of the present discussion consists in social-science approaches to problem-solving and policy-making within the debates about the role of social-science in modern states formation. It is about history and epidemiology of the social sciences, but the discussion goes beyond these instances and maintains a normative approach to academics social responsibility to contribute more directly and consciously to national development. In this sense, this is a matter of both cameral social-science (linked to public policy design and evaluation: John Goldthorpe) and public social-science (in support of to civil society for social justice: Alain Touraine, Michael Burawoy). The rationale and main objective of the thesis substantiates in three questions: first, why HIV/AIDS? second, why social-science? and, third, why Brazil and South Africa? In this regard, it is argued that: HIV/AIDS is a complex social problem that needs and allows comprehensive analysis; the role of social-science knowledge in HIV/AIDS interventions, as well as the impact of the epidemic on social-science, are understudied; and, finally, Brazil and South Africa are good examples to demonstrate how the use of social-science knowledge accounts for the success of health policy oriented to HIV/AIDS. Indeed, Brazil was far superior to South Africa until a decade ago (it is still the case, to some extent) in responding effectively to the HIV/AIDS epidemic by implementing a nation-wide comprehensive program of prevention, treatment and care. It is then suggested that this was partly due to a consistent use of social- science knowledge that helped the state to go beyond the concept of risk-groups. Based on these premises, it is here suggested that social scientists played a significant role in Brazil's National AIDS Program by infusing politics with the concept of social vulnerability to HIV/AIDS. This means that interventions need to go beyond risk-groups and information-based strategies (that characterized the initial HIV/AIDS studies and programs), as demonstrated by the global debate on the locus of behavioral change in HIV/AIDS studies and interventions. Following the shift of approaches from individual and information-based strategies to structural factors and holistic approaches (the latter being in vogue since the 1990s globally), social scientists in Brazil suggested that it was necessary to improve people's social, cultural and economic circumstances in order to create healthy supporting contexts. This was associated with Brazil state's political will to prioritize HIV/AIDS and to act collectively, which implied alliances between administrative levels (federal state, local states, and municipalities), civil society and academics. So, social scientists were great protagonists in the battle against the HIV/AIDS in Brazil within this climate of political will and collective action against the epidemic. The same cannot be said in the case of South Africa. This particularly explains the divergent policy outcomes: Brazil's low and concentrated HIV incidence rate (0.5%), and South Africa's generalized epidemic and high incidence rate of HIV infection (18%). This is despite the fact that by the HIV emergence the two countries were rather similar societies in terms of general state capacity, civil society involvement, Human Development Index, and epidemiological profile. The former point means that by the HIV outburst the initial risk-group in both countries was constituted by male middle-class homosexuals – as situation that radically and rapidly reversed more in South Africa than in Brazil, although pauperization, feminization and heterosexualization of HIV infection are aspects that characterize both countries today. Brazil's major political will and cohesiveness, with social scientists' participation, falsifies arguments according to which Brazil's superiority – compared to South Africa - in tackling HIV/AIDS is due to the countries' earlier democratization (1986 vs 1994), the role of World Bank's loans throughout the 1990s, and Brazilian elites' tradition of investment in public health. Indeed, first, Brazil's National AIDS Plan was already well established by the end of 1980s had already made progress towards a comprehensive program of prevention, treatment and care. Brazil's National AIDS Plan created early on an inter-ministerial body (compressing the ministries of health, education, labor and justice) and defined clear authorities responsible for HIV/AIDS policies. Second, South African elites' were equally prone to invest in public health, for Brazil was not superior in this field. Hence, the present work suggests that it was political will and collective action that permitted Brazil to act more promptly and aggressively against the HIV/AIDS epidemic until a decade ago. In turn, here's the core argument – this positive atmosphere facilitated the production and inclusion of massive use- inspired research that informed HIV/AIDS policy about the complexity of the epidemic and the most appropriate measures to reverse it. For example, social research helped Brazil to enlighten Brazilians' openness towards sex, sexuality and sexual diversity, whereby not only did prevention social actors find it easy to discuss those issues for the sake of prevention initiatives, but also permitted the government to involve gay groups, rather than stigmatizing them. Importantly, Brazil state's openness towards social-science was part of a general positive attitude towards science, whereby the use of biomedical measures (explanation of HIV-AIDS link and provision of antiretroviral drugs to infected persons) was an essential element in the response to the epidemic. By contrast, holistic and large-scale inquiries and, above all, their use in policy were late to emerge in South Africa (between the end 1990s and early 2000s). This contributed to HIV/AIDS policy being poorly informed by social-science until a decade ago. HIV/AIDS policy in South Africa was consequently characterized by negligence and inaction (in the initial phase), simplistic explanations (like the negative impact of poverty on vulnerability to HIV infection without the exploration of its link with cultural factors), and denial. The state had a hostile attitude towards orthodox biomedical professionals and civil society organizations who sought to combat the epidemic through mainstream science. Therefore, the state went through controversial policies that ultimately prohibited the provision of antiretroviral therapy in the public sector and was hostile to mainstream social theory of HIV/AIDS. This negative political scenario hampered the contribution of social scientists in the battle against the epidemic in South Africa. Contrary to Brazil, HIV/AIDS use-inspired research was not fomented and academics activism was not welcomed by South African state. The situation would only improve in mid-2000s when the state commenced providing public antiretroviral therapies and making progress in prevention programs. Relatedly, the state started then to work in concert with civil society and academics. This was partly a result of a series of high court instructions for the state to accomplish its constitutional duty to provide health services, following a case law-suited by Treatment Action Campaign, the leading civil society AIDS organization. More importantly, HIV/AIDS social-science which was carried out in South Africa until a decade ago relevant, nevertheless. The unfortunate story is that it was not used for policy design and evaluation. Social scientists in South Africa did seek to stress the concept of social vulnerability, warning against the impact of poverty and inequalities, misogyny, magical thinking and traditional healers, just to mention a few. But these insights found no support of the state. It is this early South African scholarship of HIV/AIDS that constitutes the basis for today's vibrant comprehensive and engaged social-science in the country, whereby South Africa is making-up with its delay. Besides reflection on the complexity of HIV/AIDS and the need for integrated interventions, we can single out some fields of research-action in which the history of HIV/AIDS scholarship materializes: public policy (cameral social-science), peer educators and teachers training, and harm reduction programs for injecting drug users (the latter characterizing especially Brazil). Both in Brazil and South Africa, integrated and engaged scholarship has boosted cross-disciplinarity and multidimensional approaches, as well as debates about academics social responsibility in terms of use-inspired research and research- action. Such debate is largely shaped by reflections on the timing of Brazil's and South Africa's responses to the epidemic - early in the former and late in the latter – and the related outcomes with regard to HIV incidence rates. It is to this debate that the present dissertation seeks to contribute by suggesting that the use of social-science knowledge made a difference in Brazil's success and South Africa's failure in tackling the HIV/AIDS epidemic until a decade ago. Furthermore, the thesis goes on, social-science engagement with HIV/AIDS, theoretically and practically, will continue to shape the way in which we conceive of the position and the role of social-science knowledge in society.

As of December 31, 2015, there were 15,995 diagnosed and reported persons living with human immunodeficiency virus (HIV) who were residents of San Francisco, California at time of diagnosis. Approximately one quarter of men who have sex with men (MSM) in San Francisco are HIV-positive. Despite a high HIV burden, a higher proportion of HIV-positive San Franciscans are virally suppressed (72% in 2014 in San Francisco) than nationally (55% nationally in 2013), and 81% of all cases in San Francisco had at least one HIV viral load or CD4 test in 2014 (versus 71% nationally in 2013). Recently, new strategies have emerged to prevent HIV transmission, including post-exposure prophylaxis, treatment as prevention and pre-exposure prophylaxis (PrEP). With these new tools, the end of the HIV epidemic is within reach. New HIV diagnoses in San Francisco are now half of what they were a decade ago, down from 528 new HIV diagnoses in 2006 to 255 in 2015. The Getting to Zero (GTZ) consortium, formed in San Francisco after World AIDS Day in 2013, which is comprised of representatives from the San Francisco Department of Public Health, the University of California San Francisco, public and private medical providers, community based organizations, other San Francisco government agencies and people living with HIV (PLWH), aims to get to zero new HIV transmissions, zero HIV deaths and zero HIV stigma in San Francisco. My dissertation is aligned with the mission of the GTZ consortium.My dissertation seeks to address how the population dynamics of MSM (through migration and HIV serostatus) could affect the prevalence and incidence of HIV in San Francisco and may help explain why there is ongoing HIV transmission in the era of PrEP and treatment as prevention. The ability to migrate has increased for PLWH as survival markedly improved following introduction of combination antiretroviral therapy in 1996. Although there is a high frequency of migration among the general U.S. population and among PLWH in San Francisco, migration patterns of MSM in San Francisco have, to my knowledge, never been described. Output from the novel migration model outlined in Chapter 2 can be used to understand the dynamics of the MSM population in San Francisco and macro-level forces that could affect the prevalence and incidence of HIV in the population. Estimating the number of MSM by HIV status also allows researchers to have a denominator of this hidden population for use in estimating prevalence, incidence, service needs and funding allocations. Further, estimating the number of HIV-negative in-migrants relative to the overall MSM population is important because research has shown that recent MSM migrants to metropolitan areas are at increased risk of HIV acquisition because of higher risk behaviors. My results suggest that the overall MSM population and all the MSM subpopulations studied decreased in size from 2006 to 2014. Further, there were differences in migration patterns by race and by HIV serostatus.Next, given the goal of eliminating all transmission of HIV, I assessed the association between knowledge of an HIV-negative partner's PrEP use and reported condomless anal sex (CAS) among sexually active MSM in San Francisco. In 2010, the iPrEx trial showed that a daily dose of tenofovir disoproxil fumerate (TDF) and emtricitabine (FTC) for HIV-negative persons in HIV serodiscordant relationships could reduce HIV transmission by 42%. In 2012, the FDA approved daily FTC/TDF for HIV prophylaxis. Although no increase in CAS was observed in the iPrEx trial, there is concern that expansion of PrEP could result in reduced condom use. The study population for iPrEx, individuals who consented to participate in a randomized-controlled trial, likely did not represent the general population of MSM. Furthermore, participants knew that they could have been randomized to receive a placebo and, therefore, it is not surprising that in this setting, no increase in CAS was observed. Recent research has focused on PrEP use and CAS reported by HIV-negative individuals on PrEP; no research to my knowledge has focused on PLWH's reported condom use during sex if they know that their HIV-negative partner is on PrEP. I found that there was a higher prevalence of reported CAS and insertive condomless anal sex (ICAS) in partnerships that were either seroconcordant or serodiscordant with PrEP, compared to partnerships that were serodiscordant without PrEP. There was evidence that men in this sample were adapting their condom use based on their sexual partner's HIV status and PrEP use, and their own viral suppression status. Discordant partnerships with PrEP had an increased adjusted prevalence of reported CAS and ICAS.I used causal inference methods to determine the effect of internalized HIV stigma (IHS) on viral suppression. Past research on IHS has focused on ART adherence as an outcome, and depression has been determined to be a mediator along this path. To my knowledge, no research has looked at the effect of IHS on viral suppression as an outcome. Research focusing on IHS in San Francisco has been limited to subgroups of HIV-positive individuals, such as homeless and marginally housed HIV-positive adults. Causal inference methods were used to estimate the counterfactual proportion of HIV-positive adults virally suppressed if all adults in HIV care in San Francisco did not experience IHS compared to the proportion of HIV-positive adults virally suppressed if all adults in HIV care in San Francisco did experience IHS, by following the causal roadmap. Three estimators were used to estimate the average treatment effect: simple substitution, inverse probability of treatment weighting, and targeted maximum likelihood estimation (TMLE). The results from each estimator were similar, and a statistically significant causal effect was observed for all. Using TMLE, the counterfactual proportion of adults virally suppressed would decrease by roughly 4.5% if all adults did not experience internalized HIV stigma as opposed to if all adults experience internalized HIV stigma.

Massive activation of infected CD4+ T cells during acute HIV-1 infection leads to reservoir seeding and T-cell destruction. During T-cell activation, the antiviral effect of the innate factor SAMHD1 is neutralized through phosphorylation at T592, allowing HIV-1 infection. Dasatinib, a tyrosine kinase inhibitor currently used for treating chronic myeloid leukemia, has been described to control HIV-1 replication through its negative effect on T-cell proliferation and viral entry. We demonstrate that Dasatinib can actually interfere with SAMHD1 phosphorylation in human peripheral blood lymphocytes, preserving its antiviral activity against HIV-1. Dasatinib prevented SAMHD1 phosphorylation in vitro and ex vivo, impairing HIV-1 reverse transcription and proviral integration. This was the major mechanism of action because the presence of Vpx, which degrades SAMHD1, in HIV-1 virions impeded the inhibitory effect of Dasatinib on HIV-1 replication. In fact, infection with VSV-pseudotyped HIV-1 virions and fusion of BlaM-Vpr-containing HIV-1 viruses with activated PBMCs in the presence of Dasatinib suggested that Dasatinib was not acting at fusion level. Finally, PBMCs from patients on chronic treatment with Dasatinib showed a lower level of SAMHD1 phosphorylation in response to activating stimuli and low susceptibility to HIV-1 infection ex vivo. Consequently, Dasatinib is a compound currently used in clinic that preserves the antiviral function of SAMHD1. Using Dasatinib as adjuvant of antiretroviral therapy during early primary HIV-1 infection would contribute to reduce viral replication and spread, prevent reservoir seeding, and preserve CD4 counts and CTL responses. These events would create a more favorable virologic and immunologic environment for future interventional studies aiming at HIV-1 eradication. ; This work was supported by the Spanish Ministry of Economy and Competitiveness (SAF2010-18388, SAF2013-44677-R, FIS PI12/00506, and FIS PI12/00969); the SPANISH AIDS Research Network RD12/0017/0015 that is included in Acción Estratégica en Salud, Plan Nacional de Investigación Científica, Desarrollo e Innovación Tecnológica 2008-2011, Instituto de Salud Carlos III, European Region Development Fund (ERDF); Bristol-Myers Squibb (BMS AI471-041); AIM-HIV Network of Excellence of the EU, grant number HEALTH-F3-2012-305938; joined program of the Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS AO2014-2); and the European FP7-HEALTH project HIT HIDDEN HIV. The work of Elena Mateos is supported by the Instituto de Salud Carlos III (Spain) (MPY 1371/12). The work of Sara Rodríguez-Mora is supported by a fellowship of Sara Borrell from Spanish Ministry of Economy and Competitiveness. The work of María Rosa López-Huertas is supported by a fellowship of the European Union Programme Health 2009 (CHAARM). The work of Dr Benjamin Descours is supported by the 31 European FP7-HEALTH project HIT HIDDEN HIV. Dr. Montserrat Plana is a researcher at the Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) and is supported by the Spanish Health Institute Carlos III (ISCIII) and the Health Department of the Catalan Government (Generalitat de Catalunya). Dr. Juan Ambrosioni developed this work in the framework of a 'Juan de la Cierva 2012' post- doctoral program, Ministerio de Competitividad, Madrid, Spain. ; Sí

INTRODUCTION: In the jurisdiction of Brasília, Brazil, significant reductions in mortality rates and lethality resulting from acquired immunodeficiency syndrome (AIDS) were observed shortly after the introduction of highly active antiretroviral therapy. In recent years, however, the decline of these rates has not been as significant. Non-adherence to treatment and delayed diagnosis appear to be the main factors that increase the risk of death from AIDS. Behavioral, socioeconomic, and biological factors could also be associated with increased risk of death due to AIDS. This study aimed to identify which of these factors were associated with deaths from AIDS in Brasília. METHODS: A case-control study was undertaken using the data recorded in the Information System of Notifiable Diseases. Cases consisted of AIDS deaths occurring in 2007, residing in Brasília, and over 12 years of age. Controls consisted of AIDS patients who did not die until December 31 2007, also residing in Brasília, and over 12 years of age. For each group, frequency and proportion tables for the variables were prepared. The statistical association of each factor in isolation with the occurrence of the deaths was verified through a model of multivariate analysis using logistic regression. RESULTS: The factors that were associated with an increased risk of death were intravenous drug use, age 50 years or more, and residing in a region whose residents have low per capita income. CONCLUSIONS: We identified factors associated with death due to AIDS that can guide health planning. ; INTRODUÇÃO: No Distrito Federal, Brasil, houve importante redução das taxas de mortalidade e de letalidade por AIDS logo após a introdução da terapia antirretroviral altamente ativa, mas nos últimos anos o declínio dessas taxas não foi significativo. Não adesão ao tratamento e diagnóstico tardio parecem ser os principais fatores que elevam o risco de óbito por AIDS. Fatores comportamentais, socioeconômicos e biológicos também podem estar associados ao maior risco de óbito por AIDS. O objetivo deste estudo foi identificar quais desses fatores apresentaram associação com os óbitos por AIDS no Distrito Federal. MÉTODOS: Estudo do tipo caso-controle, utilizando os dados registrados no Sistema de Informação de Agravos de Notificação, em que foram considerados casos os óbitos por AIDS ocorridos em 2007, residentes no Distrito Federal e maiores de 12 anos de idade e, controles os doentes de AIDS que não foram a óbito até 31 de dezembro de 2007, também residentes no Distrito Federal e com mais de 12 anos de idade. Prepararam-se, para cada grupo, tabelas de frequência e proporção para as variáveis. Foi verificada a associação estatística de cada fator isoladamente com a ocorrência dos óbitos e também por meio de um modelo de análise multivariável por regressão logística. RESULTADOS: Os fatores que apresentaram associação com maior risco de óbito foram: usar drogas injetáveis, ter idade maior ou igual a 50 anos e residir em local cujos moradores possuem baixa renda per capita. CONCLUSÕES: Identificaram-se fatores associados ao óbito por AIDS que poderão nortear o planejamento em saúde. ; Secretaria de Estado de Saúde do Distrito Federal Diretoria de Vigilância Epidemiológica ; Câmara Legislativa do Distrito Federal ; Universidade Federal de São Paulo (UNIFESP) Departamento de Medicina Programa de Pós-Graduação em Medicina Interna e Terapêutica ; UNIFESP, Depto. de Medicina Programa de Pós-Graduação em Medicina Interna e Terapêutica ; SciELO

학위논문(박사)--서울대학교 대학원 :보건대학원 보건학과(보건학전공),2020. 2. 조성일. ; 연구의 배경과 목적 인간면역결핍바이러스 (Human Immunodeficiency virus, HIV) 감염은 성매개감염의 일종이고 만성 감염이다. 1985년 첫 환자가 보고된 이후 한국에서 HIV 감염인 수는 지속적으로 증가하고 있다. HIV 감염 관리를 위해서는 진단과 치료, 유지의 각각의 단계가 원활하게 이루어지는 것이 필요하며, UNAIDS (The Joint United Nations Programme on HIV/AIDS) 에서는 90-90-90 target을 목표로 하여 감염자의 90%를 진단하고, 그 중 90%를 치료하며, 90%를 바이러스가 억제된 상태로 유지하자는 계획을 세웠다. 이후 여러 나라에서 목표를 성취했다는 보고가 발표되었지만 한국에서는 아직 HIV 감염에 대한 정확한 역학 통계가 알려져 있지 않다. 한국에서 HIV 감염은 질병관리본부에서 전수 조사를 하고 있지만, 감염 사실만을 조사하고 있어 이후의 약제 복용이나 순응도에 대한 분석을 할 수 없다. 한편 한국은 국가단일 건강보험 체계를 가지고 있고, HIV 치료는 건강 보험으로 대부분 급여 진료가 행해지므로 HIV 감염인의 병원 내원과 약제 처방을 국가 전수조사 할 수 있다. 이 연구는 건강보험 청구자료를 이용하여 HIV 감염인의 국내 역학을 파악하는 것을 목적으로 한다. 세부적으로는, (1) 건강보험 청구자료를 분석하여 국내 HIV 감염인의 숫자와 역학적 특성을 기술한다. (2) 약물 소지 비율 (medication possession ratio)을 이용하여 국내 HIV 감염인의 항레트로바이러스 약물 순응도를 평가하고, 낮은 약물 순응도와 관련이 있는 인자를 알아본다. (3) 국내 HIV-매독 중복감염 현황을 건강 보험 청구자료를 분석하여 알아보고, 약물 순응도가 HIV-매독 중복감염에 미치는 영향을 평가한다. 연구 방법 (1) 건강보험 청구자료에서 수집된 2007년부터 2015년까지 HIV 진단을 받고 HIV 치료를 위해 반드시 필요한 검사를 한 사람을 연구 대상으로 정의하였다. 후천성면역결핍증후군 (Acquired Immune Deficiency Syndrome; AIDS)는 AIDS 관련 진단이 있거나 예방적 화학요법을 받는 경우로 정의하였다. 확인된 HIV 감염인의 수를 질병관리본부의 보고서와 비교하였다. (2) 건강보험 청구자료에서 확인된 2007년부터 2016년까지 HIV 진단을 받고 항레트로바이러스 복합 처방이 있는 HIV 감염인을 확인하고, 2009년부터 2016년까지 신규 감염인을 연구 대상으로 하였다. 약물 소지비율을 평가하여 95%이상 높은 약물 순응도를 보이는 대상자의 분율을 확인하고, 낮은 약물 순응도와 연관되는 인자를 확인하였다. (3) 건강보험 청구자료에서 확인된 2008년부터 2016년까지의 신규 감염인을 연구 대상으로 하였다. HIV 감염인 중 매독 진단과 치료 약제 처방이 있는 매독 중복감염 환자를 확인하였다. 대상자의 인구학적 특성과 95% 이상의 높은 약물 순응도를 보이는 환자의 비율을 중복 감염 여부를 기준으로 비교하였다. 결과 (1) 건강보험 청구자료와 질병관리본부 보고서는 HIV 감염인 수에서 10% 정도의 차이를 보였다. 그러나 나이와 성별 추이는 연간 누적 환자와 신규 환자에서 모두 비슷한 양상을 보였다. 특히 질병관리본부 보고서에서는 상당 수의 환자에서 CD4 세포 수를 확인할 수 없었던 반면에 건강보험 청구자료에서는 예방적 화학요법 처방을 이용하여 CD4 세포수가 200/mm3 미만인 환자의 수를 확인하였다. (2) 8,501 명의 신규 HIV 감염인 중에서 70.4%의 환자가 약물소지비율 95% 이상의 높은 약물 순응도를 보였다. 예방적 화학요법, 여성, 20-29세 또는 50세 이상의 나이, 악성 종양의 과거력, 낮은 사회경제적 상황, 3차 병원 이외의 종류의 병원 진료, 그리고 상대적으로 과거에 진단되는 경우가 낮은 약물 순응도와 관련이 있었다 (각각 Odds ratio 1.7, 1.6, 1.6, 1.4, 1.6, 2.1, 1.2, 1.6 to 3.8). (3) 9,393 명의 신규 HIV 감염인 중 4,536 (48.3%)가 매독 중복감염으로 치료 받았다. 높은 약물 순응도는 HIV-매독 중복감염과 통계적인 연관이 있었다 (odds ratio 1.18; 95% confidence interval 1.08–1.30; P=0.001). 이외에 남성, 세균/원충 성매개감염, 그리고 생식기 단순포진바이러스 감염 또한 HIV-매독 중복감염과 연관이 있었다. 결론 (1) 첫 번째 연구는 건강보험 청구자료를 HIV 감염인의 역학연구에 활용할 수 있다는 것을 기술하고 있다. 질병관리본부 보고서는 전체 국내 HIV 감염인의 수에 대한 통계를 제공하며, 건강보험 청구자료는 이들의 병원 진료 현황을 보여준다. 특히 본 연구를 통해 AIDS 환자에 대한 추가적인 정보를 알 수 있다. 건강보험 청구자료와 질병관리본부 보고서의 두 가지 자료를 종합하여 이용하면 진단된 HIV 감염인을 치료로 연계하는 것에 도움을 받을 수 있다. 두 가지 자료를 종합하여 HIV 감염인 관리 체계를 구축할 수 있을 것이다. (2) 두 번째 연구는 건강보험 청구자료를 분석하여 이상적인 약물 순응도를 보이는 국내 HIV 감염인의 분율을 기술하고 있다. 연구 결과에 따르면 우리나라에서 항레트로바이러스 약물을 복용하는 환자들의 높은 약물 순응도를 보이는 비율은 다른 선진국과 비교했을 때에 양호하다. 낮은 약물 순응도와 관련이 있는 여성과 10대 그룹에는 약물 순응도를 높이기 위한 관심이 필요하다. (3) 세 번째 연구는 국내 HIV-매독 중복감염의 현황을 기술하고 있다. 높은 약물 순응도는 오히려 매독 중복감염과 관련이 있어 HIV 바이러스 억제가 되는 상태에서도 콘돔을 사용한 안전한 성관계에 대한 강조가 여전히 필요하다. ; Introduction and Objective Human immunodeficiency virus (HIV) infection is a sexually-transmissible chronic infection, the occurrence of which has increased continuously in Korea. Each step of the diagnosis, engagement in antiretroviral therapy (ART), and care maintenance is necessary to control an HIV infection. However, epidemiological data on the achievement of these steps are not well-established in Korea. This study was conducted to investigate the epidemiology of HIV infection in Korea, using nationwide claims data from the Korean National Health Insurance database. The objectives are as follows: (1) To identify the number of annual HIV infections and their epidemiological characteristics in Korea through an analysis of the national claims data and evaluate the usefulness of these data for an epidemiological study of HIV infection in Korea. (2) To identify medication adherence for ART among those diagnosed with HIV in Korea and determine risk factors for suboptimal adherence via the medication possession ratio (MPR). (3) To identify the percentage of HIV-syphilis coinfection in Korea and risk factors for HIV-syphilis coinfection by using national claims data. Methods (1) Using the National Health Institute database, we established two surveillance systems to yield the prevalence and incidence of HIV infection in Korea from 2007 to 2015. We then compared these results to those reported in the Korea Centers for Disease Control and Prevention (KCDC) registry, based on positive laboratory tests. (2) We estimated ART adherence among incident HIV-infected individuals and investigated factors affecting low medication adherence using the national health insurance claims data from 2007 to 2016. The MPR was used to measure medication adherence and risk factors for suboptimal adherence were identified by multivariable logistic regression analysis. (3) This study was retrospective in nature, using the claims database of the NHI system from 2008 to 2016. The clinical characteristics of people living with HIV with or without syphilis coinfection were analyzed. People with HIV and syphilis coinfection were divided into two groups based on an MPR cutoff of 95%: an optimal ART adherence group and a suboptimal ART adherence group. Results (1) The number of patients who visited hospitals recorded in the KCDC registry differed by about 10%. However, age and sex trends by year were comparable to the number of existing and newly diagnosed cases reported by the KCDC. In particular, the claims data provided a more accurate estimate of the number of patients with a CD4-positive T cell count of less than 200/mm3, while much of those data were missing in the KCDC registry. (2) Of the 8,501 newly diagnosed HIV-infected individuals identified during 2009-2016 with at least one ART prescription, 5,981 (70.4%) patients had adequate adherence to ART (defined as MPR ≥ 95%). Women (odds ratio [OR] 1.6), age under 20 and same or over 50 compared to 30–39 (OR 1.6, 1.4), a history of malignancy (OR 1.6), lower socioeconomic status (OR 1.2), not visiting a tertiary-level hospital (OR 1.2), and being diagnosed in the earlier years (OR for 2009 3.7-2015 1.7) were found to be risk factors for lower adherence. (3) Of the 9,393 people living with HIV, 4,536 (48.3%) were diagnosed with a syphilis coinfection. Optimal adherence to ART was independently associated with a syphilis coinfection (OR 1.18; 95% confidence interval 1.08–1.30; P=0.001). Male gender, having a bacterial or protozoan sexually transmitted disease, and having a genital herpes viral infection were also identified as risk factors for an HIV-syphilis coinfection. An HIV-syphilis coinfection was still associated with an optimal adherence >95% to ART even after the definition of syphilis infection has been limited since the diagnosis of HIV infection. Conclusions (1) The first study found that the claims data are valuable in estimating the epidemiology of people living with HIV/acquired immunodeficiency syndrome visiting the hospital. The KCDC registry reports the total number of people living with HIV and the claims data shows their hospital visits. A combination of the two databases can be used as a tool to connect diagnosed people living with HIV to the treatment they require. We suggest building a matched HIV surveillance system linking the claims data and the nationwide registry built by the government. (2) The results from the second study indicate that health authorities should take modifiable and unmodifiable barriers into consideration, in order to establish a sustainable monitoring system at the national level and to improve adherence. (3) The results from the third study suggest that the occurrence of unsafe sex is independent of medication adherence. Although HIV is unlikely to be transmitted when the viral load is controlled, consistent use of condoms is needed to prevent a syphilis infection. ; Abstract 1 Contents 6 List of Tables 8 List of Figures 10 Chapter 1. Introduction 11 Chapter 2. Usefulness of the Korean National Health Insurance database in establishing surveillance systems of treatment cascade for HIV infection 19 2-1. Introduction 20 2-2. Materials and Methods 21 2-3. Results 28 2-4. Discussion 39 Chapter 3. Adherence to antiretroviral therapy and factors affecting low medication adherence among incident HIV-infected individuals during 2009–2016: A nationwide study 45 3-1. Introduction 46 3-2. Materials and Methods 47 3-3. Results 53 3-4. Discussion 65 Chapter 4. Association of HIV-syphilis coinfection with optimal antiretroviral adherence: A nation-wide claims study 72 4-1. Introduction 73 4-2. Materials and Methods 75 4-3. Results 79 4-4. Discussion 87 Chapter 5. Discussion and Conclusion 91 References 98 Abstract in Korean 104 ; Doctor

ABSTRACT - It is the purpose of the present thesis to emphasize, through a series of examples, the need and value of appropriate pre-analysis of the impact of health care regulation. Specifically, the thesis presents three papers on the theme of regulation in different aspects of health care provision and financing. The first two consist of economic analyses of the impact of health care regulation and the third comprises the creation of an instrument for supporting economic analysis of health care regulation, namely in the field of evaluation of health care programs. The first paper develops a model of health plan competition and pricing in order to understand the dynamics of health plan entry and exit in the presence of switching costs and alternative health premium payment systems. We build an explicit model of death spirals, in which profitmaximizing competing health plans find it optimal to adopt a pattern of increasing relative prices culminating in health plan exit. We find the steady-state numerical solution for the price sequence and the plan's optimal length of life through simulation and do some comparative statics. This allows us to show that using risk adjusted premiums and imposing price floors are effective at reducing death spirals and switching costs, while having employees pay a fixed share of the premium enhances death spirals and increases switching costs. Price regulation of pharmaceuticals is one of the cost control measures adopted by the Portuguese government, as in many European countries. When such regulation decreases the products' real price over time, it may create an incentive for product turnover. Using panel data for the period of 1997 through 2003 on drug packages sold in Portuguese pharmacies, the second paper addresses the question of whether price control policies create an incentive for product withdrawal. Our work builds the product survival literature by accounting for unobservable product characteristics and heterogeneity among consumers when constructing quality, price control and competition indexes. These indexes are then used as covariates in a Cox proportional hazard model. We find that, indeed, price control measures increase the probability of exit, and that such effect is not verified in OTC market where no such price regulation measures exist. We also find quality to have a significant positive impact on product survival. In the third paper, we develop a microsimulation discrete events model (MSDEM) for costeffectiveness analysis of Human Immunodeficiency Virus treatment, simulating individual paths from antiretroviral therapy (ART) initiation to death. Four driving forces determine the course of events: CD4+ cell count, viral load resistance and adherence. A novel feature of the model with respect to the previous MSDEMs is that distributions of time to event depend on individuals' characteristics and past history. Time to event was modeled using parametric survival analysis. Events modeled include: viral suppression, regimen switch due virological failure, regimen switch due to other reasons, resistance development, hospitalization, AIDS events, and death. Disease progression is structured according to therapy lines and the model is parameterized with cohort Portuguese observational data. An application of the model is presented comparing the cost-effectiveness ART initiation with two nucleoside analogue reverse transcriptase inhibitors (NRTI) plus one non-nucleoside reverse transcriptase inhibitor(NNRTI) to two NRTI plus boosted protease inhibitor (PI/r) in HIV- 1 infected individuals. We find 2NRTI+NNRTI to be a dominant strategy. Results predicted by the model reproduce those of the data used for parameterization and are in line with those published in the literature.

Novel strategies with NRTIs‐sparing regimen in antiretroviral naïve HIV‐infected patients are currently used in clinical trials [1]. We previously presented preliminary results of this study [2] and here we present the 48‐weeks final results. Prospective, open‐label, randomised (1:1), multicenter, proof‐of‐concept trial. HIV‐infected naïve patients were assigned to once daily maraviroc (MVC) plus lopinavir/ritonavir (LPV/r) or to tenofovir/emtricitabine (TDF/FTC) plus LPV/r. Objectives of the study were the 48‐weeks virological and immunological efficacy. Data were collected at baseline (BL) and at 4, 12, 24, 36 and 48 weeks. T cell subsets from frozen peripheral blood mononuclear cells collected at BL, 4 and 48 weeks were also evaluated. ANOVA for repeated measures performed and Greenhouse‐Geisser probabilities calculated. Results reported as median (Q1–Q3) or frequency (%). Fifty patients (26 in MVC group and 24 in TDF/FTC group) were enrolled and reached week 48. Similar BL characteristics were observed in the two study groups; age: 39.1 (34.2–44) years, 2/50 (4%) females, infected since 2.9 (0.8–5.3) years, CD4+ nadir 266 (242–315) cells/µL, BL CD4+ 295 (260–369) cells/µL; CD4% 18.6 (14.6–23), HIV‐RNA 4.4 (3.9–4.8) log10 copies/mL. At W48, all patients in MVC group and 22/24 (96%) in TDF/FTC group had HIV‐RNA<50 copies/ml (p=0.225). CD4+ trend during follow‐up was different between the two groups (p=0.046) with a higher CD4 gain of 286 (183–343) vs 199 (125–285) cells/mL in MVC and TDF/FTC, respectively (p=0.033). In MVC vs TDF/FTC group, we observed a higher expression of CCR5+CD4+ T cells [W48 change: +7.5% (−4.5/11) vs −5.4 (−15.1/−0.5), p=0.016] and a higher increase of CD4+ effector memory [W48 change: +1.6% (0.7/4.8) vs ‐4.4 (−13.5/−0.2), p=0.007]. No significant variations in naïve and central memory CD4+ T cells. Treatment was well tolerated, without grade 3 or 4 adverse events. No significant difference between the two groups as for the 48‐weeks trend of bone marrow function, AST, ALT and CPK values, creatinine value, glicyde profile (fasting glucose, fasting insuline) and lipid profile (total cholesterol, LDL and HDL cholesterol, tryglicerides). Results are shown in Table 1. In naïve‐patients, virological efficacy and tolerability of a NRTIs‐sparing regimen with maraviroc and lopinavir/ritonavir was similar to conventional treatment in addition to a better immunological recovery, in particular of the Effector Memory CD4+ cells subset.















Baseline
Week 12
Week 24
Week 36
Week 48
p‐valuea




CD4+ cells/mm3
MVC+LPV/r
292 (261–359)
438 (381–500)
517 (432–620)
533 (457–682)
614 (455–709)
0.046



TDF/FTC+LPV/r
297 (257–373)
450 (354–511)
496 (367–568)
470 (402–568)
505 (419–705)



CD4%
MVC+LPV/r
19.5 (16.3–24.3)
24 (18–29.5)
26.2 (22.2–29)
28.2 (21.3–32.2)
27.7 (21.6–33)
0.718



TDF/FTC+LPV/r
18.8 (14.3–22.3)
24.7 (18.4–26.2)
25.2 (21.3–30.1)
24.9 (21.5–31.6)
25.7 (22.1–30.2)



CD4/CD8 ratio
MVC+LPV/r
0.35 (0.25–0.48)
0.45 (0.3–0.62)
0.54 (0.4–0.67)
0.66 (0.4–0.82)
0.72 (0.47–0.93)
0.316



TDF/FTC+LPV/r
0.33 (0.26–0.4)
0.44 (0.33–0.55)
0.51 (0.39–0.66)
0.52 (0.48–0.7)
0.54 (0.49–0.72)



HIV‐RNA log10 copies/ml
MVC+LPV/r
4.42 (4.07–4.84)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
0.188



TDF/FTC+LPV/r
4.41 (3.84–4.76)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
1.56 (1.56–1.56)



Haemoglobin (g/dL)
MVC+LPV/r
14.7 (13.7–15.1)
14 (13.5–14.6)
14.3 (13.7–14.9)
14.1 (13.3–15.1)
14.5 (13.6–15.2)
0.357



TDF/FTC+LPV/r
14.1 (13.8–14.9)
14.4 (13.5–15.1)
14.8 (13.5–15.3)
14.7 (13.7–15.3)
14.7 (13.6–15.2)



White blood cell (109/mm3)
MVC+LPV/r
5 (4.6–5.6)
5.6 (5.2–6.9)
5.8 (4.8–7.2)
5.9 (5–7.7)
5.9 (5–7.5)
0.806



TDF/FTC+LPV/r
4.5 (3.9–5.2)
4.3 (4.3–6.5)
5.1 (4.5–7.1)
5.1 (4.3–6.8)
5.5 (4.4–6.7)



Cholesterol (mg/dl)
MVC+LPV/r
178 (149–204)
–
202 (177–233)
–
218 (167–260)
0.794



TDF/FTC+LPV/r
160 (144–194)
–
189 (157–239)
–
199 (164–239)



Tryglicerides (mg/dl)
MVC+LPV/r
91 (64–126)
–
193 (113–254)
–
170 (105–270)
0.825



TDF/FTC+LPV/r
91 (66–148)
–
159 (106–203)
–
147 (110‐187)



Glucose (mg/dl)
MVC+LPV/r
84 (78–91)
–
86 (75–89)
–
84 (76–93)
0.200



TDF/FTC+LPV/r
81 (75–89)
–
85 (79–92)
–
82 (77–88)



Insulin (U/L)
MVC+LPV/r
5.7 (4–10.2)
–
7 (5.1–8.4)
–
6.8 (5.8–10.8)
0.554



TDF/FTC+LPV/r
7.2 (5.7–14.6)
–
6.8 (5.7–10)
–
5.8 (5.3–9.3)



Creatinine (mg/dl)
MVC+LPV/r
0.83 (0.77–0.95)
0.79 (0.72–0.85)
0.78 (0.69–0.87)
0.78 (0.71–0.86)
0.81 (0.75–0.87)
0.149



TDF/FTC+LPV/r
0.83 (0.78–0.98)
0.88 (0.79–1)
0.85 (0.75–0.93)
0.85 (0.77–0.92)
0.85 (0.74–0.95)

Roger Wumba,1 Benjamin Longo-Mbenza,2 Jean Menotti,3,4 Madone Mandina,5 Fabien Kintoki,5 Nani Hippolyte Situakibanza,1,5 Marie Kapepela Kakicha,6 Josue Zanga,1 Kennedy Mbanzulu-Makola,1 Tommy Nseka,1 Jean Pierre Mukendi,1 Eric Kendjo,7 Jean Sala,1 Marc Thellier7,81Department of Tropical Medicine, Infectious and Parasitic Diseases, Department of Parasitology, University Clinic of Kinshasa, Faculty of Medicine, University of Kinshasa, Kinshasa, Congo; 2Faculty of Health Sciences, Walter Sisulu University, Eastern Cape, South Africa; 3Laboratory of Parasitology and Mycology, Saint-Louis Hospital, Public Assistance-Hospitals of Paris, Paris, France; 4Faculty of Medicine, Lariboisière-Saint-Louis, University of Paris VII, Paris, France; 5Department of Internal Medicine, University Clinic of Kinshasa, Faculty of Medicine, University of Kinshasa, Kinshasa, Congo; 6Department of Pediatrics, University Clinic of Kinshasa, Faculty of Medicine, University of Kinshasa, Kinshasa, Congo; 7National Center for Malaria Research, AP-HP, CHU Pitie Salpêtrière, Paris, France; 8Laboratory of Parasitology and Mycology, Pitié Salpêtrière Hospital, Public Assistance-Hospitals of Paris, Pierre and Marie Curie University, Paris, FranceBackground: The objective of this study was to determine the prevalence of intestinal parasites, with special emphasis on microsporidia and Cryptosporidium, as well as their association with human immunodeficiency virus (HIV) symptoms, risk factors, and other digestive parasites. We also wish to determine the molecular biology definitions of the species and genotypes of microsporidia and Cryptosporidium in HIV patients.Methods: In this cross-sectional study, carried out in Kinshasa, Democratic Republic of the Congo, stool samples were collected from 242 HIV patients (87 men and 155 women) with referred symptoms and risk factors for opportunistic intestinal parasites. The analysis of feces specimen were performed using Ziehl–Neelsen stainings, real-time polymerase chain reaction (PCR), immunofluorescence indirect monoclonal antibody, nested PCR-restriction fragment length polymorphism, and PCR amplification and sequencing. Odds ratio (OR) and 95% confidence intervals were used to quantify the risk.Results: Of the 242 HIV patients, 7.8%, 0.4%, 5.4%, 0.4%, 2%, 10.6%, and 2.8% had Enterocytozoon bieneusi, Encephalitozoon intestinalis, Cryptosporidium spp., Isospora belli, pathogenic intestinal protozoa, nonpathogenic intestinal protozoa, and helminths, respectively. We found five genotypes of E. bieneusi: two older, NIA1 and D, and three new, KIN1, KIN2, and KIN3. Only 0.4% and 1.6% had Cryptosporidium parvum and Cryptosporidium hominis, respectively. Of the patients, 36.4%, 34.3%, 31%, and 39% had asthenia, diarrhea, a CD4 count of <100 cells/mm³, and no antiretroviral therapy (ART), respectively. The majority of those with opportunistic intestinal parasites and C. hominis, and all with C. parvum and new E. bieneusi genotypes, had diarrhea, low CD4+ counts of <100 cells/mm³, and no ART. There was a significant association between Entamoeba coli, Kaposi sarcoma, herpes zoster, chronic diarrhea, and asthenia, and the presence of 28 cases with opportunistic intestinal parasites. Rural areas, public toilets, and exposure to farm pigs were the univariate risk factors present in the 28 cases with opportunistic intestinal parasites. In logistic regression analysis, a CD4 count of <100 cells/mm³ (OR = 4.60; 95% CI 1.70–12.20; P = 0.002), no ART (OR = 5.00; 95% CI 1.90–13.20; P < 0.001), and exposure to surface water (OR = 2.90; 95% CI 1.01–8.40; P = 0.048) were identified as the significant and independent determinants for the presence of opportunistic intestinal parasites.Conclusion: E. bieneusi and Cryptosporidium are becoming more prevalent in Kinshasa, Congo. Based on the findings, we recommend epidemiology surveillance and prevention by means of hygiene, the emphasis of sensitive PCR methods, and treating opportunistic intestinal parasites that may be acquired through fecal–oral transmission, surface water, normal immunity, rural area-based person–person and animal–human infection, and transmission of HIV. Therapy, including ART and treatment with fumagillin, is needed.Keywords: diarrhea, Enterocytozoon bieneusi, Cryptosporidium hominis, Cryptosporidium parvum, risk factors, Africans

Background: Emerging adulthood (18 to 29 years old) is a critical age group in relation to the Human Immunodeficiency Virus (HIV) epidemic and to mental health. A major public health concern globally, in management of HIV, is that emerging adults have suboptimal antiretroviral therapy (ART) adherence, yet they are the largest group initiating ART. In addition, common mental disorders (CMDs), including depression and anxiety have their peak incidence during this period and they have been found to increase risk of non-adherence to ART. Those with CMDs may have different types of barriers than those without CMDs. Furthermore, those with CMDs might be more likely to have a greater number of barriers to adherence than those without because of the way symptoms of CMDs impact on memory, problem solving skills and concentration. Aims: The main aim of this study was to describe barriers to adherence to ART in emerging adults living with HIV with probable CMDs (i.e. depression and/or anxiety) and accessing HIV treatment at a government clinic in Harare, Zimbabwe, compared to emerging adults living with HIV without probable CMDs. The specific objectives were: a. to determine the prevalence of probable CMDs among emerging adults living with HIV, b. to describe the prevalence, severity and common barriers to ART adherence, measured using the 22-item Barriers to Adherence (BARTA scale) in emerging adults living with HIV with probable CMDs and to compare this with those without probable CMDs. Methods: A representative sample of 223 emerging adults aged 18 to 29 years were recruited in a crosssectional study using the random sampling technique. The Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7) and Barriers to Adherence Scale (BARTA scale) were used to assess probable depression, probable anxiety and barriers to adherence respectively. Data Analysis: Univariate Descriptive statistics were used to describe the socio-demographic, prevalence of probable CMDs, prevalence of barriers to adherence, overall median of total BARTA score (severity of barriers to ART adherence) for the whole sample and overall median number of barriers to ART adherence for the whole sample. Chi-square analyses were used to compare the prevalence of barriers (no barrier vs. at least one) between participants with and without probable CMDs. Non-parametric Wilcoxon rank-sum tests and Kruskal Wallis tests (for variables with more than two categories) were used to I. Compare the number of barriers to ART adherence between participants with and without a probable CMDs; II. Compare the severity of barriers to ART adherence between participants with and without probable CMDs, using overall scores on the BARTA scale III. Assess the relationship between demographic variables, HIV related variables, Substance Use Disorders (SUD) and total BARTA scores. Variables which were significantly associated with BARTA scores were entered into a negative binomial regression model, to assess the relationship between CMDs and severity of barriers to ART adherence, this time controlling for possible demographic confounding factors. Results: The prevalence of probable CMDs (i.e. probable depression and/or probable anxiety) was 33.2%. Specifically, 31.8% had probable depression and 16.1% had probable anxiety. Results: showed that 76.2 % of the sample experienced at least one barrier to ART adherence and that 94.5% of those with CMDs experienced at least one barrier to adherence compared to 67.1% of those without CMDs (p>0.001). We found a significant difference (U=-7.209, p<0.001) between the number of barriers experienced by participants with and without CMDs: participants with a CMD reported a greater number of barriers (median (md) =5, IQR=3-7) compared to those without CMDs (md= 1, IQR=0-4). A statistically significant difference was also found in total BARTA scores between participants with and without CMDs: participants with a CMD reported a greater BARTA score (md=7, IQR=4-12) compared to those without a CMD (md= 2, IQR=0-4; U=-7.415, p<0.001). The most frequent barriers reported by emerging adults living with HIV with probable CMDs were 'forgetting' (68.0%), 'thinking too much' (49.0%), 'having to take ART in front of others' (41.0%) and 'not having a reminder' (39.0%). The most frequent barriers for emerging adults living with HIV without probable CMDs were 'forgetting' (30%), 'not having medications with them' (21%), 'not wanting others to know their status' (20%) and 'not having a reminder' (19%). Although 'forgetting' and 'not having a reminder' were among the top barriers in both groups, those with probable CMDs reported them more frequently. Conclusion: This study has shown that firstly, CMDs and barriers to ART adherence are prevalent among emerging adults living with HIV. Secondly, emerging adults living with HIV with probable CMDs experience a high number of barriers to ART adherence and more severely than those without probable CMDs. Finally, emerging adults with CMDs reported barriers such as forgetting and not having a reminder more frequently than those without CMDs. This calls for routine screening for probable CMDs and barriers to ART adherence in HIV clinics. Furthermore, there is need to come up with tailored psychological interventions that can simultaneously treat CMDs and reduce barriers to ART adherence among emerging adults living with HIV.

Preface With an estimated 5.6 million people living with HIV in 2009, South Africa's epidemic remains the largest in the world (UNAIDS, 2010). It is approximated that 40million South Africans depend on traditional medicine for their primary health care needs and regularly visit Traditional Health Practitioners (THPs). Patients often move freely between traditional and allopathic systems of medicine. In fact, up to 90% of people living with HIV and AIDS first consult THPs before visiting practitioners of allopathic medicine. Thus THPs bear the brunt of the HIV and AIDS epidemic. With this in mind it became necessary to convene a conference where the potential contribution of traditional medicine in the fight against HIV and AIDS could be objectively assessed. It also facilitated learning and sharing experienses from practitioners, researchers, governments and NGOs/or funders that have advanced in integrating traditional medicine in HIV and AIDS. The conference covered four key priority areas in accordance with the National Strategic Plan for HIV and AIDS and STI: prevention; treatment, care and support; research, monitoring and surveillance; and financing. The Conference was titled "Traditional medicine in the era and HIV/AIDS in South Africa" and held at the International Convention Centre, Durban between 28th to 30th July 2010. This historic conference, funded by PEPFAR/CDC South Africa, was attended by more than 1500 delegates from South Africa, Belgium, Botswana, Cameroon, China, Lesotho, Nigeria, Tanzania, Uganda, United States of America, and Zambia. On each day there were 200 high school learners and 200 community members in attendance. In addition there were researchers, CAM practitioners, donors, doctors, nurses, THPs, policy makers, and members of the media. It was organised in partnership with the Department of Science and Technology, the KwaZulu-Natal Provincial Government and the University of KwaZulu-Natal and had the support of the Department of Health, the South African National AIDS Council (SANAC) and the South African Broadcasting Corporation (SABC) among others. National Parliament was represented by members of the Health and, Science and Technology Portfolio Committees, respectively. National government departments in attendance included Health, Science and Technology, and Trade and Industry. All provinces of South Africa were represented with the exception of Northern and Western Cape provinces. The House of Traditional Leaders and Local Government were represented by Her Majesty, Queen of LinduZulu, local chiefs, Mayors and Councilors. The US Government (PEPFAR) was represented by the Health Attaché in the US Embassy, US Consul General in Durban, PEPFAR Liaison Officer (KZN) and CDC (South Africa). A call for abstracts was published in 3 major national newspapers and on the internet on a number of websites. Abstract themes had to fit within the strategic areas of the National Strategic Plan for HIV/AIDS/TB. The conference received more than 70 abstracts, reviewed by a panel of national and international experts. About 50 abstracts were accepted for oral presentation and 12 as posters. Additional speakers from the 7 provincial departments of health and 7 Provincial AIDS Council THP sector representatives informed the conference on their programmes. The Department of Science and Technology and the Technology Innovation Agency shared their plans and strategies for research and development of traditional medicines in South Africa. The conference was primarily abstract-driven. Abstract contents were either research-based data using established scientific methods or demonstrated experience and information from individuals or institutions working in the field in the form of case studies or case presentations. The non-abstract-driven components of the conference addressed a variety of current viewpoints and issues including government programmes, interactive case-based sessions, and satellite symposia. The television and print media broadcasted the proceedings of the conference. Selected speakers and delegates were interviewed live. Highlights The highlights of the conference included the following: 1. South Africa could demonstrate its capacity to carry out world class clinical trials on traditional medicine. 2. Provincial Governments and Provincial AIDS Councils shared their plans and strategies to include traditional medicine in their implementations plans. 3. Traditional Health Practitioners were in full support of integrating HIV Counseling and Testing, Traditional or Medical Male Circumcision, and other national strategies in their practices but required support and capacitation for HIV testing. 4. It is necessary to intensify research on traditional medicines since a number of HIV positive patients who do not qualify for antiretroviral therapy choose them. 5. There were best practice projects promoting collaboration between traditional health practitioners and public health care workers in the fight against HIV/AIDS. 6. The media will continue to report positive and negative aspects of traditional medicine 7. The Department of Science and Technology funds the most research on indigenous knowledge systems including traditional medicines in South Africa. 8. The USA remains the largest foreign funder of HIV research and programmes on traditional medicine. This special edition carries some of the scientific papers presented at the conference. Professor Nceba Gqaleni, Chair of the Traditional Medicine in the Era of HIV and AIDS Conference Dr Vusi Shongwe, Director: Heritage, Office of the Premier, KwaZulu-Natal Government and Professor Yonah Seleti, Chief Director: National Indigenous Knowledge Systems Office, Department of Science and Technology Co-Chairpersons of the Traditional Medicine in the Era of HIV and AIDS Conference.

In recent years, HIV treatment has become so effective that a patients' viral load can become so low that it is undetectable, which in turn reduces the risk of viral transmission to zero (Eisinger, Dieffenbach, & Fauci 2019). At the same time, for people who are HIV negative, the use of the medical regimen "pre-exposure prophylaxis," or "PrEP," reduces the risk of HIV infection by 92%-99% (Anderson et al. 2012). The PrEP regimen typically targets people at high risk of HIV infection and consists of taking HIV medicines either daily or through event-based dosing ("PrEP" 2019). These innovations are celebrated as key in the fight against AIDS, and rightfully so. They offer hope to affected populations, that they might engage with the AIDS epidemic in a way that is more commemorative than somatically threatening. Thus, modern HIV medication promises access to a gay subjectivity that expands notions of sustainability otherwise made unavailable by the AIDS crisis. This access potentially alleviates stigma and enables a reorientation of mostly gay male sociability and politics across and beyond the viral serostatuses of "HIV negative" and "HIV positive." Such medical innovation does not erase the trauma of the AIDS crisis. Such trauma continually impacts gay cultures today, in the minds and on the bodies of survivors, and more broadly by informing how gay communities imagine gay sexual sociability to be virtuous, sustainable, transgressive, dangerous, etc. Contemporary gay sexual sociability is informed by the socio-technical interventions of condom use, regular STI testing, and sexual serosorting, practices that were negotiated during and after the AIDS crisis in order to retain access to gay somatic pleasures. These practices of vitality are not individual endeavors but rather socially negotiated responses, put in place and governed through an ethic of collective, cultural sustainability (Rofes 1998). The biomedical potential of this medical regimen, in the same way antiretroviral therapy (ART) made HIV positivity a manageable chronic condition, should and does invite hope. But the fact remains that while attitudes seem to be changing, there is a persistence of wariness and negative responses to the emergence of sexual cultures informed by the affective affordances of PrEP. These affective orientations do not align with the phantasmagoric futures that PrEP makes available; rather, they seem to reinstall modes of relationality based on fear of HIV. It is this persistence or "temporal drag" (Freeman 2010, 95) that this chapter concerns itself with. To further understand the relationship between the lingering fear of HIV and new prevention methods, it is necessary to interrogate how the HIV crisis materialises for gay people and their communities. Additionally, it is crucial to understand how affective sedimentations impact contemporary material and structural innovations that sustain, support, and change gay sexual sociability beyond and after the time/s of the crisis. Drawing from queer theory (Freeman 2010) and HIV/AIDS sociology (Decoteau 2008; Gordon, 2008; Gill-Peterson, 2013; Petrus, 2019), we take hauntology (Derrida 2006) as a useful framework for a diachronic and synchronic analysis of how past and present materials and ideas affect and might affect those living "post crisis" (Race 2001; Kagan 2018), particularly when the effects of the AIDS crisis (for some) manifest as distant affective echoes. This chapter leans on Derrida's (2006) concept of "hauntology" to develop what we call a "viral hauntology" coterminous with the development of new HIV prevention methods. This affect-driven intervention closely examines how the affective economies of circulation, as described by Sara Ahmed (2004), are embedded in current material infrastructures of HIV prevention technologies. We argue that viral hauntology allows us to think deeply about how 'old' technologies and their social lives fold over and into new ones, and how the folding process 'drags' in order to imagine other, more inclusive, gay socio-sexual futures. In this chapter, we think about HIV/AIDS not only as a somatic condition affecting a body, but also as a socio-technical matter. With HIV/AIDS's production of virality, certain norms and ideas about what constitutes "good" sexuality have emerged (Kagan 2018), norms that are then enforced, contested or modulated through the production and use of material infrastructures of gay sociability. Such materialist thinking is inspired by Kane Race's (2018) mobilization of Actor-Network-Theory, in which he considers how HIV/AIDS work on gay life through complex flows of chemical, digital, and communal infrastructures. Extending this research into the field of affect theory, we analyze two case studies to demonstrate how these infrastructures change through viral hauntology. The two case studies are used to unpack how socio-technical responses to the HIV/AIDS crisis play a role in the cultural and interfacial responses to the availability of the PrEP regimen. In the first case study, we examine the 'PrEP whore' figuration. We look closely at the circulation of anti-PrEP and anti-promiscuity sentiments, and how the condom's materiality and historicity—as a 'preferred' safer-sex technology for men who have sex with men (MSM)—is intertwined in this particular discourse. In the second case study, we compare how the gay hookup apps Grindr and Scruff (two of the most influential digital platforms for contemporary gay sociability) frame discussions of safer-sex practices and HIV status. In the following section, we will detail a conceptual framework for thinking about what could be called the affective 'haunting' of these HIV-impacted infrastructures, and how certain feelings 'haunt' interpretations of the HIV virus, the minds of gay people, and central infrastructures of gay life.

Ali E. Abbas (" Decomposing the Cross Derivatives of a Multiattribute Utility Function into Risk Attitude and Value ") received the M.S. degree in electrical engineering, the M.S. degree in engineering economic systems and operations research, the Ph.D. degree in management science and engineering, and the Ph.D. (minor) degree in electrical engineering, all from Stanford University, Stanford, California. He was a lecturer in the Department of Management Science and Engineering at Stanford. He previously worked for Schlumberger Oilfield Services, where he held several international positions in wireline logging, operations management, and international training. He was also involved with several consulting projects for mergers and acquisitions in California, and was a co-teacher of several executive seminars on decision analysis at Strategic Decisions Group, Menlo Park, California. He is currently an associate professor in the Department of Industrial and Enterprise Systems Engineering, University of Illinois at Urbana–Champaign, Champaign. His research interests include utility theory, decision making with incomplete information and preferences, dynamic programming, and information theory. Dr. Abbas is a member of INFORMS, a senior member of the IEEE, an associate editor for Decision Analysis and Operations Research, and an editor of the DA column in education for Decision Analysis Today. Address: Department of Industrial and Enterprise Systems Engineering, College of Engineering, University of Illinois at Urbana–Champaign, 117 Transportation Building, MC-238, 104 South Mathews Avenue, Urbana, IL 61801; e-mail: aliabbas@uiuc.edu . Vicki M. Bier (" Deterring the Smuggling of Nuclear Weapons in Container Freight Through Detection and Retaliation ") holds a joint appointment as professor in the Department of Industrial and Systems Engineering and the Department of Engineering Physics at the University of Wisconsin–Madison, where she chairs the Department of Industrial and Systems Engineering. She has directed the Center for Human Performance and Risk Analysis (formerly the Center for Human Performance in Complex Systems) since 1995. She has more than 20 years of experience in risk analysis for the nuclear power, chemical, petrochemical, and aerospace industries. Before returning to academia, she spent seven years as a consultant at Pickard, Lowe and Garrick, Inc. While there, her clients included the U.S. Nuclear Regulatory Commission, the U.S. Department of Energy, and a number of nuclear utilities, and she prepared testimony for Atomic Safety and Licensing Board hearings on the safety of the Indian Point nuclear power plants. Dr. Bier's current research focuses on applications of risk analysis and related methods to problems of security and critical infrastructure protection, under support from the Department of Homeland Security. She is also currently serving as a special term appointee for the Infrastructure Assurance Center at Argonne National Laboratory. Address: Department of Industrial and Systems Engineering, 1513 University Avenue, University of Wisconsin–Madison, Madison, WI 53706; e-mail: bier@engr.wisc.edu . Robert F. Bordley (" Using Bayes' Rule to Update an Event's Probabilities Based on the Outcomes of Partially Similar Events ") is an INFORMS Fellow and a winner of the best publication award from the Decision Analysis Society as well as five major application awards from General Motors. He is a General Motors Technical Fellow with experience in research, planning, quality, marketing, corporate strategy, and procurement. He is also an adjunct professor at the University of Michigan, Ann Arbor, and was formerly program director of Decision, Risk and Management Sciences at the National Science Foundation. Dr. Bordley has published 75 papers in decision analysis, marketing, and operations management. He has also served as chair of the American Statistical Association's Risk Analysis Section (which now has 1000 members), vice president of the Production and Operations Management Society, and a member of the INFORMS Board and the Decision Analysis Society Council. He earned a Ph.D. and M.S. in operations research and an M.B.A. in finance from the University of California, Berkeley. His primary interests have been in theoretical developments enabling high-impact application of decision analysis in a wide variety of corporate contexts (e.g., engineering design, corporate strategy, procurement, program management, etc.). Address: General Motors, Pontiac Centerpoint Campus North, 585 South Boulevard, Pontiac, MI 48341; e-mail: robert.bordley@gm.com , rbordley@umich.edu . Heidi M. Crane (" Whether to Retest the Lipids of HIV-Infected Patients: How Much Does Fasting Bias Matter? ") is an assistant professor of medicine at the University of Washington (UW) School of Medicine and the associate director of Clinical Epidemiology and Health Services Research at the UW Center for AIDS Research (CFAR), which promotes research comparing the effectiveness of management strategies for HIV-infected patients in routine clinical practice. She is co–principal investigator (PI) of a PROMIS (Patient-Reported Outcomes Measurement Information Systems) National Institutes of Health Roadmap initiative U01 on measuring patient reported outcomes in clinical care for HIV-infected patients and PI of a National Institute of Mental Health R01 project on measuring and improving adherence for HIV-infected patients in clinical care. She is also medical director of the Madison HIV Metabolic clinic, PI of an American Heart Association grant on myocardial infarction and metabolic complications among patients with HIV, and PI of an Agency for Healthcare Research and Quality grant on comparative effectiveness of antihypertensive and lipid-lowering medication among HIV-infected patients. She provides care and training in the clinical care of HIV-infected individuals, and she also mentors junior investigators in HIV research in the UW Division of Infectious Diseases. Dr. Crane is a member of the Data Management Centers for the National Institute of Allergy and Infectious Diseases–funded CFAR Network of Integrated Clinical Systems (CNICS) research platform of real-time electronic health record data for 22,000 patients from eight CFARs across the United States, and the International Epidemiological Databases to Evaluate AIDS project's North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which merges data on 110,000 HIV-infected individuals in care at 60 sites across the United States and Canada. Dr. Crane leads the CNICS Patient Reported Outcomes Committee and the CNICS and NA-ACCORD myocardial infarction event adjudication teams. Dr. Crane's research focuses on methods to improve clinical care for HIV-infected individuals as well as metabolic and other chronic comorbidities of HIV. She received her internal medicine residency training from Barnes and Jewish Hospitals, and her B.A., B.S., M.D., M.P.H. and Infectious Disease Fellowship training from the UW. Address: Harborview Medical Center, 325 9th Avenue, Box 359931, Seattle, WA 98104; e-mail: hcrane@u.washington.edu . Naraphorn Haphuriwat (" Deterring the Smuggling of Nuclear Weapons in Container Freight Through Detection and Retaliation ") is a researcher at the National Metal and Materials Technology Center in Thailand. She applies tools including optimization, decision analysis, and process simulation to improve production processes and operations for small and medium enterprises. She earned her Ph.D. from the University of Wisconsin–Madison in the Department of Industrial and Systems Engineering in August 2010. During her doctoral study, she was supported by the Center for Risk and Economic Analysis of Terrorism Events (CREATE) at the University of Southern California, where she conducted game-theoretic studies in the applications of security. She also received an honorable mention in the 2004–2005 University Book Store Academic Excellence Award Competition for a project related to computer security. Address: 114 Thailand Science Park, Paholyothin Road, Klong 1, Klong Luang, Pathumthani 12120, Thailand; e-mail: naraphoh@mtec.or.th . Joseph B. Kadane (" Whether to Retest the Lipids of HIV-Infected Patients: How Much Does Fasting Bias Matter? ") is Leonard J. Savage University Professor of Statistics and Social Sciences, Emeritus, at Carnegie Mellon University. His research focus is on both foundational issues of Bayesian analysis and applications in many settings. These currently include physics, phylogenetics, air pollution, Internet security, law, and medicine, as well as Internet auctions. He also serves as an expert witness in legal matters. Address: Tepper School of Business, Carnegie Mellon University, 5000 Forbes Avenue, Pittsburgh, PA 15213; e-mail: kadane@andrew.cmu.edu . L. Robin Keller (" From the Editors: Deterrence, Multiattribute Utility, and Probability and Bayes' Updating ") is a professor of operations and decision technologies in the Merage School of Business at the University of California, Irvine. She received her Ph.D. and M.B.A. in management science and her B.A. in mathematics from the University of California, Los Angeles. She has served as a program director for the Decision, Risk, and Management Science Program of the U.S. National Science Foundation (NSF). Her research is on decision analysis and risk analysis for business and policy decisions and has been funded by NSF and the U.S. Environmental Protection Agency. Her research interests cover multiple-attribute decision making, riskiness, fairness, probability judgments, ambiguity of probabilities or outcomes, risk analysis (for terrorism, environmental, health, and safety risks), time preferences, problem structuring, cross-cultural decisions, and medical decision making. She is currently Editor-in-Chief of Decision Analysis, published by the Institute for Operations Research and the Management Sciences (INFORMS). She is a Fellow of INFORMS and has held numerous roles in INFORMS, including board member and chair of the INFORMS Decision Analysis Society. She is a recipient of the George F. Kimball Medal from INFORMS. She has served as the decision analyst on three National Academy of Sciences committees. Address: The Paul Merage School of Business, University of California, Irvine, Irvine, CA 92697-3125; e-mail: lrkeller@uci.edu . Mari M. Kitahata (" Whether to Retest the Lipids of HIV-Infected Patients: How Much Does Fasting Bias Matter? ") is professor of medicine at the University of Washington (UW) School of Medicine, director of Clinical Epidemiology and Health Services Research at the Center for AIDS Research (CFAR), and principal investigator of the UW HIV Cohort. She has provided care and training in the clinical management of HIV-infected individuals for two decades, and she mentors investigators in HIV research in the UW Division of Infectious Diseases. Dr. Kitahata studies the outcomes of care for persons with HIV infection, and her research has elucidated key determinants of increased survival, including care managed by physicians with HIV expertise and earlier initiation of antiretroviral treatment. The need for observational research to complement the invaluable information provided by randomized controlled trials has grown tremendously, which is why she established the CFAR Clinical Epidemiology and Health Services Research program at UW in 1995 and was among the first CFARs in the United States to do so. Dr. Kitahata developed the structure and methods to merge comprehensive HIV patient data and biological specimens from multiple settings into a powerful resource for researchers conducting basic, translational, clinical outcomes/comparative effectiveness, and behavioral/prevention research. She has led efforts to establish networks of national and international HIV research collaborations to address the most pressing questions regarding treatment and outcomes for HIV-infected individuals that cannot be answered through smaller cohort studies. Dr. Kitahata directs the Data Management Centers for the National Institute of Allergy and Infectious Diseases–funded CFAR Network of Integrated Clinical Systems (CNICS) research platform of real-time electronic health record (EHR) data for 22,000 patients from eight CFARs across the United States, and the International Epidemiological Databases to Evaluate AIDS project's North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which merges data on 110,000 HIV-infected individuals in care at 60 sites across the United States and Canada. Dr. Kitahata serves on the Board of Directors for the Infectious Diseases Society of America (IDSA) HIV Medicine Association, the U.S. Public Health Service/IDSA Guidelines Committee for Prevention of Opportunistic Infections, and the International Training and Education Center on HIV (I-TECH), where she developed a national EHR system for the Haitian Ministry of Health. Dr. Kitahata received her B.S. from Yale University, M.D. from the University of Pennsylvania, internal medicine residency training at the University of California, San Francisco, and M.P.H. and Fellowship training at the University of Washington, where she was a Robert Wood Johnson Clinical Scholar. Address: University of Washington Medical Center, 1959 NE Pacific Street, UW Box 356423, Seattle, WA 98195-6423; e-mail: kitahata@u.washington.edu . Sanjeev R. Kulkarni (" Aggregating Large Sets of Probabilistic Forecasts by Weighted Coherent Adjustment ") is a professor in the Department of Electrical Engineering at Princeton University. He is also an affiliated faculty member in the Department of Operations Research and Financial Engineering and the Department of Philosophy. Prior to joining Princeton, he was a member of the technical staff at MIT Lincoln Laboratory. During his time at Princeton, he has held visiting or consulting positions with Australian National University, Susquehanna International Group, and Flarion Technologies. Professor Kulkarni has served as an associate editor for the IEEE Transactions on Information Theory, and he is a Fellow of the IEEE. His research interests include statistical pattern recognition, nonparametric statistics, learning and adaptive systems, information theory, wireless networks, and image/video processing. Address: School of Engineering and Applied Science, Princeton University, Princeton, NJ 08544; e-mail: kulkarni@princeton.edu . Daniel N. Osherson (" Aggregating Large Sets of Probabilistic Forecasts by Weighted Coherent Adjustment ") earned his Ph.D. in psychology at the University of Pennsylvania in 1973. Since then he has taught at Stanford University, the University of Pennsylvania, Massachusetts Institute of Technology, Università San Raffael, Rice University, and Princeton University. His work centers on probability judgment and learning. Address: Department of Psychology, Princeton University, Princeton, NJ 08544; e-mail: osherson@princeton.edu . H. Vincent Poor (" Aggregating Large Sets of Probabilistic Forecasts by Weighted Coherent Adjustment ") is dean of the School of Engineering and Applied Science at Princeton University, where he is also the Michael Henry Strater University Professor of Electrical Engineering. He holds a Ph.D. from Princeton. His research interests are in the areas of statistical signal processing, stochastic analysis, and information theory, and their applications to wireless networks and related fields. Among his publications in these areas are the recent books Quickest Detection (Cambridge University Press, 2009) and Information Theoretic Security (NOW Publishers, 2009). Dean Poor is a member of the U.S. National Academy of Engineering and the U.S. National Academy of Sciences, and he is a Fellow of the IEEE, the Institute of Mathematical Statistics, the American Academy of Arts and Sciences, and the Royal Academy of Engineering of the United Kingdom. A former Guggenheim Fellow, recent recognition of his work included the Institution of Engineering and Technology Ambrose Fleming Medal, the IEEE Eric E. Sumner Award, and an honorary D.Sc. from the University of Edinburgh. Address: School of Engineering and Applied Science, Princeton University, Princeton, NJ 08544; e-mail: poor@princeton.edu . Guanchun Wang (" Aggregating Large Sets of Probabilistic Forecasts by Weighted Coherent Adjustment ") received an undergraduate degree in electrical engineering at Shanghai Jiao Tong University. He is currently a Ph.D. student in the Department of Electrical Engineering at Princeton University. His research interests include statistical learning, information retrieval, and judgment aggregation. He also worked as a summer associate for McKinsey's technology practice. Address: School of Engineering and Applied Science, Princeton University, Princeton, NJ 08544; e-mail: guanchun@princeton.edu . Henry H. Willis (" Deterring the Smuggling of Nuclear Weapons in Container Freight Through Detection and Retaliation ") is a professor of policy analysis at the Pardee RAND Graduate School and the associate director of the RAND Homeland Security and Defense Center. His research has applied risk analysis tools to resource allocation and risk management decisions in the areas of public health and emergency preparedness, terrorism and national security policy, energy and environmental policy, and transportation planning. Dr. Willis serves on the editorial board of the journal Risk Analysis and served on the National Academies of Science Committee on Evaluating Testing, Costs, and Benefits of Advanced Spectroscopic Portals. He earned his Ph.D. from the Department of Engineering and Public Policy at Carnegie Mellon University and holds degrees in chemistry and environmental studies from the University of Pennsylvania (B.A.) and in environmental science from the University of Cincinnati (M.A.). Address: RAND Corporation, 4570 Fifth Avenue, Suite 600, Pittsburgh, PA 15213; e-mail: hwillis@rand.org . Xiting (Cindy) Yang (" Whether to Retest the Lipids of HIV-Infected Patients: How Much Does Fasting Bias Matter? ") completed her Ph.D. from Carnegie Mellon University in the area of elicitation, specifically focusing on elicitation of expert knowledge on phylogenies in the format of rooted trees. She is currently a statistical reviewer at the Center for Devices and Radiological Health, U.S. Food and Drug Administration. Her current research focuses on clinical trials and elicitation. Address: U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 2223, Silver Spring, MD 20993-0002; e-mail: xiting.yang@fda.hhs.gov .

Andreeva recently discussed several "challenges for research in poor countries" (Andreeva, 2012). Below is a list of some of these challenges and my comments. For many public health studies in low- or middle-income countries, population surveys are the only affordable means of data collection. Population surveys are valuable sources of health information. For example, surveys have estimated the prevalence, severity, and treatment of mental disorders in various countries, including Ukraine (WHO, 2004). But population surveys can be very expensive, so alternative approaches to data collection should not be overlooked. Some other methods are case control studies, ecologic studies, and qualitative research designs such as focus groups. A case control design was used by Donetsk State Medical University to investigate contraceptive practices and factors behind contraceptive preferences of Ukrainian women (Mogilevkina, 2003). For a case control study of diphtheria vaccine efficacy in Ukraine, demographic and vaccination data were gathered from health center records (Tsu, 2000). Focus group methods were used by the Ukraine Institute for Public Health Policy and others to investigate the obstacles to antiretroviral therapy perceived by HIV-infected injection drug users (Mimiaga, 2010) and in a separate study on the topics of everyday understanding of health and the factors influencing it (Abbott, 2006). Another challenge faced by survey scientists is related to the validity of self-reported data. Validity is central to all research. According to Bonita et al (2006, page 57), "A study is valid if its results correspond to the truth." Self-reports can be satisfactory data sources if investigators take sufficient care in their design and use (Schaeffer, 2003). For example, before conducting health surveys in low and middle-income countries with questionnaires that were developed for use in high-income countries, researchers may first want to use focus group interview methods to gauge what the survey questions mean to people in the target countries (Kitzinger, 1995). If necessary, focus groups can be used to help researchers to modify question wording appropriately. In any case, for many health measures, it is difficult to think of an alternative to self-reports. The recent finding that fewer teenagers in the United States are driving after drinking, for example, comes from risk behavior data collected from thousands of high school students through national surveys (Shults, 2012). Due to high subscription fees, many researchers in low- and medium income countries lack access to necessary literature. This is a serious obstacle but it has a partial, temporary solution. In 2002 the Access to Research in Health Programme (HINARI) was established by the World Health Organization in partnership with major publishers (http://www.who.int/hinari/en/ accessed 4 Oct 2012). This venture provides free or low cost online access to the major journals in biomedical and related social sciences to local, not-for-profit institutions in developing countries. Some 8,500 journals and 7000 e-books (in 30 different languages) are now available to health institutions in more than 100 countries. To move access to global knowledge beyond HINARI, an international team of editors, researchers, and authors has proposed that WHO take the lead in championing the goal of "health information for all" (Godlee, et al., 2004). Besides HINARI, researchers in some developing countries have gained access to scientific literature through partnerships with foreign researchers as, for example, in projects supported by the Fogarty International Center of the US National Institutes of Health (http://www.fic.nih.gov, accessed 4 Oct 2012). For persons interested in tobacco control, an inventory of financial and structural resources to support global tobacco control research and research capacity in developing countries is available (Lando, et al., 2005). Many decisions in low and middle income countries are still opinion-based. Alas this is also all too often the case in the US and Europe. For example, little policy has developed in response to the growing threat from climate change to the health and the environment. The process from the discovery of scientific knowledge to its effects on human behavior is usually long and unpredictable. Current epidemiology training focuses on epidemiologic methods, with little attention on how the science of epidemiology is translated into effective health policy (Brownson, 1998, page 377). Actually, research findings always have some degree of uncertainty, and policy choices depend on many social, cultural, and economic factors, including people's opinions and beliefs. Fortunately, expert guidance is available on ways to communicate research findings to the public and policymakers that increase the chance that good science will result in good public health (Nelson, 2011; Remington, et al., 2011; Brownson, et al., 2011). A somewhat contrary view is that researchers are not responsible for the translation of their findings into public policy and should enter the political fray cautiously (Rothman & Poole, 1985). The golden standard of studies generating such evidence is randomized controlled trials. Bonita et al (2006, page 95) distinguish between various study designs by ranking their ability to provide evidence for causality between an exposure and a disease: "strong" for randomized controlled trials, "moderate" for cohort and case-control studies, and "weak" for cross-sectional and ecological studies. However, Steven N Goodman of Stanford University and Gerald J Dal Pan of the US Food and Drug Administration, speakers at the 2012 American College of Epidemiology Annual Meeting, indicated that the traditional hierarchy of scientific evidence may be too simple. They argued that experiments have more limits than generally appreciated, and evidence from observational studies can also be "golden".In any case, research conclusions have historically lacked widespread credibility in the scientific community until they have been confirmed by multiple studies using different study designs in different populations. They consider this as public health surveillance rather than data for testing research hypotheses about effects of the intended policy measures. I would agree that some surveys, such as the tobacco prevalence survey in several eastern European countries, including Ukraine (Andreeva, et al., 2010), are a type of public health surveillance. However, such data collection activities differ from traditional disease surveillance systems that detect and investigate new cases of notifiable diseases, including tuberculosis, measles, and others (Bonita, et al., 2006). For several decades, the US Agency for International Development has funded the Demographic and Health Surveys (DHS) that collect nationally-representative household data for a wide range of monitoring and evaluation indicators on population, health, and nutrition (http://measuredhs.com/accessed 3 Oct 2012). These surveys have been completed in Ukraine and a half dozen other countries of the former Soviet Union, and all DHS countries, especially ones with repeated surveys, have results that can be assessed with relevance to a health policy. I am reluctant to classify prevalence surveys as "descriptive" or "analytic" without more information about the specific survey. In the US, the Behavioral Risk Factor Surveys--conducted annually in the 50 states with coordination and support from the US Centers for Disease Control and Prevention--have been used for both description and analysis. Smart people from poor countries will definitely benefit from considerate reviews of their studies by more experienced researchers. A core principle of global health is that the knowledge and experience of every country, regardless of income level, is required for truly effective public health science and action. Journals have a mission, and they will publish work from any country if it fits their mission. Some journals explicitly invite submissions from developing countries including papers from authors whose mother language is not English. On the other hand, journals have major limits (Nordstrom, 2008). To protect their resources, they routinely reject some manuscripts without circulating them for external review because the editor determines they have little chance of acceptance. Most journals have no paid staff, and most peer reviewers are volunteers. An editor of one western journal has candidly discussed the challenges and opportunities of reviewing and publishing research manuscripts from developing countries (Malone, 2012).

I would like to thank dr hab. Marek Świerczyński prof. UKSW for his comments and suggestions, which helped me considerably to improve the article. ; A compulsory licence is an authorisation under the state administration to use intellectual property rights by third parties, subject to payment of remuneration, regardless of the patent holder's objection. In the Polish legal system, the institution of a compulsory licence is regulated by: the Paris Convention for the Protection of Industrial Property Rights (20 March 1883), the Agreement on Trade-Related Aspects of Intellectual Property Rights (15 April 1994), Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on the granting of compulsory licences for patents relating to the manufacture of pharmaceutical products for export to countries with public health problems and the Industrial Property Law Act (30 June 2000). The basic research thesis of my paper was based on the assumption that a compulsory licence does not meet the objective of providing access to biologics. The regulations governing this institution need to be changed, first of all towards the re-granting of a compulsory licence with the proper meaning of balancing the interests of the public (society) and private (patent holder). ; This article was written based on the performance of the scientific research project no. 2017/25/N/HS5/01505 named: Legal model of biosimilars, financed by National Scientific Center. ; z.wieckowski@uksw.edu.pl ; Assistant at Law and Administration Faculty on the Cardinal Stephan Wyszynski University in Warsaw. ; Cardinal Stephan Wyszynski University in Warsaw, Poland, Law and Administration Faculty ; Bashaar, M., Hassali, M. A., & Saleem, F. (2017). 40th anniversary of essential medicines: a loud call for improving its access, GaBI Journal, 6(4), 174-177. ; Beyer, P. (2013). 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