Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial

Background: Antiretroviral therapy (ART) suppresses HIV viral load in all body compartments and so limits the risk of HIV transmission. It has been suggested that ART not only contributes to preventing transmission at individual but potentially also at population level. This trial aims to evaluate the effect of ART initiated immediately after identification/diagnosis of HIV-infected individuals, regardless of CD4 count, on HIV incidence in the surrounding population. The primary outcome of the overall trial will be HIV incidence over two years. Secondary outcomes will include i) socio-behavioural outcomes (acceptability of repeat HIV counselling and testing, treatment acceptance and linkage to care, sexual partnerships and quality of life); ii) clinical outcomes (mortality and morbidity, retention into care, adherence to ART, virologic failure and acquired HIV drug resistance), iii) cost-effectiveness of the intervention. The first phase will specifically focus on the trial's secondary outcomes.Methods/design: A cluster-randomised trial in 34 (2 × 17) clusters within a rural area of northern KwaZulu-Natal (South Africa), covering a total population of 34,000 inhabitants aged 16 years and above, of whom an estimated 27,200 would be HIV-uninfected at start of the trial. The first phase of the trial will include ten (2 × 5) clusters. Consecutive rounds of home-based HIV testing will be carried out. HIV-infected participants will be followed in dedicated trial clinics: in intervention clusters, they will be offered immediate ART initiation regardless of CD4 count and clinical stage; in control clusters they will be offered ART according to national treatment eligibility guidelines (CD4 <350 cells/μL, World Health Organisation stage 3 or 4 disease or multidrug-resistant/extensively drug-resistant tuberculosis). Following proof of acceptability and feasibility from the first phase, the trial will be rolled out to further clusters.Discussion: We aim to provide proof-of-principle evidence regarding the effectiveness of Treatment-as-Prevention in reducing HIV incidence at the population level. Data collected from the participants at home and in the clinics will inform understanding of socio-behavioural, economic and clinical impacts of the intervention as well as feasibility and generalizability. © 2013 Iwuji et al.; licensee BioMed Central Ltd

Systematizing Genome Privacy Research: A Privacy-Enhancing Technologies Perspective

Rapid advances in human genomics are enabling researchers to gain a better understanding of the role of the genome in our health and well-being, stimulating hope for more effective and cost efficient healthcare. However, this also prompts a number of security and privacy concerns stemming from the distinctive characteristics of genomic data. To address them, a new research community has emerged and produced a large number of publications and initiatives. In this paper, we rely on a structured methodology to contextualize and provide a critical analysis of the current knowledge on privacy-enhancing technologies used for testing, storing, and sharing genomic data, using a representative sample of the work published in the past decade. We identify and discuss limitations, technical challenges, and issues faced by the community, focusing in particular on those that are inherently tied to the nature of the problem and are harder for the community alone to address. Finally, we report on the importance and difficulty of the identified challenges based on an online survey of genome data privacy expertsComment: To appear in the Proceedings on Privacy Enhancing Technologies (PoPETs), Vol. 2019, Issue

Behavioral Genetics Research and Criminal DNA Databases

Kaye discusses DNA databanks and the potential use of such databanks for behavioral genetics research. He addresses the concern that DNA databanks serve as a limitless repository for future research and that the samples used in the databanks could be used for research into a crime gene

Routes for breaching and protecting genetic privacy

We are entering the era of ubiquitous genetic information for research, clinical care, and personal curiosity. Sharing these datasets is vital for rapid progress in understanding the genetic basis of human diseases. However, one growing concern is the ability to protect the genetic privacy of the data originators. Here, we technically map threats to genetic privacy and discuss potential mitigation strategies for privacy-preserving dissemination of genetic data.Comment: Draft for comment

A Quantum of Solace: An Exploratory Mixed Methods Study of Online Support in the Self-Management of Anxiety in HPV Positive Women

The implementation of human papillomavirus (HPV) DNA detection as the primary screening tool for screening and management of cervical intraepithelial neoplasia (CIN) proposed for roll-out in 2019-2020 will diagnose more women as HPV positive than are currently diagnosed with CIN due to the relative differences in prevalence between conditions (Sargent et al. 2008; Peto et al. 2004). At present there is no acceptable treatment for HPV (McRae et al. 2014). Anxiety over positivity (Friedman & Shepeard 2007), stigma (Kim 2012), and uncertainty (Kosenko et al. 2012) may constitute a biographical disruption. The stigmatised nature of HPV mean support from regular channels may be restricted due to fears of social rejection following disclosure (Kosenko et al. 2012; Crandall & Moriarty 1995). Online support might instead be utilised to allow access to disease information and social support. Methods: The study was a mixed methods study based on the follow-up explanations model, involving the administration of an online survey questionnaire (N = 107). Following descriptive data analysis, individuals were recruited for email interviews to describe their lived experiences of HPV positivity (N = 3). These narratives were then analysed using thematic analysis. Findings: Women responding to the questionnaire and the interviews reported anxiety over fears of transmission to loved ones. Interview narratives disclosed themes of anxiety caused by the mismanagement of information (too much/too little, conflicting or given at the wrong moment), uncertainty over viral clearance and residual issues of stigma. Women reported the use of online support to exchange information and experiences and provide emotional support. Conclusions: Both the questionnaire and the interview data indicate that uncertainty, anxiety over cancer development and guilt over transmission constitute a biographical disruption among women aware of their HPV positive status, and that the use of online support may be helpful in managing the uncertainty of HPV positivity

Quality of Life of People Living with HIV in Australia: The Role of Stigma, Social Disconnection and Mental Health.

HIV is a manageable chronic illness, due to advances in biomedical management. However, many people living with HIV (PLHIV) continue to experience psychosocial challenges, which have been associated with poorer quality of life (QoL). This study aimed to explore how psychosocial factors contributed to the QoL of PLHIV in Australia; specifically, the relationship between HIV-related stigma, social connectedness, mental health, and QoL. Participants were 122 PLHIV attending The Albion Centre (a tertiary HIV clinic in Sydney, Australia), who completed questionnaires which measured HIV-related stigma, social support, mental health symptomology and QoL. Results indicated that HIV-related stigma predicted poorer QoL, as did mental health symptomology. Conversely, social connectedness improved QoL. Additionally, social connectedness was found to mediate the relationship between HIV-related stigma and QoL, whereas the hypothesized moderating role of mental health symptomology on this model was not significant. These findings provide insight into the impact of psychosocial factors on QoL, offering practitioners various points of clinical intervention

The impact of disability on performance in a high-stakes postgraduate surgical examination : a retrospective cohort study

Open Access via Sage Agreement Fundings: Royal College of Physicians and Surgeons of Glasgow Royal College of Surgeons in Ireland Royal College of Surgeons of Edinburgh Royal College of Surgeons of England Acknowledgements The authors would like to acknowledge Iain Targett at the Royal College of Surgeons of England, for his help with data collection and Gregory Ayre from the Intercollegiate Committee for Basic Surgical Examinations for their support during this project. Our thanks to members of the UKMED Research Group who provided useful feedback on an earlier version of this manuscript, and whose comments were helpful in refining the paper. The authors would also like to acknowledge Sebastian Shaw for his valued expertise in SpLD and Daniel Smith for his help with the UKMED database. Data Source: UK Medical Education Database (‘UKMED’). UKMEDP043 extract generated on 25/07/2018. We are grateful to UKMED for the use of these data. However, UKMED bears no responsibility for their analysis or interpretation. The data include information derived from that collected by the Higher Education Statistics Agency Limited (‘HESA’) and provided to the GMC (‘HESA Data’). Source: HESA Student Records 2007/2008 to 2015/2016. Copyright Higher Education Statistics Agency Limited. The Higher Education Statistics Agency Limited makes no warranty as to the accuracy of the HESA Data, cannot accept responsibility for any inferences or conclusions derived by third parties from data or other Information supplied by it.Peer reviewedPublisher PD

Better governance, better access: practising responsible data sharing in the METADAC governance infrastructure.

BACKGROUND: Genomic and biosocial research data about individuals is rapidly proliferating, bringing the potential for novel opportunities for data integration and use. The scale, pace and novelty of these applications raise a number of urgent sociotechnical, ethical and legal questions, including optimal methods of data storage, management and access. Although the open science movement advocates unfettered access to research data, many of the UK's longitudinal cohort studies operate systems of managed data access, in which access is governed by legal and ethical agreements between stewards of research datasets and researchers wishing to make use of them. Amongst other things, these agreements aim to respect the reasonable expectations of the research participants who provided data and samples, as expressed in the consent process. Arguably, responsible data management and governance of data and sample use are foundational to the consent process in longitudinal studies and are an important source of trustworthiness in the eyes of those who contribute data to genomic and biosocial research. METHODS: This paper presents an ethnographic case study exploring the foundational principles of a governance infrastructure for Managing Ethico-social, Technical and Administrative issues in Data ACcess (METADAC), which are operationalised through a committee known as the METADAC Access Committee. METADAC governs access to phenotype, genotype and 'omic' data and samples from five UK longitudinal studies. FINDINGS: Using the example of METADAC, we argue that three key structural features are foundational for practising responsible data sharing: independence and transparency; interdisciplinarity; and participant-centric decision-making. We observe that the international research community is proactively working towards optimising the use of research data, integrating/linking these data with routine data generated by health and social care services and other administrative data services to improve the analysis, interpretation and utility of these data. The governance of these new complex data assemblages will require a range of expertise from across a number of domains and disciplines, including that of study participants. Human-mediated decision-making bodies will be central to ensuring achievable, reasoned and responsible decisions about the use of these data; the METADAC model described in this paper provides an example of how this could be realised

UK Strategy for Data Resources for Social and Economic Research 2009-2012

In the United Kingdom a group has been established to help ensure that the right data resources are created and made available to help inform the important choices that decision makers need to make. The group is the UK Data Forum. The members of the Forum come from national research councils, chief statisticians and researchers within government, the national statistics office, national library and national archives, devolved administrations, sub-national bodies and other organisations in the private, public and not for profit sectors. The current Strategy for Data Resources for Social and Economic Research: 2009-2012 sets out practical actions on areas for collaboration and the development of cross-cutting facilities. The strategy is owned by the members of the Forum and represents a statement of intent by them. A central feature of the current strategy, and one of the strongest themes from the consultation undertaken to inform its development, is the internationalisation of the research agenda. Actions in the strategy include initiatives to make collaborative agreements with other agencies within and outside the UK at national, European Union and international levels. The Forum believes that the potential for close working with colleagues in the UK and Germany is likely to be especially valuable.Sharing the strategy with you on this site is a first step in encouraging what we hope will be a deep and fruitful relationship in the future.