New genomic techniques, old divides: Stakeholder attitudes towards new biotechnology regulation in the EU and UK

The European Union and United Kingdom are in the process of establishing new regulation regarding the use of new genomic techniques in crop and animal breeding. As part of this process, consultations have been launched to understand the views of stakeholders towards the use of new genomic techniques in plant and animal breeding. The responsible research and innovation framework emphasises the importance of dialogue between technology developers and stakeholders, including the public, but what are the opinions of stakeholders towards the regulation of NGTs in Europe and do they view these consultations as opportunities to engage with technology governance? We conducted semi-structured interviews with experts from a range of agri-food stakeholder groups in the European Union and United Kingdom to understand current attitudes towards new biotechnology regulation, how they viewed the process of consultation in both places and what influence they felt they had in shaping regulations. We found that the discussion is similar in both EU and UK, with predictable and fixed opinions determined by attitudes towards the perceived risks associated with direct mutagenesis. Both UK and EU consultations were considered to have the same weaknesses and stakeholders discussed a desire for more dialogic forms of engagement. We highlight several options for new forms of involvement in biotechnology regulation by exploring relevant responsible research and innovation literature

Medical device regulation and oversight in African countries: a scoping review of literature and development of a conceptual framework

Regulatory and other governance arrangements influence the introduction of medical devices into health systems and are essential for ensuring their effective and safe use. Challenges with medical device safety, quality and use are documented globally, with evidence suggesting these are linked to poor governance. Yet, medical device regulation and oversight remain inadequately defined and described, particularly in low-income and middle-income settings. Through this review, we sought to examine the literature available on regulatory and oversight processes for medical devices in African countries. Following a systematic approach, we searched academic databases including PubMed, Embase (Ovid) and MEDLINE (Ovid), supplemented by search for grey literature and relevant organisational websites, for documents describing medical device regulation and oversight in African countries. We summarised the data to present key actors, areas for regulation and oversight and challenges. A total of 39 documents reporting regulation and oversight of medical devices were included for analysis. Regulatory and oversight guidelines and processes were reported as inadequate, including limited pre-market testing, reliance on international certifications and limited processes for post-market monitoring and reporting of adverse events. Challenges for regulation and oversight reported included inadequate funding, personnel and technical expertise to perform regulatory functions. The literature highlighted gaps in guidelines for donated medical devices and in information on governance processes at the national level. The current literature provides a general overview of medical device regulatory guidelines and limited evidence on the implementation of regulatory/oversight processes at national and especially subnational levels. We recommend further research to elucidate existing governance arrangements for medical devices within African countries and propose a conceptual framework to inform future studies. The framework provides entry points for careful examination of governance and oversight in policy and practice, the exploration of governance realities across the health system and the influence of wider system dynamics

Examining the potential public health benefit of offering STI testing to men in amateur football clubs: evidence from cross-sectional surveys

Background: In Britain, young people continue to bear the burden of sexually transmitted infections (STIs) so efforts are required, especially among men, to encourage STI testing. The SPORTSMART study trialled an intervention that sought to achieve this by offering chlamydia and gonorrhoea test-kits to men attending amateur football clubs between October and December 2012. With football the highest participation team sport among men in England, this paper examines the potential public health benefit of offering STI testing to men in this setting by assessing their sociodemographic characteristics, sexual behaviours, and healthcare behaviour and comparing them to men in the general population. Methods: Data were collected from 192 (male) members of 6 football clubs in London, United Kingdom, aged 18–44 years via a 20-item pen-and-paper self-completion questionnaire administered 2 weeks after the intervention. These were compared to data collected from 409 men of a similar age who were resident in London when interviewed during 2010–2012 for the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3), a national probability survey that used computer-assisted-personal-interviewing with computer-assisted-self-interview. Age standardisation and multivariable regression were used to account for sociodemographic differences between the surveys. Results: Relative to men in the general population, SPORTSMART men were younger (32.8 % vs. 21.7 % aged under 25 y), and more likely to report (all past year) at least 2 sexual partners (adjusted odds ratio, AOR: 3.25, 95 % CI: 2.15–4.92), concurrent partners (AOR: 2.05, 95 % CI: 1.39–3.02), and non-use of condoms (AOR: 2.17, 95 % CI: 1.39–3.41). No difference was observed in STI/HIV risk perception (AOR for reporting “not at all at risk” of STIs: 1.25, 95 % CI: 0.76–2.04; of HIV: AOR: 1.54, 95 % CI: 0.93–2.55), nor in reporting STI testing in the past year (AOR: 0.83, 95 % CI: 0.44–1.54), which was reported by only one in six men. Conclusions: Relative to young men in the general population, football club members who completed the SPORTSMART survey reported greater sexual risk behaviour but similar STI/HIV risk perception and STI testing history. Offering STI testing in amateur football clubs may therefore widen access to STI testing and health promotion messages for men at higher STI risk, which, given the minority currently testing and the popularity of football in England, should yield both individual and public health benefit

Exploring the costs and outcomes of sexually transmitted infection (STI) screening interventions targeting men in football club settings: preliminary cost-consequence analysis of the SPORTSMART pilot randomised controlled trial

Background: The objective of this study was to compare the costs and outcomes of two sexually transmitted infection (STI) screening interventions targeted at men in football club settings in England, including screening promoted by team captains. Methods: A comparison of costs and outcomes was undertaken alongside a pilot cluster randomised control trial involving three trial arms: (1) captain-led and poster STI screening promotion; (2) sexual health advisor-led and poster STI screening promotion and (3) poster-only STI screening promotion (control/comparator). For all study arms, resource use and cost data were collected prospectively. Results: There was considerable variation in uptake rates between clubs, but results were broadly comparable across study arms with 50% of men accepting the screening offer in the captain-led arm, 67% in the sexual health advisor-led arm and 61% in the poster-only control arm. The overall costs associated with the intervention arms were similar. The average cost per player tested was comparable, with the average cost per player tested for the captain-led promotion estimated to be £88.99 compared with £88.33 for the sexual health advisor-led promotion and £81.87 for the poster-only (control) arm. Conclusions: Costs and outcomes were similar across intervention arms. The target sample size was not achieved, and we found a greater than anticipated variability between clubs in the acceptability of screening, which limited our ability to estimate acceptability for intervention arms. Further evidence is needed about the public health benefits associated with screening interventions in non-clinical settings so that their cost-effectiveness can be fully evaluated

The SPORTSMART study: a pilot randomised controlled trial of sexually transmitted infection screening interventions targeting men in football club settings

Background: Uptake of chlamydia screening by men in England has been substantially lower than by women. Non-traditional settings such as sports clubs offer opportunities to widen access. Involving people who are not medically trained to promote screening could optimise acceptability. Methods: We developed two interventions to explore the acceptability and feasibility of urine-based sexually transmitted infection (STI) screening interventions targeting men in football clubs. We tested these interventions in a pilot cluster randomised control trial. Six clubs were randomly allocated, two to each of three trial arms: team captain-led and poster STI screening promotion; sexual health adviser-led and poster STI screening promotion; and poster-only STI screening promotion (control/comparator). Primary outcome was test uptake. Results: Across the three arms, 153 men participated in the trial and 90 accepted the offer of screening (59%, 95% CI 35% to 79%). Acceptance rates were broadly comparable across the arms: captain-led: 28/56 (50%); health professional-led: 31/46 (67%); and control: 31/51 (61%). However, rates varied appreciably by club, precluding formal comparison of arms. No infections were identified. Process evaluation confirmed that interventions were delivered in a standardised way but the control arm was unintentionally ‘enhanced’ by some team captains actively publicising screening events. Conclusions: Compared with other UK-based community screening models, uptake was high but gaining access to clubs was not always easy. Use of sexual health advisers and team captains to promote screening did not appear to confer additional benefit over a poster-promoted approach. Although the interventions show potential, the broader implications of this strategy for UK male STI screening policy require further investigation

Characterizing the Cool KOIs. V. KOI-256: A Mutually Eclipsing Post-common Envelope Binary

We report that Kepler Object of Interest 256 (KOI-256) is a mutually eclipsing post-common envelope binary (ePCEB), consisting of a cool white dwarf (M_★ = 0.592 ± 0.089 M_☉, R_★ = 0.01345 ± 0.00091 R_☉, T_(eff) = 7100 ± 700 K) and an active M3 dwarf (M_★ = 0.51 ± 0.16 M_☉, R_★ = 0.540 ± 0.014 R_☉, T_(eff) = 3450 ± 50 K) with an orbital period of 1.37865 ± 0.00001 days. KOI-256 is listed as hosting a transiting planet-candidate by Borucki et al. and Batalha et al.; here we report that the planet-candidate transit signal is in fact the occultation of a white dwarf as it passes behind the M dwarf. We combine publicly-available long- and short-cadence Kepler light curves with ground-based measurements to robustly determine the system parameters. The occultation events are readily apparent in the Kepler light curve, as is spin-orbit synchronization of the M dwarf, and we detect the transit of the white dwarf in front of the M dwarf halfway between the occultation events. The size of the white dwarf with respect to the Einstein ring during transit (R_(Ein) = 0.00473 ± 0.00055 R ☉) causes the transit depth to be shallower than expected from pure geometry due to gravitational lensing. KOI-256 is an old, long-period ePCEB and serves as a benchmark object for studying the evolution of binary star systems as well as white dwarfs themselves, thanks largely to the availability of near-continuous, ultra-precise Kepler photometry

Characterizing the cool kois. V. koi-256: A mutually eclipsing post-common envelope binary

We report that Kepler Object of Interest 256 (KOI-256) is a mutually eclipsing post-common envelope binary (ePCEB), consisting of a cool white dwarf (M* = 0.592 ± 0.089 M, R = 0.01345 ± 0.00091 R , T eff = 7100 ± 700 K) and an active M3 dwarf (M* = 0.51 ± 0.16 M , R* = 0.540 ± 0.014 R , T eff = 3450 ± 50 K) with an orbital period of 1.37865 ± 0.00001 days. KOI-256 is listed as hosting a transiting planet-candidate by Borucki et al. and Batalha et al.; here we report that the planet-candidate transit signal is in fact the occultation of a white dwarf as it passes behind the M dwarf. We combine publicly-available long- and short-cadence Kepler light curves with ground-based measurements to robustly determine the system parameters. The occultation events are readily apparent in the Kepler light curve, as is spin-orbit synchronization of the M dwarf, and we detect the transit of the white dwarf in front of the M dwarf halfway between the occultation events. The size of the white dwarf with respect to the Einstein ring during transit (R Ein = 0.00473 ± 0.00055 R ) causes the transit depth to be shallower than expected from pure geometry due to gravitational lensing. KOI-256 is an old, long-period ePCEB and serves as a benchmark object for studying the evolution of binary star systems as well as white dwarfs themselves, thanks largely to the availability of near-continuous, ultra-precise Kepler photometry. © 2013. The American Astronomical Society. All rights reserved.

Why MSM in rural South African communities should be an HIV prevention research priority.

Research into HIV and men who have sex with men's (MSM) health in South Africa has been largely confined to the metropolitan centres. Only two studies were located making reference to MSM in rural contexts or same-sex behaviors among men in the same. There is growing recognition in South Africa that MSM are not only disproportionately affected by HIV and have been underserved by the country's national response, but that they contribute significantly to sustaining the high number of new infections recorded each year. We argue that to meet the objectives of the country's national strategic plan for HIV, STI and TB it is important we know how these behaviours may be contributing to the sustained rural HIV epidemic in the youngest age groups and determine what constitutes appropriate and feasible programmatic response that can be implemented in the country's public sector health services

Revisiting HIV-1 uncoating

HIV uncoating is defined as the loss of viral capsid that occurs within the cytoplasm of infected cells before entry of the viral genome into the nucleus. It is an obligatory step of HIV-1 early infection and accompanies the transition between reverse transcription complexes (RTCs), in which reverse transcription occurs, and pre-integration complexes (PICs), which are competent to integrate into the host genome. The study of the nature and timing of HIV-1 uncoating has been paved with difficulties, particularly as a result of the vulnerability of the capsid assembly to experimental manipulation. Nevertheless, recent studies of capsid structure, retroviral restriction and mechanisms of nuclear import, as well as the recent expansion of technical advances in genome-wide studies and cell imagery approaches, have substantially changed our understanding of HIV uncoating. Although early work suggested that uncoating occurs immediately following viral entry in the cell, thus attributing a trivial role for the capsid in infected cells, recent data suggest that uncoating occurs several hours later and that capsid has an all-important role in the cell that it infects: for transport towards the nucleus, reverse transcription and nuclear import. Knowing that uncoating occurs at a later stage suggests that the viral capsid interacts extensively with the cytoskeleton and other cytoplasmic components during its transport to the nucleus, which leads to a considerable reassessment of our efforts to identify potential therapeutic targets for HIV therapy. This review discusses our current understanding of HIV uncoating, the functional interplay between infectivity and timely uncoating, as well as exposing the appropriate methods to study uncoating and addressing the many questions that remain unanswered