Vegetation recovery in an oil-impacted and burned Phragmites australis tidal freshwater marsh.

In-situ burning of oiled marshes is a cleanup method that can be more effective and less damaging than intrusive manual and mechanical methods. In-situ burning of oil spills has been examined for several coastal marsh types; however, few published data are available for Phragmites australis marshes. Following an estimated 4200gallon crude oil spill and in-situ burn in a Phragmites tidal freshwater marsh at Delta National Wildlife Refuge (Mississippi River Delta, Louisiana), we examined vegetation impacts and recovery across 3years. Oil concentrations in marsh soils were initially elevated in the oiled-and-burned sites, but were below background levels within three months. Oiling and burning drastically affected the marsh vegetation; the formerly dominant Phragmites, a non-native variety in our study sites, had not fully recovered by the end of our study. However, overall vegetation recovery was rapid and local habitat quality in terms of native plants, particularly Sagittaria species, and wildlife value was enhanced by burning. In-situ burning appears to be a viable response option to consider for future spills in marshes with similar plant species composition, hydrogeomorphic settings, and oiling conditions. In addition, likely Phragmites stress from high water levels and/or non-native scale insect damage was also observed during our study and has recently been reported as causing widespread declines or loss of Phragmites stands in the Delta region. It remains an open question if these stressors could lead to a shift to more native vegetation, similar to what we observed following the oil spill and burn. Increased dominance by native plants may be desirable as local patches, but widespread loss of Phragmites, even if replaced by native species, could further acerbate coastal erosion and wetland loss, a major concern in the region.

Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence.

Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female HIV transmission. Post-use assay results from three Ring-004 clinical trials showed that of the 25mg drug load, approximately 4mg of dapivirine is released from the matrix ring over a 28-day use period. Data obtained by both in vitro and in vivo studies indicate that dapivirine is released according to a diffusion mechanism, as determined by conformance of both data sets to the Higuchi equation. This, coupled with the low variability associated with batch production over two manufacturing sites and 20 batches of material, provides evidence that post-use ring analysis can contribute to the assessment of adherence to ring use. Limitations of this method include the potential of intra-participant and inter-participant variability and uncertainty associated with measuring the low amount of dapivirine actually released relative to the drug load. Therefore, residual drug levels should not serve as the only direct measurement for microbicide adherence in vaginal ring clinical trials but should preferably be used as part of a multi-pronged approach towards understanding and assessing adherence to vaginal ring use.

Innovations in access to care: a patient-centered approach.

To receive health care, patients with nonemergent problems must gain access to a complex, interdependent ambulatory care system currently structured around the conventional office appointment model. The system does not effectively accommodate diverse patient needs and preferences, contributing to both overuse and underuse of health care resources. A patient-centered access model would help patients secure appropriate and preferred medical assistance when and where it is needed. Characteristics of patient-centered access include availability, appropriateness, preference, and timeliness. One or more of these characteristics often is missing in patients' health care experiences. The goal of this paper is to present patient-centered access as an integrated concept and philosophy to provide context for evaluating specific access initiatives. On the basis of an assessment of existing literature, 3 organizing principles of patient-centered access are proposed and discussed: work at the high end of expertise; align care with need and preference; and serve when service is needed. Patient-centered access warrants serious consideration, given the stakes involved for patients, providers, and payers. Few concepts support all 6 of the Institute of Medicine's aims for the 21st century: safety, effectiveness, patient-centeredness, timeliness, efficiency, and equitability. Patient-centered access is such a concept.

Development of dapivirine vaginal ring for HIV prevention.

In the continuing effort to develop effective HIV prevention methods for women, a vaginal ring containing the non-nucleoside reverse transcriptase inhibitor dapivirine is currently being tested in two safety and efficacy trials. This paper reviews dapivirine ring's pipeline development process, including efforts to determine safe and effective dosing levels as well as identify delivery platforms with the greatest likelihood of success for correct and consistent use. Dapivirine gel and other formulations were developed and tested in preclinical and clinical studies. Multiple vaginal ring prototypes were also tested, resulting in the current ring design as well as additional designs under consideration for future testing. Efficacy results from clinical trials are expected in 2015. Through ongoing consultations with national regulatory authorities, licensure requirements for dapivirine vaginal ring approval have been defined. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research.