Rates of HIV acquisition remain high among adolescent girls and young women (AGYW) in sub-Saharan Africa. We explored South African, Ugandan, and Zimbabwean AGYW's experiences in a crossover trial of two HIV prevention products: Daily oral pre-exposure prophylaxis pills and a monthly dapivirine vaginal ring. A subset of participants (n = 25) across all sites completed up to three serial in-depth interviews (SIDIs).
View Article and Find Full Text PDFBackground: Vaginal rings formulated to deliver two drugs simultaneously have potential as user-controlled, long-acting methods for dual prevention of HIV and pregnancy.
Methods: Two phase 1 randomized trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019) respectively enrolled 24 and 25 healthy, HIV-negative participants to evaluate safety, pharmacokinetics, and vaginal bleeding associated with use of a vaginal ring containing 200mg dapivirine (DPV) and 320mg levonorgestrel (LNG) designed for 90-day use. MTN-030/IPM 041 compared the DPV/LNG ring to a DPV-only ring (200mg) over 14 days of use.
Background: On-demand topical products could be an important tool for human immunodeficiency virus (HIV) prevention. We evaluated the safety, pharmacokinetics, and ex vivo pharmacodynamics of a tenofovir alafenamide/elvitegravir (TAF/EVG, 20 mg/16 mg) insert administered rectally.
Methods: MTN-039 was a phase 1, open-label, single-arm, 2-dose study.
Background: Half of new HIV acquisitions in Africa occur in adolescent girls and young women. Pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate plus emtricitabine or the monthly dapivirine vaginal ring is efficacious but has lower adherence and effectiveness among adolescent girls and young women. We aimed to assess product adherence, safety, and choice of oral PrEP compared with the dapivirine ring among African adolescent girls and young women.
View Article and Find Full Text PDFDisturbances to forested watersheds often result in increases of nutrients and light to nearby streams. Such changes are generally expected to produce a shift to a more autotrophic aquatic ecosystem, with measurable increases in algae, and associated implications for food webs and fisheries. Although this paradigm is widely established, results from our 10-year study (2007-2016) in 12 headwater streams and four sites downstream in the Trask River Watershed (Oregon, USA), did not concur.
View Article and Find Full Text PDFPredicting the edges of species distributions is fundamental for species conservation, ecosystem services, and management decisions. In North America, the location of the upstream limit of fish in forested streams receives special attention, because fish-bearing portions of streams have more protections during forest management activities than fishless portions. We present a novel model development and evaluation framework, wherein we compare 26 models to predict upper distribution limits of trout in streams.
View Article and Find Full Text PDFClinical trials often depend on participants receiving study product to meet objectives of the protocol. Vitally important are considerations for how sites receive and dispense study product during a study while ensuring appropriate handling, accountability and compliance. The process for provision of study product is detailed in Standard Operating Procedures (SOPs) which are adhered to by the research site throughout the trial.
View Article and Find Full Text PDFObservations of the presence or absence of surface water in streams are useful for characterizing streamflow permanence, which includes the frequency, duration, and spatial extent of surface flow in streams and rivers. Such data are particularly valuable for headwater streams, which comprise the vast majority of channel length in stream networks, are often non-perennial, and are frequently the most data deficient. Datasets of surface water presence exist across multiple data collection groups in the United States but are not well aligned for easy integration.
View Article and Find Full Text PDFFor women in the United States who remain sexually active beyond child-bearing years, susceptibility to HIV infection remains, yet condom use is low. We assessed acceptability of the dapivirine vaginal ring (ring) among 96 postmenopausal US women enrolled in a placebo-controlled multisite phase II trial of the ring, using questionnaires and in-depth interviews. Three quarters of women reported "perfect" adherence (ring never out) over the 3-month trial period.
View Article and Find Full Text PDFDissolved organic carbon (DOC) and nitrogen (DON) are important energy and nutrient sources for aquatic ecosystems. In many northern temperate, freshwater systems DOC has increased in the past 50 years. Less is known about how changes in DOC may vary across latitudes, and whether changes in DON track those of DOC.
View Article and Find Full Text PDFThis study describes the acceptability of a rectal microbicide gel formulation using dapivirine (DPV) among men and women from two countries (United States and Thailand) participating in the Microbicide Trials Network-026 trial. We evaluated participants' acceptability of a rectal DPV/placebo gel as part of a Phase I trial (N = 26; 18 male, 8 female). Participants reported favorable acceptability of the study gel, with most participants reporting that they liked the gel the same (n = 14; 53.
View Article and Find Full Text PDFWe triangulated quantitative and qualitative assessments to evaluate participants' acceptability of 0.05% dapivirine rectal microbicide (RM) gel administered via two separate modalities (a rectal applicator and an artificial phallus for use as a coital simulation device) as part of a Phase I trial (N = 14) among men who have sex with men (MSM) randomized using a 1:1 ratio. Overall, participants reported favorable acceptability of the gel (n = 11; 78.
View Article and Find Full Text PDFDapivirine (DPV), formulated as vaginal ring, demonstrated HIV risk reduction. MTN-026 explored DPV, formulated as rectal gel, for safety, pharmacokinetics (PK), and acceptability. HIV-uninfected men and women aged 18-45 years were enrolled at United States and Thailand sites and randomized 2:1 to receive DPV 0.
View Article and Find Full Text PDFAnthropogenic increases in nitrogen (N) and phosphorus (P) concentrations can strongly influence the structure and function of ecosystems. Even though lotic ecosystems receive cumulative inputs of nutrients applied to and deposited on land, no comprehensive assessment has quantified nutrient-enrichment effects within streams and rivers. We conducted a meta-analysis of published studies that experimentally increased concentrations of N and/or P in streams and rivers to examine how enrichment alters ecosystem structure (state: primary producer and consumer biomass and abundance) and function (rate: primary production, leaf breakdown rates, metabolism) at multiple trophic levels (primary producer, microbial heterotroph, primary and secondary consumers, and integrated ecosystem).
View Article and Find Full Text PDFSeasonal changes in the magnitude and duration of streamflow can have important implications for aquatic species, drinking water supplies, and water quality. In many regions, including the Pacific Northwest (U.S.
View Article and Find Full Text PDFFish passage out of reservoirs is a critical issue for downstream movement of juvenile salmonids and other migratory species. Reservoirs can delay downstream migrations by juvenile salmon for months or years. Here, we examine whether a novel management activity implementing annual short-term draining of a reservoir to streambed improves timely downstream migration of juvenile salmonids.
View Article and Find Full Text PDFBackground: As daily oral preexposure prophylaxis (PrEP) becomes standard for HIV prevention, routine use of PrEP is likely to increase within clinical trials of novel preventive agents. We describe the prevalence and characteristics of participants reporting nonstudy oral PrEP use within Microbicide Trials Network-017 (MTN-017), a phase 2 trial of a rectal microbicide.
Setting And Methods: One hundred ninety-five HIV-uninfected men who have sex with men and transgender women were enrolled and followed in MTN-017 across 8 sites in the United States, Thailand, South Africa, and Peru from 2013 to 2015.
Large dams and their respective reservoirs provide renewable energy and water security, but also can profoundly alter riverine ecosystems. Here, we present evidence of changing aquatic food web structure in the seasons following short-duration, extreme manipulation of water levels in a reservoir (i.e.
View Article and Find Full Text PDFStatistically downscaled climate change scenarios from four General Circulation Models for two Representative Concentration Pathways (RCP) were applied as inputs to a biogeochemical model, PnET-BGC, to examine potential future dynamics of water, carbon, and nitrogen in an old-growth Douglas-fir forest in the western Cascade Range. Projections show 56% to 77% increases in stomatal conductance throughout the year from 1986-2010 to 2076-2100, and 65% to 104% increases in leaf carbon assimilation between October and June over the same period. However, future dynamics of water and carbon under the RCP scenarios are affected by a 49% to 86% reduction in foliar biomass resulting from severe air temperature and humidity stress to the forest in summer.
View Article and Find Full Text PDF