“Like a ticking time bomb”: the persistence of trauma in the HIV diagnosis experience among black men who have sex with men in New York City

Background Black men who have sex with men (MSM) are disproportionately affected by HIV compared to almost every other demographic group in the country and have worse outcomes along the care continuum. Diagnosis is a critical juncture. This study aims to explore the impact and meaning of an HIV diagnosis for Black MSM, and how this has changed over time, both for the individual’s experience living with HIV as well as for Black MSM in general. Methods From 2017 to 2018, we conducted in-depth interviews with 16 black MSM living with HIV in New York City diagnosed between 1985 and 2016. Results Inductive analysis of the qualitative data allowed three major themes to emerge: diagnosis trauma, lack of patient -centeredness in the healthcare system, and acceptance of HIV diagnosis over time. Conclusions This small pilot study signals that an HIV diagnosis experience possibly remains traumatic for black MSM even in the era of highly effective ART, and they often perceive a lack of patient-centeredness in the delivery of a new diagnosis. This has persisted over time. In most cases, black MSM in our sample overcame this trauma due to self-motivation, social support and seeking out and fostering trusting relationships with their HIV provider and the healthcare system

Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression

BACKGROUND: The established composite kidney end point in clinical trials combines clinical events with sustained large changes in GFR. However, the statistical method does not weigh the relative clinical importance of the end point components. A HCE accounts for the clinical importance of the end point components and enables combining dichotomous outcomes with continuous measures. METHODS: We developed and validated a new HCE for kidney disease progression, performing post hoc analyses of seven major Phase 3 placebo-controlled trials that assessed the effects of canagliflozin, dapagliflozin, finerenone, atrasentan, losartan, irbesartan, and aliskiren in patients with CKD. We calculated the win odds (WOs) for treatment effects on a kidney HCE, defined as a hierarchical composite of all-cause mortality; kidney failure; sustained 57%, 50%, and 40% GFR declines from baseline; and GFR slope. The WO describes the odds of a more favorable outcome for receiving the active compared with the control. We compared the WO with the hazard ratio (HR) of the primary kidney outcome of the original trials. RESULTS: In all trials, treatment effects calculated with the WO reflected a similar direction and magnitude of the treatment effect compared with the HR. Clinical trials incorporating the HCE would achieve increased statistical power compared with the established composite end point at equivalent sample sizes. CONCLUSIONS: In seven major kidney clinical trials, the WO and HR provided similar direction of treatment effect estimates with smaller HRs associated with larger WOs. The prioritization of clinical outcomes and inclusion of broader composite end points makes the HCE an attractive alternative to the established kidney end point

The Lantern, 2016-2017

• Our Lady of Perpetual Virginity • Essential Terms for the Audience • Stories Untold • Jesus Camp • The Second Avenue Schmear • Driving to the Beach • Thanks, Alice • Decay • Peanut Butter Rhapsody • Transactions • Traffic • Sissy • Melting Wings • Ocean • Small Town Summer • Third Story • Family Trees • Mixed, Just Like Me • Sour Graves • How Sweet the Sound • Goodnight, Halfmoon • I\u27m Going to Ask Him How • Music • Pizza • Manhoodlike • Meditations From a Bunk Bed in a Home on Mount Pocono • Soft • Twilight\u27s Palette • The Oracle • Cynicism • River Ganges • Pinata Body and Hearing the Gun Shot • Song With No Music • Of Mornings Considering Womanhood • 10 Hours in Philadelphia • To Cut • Sachrang • Bavarian Wave Swinger • Irish Rain • Remembrances, Well • The Roses • Buttermilk • The Universe Will Always Listen if You Ask Her, Which is Why I Like Her More Than God • A Lukewarm Light • A Thought of Death • Hobson • Decaying Light • Window Women • Dead Bee • The Imagery • For Rent • Mona Lisa MMXVIhttps://digitalcommons.ursinus.edu/lantern/1185/thumbnail.jp

Transactional sex, condomless anal sex, and HIV risk among men who have sex with men

To understand the HIV epidemic among men who have sex with men who engage in transactional sex (MSM-TS) in Paris, France, we sought to examine the association between engagement in transactional sex and HIV risk behaviors among MSM in Paris, France. Users of a geosocial-networking application in Paris were provided an anonymous web-based survey ( N =580), which included questions about transactional sex and behavioral risk factors for HIV along with sexually transmitted infection (STI)/HIV status. Multivariate analyses showed that engagement in transactional sex was associated with condomless receptive and insertive anal intercourse (adjusted relative risk [aRR]= 1.34, 95% confidence interval [CI]=1.04–1.72 and aRR=1.41, 95% CI=1.04–1.91, respectively). MSM-TS were more likely to have engaged in substance use before or during sex (aRR=1.35, 95% CI=1.13–1.62), to have participated in group sex (aRR=1.37, CI=1.13–1.62), and to have had an STI during the last year (aRR=1.68, 95% CI=1.16–2.45). Transactional sex was not associated with HIV status. MSM-TS in Paris engaged in higher HIV risk behaviors, however, did not have higher rates of HIV infection. Sexual health interventions should continue to target MSM-TS; however, future studies should characterize the social, cultural, and structural factors that interact with individual behaviors to elevate HIV risk for MSM-TS

Validity and Utility of a Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression:A Review

Clinical trials in nephrology often use composite end points comprising clinical events, such as onset of ESKD and initiation of kidney function replacement therapy, along with a sustained large (e.g., $50$50%. By contrast, hierarchical composite end points (HCEs) combine multiple outcomes and prioritize each patient’s most clinically relevant outcome for inclusion in analysis. In this review, we consider the use of HCEs in clinical trials of CKD progression, emphasizing the potential to combine dichotomous clinical events such as those typically used in CKD progression trials, with the continuous variable of GFR over time, while ranking all components according to clinical significance. We consider maraca plots to visualize overall treatment effects and the contributions of individual components, discuss the application of win odds in kidney HCE trials, and review general design considerations for clinical trials for CKD progression with kidney HCE as an efficacy end point.</p

Validity and Utility of a Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression:A Review

Clinical trials in nephrology often use composite end points comprising clinical events, such as onset of ESKD and initiation of kidney function replacement therapy, along with a sustained large (e.g., $50$50%. By contrast, hierarchical composite end points (HCEs) combine multiple outcomes and prioritize each patient’s most clinically relevant outcome for inclusion in analysis. In this review, we consider the use of HCEs in clinical trials of CKD progression, emphasizing the potential to combine dichotomous clinical events such as those typically used in CKD progression trials, with the continuous variable of GFR over time, while ranking all components according to clinical significance. We consider maraca plots to visualize overall treatment effects and the contributions of individual components, discuss the application of win odds in kidney HCE trials, and review general design considerations for clinical trials for CKD progression with kidney HCE as an efficacy end point.</p

Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression

Background The established composite kidney end point in clinical trials combines clinical events with sustained large changes in GFR. However, the statistical method does not weigh the relative clinical importance of the end point components. A HCE accounts for the clinical importance of the end point components and enables combining dichotomous outcomes with continuous measures. Methods We developed and validated a new HCE for kidney disease progression, performing post hoc analyses of seven major Phase 3 placebo-controlled trials that assessed the effects of canagliflozin, dapagliflozin, finerenone, atrasentan, losartan, irbesartan, and aliskiren in patients with CKD. We calculated the win odds (WOs) for treatment effects on a kidney HCE, defined as a hierarchical composite of all-cause mortality; kidney failure; sustained 57%, 50%, and 40% GFR declines from baseline; and GFR slope. The WO describes the odds of a more favorable outcome for receiving the active compared with the control. We compared the WO with the hazard ratio (HR) of the primary kidney outcome of the original trials. Results In all trials, treatment effects calculated with the WO reflected a similar direction and magnitude of the treatment effect compared with the HR. Clinical trials incorporating the HCE would achieve increased statistical power compared with the established composite end point at equivalent sample sizes. Conclusions In seven major kidney clinical trials, the WO and HR provided similar direction of treatment effect estimates with smaller HRs associated with larger WOs. The prioritization of clinical outcomes and inclusion of broader composite end points makes the HCE an attractive alternative to the established kidney end point.</p