32 research outputs found
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Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs
Background
The resurgence of HIV outbreaks and rising prevalence among people who inject drugs (PWID) remain exigent obstacles to Ending the HIV Epidemic in the USA. Adapting a low threshold, comprehensive treatment model for PWID with HIV can leverage syringe services programs (SSPs) to increase availability and accessibility of antiretrovirals (ART), medications for opioid use disorder (MOUD), and hepatitis C cure. We developed Tele-Harm Reduction, a telehealth-enhanced, harm reduction intervention delivered within an SSP venue.
Methods
The T-SHARP trial is an open-label, multi-site, randomized controlled superiority trial with two parallel treatment arms. Participants (n=240) recruited from SSPs in Miami, Ft. Lauderdale, and Tampa, Florida, who are PWID with uncontrolled HIV (i.e., HIV RNA>200) will be randomized to Tele-Harm Reduction or off-site linkage to HIV care. The primary objective is to compare the efficacy of Tele-Harm Reduction for initiation of ART at SSPs vs. off-site linkage to an HIV clinic with respect to viral suppression across follow-up (suppression at 3, 6, and 12 months post randomization). Participants with HIV RNA<200 copies/ml will be considered virally suppressed. The primary trial outcome is time-averaged HIV viral suppression (HIV RNA <200 copies/ml) over 3-, 6-, and 12-month follow-up. Secondary outcomes include initiation of MOUD measured by urine drug screen and HCV cure, defined as achieving 12-week sustained virologic response (negative HCV RNA at 12 weeks post treatment completion). A cost-effectiveness analysis will be performed.
Discussion
The T-SHARP Trial will be the first to our knowledge to test the efficacy of an innovative telehealth intervention with PWID with uncontrolled HIV delivered via an SSP to support HIV viral suppression. Tele-Harm Reduction is further facilitated by a peer to support adherence and bridge the digital divide. This innovative, flipped healthcare model sets aside the traditional healthcare system, reduces multi-level barriers to care, and meets PWID where they are. The T-SHARP trial is a pragmatic clinical trial that seeks to transform the way that PWID access HIV care and improve HIV clinical outcomes.
Trial registration
ClinicalTrials.gov
NCT05208697. Trial registry name: Tele-Harm Reduction. Registration date: January 26, 2022
Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures
Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo
Establishing a Majority: Observer Race Influences Estimates of Crowd Ethnicity
Inspired by recent studies of “ensemble” face processing, we asked whether observers could accurately estimate the ethnic composition of an array of faces. We also examined whether such estimates were influenced by the race of the observer. We developed a new task in which a set of 16 faces was continuously shuffled within a moving 4 × 4 grid. This design prevents explicit estimation and blocks spatial sub-sampling. Across trials we systematically varied the proportion of Asian and Caucasian faces. Two groups of observers were assigned different target and distractor races. Their task was to indicate whether there were more targets or distractors present on each trial. Each group consisted of 8 Asian and 8 Caucasian observers. We fitted cumulative normal functions to the response distributions and extracted the PSE and JND as dependent measures. The same 2 (Observer Race) x 2 (Target Race) ANOVA was used for analysis. For PSE, there were main effects of Observer and Target that did not interact. Observers consistently weighted other-race faces more heavily than own-race faces and PSEs were generally shifted in the direction of the Target. For JND, there was a main effect of Observer and a Observer x Target interaction. While Asian observers were generally more sensitive, both groups had smaller JNDs when the target was the other-race. Overall, our findings indicate that observers can rapidly estimate the racial composition of a group of faces, but these estimates are influenced by their own race
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