8 research outputs found
Recommended from our members
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
A Retrospective Analysis of Vitamin D Levels in Hospitalized COVID-19 Patients With Suspected Pulmonary Embolism.
Introduction Despite using anti-coagulation therapy in hospitalized coronavirus disease 2019 (COVID-19) patients, they have high rates of pulmonary embolism (PE) and deep vein thrombosis (DVT). The main objective of this study was to evaluate the association between vitamin D deficiency and thrombotic events (defined as the occurrence of a new PE or DVT) in hospitalized COVID-19 patients. Materials and Methods This was a retrospective, cross-sectional study of 208 hospitalized COVID-19 patients who received a computed tomographic pulmonary angiography (CTPA) based on clinical suspicion of PE between January 1, 2020, and February 5, 2021. A/mL serum vitamin D level was used to categorize vitamin D deficiency. Nonparametric tests and multivariate binary logistic regression were used to evaluate the association between serum vitamin D levels and clinical outcomes. Results The mean vitamin D level was 26.7±13.0 ng/mL (n=208), and approximately one-third of patients were vitamin D deficient (n=68, 32.7%). No association was found between vitamin D deficiency and the occurrence of thrombotic events. The incidence of PE was 19.1% in vitamin D deficient patients compared to 11.4% in vitamin D sufficient patients (p=0.13). Vitamin D deficiency was positively associated with ICU admission (OR 3.047, 95%CI 1.57-5.91, p=0.001) and mortality (OR 3.76, 95%CI 1.29-11.01, p=0.016). Conclusions This study found no association between vitamin D deficiency and the occurrence of a new PE or DVT in hospitalized COVID-19 patients. Patients with vitamin D deficiency were more likely to be admitted to the ICU and had increased overall mortality
Prevalence and management of diabetes among the uninsured: A multicenter study in Tampa Bay, FL.
AIMS: This study describes the prevalence and management of uninsured patients with diabetes in free clinics around the Tampa Bay area.
METHODS: A retrospective chart review collected data from uninsured patients who visited nine free clinics from January 2016 to December 2017. The data included sociodemographics, chronic disease diagnoses and treatments, and social history. Statistical analysis including chi-square tests and logistic regression were used to describe patients with diabetes.
RESULTS: With a prevalence of 19.41% among 6815 uninsured patients and a mean HbA1c of 7.9% (63 mmol/mol), patients with diabetes were more likely to be White, women, obese, unemployed, and have hypertension and depression compared to patients without diabetes. There were no significant differences in sociodemographic variables between those with controlled and uncontrolled diabetes. Among the variables studied by logistic regression, unemployment was found to be a significant predictor of poor glycemic control among men.
CONCLUSIONS: Diabetes is a challenging chronic disease among the uninsured of Tampa Bay due to its prevalence and suboptimal glycemic control. Obesity and unemployment represent significant challenges that increase the burden of diabetes among the uninsured. Free clinics may benefit from additional resources and intervention programs, with future research assessing their effects on care outcomes
Bundling HIV and TB Care at a District-Level Center in Sierra Leone: A high-yield method for diagnosing co-infection with TB and antiretroviral treatment failure among people living with HIV
Background: Protocols for HIV care are widely accepted by all international organizations and are proven to reduce mortality and complications from living with HIV. Unfortunately, executing best practice recommendations in Sierra Leone is difficult due to shortages in staff, training, and medications. Methods: From June 2016 to August 2016, we implemented both an HIV guideline-based clinical evaluation protocol and a patient-centered workflow for TB screening and CD4 testing in the HIV clinic at Koidu Government Hospital (KGH) in rural Sierra Leone. The primary outcome of interest was how often this service center resulted in a clinically significant change in the patients’ HIV regimen. Reasons for changing regimen included diagnosis of co-infection with tuberculosis (TB), diagnosis of clinical or presumed immunologic treatment failure of antiretroviral (ART) medications and, need for adherence to weight-based dosing in pediatric patients. Findings: A total of 188 patients with HIV were seen in the clinic; 49 (26%) of these patients had a clinically significant change in their HIV regimen. The most common reason for regimen change was TB co-infection diagnosis in 38 (20%) patients. The other reasons for HIV regimen changes included: eight children whose ART was adjusted to meet appropriate levels for weight-based guidelines, five patients diagnosed with presumed immunologic treatment failure (some also co-infected with tuberculosis), and two patients with a serious side effect to ART. Interpretation: A comprehensive, patient-centric HIV clinic can result in high rates of case detection for tuberculosis and recognition of immunological ART failure. Keywords: HIV, Immunological failure, Co-infection, Quality, Tuberculosis, Afric
Recommended from our members