Same-day Testing Research Articles

Diagnostic accuracy of Truenat MTB Plus, Truenat MTB Ultima and Xpert MTB/RIF Ultra for the diagnosis of pulmonary TB in an HIV-endemic setting.

Truenat MTB Plus (MTB Plus) and MTB Ultima (Ultima) are World Health Organization-endorsed low-complexity tuberculosis (TB) tests, however, performance data are scarce. Adults (≥18 years; n=498) self-presenting with symptoms to primary care clinics in Cape Town, South Africa (19/02/2016-22/02/2023) provided sputa. We evaluated the accuracy of MTB Plus and Ultima, with Xpert MTB/RIF Ultra (Ultra) as a comparator, vs. a single culture (TB reference standard) or MTBDRplus on an isolate (rifampicin susceptibility reference standard). The proportion of MTB Plus and Ultima unsuccessful results was 20% (95% confidence interval 17, 23) and 14 (11, 16), respectively, with ≥half resolving upon retesting the same eluate. In a three-way analysis, MTB Plus, Ultima and Ultra had sensitivities of 84% (78, 88), 90% (85, 93), and 92% (87, 95), and specificities of 95% (92, 97), 85% (80, 88) and 95% (92, 97) for TB. The proportion of unsuccessful results for MTB-RIF Dx done the same day as DNA extraction was 9% (3, 16; MTB Plus-positives) and 18% (10, 26; Ultima-positives) [if after day-of-extraction, these were 27% (18, 35) and 44% (35, 51)]. Same-day rifampicin susceptibility testing was often unsuccessful in samples with "very low" load [73% (58, 89) MTB Plus, 75% (65, 86) Ultima] but had 100% (40, 100) sensitivity and 99% (96, 100) specificity (for both MTB Plus- or Ultima-positive DNA). Lot variation in unsuccessful and false-positive results was observed. Ultima showed comparable sensitivity to Ultra but specificity, lot variation, and, like MTB-RIF Dx, unsuccessful result rates were suboptimal. European & Developing Countries Clinical Trials Partnership, and South African Medical Research Council.

Refining Cardiovascular Calcification in the Appraisal of Ischemic Heart.

Even in asymptomatic patients, there is a high association of ischemia on myocardial perfusion scans in those with coronary artery calcification or valvular calcifications. Patients without coronary artery calcifications have exceeding-low rates of cardiovascular events. The absence of cardiovascular calcification, including coronary artery, valvular, and thoracic aorta is a strong negative predictor of myocardial ischemia. In individuals with suspected ischemia who had chest computed tomography imaging, evaluation for cardiovascular calcification (coronary artery, valves, and thoracic aorta) is an invaluable tool to guide management for further diagnostic imaging. We hypothesize that the complete absence of cardiovascular calcification has a high negative predictive value for defects in myocardial perfusion imaging such as single-photon emission computed tomography(SPECT) or positron emission tomography(PET). Non-contrast computed tomography performed for SPECT/PET CT attenuation correction from March 1, 2017, to September 30, 2017, were retrospectively reviewed for the absence of cardiovascular calcification by a cardiologist andradiologist who were blinded to patients' medical history. Medical records were reviewed to include patient demographics and medical history. A total of 132 patients were analyzed. Of the 132 patients without calcifications, seven patients had small myocardial perfusion defects suggestive of ischemia or infarct, but none were considered significant defects. Of these seven patients, six were managed medically and one was from an outside institution with no follow-up data. Two of the seven patients had follow-up invasive angiography or coronary CTA that did not show significant atherosclerotic coronary artery disease. A complete absence of cardiovascular calcification indicates a 100% negative predictive value for a significant perfusion defect on same-day confirmatory nuclear stress testing. Patients with suspected ischemia but absent cardiovascular calcifications can be safely managed medically without further testing for ischemia.

Understanding effective post-test linkage strategies for HIV prevention and care: a scoping review.

Following HIV testing services (HTS), the World Health Organization recommends prompt linkage to prevention and treatment. Scale-up of effective linkage strategies is essential to achieving the global 95-95-95 goals for maintaining low HIV incidence by 2030 and reducing HIV-related morbidity and mortality. Whereas linkage to care including same-day antiretroviral therapy (ART) initiation for all people with HIV is now routinely implemented in testing programmes, linkage to HIV prevention interventions including behavioural or biomedical strategies, for HIV-negative individuals remains sub-optimal. This review aims to evaluate effective post-HTS linkage strategies for HIV overall, and highlight gaps specifically in linkage to prevention. Using the five-step Arksey and O'Malley framework, we conducted a scoping review searching existing published and grey literature. We searched PubMed, Cochrane Library, CINAHL, Web of Science and EMBASE databases for English-language studies published between 1 January 2010 and 30 November 2023. Linkage interventions included as streamlined interventions-involving same-day HIV testing, ART initiation and point-of-care CD4 cell count/viral load, case management-involving linkage coordinators developing personalized HIV care and risk reduction plans, incentives-financial and non-financial, partner services-including contact tracing, virtual-like social media, quality improvement-like use of score cards, and peer-based interventions. Outcomes of interest were linkage to any form of HIV prevention and/or care including ART initiation. Of 2358 articles screened, 66 research studies met the inclusion criteria. Only nine linkage to prevention studies were identified (n = 9/66, 14%)-involving pre-exposure prophylaxis, voluntary medical male circumcision, sexually transmitted infection and cervical cancer screening. Linkage to care studies (n = 57/66, 86%) focused on streamlined interventions in the general population and on case management among key populations. Despite a wide range of HIV prevention interventions available, there was a dearth of literature on HIV prevention programmes and on the use of messaging on treatment as prevention strategy. Linkage to care studies were comparatively numerous except those evaluating virtual interventions, incentives and quality improvement. The findings give insights into linkage strategies but more understanding of how to provide these effectively for maximum prevention impact is needed.

Right Ventricular Structure and Function in Adolescent Athletes: A 3D Echocardiographic Study.

The aim of this study was to characterize the right ventricular (RV) contraction pattern and its associations with exercise capacity in a large cohort of adolescent athletes using resting three-dimensional echocardiography (3DE). We enrolled 215 adolescent athletes (16±1 years, 169 males, 12±6 hours of training/week) and compared them to 38 age and sex-matched healthy, sedentary adolescents. We measured the 3DE-derived biventricular ejection fractions (EF). We also determined the relative contributions of longitudinal EF (LEF/RVEF) and radial EF (REF/RVEF) to the RVEF. Same-day cardiopulmonary exercise testing was performed to calculate VO2/kg. Both LV and RVEFs were significantly lower (athletes vs. controls; LVEF: 57±4 vs 61±3, RVEF: 55±5 vs 60±5%, p<0.001). Interestingly, while the relative contribution of radial shortening to the global RV EF was also reduced (REF/RVEF: 0.40±0.10 vs 0.49±0.06, p<0.001), the contribution of the longitudinal contraction was significantly higher in athletes (LEF/RVEF: 0.45±0.08 vs 0.40±0.07, p<0.01). The supernormal longitudinal shortening correlated weakly with a higher VO2/kg (r=0.138, P=0.044). Similarly to the adult athlete's heart, the cardiac adaptation of adolescent athletes comprises higher biventricular volumes and lower resting functional measures with supernormal RV longitudinal shortening. Characteristic exercise-induced structural and functional cardiac changes are already present in adolescence.

Improving timeliness and equity in germline genetic testing for pancreatic ductal adenocarcinoma patients: A comparative analysis and future strategies.

611 Background: Germline genetic testing is recommended for patients with pancreatic ductal adenocarcinoma (PDAC). Our previous study identified delays in germline testing for socioeconomically disadvantaged patients. We aimed to compare delays before and after implementing recommendations for same-day germline testing and identify reasons why germline testing was not performed. Methods: Using an IRB-approved protocol, PDAC patients were identified from Jan 2022 to Dec 2022 in our EMR system. Median income was estimated by zip code. Delays were calculated as the difference between diagnosis and germline test date. Social work needs were assessed through EMR review. An in-depth chart review was conducted to identify why tests were not performed. Results: An additional 100 patients were found with tests performed. Compared to our previous 135-patient study with a median delay of 27 days (d) in testing, our recent data showed a median delay of 15d (p=0.0215). In our previous study, 50 out of 135 patients (37%) received testing within two weeks of their PDAC diagnosis, whereas our recent data showed that 49 out of 100 patients (49%) received testing within two weeks (c2=3.372, p=0.0663), a 32% relative increase. The negative correlation between median income and delays in testing (r=-0.2578, p=0.0025) found in our previous study no longer existed in our recent analysis (r=0.0419, p=0.6802). Compared to our previous study in underserved minority (UM) patients (African American and Hispanic), our recent data showed a significant decrease in the delays for testing in UM patients (66d vs 19d, p=0.0041). We did not identify a difference in delays for testing between UM and not UM patients in the recent dataset (UM: 19d vs not UM: 15d, p=0.8075). In addition, compared to our previous study in patients with social work (SW) needs, our recent data showed a significant decrease in the delays for patients with SW needs (104d vs 13d, p=0.0004). We did not detect a significant difference between patients with SW needs and without SW needs in our recent data (SW: 13d vs no SW: 15d, p=0.8041). Finally, in our analysis of 87 patients without documented tests, 51 (59%) received care elsewhere, 25 (29%) were never offered tests, 5 (6%) refused tests, and 6 (7%) pursued a palliative approach. Conclusions: Our recent analysis showed a significant decrease in delays of testing, as more patients received prompt testing after PDAC diagnosis. Socioeconomically disadvantaged patients and those with social work needs no longer experienced significant delays in testing. To further mitigate delays, we plan to initiate germline testing during the first visit by providing introductory videos to increase understanding of consent. Furthermore, the substantial number of patients who were not offered tests will raise physician awareness regarding the necessity of offering germline tests.

Impact of time of culture specimen collection on the recovery of Neisseria gonorrhoeae after a positive nucleic acid amplification test

ObjectivesCulture of Neisseria gonorrhoeae remains essential for antimicrobial resistance (AMR) surveillance. We evaluated the effect of time of specimen collection on culture yield following a positive nucleic acid amplification test...

Lessons Learned From Global Hepatitis C Elimination Programs.

In 2016, the World Health Organization introduced global targets for the care and management of hepatitis C virus (HCV) infection to eliminate hepatitis C as a public health threat by 2030. Despite significant improvements in testing and treatment, in 2020 only 23% of all persons infected with HCV globally were diagnosed. We explore examples from global hepatitis C programs in Georgia, Rwanda, and Nigeria that have used decentralized and integrated models to increase access to HCV testing. Georgia established the world's first national hepatitis C elimination program in 2015. In 2022, 2.6 million people (80% of the adults) have been screened for antibodies for HCV infection, and 80 000 persons with HCV RNA detected were treated. To achieve these results, Georgia implemented HCV core antigen testing, utilization of point-of-care (POC) HCV RNA testing, and simplification of HCV viremia detection by qualitative HCV RNA testing. Rwanda was the first country in sub-Saharan Africa to commit to HCV elimination in 2018, and as of 2022 it has achieved its screening target of 7 million people and initiated approximately 60 000 patients on hepatitis C treatment by rapid decentralization and integration of HCV services. In Nigeria, the integrated near-POC testing approach in Nasarawa State has been effective in expanding access to HCV viremia testing and enabling the possibility of same-day testing and treatment initiation. Examples of decentralization and integration of HCV testing and linkage to care in Georgia, Rwanda, and Nigeria could help inform effective strategies to reach 2030 hepatitis C elimination goals in other countries.

Barriers and Strategies for Hepatitis B and C Elimination in Pakistan.

Pakistan has a high hepatitis burden for both hepatitis C virus (HCV) and hepatitis B virus (HBV). To achieve World Health Organization (WHO) 2030 targets for hepatitis elimination, there is a need to constitute progress in the country, find the barriers and strategies for HCV elimination, and take actions to address the gaps. We collected data from (1) WHO estimates in 2020, (2) midterm review questionnaire of the WHO regional action plan, and (3) WHO estimates on immunization. We analyzed these data to inform (1) the burden defined as prevalence and mortality and (2) response in 3 thematic areas: governance, policy, and finance; strategic information; and service delivery. The prevalence of hepatitis B in the general population is 1.6% with 12 000 deaths/year. The prevalence of hepatitis C in the general population is 7.5% with 19 000 deaths and 545 000 new cases (incidence)/year. The selected indicators to monitor progress on viral hepatitis in Pakistan were governance and financing, policies and guidelines, and strategic information. The overall governance indicators are good with a focal point, a national hepatitis strategy, an operational plan, strategy for price reduction, and involvement of civil society but the costed action plan and the advocacy strategy are missing. The indicators on policies and guidelines are also adequately addressed. The hepatitis B and C testing and treatment guidelines are available, there is a policy to screen all blood donations, and there is an injection safety policy, but the policy for timely hepatitis B vaccine birth dose and hepatitis B vaccination for the vulnerable is missing. Both indicators regarding strategic information, that is measures of key hepatitis indicators and regular data review, are missing. The status of 5 key interventions in Pakistan show that the hepatitis B vaccination coverage is 74% and only 3% of newborn children are given the hepatitis B vaccine birth dose. Only 22% of HCV cases have been diagnosed and 2% have received treatment. Treatment response is 96%. Same-day testing and treatment of hepatitis C reduced the overall dropout rate and improved the cascade of care. Decentralization and task shifting are important tools to improve service delivery and reach communities. Finances to implement hepatitis elimination is a major barrier. Pakistan has the highest hepatitis disease burden. With the current pace, hepatitis elimination appears impossible. Introduction of the birth dose of hepatitis B vaccine and improving access and affordability of testing can improve the testing and treatment numbers. Finances need to be mobilized from within the country and outside to support disease elimination.

Same day service: A genetic testing station model to improve germline genetic testing in patients with ovarian cancer

ObjectiveGenetic testing for ovarian cancer (OC) patients is essential to consideration of PARP inhibitor therapy. To improve access, we piloted a Genetic Testing Station (GTS) allowing patients to have a same-day genetic testing visit facilitated by Genetic Counselor Assistants (GCAs) under the supervision of Genetic Counselors (GCs). MethodsThe GTS was implemented December 2018 and operated through February 2020. Gynecologic Oncologists offered ovarian cancer patients a same-day GTS visit with a GCA. The patient received education via videos designed by GCs and then provided consent, a brief family history, and a sample for a standardized 133-gene panel. Results were provided by a GC. Patients were retrospectively identified by querying the medical record for OC patients seen 12 months prior to and 18 months after GTS implementation. ResultsA total of 482 patients pre-GTS were compared to 625 patients post-GTS. Genetic testing increased from 68.5% to 75.4% (p = 0.012) after implementation, primarily in patients with epithelial histologies (80% vs 89% in pre-GTS vs post-GTS, p = 0.005). Time from referral for genetic testing to obtaining results was evaluated in the post-GTS cohort, comparing patients who had traditional counseling to those who utilized the GTS. Time to obtaining results was 21 days in the GTS group (95% CI [10, 34]) compared to 56 days (95% CI [41,76]) in the traditional genetic counseling group. ConclusionsThe GTS reduces barriers to care and facilitates discussion of precision treatment within a timely fashion while optimizing GC clinic time. Access improvement remains integral to improving uptake of genetic testing.

Impact of a multi-disease integrated screening and diagnostic model for COVID-19, TB, and HIV in Lesotho.

The surge of the COVID-19 pandemic challenged health services globally, and in Lesotho, the HIV and tuberculosis (TB) services were similarly affected. Integrated, multi-disease diagnostic services were proposed solutions to mitigate these disruptions. We describe and evaluate the effect of an integrated, hospital-based COVID-19, TB and HIV screening and diagnostic model in two rural districts in Lesotho, during the period between December 2020 and August 2022. Adults, hospital staff, and children above 5 years attending two hospitals were pre-screened for COVID-19 and TB symptoms. After a positive pre-screening, participants were offered to enroll in a service model that included clinical evaluation, chest radiography, SARS-CoV-2, TB, and HIV testing. Participants diagnosed with COVID-19, TB, or HIV were contacted after 28 days to evaluate their health status and linkage to HIV and/or TB care services. Of the 179160 participants pre-screened, 6623(3.7%) pre-screened positive, and 4371(66%) were enrolled in this service model. Of the total 458 diagnoses, only 17 happened in children. One positive rapid antigen test for SARS-CoV-2 was found per 11 participants enrolled, one Xpert-positive TB case was diagnosed per 85 people enrolled, and 1 new HIV diagnosis was done per 182 people enrolled. Of the 321(82.9%) participants contacted after 28 days of diagnosis, 304(94.7%) reported to be healthy. Of the individuals that were newly diagnosed with HIV or TB, 18/24(75.0%) and 46/51(90.1%) started treatment within 28 days of the diagnosis. This screening and diagnostic model successfully maintained same-day, integrated COVID-19, TB, and HIV testing services, despite frequent disruptions caused by the surge of COVID-19 waves, healthcare seeking patterns, and the volatile context (social measures, travel restrictions, population lockdowns). There were positive effects in avoiding diagnostic delays and ensuring linkage to services, however, diagnostic yields for adults and children were low. To inform future preparedness plans, research will need to identify essential health interventions and how to optimize them along each phase of the emergency response.

Digital cancer genetic risk assessment in a gynecologic oncology clinic.

10612 Background: Population-based screening for hereditary cancer syndromes and referral of those who screen positive for genetic testing is a cost effective, evidence-based national health priority. However, under-recognition of hereditary cancer syndromes remains a critical concern, with fewer than 20% of individuals with Hereditary Breast and Ovarian Cancer Syndrome and Lynch Syndrome identified. Here, we evaluate the Ambry Genetics Comprehensive, Assessment, Risk, and Education (CARE) Program, a risk-stratification tool to assess eligibility for National Comprehensive Cancer Network (NCCN) genetic testing criteria and lifetime risk for breast cancer based on the Tyrer-Cuzick (version 8.0) risk algorithm. Methods: Between November 2022 and February 2023, new patients in a gynecologic oncology clinic were prompted by text message to complete CARE prior to their appointment. Those using CARE then completed a System Usability Scale (SUS), a validated 10-item questionnaire for the assessment of perceived usability. Results: Sixty patients presented for a new patient gynecologic oncology appointment and were prompted to complete CARE. The median patient age was 55 years (interquartile range, 40-68). The patients self-identified as Non-Hispanic White (44, 73%), Non-Hispanic Black (5, 8%), Asian (5, 8%), Hispanic (3, 5%), other (2, 3%), and unknown (1, 2%). All identified as female. Forty-three patients (72%) completed CARE. Among CARE users, 11 (26%) were identified as meeting criteria for genetic testing; of these, 9 (82%) proceeded with point-of-care same day genetic testing. Nine (21%) patients were eligible for enhanced breast cancer screening based on an estimated lifetime breast cancer risk of 20% or greater; of these, 100% were referred for high-risk breast screening. There were no patient demographics associated with completion of CARE. Forty-one patients (72%) completed the SUS survey; the median SUS score was 80 (interquartile range, 60-92.5), which corresponded to 85-89th percentile and a letter grade of A-. Conclusions: Implementation of a digital tool for cancer genetic risk assessment identified a quarter of patients to be eligible for genetic testing, among whom 82% completed same-day genetic testing. Additionally, the tool was reviewed favorably by patient users. Large randomized controlled trials of health information technology tools are needed to move closer to the goal of population-based hereditary cancer risk assessment.

Profiles and persistence of initial antiretroviral therapy among HIV infected patients in taiwan: A nationwide population-based cross-sectional study from 2011 to 2017.

Antiretroviral therapy (ART) has been applied for treating patients with human immunodeficiency virus (HIV) for decades. Our study explored initial ART use patterns and ART persistence in patients who begin HIV treatment in Taiwan. The National Health Insurance Research Database in Taiwan was used in our study. The study cohort included patients who are incident ART users from 2011 to 2017. The patterns of ART-based regimens initiated were documented, mainly including non-nucleoside reverse transcriptase inhibitor (NNRTI)-based, protease inhibitor (PI)-based and integrase inhibitor (INI)-based regimens. Time from HIV diagnosis to ART initiation, ART persistence, and ART treatment patterns were documented. There were 19,726 incident ART users. While NNRTI-based regimen was the first choice of initial ART from 2011 to 2017, INI-based regimen accounted for 52.9% of total ART initiation and was the most commonly prescribed regimen in 2017. PI-based regimen decreased from 17.0% to 0.7% during the study period. We found that changes of initial ART between 2011 and 2017 were common, consist with the changes of National Imbursement Guideline for HIV therapy in Taiwan. We found a trend of rapidly increasing INI-based regimen and decreasing PI-based regimen during the study period. Shorten time window for initiating ART was found according to reimbursement regulation of STR as the first-line therapy and government policy of same-day HIV testing and treatment initiation. The persistence of ART was influenced by treatment guideline during the study period.

Utility of Patient-Reported Risk Factors for Identifying Advanced Chronic Kidney Disease Before Outpatient CT: Comparison With Recent ACR/NKF Consensus Criteria.

BACKGROUND. Practices vary for screening patients for risk of renal dysfunction before administration of iodinated contrast medium. A 2020 American College of Radiology/National Kidney Foundation (ACR/NKF) consensus statement provided streamlined screening criteria. OBJECTIVE. The purpose of this study was to assess the yield of patient-reported risk factors for identifying estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 before outpatient CT. METHODS. This retrospective study was performed at a health system that implemented an electronic screening form for patients to complete before outpatient CT encounters to report undergoing dialysis, taking cancer-treating medications, having kidney disease, undergoing prior kidney surgery, having diabetes mellitus treated with medication, having hypertension treated with medication, or having multiple myeloma. Patients with any risk factor were required to undergo eGFR testing before CT. Of 44,708 patients completing the form from June 1, 2020, through February 28, 2021, 10,256 patients (5315 men, 4941 women; mean age, 66.8 ± 11.9 [SD] years; range, 21-98 years) underwent eGFR testing on the day of CT. Multivariable regression analysis for predicting reduced eGFR was performed. Findings were compared with those from theoretic use of the ACR/NKF criteria. RESULTS. Same-day testing yielded eGFR less than 30 mL/min/1.73 m2 in 1.4% (144/10,256) of patients. The only significant independent predictors of low eGFR were dialysis (odds ratio [OR], 203.30], kidney disease (OR, 12.55), and diabetes mellitus treated with medication (OR, 2.44). If the ACR/NKF criteria (only kidney disease, defined as dialysis, kidney disease, or prior kidney surgery) had been followed as a trigger for eGFR testing, the number of patients needing testing would have decreased 89.7%, from 10,256 to 1059; yield would have increased to 7.2% (76/1059); and 47.2% (68/144) of patients with low eGFR would have been missed. If the ACR/NKF criteria had been followed but diabetes mellitus been considered a required rather than an optional criterion, the number of patients needing testing would have decreased 77.1%, to 2353; yield would have increased to 4.0% (95/2353); and 34.0% (49/144) of patients with low eGFR would have been missed. CONCLUSION. Using patient-reported risk factors resulted in frequent eGFR testing but low yield of low eGFR. Commonly applied risk factors were not independently associated with low eGFR. CLINICAL IMPACT. Application of ACR/NKF criteria would substantially reduce eGFR testing, but patients with renal dysfunction would be missed. The statement should consider omitting kidney surgery as a trigger for eGFR testing and including diabetes mellitus as a required trigger.

110 Methylmalonic acid testing in neurological patients

Vitamin B12 deficiency can lead to neurological abnormalities including paraesthesia, ataxia and subacute combined degeneration of the cord (SACD). Nitrous oxide abuse leads to SACD via func- tional B12 deficiency. Methylmalonic acid (MMA) testing is increasingly available, but it remains unclear where MMA levels are clinically useful.We performed a quality improvement project examining Vitamin B12 and MMA levels in a cohort of neu- rological patients. All patients known to neurology who underwent same-day testing of B12 and MMA levels (2016–2019) were included.60 individual patient records were evaluated. 17 individuals (28%) had high MMA, of whom 6 individuals had SACD and 11 had peripheral neuropathy. These patients had B12 levels between 91–371ng/L (lower limit of normal (LLN) is 197ng/L). Of these, only one had severe B12 deficiency, 4 had moderate deficiency (150–197ng/L) and 12 (71%) had normal B12. The highest B12 level associated with raised MMA was 372ng/L. All individuals with B12 &gt;372ng/L and neurological symptoms had normal MMA.In individuals with serum vitamin B12 above the lower 1/3 of the reference range and neurological symptoms/signs, MMA does not add to the clinical picture. Furthermore, MMA testing does not change management in patients with B12 levels below the LLN, all of whom should be treated for B12 deficiency. We suggest testing MMA in those with Vitamin B12 levels in the lower 1/3 of the reference range.katieyoganathan@gmail.com

Rapid Treatment Initiation for Hepatitis C in Young People Who Inject Drugs: The Seek, Test, and Rapid Treatment Randomized Trial.

BackgroundYoung people who inject drugs (PWID) have high hepatitis C virus (HCV) incidence and low treatment initiation rates. Novel, simplified care models need to be developed to engage, treat, and cure hard-to-reach patient populations, such as young PWID. We present final data from the randomized pilot clinical trial “HCV-Seek Test and Rapid Treatment” for curing HCV in young PWID.MethodsParticipants were recruited from the community and eligible if they were 18–29 years of age, HCV antibody-positive, treatment naive, and had injected drugs in the past 30 days. Participants were randomized 1:1 to “Rapid Treatment or Usual Care”. Participants randomized to Rapid Treatment received same-day medical evaluation, confirmatory and baseline laboratory testing, and a 7-day starter pack of sofosbuvir/velpatasvir at a syringe service program (SSP). Participants in “Usual Care” received same-day HCV confirmatory testing at the SSP and, if positive, facilitated referral to local providers. The primary endpoint was sustained virologic response at 12 weeks (SVR12) in HCV ribonucleic acid (RNA)+ participant.ResultsForty-seven HCV antibody-positive participants were enrolled, and 25 participants had confirmed HCV and were included in the modified intention to treat analysis, with 9 of 14 (64%) of the Rapid Treatment arm and 1 of 11 (9.1%) of the Usual Care arm achieving a confirmed SVR12 (P = .01).ConclusionsAmong young HCV RNA+ PWID, significantly higher rates of cure were achieved using the Rapid Treatment model compared with facilitated referral. Providing easy access to HCV treatment for young PWID in low-threshold settings and initiating HCV treatment quickly appears to be a promising strategy for treating this hard-to-reach population.

Facilitators and barriers to status disclosure and partner testing of women living with HIV in Indonesia: a mixed methods study

This mixed-methods study investigated HIV status disclosure and partner testing of women living with HIV (WLWH) in a concentrated epidemic setting in Bandung, Indonesia. The qualitative exploratory strand used theoretical sampling to carry out semi-structured interviews with 47 HIV-infected women with varying anti-retroviral therapy status. The quantitative strand included 122 female patients receiving HIV care at a referral clinic. HIV diagnosis made women reassess their sexual partnerships. Some lost their partner due to death or divorce. Women with a longstanding HIV infection often formed new partnerships. They disclosed their status to new partners without assistance from health providers; the type and stability of the partnership influenced decision to disclose. Fear of rejection prevented initial disclosure prior to bringing the new partners to a health provider. Disclosure did not always result in partner testing because of low risk-awareness or denial of the partner. Despite a similar proportion of status disclosure to partner (92.8%), only 53.7% of new partners of WLWH were tested in contrast to 89.7% of partners tested among WLWH who stayed with the same partner. In antenatal care, where same-day testing was often done for pregnant couples, more partners were tested. Overall, consistent condom use was low and HIV status forced WLWH who continued sex work to work at settings where condom use was not enforced. WLWH face barriers to HIV status disclosure and partner testing and would benefit from partnership counselling. Guidelines for partner notification and testing should include specific strategies for women with longstanding HIV infection.

Voluntary Cough Effectiveness and Airway Clearance in Neurodegenerative Disease

Voluntary cough dysfunction is highly prevalent across multiple patient populations. Voluntary cough has been utilized as a screening tool for swallowing safety deficits and as a target for compensatory and exercise-based dysphagia management. However, it remains unclear whether voluntary cough dysfunction is associated with the ability to effectively clear the airway. Individuals with neurodegenerative disorders performed same-day voluntary cough testing and flexible endoscopic evaluations of swallowing (FEES). Participants who were cued to cough after exhibiting penetration to the vocal folds and/or aspiration with thin liquids during FEES met inclusion criteria. One-hundred and twenty-three trials were blinded, and the amount of residue before and after a cued cough on FEES was measured with a visual analog scale. Linear and binomial mixed-effects models examined the relationship between cough airflow during voluntary cough testing and the proportion of residue expelled. Peak expiratory flow rate (p = .004) and cough expired volume from the entire epoch (p = .029) were significantly associated with the proportion of aspiration expelled from the subglottis. Peak expiratory flow rate values of 3.00 L/s, 3.50 L/s, and 5.30 L/s provided high predicted probabilities that ≥ 25%, ≥ 50%, and ≥ 80% aspirate was expelled. Accounting for depth of aspiration significantly improved model fit (p < .001). These findings suggest that voluntary cough airflow is associated with cough effectiveness to clear aspiration from the subglottis, although aspiration amount and depth may play an important role in this relationship. These findings provide further support for the clinical utility of voluntary cough in the management of dysphagia.

911. Rapid Hepatitis C Treatment Initiation in Young People Who Inject Drugs: Final Results from the HCV-Seek, Test and Rapid Treatment (HCV-ST&amp;RT) Randomized Pilot Clinical Trial

BackgroundYoung people who inject drugs (PWID) have higher HCV incidence and lower treatment initiation rates compared to their older peers. Novel, simplified care models need to be developed to engage, treat and cure hard to reach patient populations, such as young PWID.MethodsWe present final data from the randomized pilot clinical trial HCV-Seek Test & Rapid Treatment (HCV-ST&RT) for curing HCV in young PWID. Eligible participants were 18-29 years of age, HCV Ab+, treatment naïve, and had injected drugs in the past 30 days. Participants were randomized 1:1 to the Rapid Treatment or Usual Care arm. Participants randomized to Rapid Treatment received a same-day medical evaluation, confirmatory and baseline lab testing, and 7-day starter pack of sofosbuvir/velpatasvir. Participants in Usual Care received same-day HCV confirmatory testing and, if positive, facilitated referral to local providers. The primary endpoint was sustained virologic response (SVR12) in RNA+ participant within 12 months of enrollment. ResultsAmong 47 eligible participants, 38 were enrolled and randomized. 14/18 in the Rapid Treatment arm and 11/20 in the Usual Care arm were confirmed HCV RNA+ and included in the intention-to-treat analysis. Demographics of the RNA+ participants were similar in the two arms with a mean age of 26 years; 24% women; 36% Hispanic and 4% non-Hispanic black. At baseline 24% were homeless, 52% received medication for opioid use disorder in the prior 90 days, and participants injected a median of 20 of the last 30 days. In the intention-to-treat analysis, 9/14 (64%) of the Rapid Treatment arm and 2/11 (18%) of the Usual Care arm had confirmed SVR12 (p=0.042). Of the 5 participants in the Rapid Treatment arm who did not achieve SVR12, 1 had treatment failure, 1 never started DAA therapy, 1 had an on-treatment response with pending SVR12 confirmation, and 2 were lost to follow-up. ConclusionAmong young HCV RNA+ PWID, significantly higher rates of cure were achieved using the Rapid Treatment model with same day, low-threshold, simplified HCV care compared to facilitated referral. Meeting young PWID where they’re at and initiating HCV treatment ‘in the moment’ without the need for repeat visits appears to be a promising strategy for treating this hard to reach population.Disclosures Benjamin Eckhardt, MD, MS, Gilead Sciences (Grant/Research Support) Shashi Kapadia, MD, Gilead Sciences Inc (Grant/Research Support) Kristen Marks, MD, Gilead Sciences (Grant/Research Support)

MP60-09 GERMLINE TESTING FOR PROSTATE CANCER: WHICH REFERRAL METHOD IS BEST?

You have accessJournal of UrologyProstate Cancer: Markers (MP60)1 Sep 2021MP60-09 GERMLINE TESTING FOR PROSTATE CANCER: WHICH REFERRAL METHOD IS BEST? David Ahlborn, Ilene Staff, Tara McLaughlin, and Joseph Wagner David AhlbornDavid Ahlborn More articles by this author , Ilene StaffIlene Staff More articles by this author , Tara McLaughlinTara McLaughlin More articles by this author , and Joseph WagnerJoseph Wagner More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002095.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Emerging evidence supports the importance of germline genetic counseling and testing as a key component of prostate cancer (PCa) management. However, there is little guidance for urologists on how to implement practice guidelines. We explored the relationships between referral method, reason for testing, completion of testing, and time to testing in PCa patients and aimed to identify the most effective referral method. METHODS: With IRB approval, we queried the electronic medical record (EMR) for patients who were counseled and offered germline testing per NCCN guidelines from 1/29/19 – 2/3/21. Patients qualified for testing due to pathologic high risk (HR), family history (FH), or both. As referral methods evolved over time, we compared three cohorts of patients referred for testing through one of three methods. Patients were offered either 1) telephone number for a genetic counselor (TN); 2) EMR referral to a genetic counselor who calls the patient (ER); 3) same-day in-office testing (IO). The proportions of patients in each cohort who received testing were compared using chi square. Time to testing for each cohort was compared using Kaplan Meier. Multivariate logistic regression and Cox regression evaluated the independent influence of referral method and reason for referral on these outcomes. All analyses used SPSSv26. RESULTS: 177 patients were offered germline testing (47 TN, 70 ER, and 60 IO.) The cohorts did not differ in age, race, PSA, or clinical stage. The percentage of patients referred for both HR and FH was lower in the TN group compared to the ER and IO groups (6% vs 21% vs 27%, respectively, p<.025). Time to testing (Fig. 1) and receipt of testing was significantly associated with the referral method. Testing was obtained in 8 (17%) of TN, 39 (56%) of ER referrals and 39 (65%) of IO (p<0.001). 47/96 (49%) of men with family history, 16/47 (34%) of those with high risk and 23/34 (68%) of those with both risk factors obtained testing (p=0.012). Multivariate analyses indicated that referral method was independently associated with receipt of test and time to test (p < .001) while reason for testing was not significant. CONCLUSIONS: In-office germline testing is the most effective and expedient method to obtain germline testing results. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1044-e1045 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information David Ahlborn More articles by this author Ilene Staff More articles by this author Tara McLaughlin More articles by this author Joseph Wagner More articles by this author Expand All Advertisement Loading ...

To Test or Not to Test: COVID-19 Prevention Strategies to Keep Large Gatherings Safe

To Test or Not to Test: COVID-19 Prevention Strategies to Keep Large Gatherings Safe