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2.
Open Forum Infect Dis ; 8(8): ofab385, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34405093

RESUMO

We characterized the antibody composition of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) and the immunologic responses of hospitalized COVID-19 patients after receiving CCP or nonimmune fresh frozen plasma. Despite selection of CCP with significantly higher total immunoglobulin G than recipients, neutralizing antibody levels did not differ between donor plasma and CCP recipients.

3.
Open Forum Infect Dis ; 8(7): ofab200, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34285929

RESUMO

From directly observed therapy studies, urine tenofovir (TFV) levels were 74% lower when taking tenofovir alafenamide (TAF) vs tenofovir disoproxil fumarate. Urine TFV remains quantifiable across a range of TAF adherence patterns, but a separate point-of-care lateral flow immunoassay with a lower TFV threshold will be needed to support TAF adherence monitoring.

4.
JAMA Netw Open ; 4(7): e2116113, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-34236410

RESUMO

Importance: Policies to promote social distancing can minimize COVID-19 transmission but come with substantial social and economic costs. Quantifying relative preferences among the public for such practices can inform locally relevant policy prioritization and optimize uptake. Objective: To evaluate relative utilities (ie, preferences) for COVID-19 pandemic social distancing strategies against the hypothetical risk of acquiring COVID-19 and anticipated income loss. Design, Setting, and Participants: This survey study recruited individuals living in the Missouri area from May to June 2020 via randomly distributed unincentivized social media advertisements and local recruitment platforms for members of minority racial and ethnic groups. Participants answered 6 questions that asked them to choose between 2 hypothetical counties where business closures, social distancing policy duration, COVID-19 infection risk, and income loss varied. Main Outcomes and Measures: Reweighted population-level relative preferences (utilities) for social distancing policies, subgroups, and latent classes. Results: The survey had a 3% response rate (3045 of 90 320). Of the 2428 respondents who completed the survey, 1669 (75%) were 35 years and older, 1536 (69%) were women, and 1973 (89%) were White. After reweighting to match Missouri population demographic characteristics, the strongest preference was for the prohibition of large gatherings (mean preference, -1.43; 95% CI, -1.67 to -1.18), with relative indifference to the closure of social and lifestyle venues (mean preference, 0.05; 95% CI, -0.08 to 0.17). There were weak preferences to keep outdoor venues (mean preference, 0.50; 95% CI, 0.39 to 0.61) and schools (mean preference, 0.18; 95% CI, 0.05 to 0.30) open. Latent class analysis revealed 4 distinct preference phenotypes in the population: risk averse (48.9%), conflicted (22.5%), prosocial (14.9%), and back to normal (13.7%), with men twice as likely as women to belong to the back to normal group than the risk averse group (relative risk ratio, 2.19; 95% CI, 1.54 to 3.12). Conclusions And relevance: In this survey study using a discrete choice experiment, public health policies that prohibited large gatherings, as well as those that closed social and lifestyle venues, appeared to be acceptable to the public. During policy implementation, these activities should be prioritized for first-phase closures. These findings suggest that policy messages that address preference heterogeneity (eg, focusing on specific preference subgroups or targeting men) could improve adherence to social distancing measures for COVID-19 and future pandemics.


Assuntos
COVID-19/prevenção & controle , Comportamentos Relacionados com a Saúde , Distanciamento Físico , Adolescente , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Missouri/epidemiologia , Opinião Pública , Inquéritos e Questionários , Adulto Jovem
5.
Ann Intern Med ; 174(8): 1151-1158, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34125574

RESUMO

The development of the National Institutes of Health (NIH) COVID-19 Treatment Guidelines began in March 2020 in response to a request from the White House Coronavirus Task Force. Within 4 days of the request, the NIH COVID-19 Treatment Guidelines Panel was established and the first meeting took place (virtually-as did subsequent meetings). The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies, and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available. The initial version of the guidelines was completed within 2 weeks and posted online on 21 April 2020. Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches. Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year. This process has provided important lessons for responding to an unprecedented public health emergency: Providers and stakeholders are eager to access credible, current treatment guidelines; governmental agencies, professional societies, and health care leaders can work together effectively and expeditiously; panelists from various disciplines, including biostatistics, are important for quickly developing well-informed recommendations; well-powered randomized clinical trials continue to provide the most compelling evidence to guide treatment recommendations; treatment recommendations need to be developed in a confidential setting free from external pressures; development of a user-friendly, web-based format for communicating with health care providers requires substantial administrative support; and frequent updates are necessary as clinical evidence rapidly emerges.


Assuntos
COVID-19/terapia , Pandemias , Guias de Prática Clínica como Assunto , Comitês Consultivos , COVID-19/tratamento farmacológico , COVID-19/epidemiologia , Criança , Interpretação Estatística de Dados , Aprovação de Drogas , Medicina Baseada em Evidências , Feminino , Humanos , Relações Interprofissionais , National Institutes of Health (U.S.) , Gravidez , SARS-CoV-2 , Participação dos Interessados , Estados Unidos
6.
J Int AIDS Soc ; 24(5): e25744, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-34021709

RESUMO

INTRODUCTION: Randomized trials of new agents for HIV pre-exposure prophylaxis (PrEP) compare against emtricitabine and tenofovir disoproxil fumarate (F/TDF), without a placebo group. We used the well-characterized adherence-efficacy relationship for F/TDF to back-calculate the (non-PrEP) counterfactual background HIV incidence (bHIV) in a randomized trial of a novel PrEP agent and estimate comparative efficacy (to counterfactual bHIV). METHODS: The DISCOVER trial (ClinicalTrials.gov: NCT02842086) randomized 5387 men who have sex with men (MSM) and transgender women who have sex with men and demonstrated non-inferiority of emtricitabine and tenofovir alafenamide (F/TAF) to F/TDF (HIV incidence rate ratio [IRR] 0·47, 95% CI: 0·19 to 1.15). Tenofovir diphosphate (TFV-DP) levels in dried blood spots (DBS) were assessed for all diagnosed with HIV and in a random 10% of the cohort. We used a Bayesian model with a diffuse prior distribution, derived from established data relating tenofovir diphosphate levels to HIV prevention efficacy. This prior, combined with the F/TDF seroconversion rate and tenofovir diphosphate levels in DISCOVER, yielded Bayesian inferences on the counterfactual bHIV. RESULTS: There were six versus 11 postbaseline HIV infections (0.14 vs. 0.25/100 person-years [PY]) on F/TAF and F/TDF respectively. Of the 11 on F/TDF, 10 had low, none had medium and one had high tenofovir diphosphate levels; among HIV-negative controls, 5% of the person-time years had low, 9% had medium and 86% had high TFV-DP levels. A non-informative prior distribution for counterfactual bHIV, combined with the prior for TFV-DP level-efficacy relationship, yielded a posterior counterfactual bHIV of 3·4 infections/100 PY (0.80 Bayesian credible interval [CrI] 1·9 to 5·9), which suggests a median HIV efficacy of 96% (0.95 CrI [88% to 99%]) for F/TAF and 93% (0.95 CrI [87% to 96%]) for F/TDF compared to bHIV. CONCLUSIONS: Based on the established connection of drug concentrations to PrEP prevention efficacy, a Bayesian framework can be used to estimate a synthetic non-PrEP control group in randomized, active-controlled PrEP trials that include a F/TDF-comparator group.


Assuntos
Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Minorias Sexuais e de Gênero , Fármacos Anti-HIV/uso terapêutico , Teorema de Bayes , Emtricitabina/uso terapêutico , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Homossexualidade Masculina , Humanos , Masculino , Tenofovir/uso terapêutico
7.
Lancet HIV ; 8(6): e334-e341, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33933189

RESUMO

BACKGROUND: Most cohorts show similar or lower COVID-19 incidence among people living with HIV compared with the general population. However, incidence might be affected by lower testing rates among vulnerable populations. We aimed to compare SARS-CoV-2 IgG seroprevalence, disease severity, and neutralising antibody activity after infection among people with and without HIV receiving care in a county hospital system over a 3-month period. METHODS: In this matched case-control observational study, remnant serum samples were collected between Aug 1 and Oct 31, 2020, from all people living with HIV who underwent routine outpatient laboratory testing in a municipal health-care system (San Francisco General Hospital, CA, USA). Samples from people living with HIV were date of collection-matched (same day) and age-matched (±5 years) to samples from randomly selected adults (aged 18 years or older) without HIV receiving care for chronic conditions at the same hospital. We compared seroprevalence by HIV status via mixed-effects logistic regression models, accounting for the matched structure of the data (random effects for the matched group), adjusting for age, sex, race or ethnicity, and clinical factors (ie, history of cardiovascular or pulmonary disease, and type 2 diabetes). Severe COVID-19 was assessed in participants with past SARS-CoV-2 (IgG or PCR) infection by chart review and compared with multivariable mixed-effects logistic regression, adjusting for age and sex. SARS-CoV-2 IgG, neutralising antibody titres, and antibody avidity were measured in serum of participants with previous positive PCR tests and compared with multivariable mixed-effects models, adjusting for age, sex, and time since PCR-confirmed SARS-CoV-2 infection. FINDINGS: 1138 samples from 955 people living with HIV and 1118 samples from 1062 people without HIV were tested. SARS-CoV-2 IgG seroprevalence was 3·7% (95% CI 2·4 to 5·0) among people with HIV compared with 7·4% (5·7 to 9·2) among people without HIV (adjusted odds ratio 0·50, 95% CI 0·30 to 0·83). Among 31 people with HIV and 70 people without HIV who had evidence of past infection, the odds of severe COVID-19 were 5·52 (95% CI 1·01 to 64·48) times higher among people living with HIV. Adjusting for time since PCR-confirmed infection, SARS-CoV-2 IgG concentrations were lower (percentage change -53%, 95% CI -4 to -76), pseudovirus neutralising antibody titres were lower (-67%, -25 to -86), and avidity was similar (7%, -73 to 87) among people living with HIV compared with those without HIV. INTERPRETATION: Although fewer infections were detected by SARS-CoV-2 IgG testing among people living with HIV than among those without HIV, people with HIV had more cases of severe COVID-19. Among people living with HIV with past SARS-CoV-2 infection, lower IgG concentrations and pseudovirus neutralising antibody titres might reflect a diminished serological response to infection, and the similar avidity could be driven by similar time since infection. FUNDING: US National Institute of Allergy and Infectious Diseases, US National Institutes of Health.


Assuntos
Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , COVID-19/imunologia , Infecções por HIV/imunologia , Imunoglobulina G/sangue , SARS-CoV-2/imunologia , Idoso , COVID-19/sangue , COVID-19/epidemiologia , COVID-19/virologia , Estudos de Casos e Controles , Feminino , Infecções por HIV/sangue , Infecções por HIV/epidemiologia , Infecções por HIV/virologia , HIV-1/imunologia , HIV-1/patogenicidade , Humanos , Masculino , Pessoa de Meia-Idade , Testes de Neutralização , SARS-CoV-2/patogenicidade , São Francisco/epidemiologia , Estudos Soroepidemiológicos , Índice de Gravidade de Doença
8.
J Acquir Immune Defic Syndr ; 88(1): 57-60, 2021 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-33990489

RESUMO

BACKGROUND: Tenofovir alafenamide (TAF) is increasingly used in HIV treatment, with or without agents that require pharmacologic boosters such as ritonavir/cobicistat. Boosters increase TAF levels, so the TAF dose is lowered in single-pill combinations. We hypothesized that individuals on dose-adjusted boosted TAF would have similar urine tenofovir (TFV) concentrations to those on unboosted TAF. SETTING/METHODS: We collected urine samples from patients with HIV on TAF, with evidence of virologic suppression and high self-reported adherence at 2 San Francisco clinics from June 2019 to January 2020. We measured urine TFV levels by liquid chromatography/tandem mass spectrometry and used linear regression to compare natural log-transformed urine TFV levels for patients on boosted versus unboosted TAF. RESULTS: Our analysis included 30 patients on unboosted TAF (25 mg daily TAF) and 15 on boosted TAF (12 on 10 mg daily TAF and 3 on 25 mg daily TAF). Patients on unboosted vs. boosted TAF had similar baseline age, weight, sex, and creatinine. In unadjusted univariate linear regression, there were no significant differences in urine TFV levels based on presence/absence of boosting after TAF dose reduction to 10 mg (geometric mean ratio 1.07; 95% confidence interval: 0.53 to 2.16). This finding was unchanged in adjusted analysis. CONCLUSIONS: No significant differences in urine TFV levels were seen for patients on unboosted vs. boosted dose-reduced TAF. These results have important implications for our forthcoming point-of-care urine immunoassay for TAF, implying that separate adherence cutoffs will not be necessary for patients on boosters and dose-reduced TAF. A single POC TAF immunoassay will, thus, support monitoring on most TAF-based antiretroviral therapy.

9.
Curr HIV/AIDS Rep ; 18(4): 299-308, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33948789

RESUMO

PURPOSE OF REVIEW: Retention in care is both dynamic and longitudinal in nature, but current approaches to retention often reduce these complex histories into cross-sectional metrics that obscure the nuanced experiences of patients receiving HIV care. In this review, we discuss contemporary approaches to assessing retention in care that captures its dynamic nature and the methodological and data considerations to do so. RECENT FINDINGS: Enhancing retention measurements either through patient tracing or "big data" approaches (including probabilistic matching) to link databases from different sources can be used to assess longitudinal retention from the perspective of the patient when they transition in and out of care and access care at different facilities. Novel longitudinal analytic approaches such as multi-state and group-based trajectory analyses are designed specifically for assessing metrics that can change over time such as retention in care. Multi-state analyses capture the transitions individuals make in between different retention states over time and provide a comprehensive depiction of longitudinal population-level outcomes. Group-based trajectory analyses can identify patient subgroups that follow distinctive retention trajectories over time and highlight the heterogeneity of retention patterns across the population. Emerging approaches to longitudinally measure retention in care provide nuanced assessments that reveal unique insights into different care gaps at different time points over an individuals' treatment. These methods help meet the needs of the current scientific agenda for retention and reveal important opportunities for developing more tailored interventions that target the varied care challenges patients may face over the course of lifelong treatment.


Assuntos
Infecções por HIV , Retenção nos Cuidados , Estudos Transversais , Infecções por HIV/tratamento farmacológico , Humanos
10.
J Dev Behav Pediatr ; 2021 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-34034294

RESUMO

OBJECTIVE: Having primary care delivered through a medical home is believed to improve mental health care delivery to children. Children with attention-deficit/hyperactivity disorder (ADHD) are commonly treated in pediatric practices, yet little is known about ADHD treatment patterns in medical homes. Our objective was to assess for treatment variation depending on parent-perceived medical home (PPMH) status. We hypothesized that having a PPMH would be associated with receiving ADHD treatments recommended by clinical guidelines. METHODS: We used the 2016 National Survey of Children's Health-a nationally representative cross-sectional survey of children in the United States. Analyses included an unweighted sample of 4,252, representing 5.4 million children aged 3 to 17 years with parent-reported ADHD. Child characteristics were analyzed using descriptive statistics. Associations between ADHD treatment types and PPMH status were assessed using a multinomial logistic regression, adjusting for child characteristics. RESULTS: Having a PPMH was associated with increased prevalence odds of children's receipt of medications alone for ADHD (vs no treatment). The prevalence odds of receiving behavioral treatment alone (vs medications alone) for ADHD decreased by 43% when children had a PPMH (95% confidence interval, 0.38-0.85, p = 0.01). PPMH status was not associated with a statistically significant difference in prevalence odds of receiving combination treatment (vs medications alone) for pediatric ADHD. CONCLUSION: Having a PPMH was associated with children's receipt of ADHD medications alone, but not behavioral treatments. Our findings suggest that medical homes may need further improvement to ensure that children with ADHD receive treatments as recommended by clinical guidelines.

12.
JAMA Netw Open ; 4(3): e213256, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33769506

RESUMO

Importance: Black and Latinx transgender youth experience stigma that may increase their susceptibility to mental health symptoms. Objective: To compare past-year mental health symptoms and psychosocial factors among Black and Latinx transgender youth, White transgender youth, and Black and Latinx cisgender youth. Design, Setting, and Participants: This survey study used data from the 2015-2017 Biennial California Healthy Kids Survey with a weighted sample (N = 45 269) representative of California's secondary school population. The analytic sample (n = 19 780) included Black and Latinx transgender youth, White transgender youth, and Black and Latinx cisgender youth in the 9th and 11th grades. Data analysis was conducted from July 2020 to February 2021. Main Outcomes and Measures: Outcomes include past-year depressive symptoms and suicidality. Psychosocial risk factors include school-based victimization, gender-based harassment, sexuality-based harassment, and race-based harassment; protective factors include school connectedness and caring adult relationships. Results: The analytic sample of 19 780 participants (in 9th grade: weighted percentage, 51% [95% CI, 50% to 52%]; female participants: weighted percentage, 50% [95% CI, 49% to 51%]) included 252 Black and Latinx transgender youth (weighted percentage, 1.3% [95% CI, 1.1% to 1.5%]), 104 White transgender youth (weighted percentage, 0.7% [95% CI, 0.6% to 0.8%]), and 19 424 Black and Latinx cisgender youth (weighted percentage, 98.0% [95% CI, 97.8% to 98.2%]). For Black and Latinx transgender youth, estimated prevalence of depressive symptoms and suicidality were 50% (95% CI, 44% to 57%) and 46% (95% CI, 39% to 52%), respectively. Logistic regression models adjusted for grade, living arrangement, and reported sex indicated that compared with White transgender youth, Black and Latinx transgender youth had similar odds of depressive symptoms (adjusted odds ratio, 0.6; 95% CI, 0.4 to 1.1) and suicidality (adjusted odds ratio, 1.1; 95% CI, 0.6 to 1.8) and similar odds of all forms of harassment (eg, race-based harassment: adjusted odds ratio, 1.5; 95% CI, 0.8 to 2.6). Regression models indicated that compared with White transgender youth, Black and Latinx transgender youth had similar levels of victimization (adjusted linear regression coefficient, 0.5; 95% CI, -0.3 to 1.3) and caring adult relationships (adjusted linear regression coefficient, -0.6; 95% CI, -1.4 to 0.09) but lower levels of school connectedness (adjusted linear regression coefficient, -1.6; 95% CI, -2.9 to -0.4). With similar analyses, compared with Black and Latinx cisgender youth, Black and Latinx transgender youth had higher odds of depressive symptoms (adjusted odds ratio, 2.7; 95% CI, 2.0 to 3.7) and suicidality (adjusted odds ratio, 5.9; 95% CI, 4.3 to 8.0), higher odds and levels of all forms of harassment and victimization (eg, race-based harassment: adjusted odds ratio, 3.2; 95% CI, 2.4 to 4.5), and lower levels of school connectedness (adjusted linear regression coefficient, -2.6; 95% CI -3.3 to -1.8) and caring adult relationships (adjusted linear regression coefficient, -0.9; 95% CI -1.3 to -0.5). Conclusions and Relevance: In this study, Black and Latinx transgender youth had high rates of mental health symptoms, with rates comparable with White transgender youth but higher than Black and Latinx cisgender youth. Their unique pattern of psychosocial risk and protective factors for these mental health symptoms should be factored in clinical preventive services and school-based interventions to support them.


Assuntos
Afro-Americanos , Hispano-Americanos , Transtornos Mentais/etnologia , Saúde Mental , Grupo Associado , Pessoas Transgênero/psicologia , Adolescente , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Transtornos Mentais/psicologia , Prevalência , Fatores de Proteção , Estudos Retrospectivos , Fatores de Risco , Estados Unidos/epidemiologia , Adulto Jovem
13.
Lancet Infect Dis ; 21(9): e296-e301, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33631099

RESUMO

Adherence to non-pharmaceutical interventions to prevent the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been highly variable across settings, particularly in the USA. In this Personal View, we review data supporting the importance of the viral inoculum (the dose of viral particles from an infected source over time) in increasing the probability of infection in respiratory, gastrointestinal, and sexually transmitted viral infections in humans. We also review the available evidence linking the relationship of the viral inoculum to disease severity. Non-pharmaceutical interventions might reduce the susceptibility to SARS-CoV-2 infection by reducing the viral inoculum when there is exposure to an infectious source. Data from physical sciences research suggest that masks protect the wearer by filtering virus from external sources, and others by reducing expulsion of virus by the wearer. Social distancing, handwashing, and improved ventilation also reduce the exposure amount of viral particles from an infectious source. Maintaining and increasing non-pharmaceutical interventions can help to quell SARS-CoV-2 as we enter the second year of the pandemic. Finally, we argue that even as safe and effective vaccines are being rolled out, non-pharmaceutical interventions will continue to play an essential role in suppressing SARS-CoV-2 transmission until equitable and widespread vaccine administration has been completed.


Assuntos
COVID-19/prevenção & controle , Controle de Doenças Transmissíveis/métodos , SARS-CoV-2 , Viroses/prevenção & controle , COVID-19/transmissão , Desinfecção das Mãos , Humanos , Máscaras/virologia , Distanciamento Físico , Índice de Gravidade de Doença , Ventilação , Viroses/transmissão
14.
Am J Epidemiol ; 190(8): 1671-1680, 2021 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-33615327

RESUMO

Subgroup analyses of randomized controlled trials guide resource allocation and implementation of new interventions by identifying groups of individuals who are likely to benefit most from the intervention. Unfortunately, trial populations are rarely representative of the target populations of public health or clinical interest. Unless the relevant differences between trial and target populations are accounted for, subgroup results from trials might not reflect which groups in the target population will benefit most from the intervention. Transportability provides a rigorous framework for applying results derived in potentially highly selected study populations to external target populations. The method requires that researchers measure and adjust for all variables that 1) modify the effect of interest and 2) differ between the target and trial populations. To date, applications of transportability have focused on the external validity of overall study results and understanding within-trial heterogeneity; however, this approach has not yet been used for subgroup analyses of trials. Through an example from the Iniciativa Profilaxis Pre-Exposición (iPrEx) study (multiple countries, 2007-2010) of preexposure prophylaxis for human immunodeficiency virus, we illustrate how transporting subgroup analyses can produce target-specific subgroup effect estimates and numbers needed to treat. This approach could lead to more tailored and accurate guidance for resource allocation and cost-effectiveness analyses.


Assuntos
Interpretação Estatística de Dados , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Adulto , Análise Custo-Benefício , Infecções por HIV/economia , Infecções por HIV/prevenção & controle , Alocação de Recursos para a Atenção à Saúde , Homossexualidade Masculina , Humanos , Masculino , Profilaxia Pré-Exposição/economia , Profilaxia Pré-Exposição/métodos , Reprodutibilidade dos Testes , Fatores Socioeconômicos
15.
Clin Infect Dis ; 72(3): 486-489, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33527128

RESUMO

New tools are needed to support pre-exposure prophylaxis (PrEP) adherence for human immunodeficiency virus (HIV) prevention, including those that enable real-time feedback. In a large, completed PrEP trial, adequate urine tenofovir levels measured using a novel immunoassay predicted HIV protection and showed good sensitivity and specificity for detectable plasma tenofovir.


Assuntos
Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Fármacos Anti-HIV/uso terapêutico , Emtricitabina/uso terapêutico , HIV , Infecções por HIV/tratamento farmacológico , Infecções por HIV/prevenção & controle , Humanos , Imunoensaio , Adesão à Medicação , Tenofovir/uso terapêutico
16.
Am J Kidney Dis ; 77(1): 12-22, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32800842

RESUMO

RATIONALE & OBJECTIVE: Observational studies have reported a U-shaped association between blood pressure (BP) before a hemodialysis session and death. In contrast, because a linear association between out-of-dialysis-unit BP and death has been reported, home BP may be a better target for treatment. To test the feasibility of this approach, we conducted a pilot trial of treating home versus predialysis BP in hemodialysis patients. STUDY DESIGN: A 4-month, parallel, randomized, controlled trial. SETTINGS & PARTICIPANTS: 50 prevalent hemodialysis patients in San Francisco and Seattle. Participants were randomly assigned using 1:1 block randomization, stratified by site. INTERVENTIONS: To target home systolic BP (SBP) of 100-<140 mm Hg versus predialysis SBP of 100-<140mm Hg. Home and predialysis SBPs were ascertained every 2 weeks. Dry weight and BP medications were adjusted to reach the target SBP. OUTCOMES: Primary outcomes were feasibility, adherence, safety. and tolerability. RESULTS: 50 of 70 (71%) patients who were approached agreed to participate. All enrollees completed the study except for 1 who received a kidney transplant. In the home BP treatment group, adherence to obtaining/reporting home BP was 97.4% (and consistent over the 4 months). There was no increased frequency of high (defined as SBP>200mm Hg; 0.2% vs 0%) or low (defined as<90mm Hg; 1.8% vs 1.2%) predialysis BP readings in the home versus predialysis treatment arms, respectively. However, participants in the home BP arm had higher frequency of fatigue (32% vs 16%). LIMITATIONS: Small sample size. CONCLUSIONS: This pilot trial demonstrates feasibility and high adherence to home BP measurement and treatment in hemodialysis patients. Larger trials to test the long-term feasibility, efficacy, and safety of home BP treatment in hemodialysis patients should be conducted. FUNDERS: National Institutes of Health, Satellite Healthcare, and Northwest Kidney Centers. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT03459807.


Assuntos
Monitorização Ambulatorial da Pressão Arterial/métodos , Falência Renal Crônica , Cooperação do Paciente/estatística & dados numéricos , Diálise Renal , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/fisiologia , Determinação da Pressão Arterial/métodos , Determinação da Pressão Arterial/estatística & dados numéricos , Feminino , Serviços de Assistência Domiciliar , Humanos , Falência Renal Crônica/diagnóstico , Falência Renal Crônica/mortalidade , Falência Renal Crônica/fisiopatologia , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Projetos Piloto , Prognóstico , Diálise Renal/métodos , Diálise Renal/estatística & dados numéricos , Medição de Risco/métodos
17.
Ann Am Thorac Soc ; 18(4): 613-622, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33064950

RESUMO

Rationale: Single-center studies demonstrated that methamphetamine use is associated with pulmonary arterial hypertension (Meth-APAH). We used the Pulmonary Hypertension Association Registry to evaluate the national distribution of Meth-APAH and to compare its impact on patient-reported and clinical outcomes relative to idiopathic PAH.Objectives: To determine if patients with Meth-APAH differ from those with idiopathic PAH in demographics, regional distribution in the United States, hemodynamics, health-related quality of life, PAH-specific treatment, and health care use.Methods: The Pulmonary Hypertension Association Registry is a U.S.-based prospective cohort of patients new to care at a Pulmonary Hypertension Care Center. The registry collects baseline demographics, clinical parameters, and repeated measures of health-related quality of life, World Health Organization functional class, 6-minute walk distance, therapy, and health care use. Repeated measures of functional class, health-related quality of life, type of therapy, emergency department visits, and hospitalizations were compared using generalized estimating equations.Results: Of 541 participants included, 118 had Meth-APAH; 83% of Meth-APAH arose in the western United States. The Meth-APAH group was younger and had a poorer socioeconomic status and lower cardiac index than the idiopathic PAH group, despite no difference in mean pulmonary artery pressure or pulmonary vascular resistance. The Meth-APAH group had a more advanced functional class in longitudinal models (0.22 points greater; 95% confidence interval [CI], 0.07 to 0.37) and worse PAH-specific (emPHasis-10) health-related quality of life (-5.4; 95% CI, -8.1 to -2.8). There was no difference in dual combination therapy; however, participants with Meth-APAH were less likely to be initiated on triple therapy (odds ratio [OR], 0.43; 95% CI, 0.24 to 0.77) or parenteral therapy (OR, 0.10; 95% CI, 0.04 to 0.24). Participants with Meth-APAH were more likely to seek care in the emergency department (incidence rate ratio, 2.30; 95% CI, 1.71 to 3.11) and more likely to be hospitalized (incidence rate ratio, 1.42; 95% CI, 1.10 to 1.83).Conclusions: Meth-APAH represents a unique clinical phenotype of PAH, most common in the western United States. It accounts for a notable proportion of PAH in expert centers. Assessment for methamphetamine use is necessary in patients with PAH.

18.
AIDS ; 35(3): 517-519, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33306555

RESUMO

Coronavirus disease-2019 (COVID-19) threatens to further worsen HIV outcomes among people experiencing homelessness. We conducted an interrupted time-series analysis of care engagement and viral suppression among unhoused individuals in the 'POP-UP' low-barrier, high-intensity HIV primary care program during COVID-19. Among 85 patients, care engagement and viral suppression did not decrease in the 5 months following implementation of San Francisco's 'shelter-in-place' ordinance. Low-barrier, in-person HIV care for homeless individuals may be important for maintaining HIV outcomes during COVID-19.


Assuntos
COVID-19 , Infecções por HIV/terapia , Pessoas em Situação de Rua , Pandemias , Humanos , Análise de Séries Temporais Interrompida , Atenção Primária à Saúde , São Francisco
19.
Clin Infect Dis ; 2020 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-33011803

RESUMO

BACKGROUND: Understanding patient reported reasons for lapses of retention in HIV treatment can drive improvements in the care cascade. A systematic assessment of outcomes among a random sample of patients lost to follow up (LTFU) from 32 clinics in Zambia to understand the reasons for silent transfers and disengagement from care was undertaken. METHODS: We traced a simple random sample of LTFU patients (>90 days from last scheduled visit) as determined from clinic-based electronic medical records from a probability sample of facilities. Among patients found in person, we solicited reasons for either stopping or switching care and predictors for reengagement. We coded reasons into structural, psychosocial and clinic based barriers. RESULTS: Among 1751 LTFU patients traced and found alive, 31% of patients starting ART between July 1 2013 and July 31 2015 silently transferred or were disengaged (40% male, median age 35 years, median CD4 level 239 cells/ul), median time on ART at LTFU was 480 days (IQR: 110-1295). Among the 544 patients not in care, the median prevalence for patient reported structural, psychosocial and clinic-level barriers was 27.3%, 13.9% and 13.4% respectively, and were highly variable across facilities. Structural reasons, including, "relocated to a new place" were mostly cited amongst 289 patients who silently transferred (35.5%). We found that men were less likely to reengage in care than women (OR: 0.39; 95% CI: 0.22-0.67; p-value: 0.001). CONCLUSION: Efforts to improve retention of patients on ART may need to be tailored at the facility level to address patient reported barriers.

20.
Lancet HIV ; 7(11): e791-e796, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33128906

RESUMO

Trials of candidate agents for HIV pre-exposure prophylaxis (PrEP) might randomly assign participants to be given a new PrEP agent or oral coformulated tenofovir disoproxil fumarate plus emtricitabine. This design presents unique challenges in interpretation. First, with two active arms, HIV incidence might be low. Second, the effectiveness of tenofovir disoproxil fumarate plus emtricitabine varies across populations; thus, similar HIV incidence between groups could be consistent with a wide range of effectiveness for the new PrEP. We propose a two-part approach to trial results. First, we use Bayesian methods to incorporate assumptions about the background incidence of HIV in the trial in the absence of PrEP, possibly augmented by external data. On the basis of the estimated background incidence, we estimate and compare the number of averted (or prevented) HIV infections in each of the two trial groups, calculating the averted infections ratio. We apply these methods to a completed trial of tenofovir alafenamide plus emtricitabine for PrEP. Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.


Assuntos
Estudos de Equivalência como Asunto , Infecções por HIV/prevenção & controle , Profilaxia Pré-Exposição/métodos , Adenina/análogos & derivados , Adenina/uso terapêutico , Fármacos Anti-HIV/uso terapêutico , Teorema de Bayes , Emtricitabina/uso terapêutico , Humanos , Avaliação de Resultados em Cuidados de Saúde , Tamanho da Amostra , Tenofovir/uso terapêutico
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