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Andrey S. Borisov - One of the best experts on this subject based on the ideXlab platform.

  • update of recommendations for use of once weekly isoniazid rifapentine regimen to treat latent mycobacterium tuberculosis infection
    Morbidity and Mortality Weekly Report, 2018
    Co-Authors: Andrey S. Borisov, Gibril J. Njie, Sapna Bamrah Morris, Carla A Winston, Deron C Burton, Stefan V Goldberg, Rachel Yelk S Woodruff, Leeanna Allen, Philip A Lobue, Andrew Vernon
    Abstract:

    Treatment of latent tuberculosis infection (LTBI) is critical to the control and elimination of tuberculosis disease (TB) in the United States. In 2011, CDC recommended a short-course combination regimen of once-weekly isoniazid and rifapentine for 12 weeks (3HP) by Directly Observed Therapy (DOT) for treatment of LTBI, with limitations for use in children aged <12 years and persons with human immunodeficiency virus (HIV) infection (1). CDC identified the use of 3HP in those populations, as well as self-administration of the 3HP regimen, as areas to address in updated recommendations. In 2017, a CDC Work Group conducted a systematic review and meta-analyses of the 3HP regimen using methods adapted from the Guide to Community Preventive Services. In total, 19 articles representing 15 unique studies were included in the meta-analysis, which determined that 3HP is as safe and effective as other recommended LTBI regimens and achieves substantially higher treatment completion rates. In July 2017, the Work Group presented the meta-analysis findings to a group of TB experts, and in December 2017, CDC solicited input from the Advisory Council for the Elimination of Tuberculosis (ACET) and members of the public for incorporation into the final recommendations. CDC continues to recommend 3HP for treatment of LTBI in adults and now recommends use of 3HP 1) in persons with LTBI aged 2-17 years; 2) in persons with LTBI who have HIV infection, including acquired immunodeficiency syndrome (AIDS), and are taking antiretroviral medications with acceptable drug-drug interactions with rifapentine; and 3) by DOT or self-administered Therapy (SAT) in persons aged ≥2 years.

  • Isoniazid-Rifapentine for Latent Tuberculosis Infection: A Systematic Review and Meta-analysis.
    American journal of preventive medicine, 2018
    Co-Authors: Gibril J. Njie, Andrew Vernon, Sapna Bamrah Morris, Rachel S. Yelk Woodruff, Ruth N. Moro, Andrey S. Borisov
    Abstract:

    Context Latent tuberculosis infection diagnosis and treatment is a strategic priority for eliminating tuberculosis in the U.S. The Centers for Disease Control and Prevention has recommended the short-course regimen of 3-month isoniazid-rifapentine administered by Directly Observed Therapy. However, longer-duration regimens remain the most widely prescribed latent tuberculosis infection treatments. Limitation on adoption of 3-month isoniazid-rifapentine in the U.S. might be because of patients’ preference for self-administered Therapy, providers’ lack of familiarity with 3-month isoniazid-rifapentine, or lack of resources to support Directly Observed Therapy. This review examines the most recent evidence regarding 3-month isoniazid-rifapentine’s effectiveness, safety, and treatment completion when Directly compared with other latent tuberculosis infection regimens primarily comprising 9-month isoniazid treatment. Evidence acquisition Using Community Guide methodology, reviewers identified, evaluated, and summarized available evidence published during January 2006–June 2017. Analysis of the data was completed in 2017. Evidence synthesis The analysis included 15 unique studies. Three-month isoniazid-rifapentine was determined to be equal to other latent tuberculosis infection regimens in effectiveness (OR=0.89, 95% CI=0.46, 1.70), and has higher treatment completion (87.5%, 95% CI=83.2%, 91.3%) compared with other latent tuberculosis infection regimens (65.9%, 95% CI=53.5%, 77.3%). Three-month isoniazid-rifapentine was associated with similar risk to other latent tuberculosis infection regimens for adverse events (relative risk=0.59, 95% CI=0.23, 1.52); discontinuing treatment because of adverse events (relative risk=0.48, 95% CI=0.17, 1.34); and death (relative risk=0.79, 95% CI=0.56, 1.11). Conclusions The 3-month isoniazid-rifapentine regimen is as safe and effective as other recommended latent tuberculosis infection regimens and achieves significantly higher treatment completion rates.

Timothy P Flanigan - One of the best experts on this subject based on the ideXlab platform.

  • addressing the need for treatment paradigms for drug abusing patients with multiple morbidities
    Clinical Infectious Diseases, 2004
    Co-Authors: Thomas F Kresina, Timothy P Flanigan, Jennifer A Mitty, Jacques Normand, Jag H Khalsa, Henry Francis
    Abstract:

    Persons who use and abuse drugs are at risk for multiple morbidities that involve addiction, bloodborne infectious diseases, and sexually transmitted diseases, in addition to psychiatric illness and social instability. Infectious diseases acquired as a result of drug use can diffuse into non-drug using populations through other high-risk behaviors. Drug users also have substantial comorbidities from noncommunicable diseases and complications that can affect virtually every organ system in the body. Diagnosis of comorbidities and complications associated with drug abuse usually occurs late in the disease course, particularly for persons who are disenfranchised and have limited or no access to medical care. Medical management of these comorbid conditions constitutes a significant challenge. Directly Observed Therapy (DOT) can be useful but needs to conform to the needs of the targeted treatment population for full efficacy. DOT may have its greatest impact with drug users destabilized by cocaine or methamphetamine use but has yet to be fully investigated in this patient population.

  • Directly Observed Therapy for the treatment of people with human immunodeficiency virus infection a work in progress
    Clinical Infectious Diseases, 2002
    Co-Authors: Jennifer A Mitty, Valerie E Stone, Michael Sands, Grace E Macalino, Timothy P Flanigan
    Abstract:

    The principle of Directly Observed Therapy (DOT) has its roots in the treatment of tuberculosis (TB), for which DOT programs have improved cure rates in hard-to-reach populations. Human immunodeficiency virus (HIV) and TB affect similar populations, and there are concerns about both regarding the development of drug resistance associated with poor adherence to Therapy. Accordingly, DOT may benefit certain HIV-infected people who have difficulty adhering to highly active antiretroviral Therapy. However, important differences exist in the treatment of these diseases that raise questions about how DOT can be adapted to HIV Therapy. DOT for management of HIV infection has been effective among prisoners and in pilot programs in Haiti, Rhode Island, and Florida. Although DOT can successfully treat HIV infection in marginalized populations in the short term, a multitude of questions remain. This review provides an account of the preliminary development of DOT programs for the treatment of HIV-infected individuals.

  • enhancing adherence to haart a pilot program of modified Directly Observed Therapy
    Aids Reader, 2001
    Co-Authors: Molly S Stenzel, Jennifer A Mitty, Michelle Mckenzie, Timothy P Flanigan
    Abstract:

    Based on the model of Directly Observed Therapy (DOT) for tuberculosis, we implemented an uncontrolled pilot program of modified DOT to increase adherence to HAART. Participants met every weekday with an outreach worker who Observed them taking the morning dose of HAART. Thirty-seven patients with a history of poor adherence were enrolled and followed for a mean duration of 10 months. The program was feasible and well accepted by the participants. Self-reported adherence to nonObserved doses improved, and those who remained in the program for a year (n = 18) demonstrated a mean 1.53-log decrease from baseline in plasma HIV RNA level.

Judith I Tsui - One of the best experts on this subject based on the ideXlab platform.

  • video Directly Observed Therapy intervention using a mobile health application among opioid use disorder patients receiving office based buprenorphine treatment protocol for a pilot randomized controlled trial
    Addiction Science & Clinical Practice, 2020
    Co-Authors: Zachery A Schramm, Jared W Klein, Andrew J Saxon, Jeffrey H Samet, Brian G Leroux, Andrea C Radick, Alicia S Ventura, Theresa W Kim, Judith I Tsui
    Abstract:

    Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person Directly Observed Therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT delivered via a smartphone app on office-based buprenorphine treatment outcomes, namely illicit opioid use and retention. Participants will be recruited from office-based opioid addiction treatment programs in outpatient clinics at two urban medical centers and randomized to either video DOT (intervention) delivered via a HIPAA-compliant, asynchronous, mobile health (mHealth) technology platform, or treatment-as-usual (control). Eligibility criteria are: 18 years or older, prescribed sublingual buprenorphine for a cumulative total of 28 days or less from the office-based opioid treatment program, and able to read and understand English. Patients will be considered ineligible if they are unable or unwilling to use the intervention, provide consent, or complete weekly study visits. All participants will complete 13 in-person weekly visits and be followed via electronic health record data capture at 12- and 24-weeks post-randomization. Data gathered include the following: demographics; current and previous treatment for OUD; self-reported diversion of prescribed buprenorphine; status of their mental and physical health; and self-reported lifetime and past 30-day illicit substance use. Participants provide urine samples at each weekly visit to test for illicit drugs and buprenorphine. The primary outcome is percentage of weekly urines that are negative for opioids over the 12-weeks. The secondary outcome is engagement in treatment at week 12. Video DOT delivered through mHealth technology platform offers possibility of improving patients’ buprenorphine adherence by providing additional structure and accountability. The TAAB study will provide important preliminary estimates of the impact of this mHealth technology for patients initiating buprenorphine, as well as the feasibility of study procedures, thus paving the way for further research to assess feasibility and generate preliminary data for design of a future Phase III trial. Trial Registration ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.

  • acceptability and feasibility of a mobile health application for video Directly Observed Therapy of buprenorphine for opioid use disorders in an office based setting
    Journal of Addiction Medicine, 2020
    Co-Authors: Margo E Godersky, Jared W Klein, Joseph O Merrill, Kendra L Blalock, Andrew J Saxon, Jeffrey H Samet, Judith I Tsui
    Abstract:

    INTRODUCTION/BACKGROUND Video Directly Observed Therapy (video-DOT) through a mobile health platform may improve buprenorphine adherence and decrease diversion. This pilot study tested the acceptability and feasibility of using this technology among patients receiving buprenorphine in an office-based setting. METHODS Participants were instructed to record videos of themselves taking buprenorphine. Data were collected from weekly in-person visits over a 4-week period; assessments included self-report of medication adherence, substance use, satisfaction with treatment and use of the application, and also urine drug testing. Open-ended questions at the final visit solicited feedback on patients' experiences using the mobile health application. RESULTS The sample consisted of 14 patients; a majority were male (86%) and White (79%). All participants except 1 (93%) were able to use the application successfully to upload videos. Among those who successfully used the application, the percentage of daily videos uploaded per participant ranged from 18% to 96%; on average, daily videos were submitted by participants 72% of the time. Most participants (10/14; 71%) reported being "very satisfied" with the application; of the remaining 4 participants, 2 were "satisfied" and 2 were "neutral." Participants reported liking the accountability and structure of the application provided and its ease of use. Negative feedback included minor discomfort at viewing one's self during recording and the time required. CONCLUSIONS Based on these results, use of a mobile health application for video-DOT of buprenorphine appears feasible and acceptable for patients who are treated in an office-based setting. Further research is needed to test whether use of such an application can improve treatment delivery and health outcomes.

Tawanda Gumbo - One of the best experts on this subject based on the ideXlab platform.

  • a meta analysis of self administered vs Directly Observed Therapy effect on microbiologic failure relapse and acquired drug resistance in tuberculosis patients
    Clinical Infectious Diseases, 2013
    Co-Authors: Jotam G Pasipanodya, Tawanda Gumbo
    Abstract:

    Background. Preclinical studies and Monte Carlo simulations have suggested that there is a relatively limited role of adherence in acquired drug resistance (ADR) and that very high levels of nonadherence are needed for Therapy failure. We evaluated the superiority of Directly Observed Therapy (DOT) for tuberculosis patients vs selfadministered Therapy (SAT) in decreasing ADR, microbiologic failure, and relapse in meta-analyses. Methods. Prospective studies performed between 1965 and 2012 in which adult patients with microbiologically proven pulmonary Mycobacterium tuberculosis were separately assigned to either DOT or SAT as part of shortcourse chemoTherapy were chosen. Endpoints were microbiologic failure, relapse, and ADR in patients on either DOT or SAT. Results. Ten studies, 5 randomized and 5 observational, met selection criteria: 8774 patients were allocated to DOT and 3708 were allocated to SAT. For DOT vs SAT, the pooled risk difference for microbiologic failure was .0 (95% confidence interval [CI], −.01 to .01), for relapse .01 (95% CI, −.03 to .06), and for ADR 0.0 (95% CI, −0.01 to 0.01). The incidence rates for DOT vs SAT were 1.5% (95% CI, 1.3%–1.8%) vs 1.7% (95% CI, 1.2%–2.2%) for microbiologic failure, 3.7% (95% CI, 0.7%–17.6%) vs 2.3% (95% CI, 0.7%–7.2%) for relapse, and 1.5% (95% CI, 0.2%–9.90%) vs 0.9% (95% CI, 0.4%–2.3%) for ADR, respectively. There was no evidence of publication bias. Conclusions. DOT was not significantly better than SAT in preventing microbiologic failure, relapse, or ADR, in evidence-based medicine. Resources should be shifted to identify other causes of poor microbiologic outcomes.

  • multidrug resistant tuberculosis not due to noncompliance but to between patient pharmacokinetic variability
    The Journal of Infectious Diseases, 2011
    Co-Authors: Shashikant Srivastava, Jotam G Pasipanodya, Claudia Meek, Richard D Leff, Tawanda Gumbo
    Abstract:

    Drug-susceptible tuberculosis is currently treated with isoniazid, rifampin, and pyrazinamide as part of a Directly Observed Therapy–short-course strategy (DOTS). However, Therapy success is threatened by the emergence of multidrug-resistant tuberculosis (MDR-tuberculosis), defined as simultaneous resistance to isoniazid and rifampin. It is believed that most MDR-tuberculosis arises due to poor adherence, hence the need for a DOTS. The World Health Organization (WHO) has built DOTS into the global approach for tuberculosis control. However, the level of nonadherence associated with the emergence of MDR-tuberculosis is unknown; thus the program requires that all tuberculosis patients be supervised by healthcare workers while swallowing antibiotics. The WHO Director-General has called DOTS the most important health breakthrough of past decades [1]. Most studies that established the utility of Directly supervised Therapy were retrospective and relied on examining rates of MDR-tuberculosis before and after implementation of DOTS programs [2, 3]. However, DOTS has 5 components, including provision of an adequate and standardized drug supply, which could lead to reduction of MDR-tuberculosis rates independent of adherence. Recently, a meta-analysis questioned the efficacy of direct supervision by a healthcare worker [4]. Moreover, despite >98% adherence, extensive emergence of MDR-tuberculosis still occurs [5]. We were interested in determining whether poor adherence leads to Therapy failure and to MDR-tuberculosis emergence. Because DOTS is now accepted worldwide, it would be neither ethical nor desirable to perform a randomized clinical study to answer these questions. Therefore, we examined the questions in our hollow fiber system (HFS) model of tuberculosis.

Marielouise Newell - One of the best experts on this subject based on the ideXlab platform.

  • interventions to increase antiretroviral adherence in sub saharan africa a systematic review of evaluation studies
    Lancet Infectious Diseases, 2011
    Co-Authors: Jessica E Haberer, Till Barnighausen, Krisda H Chaiyachati, Natsayi Chimbindi, Ashleigh Peoples, Marielouise Newell
    Abstract:

    The success of potent antiretroviral treatment for HIV infection is primarily determined by adherence. We systematically review the evidence of effectiveness of interventions to increase adherence to antiretroviral treatment in sub-Saharan Africa. We identified 27 relevant reports from 26 studies of behavioural, cognitive, biological, structural, and combination interventions done between 2003 and 2010. Despite study diversity and limitations, evidence suggests that treatment supporters, Directly Observed Therapy, mobile-phone text messages, diary cards, and food rations can effectively increase adherence in sub-Saharan Africa. However, some interventions are unlikely to have large or lasting effects, and others are effective only in specific settings. These findings emphasise the need for more research, particularly for randomised controlled trials, to examine the effect of context and specific features of intervention content on effectiveness. Future work should assess intervention targeting and selection of interventions based on behavioural theories relevant to sub-Saharan Africa.