91 research outputs found
Executive Summary: Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis
No full textThe American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Diseases Society of America jointly sponsored the development of this guideline for the treatment of drug-susceptible tuberculosis, which is also endorsed by the European Respiratory Society and the US National Tuberculosis Controllers Association. Representatives from the American Academy of Pediatrics, the Canadian Thoracic Society, the International Union Against Tuberculosis and Lung Disease, and the World Health Organization also participated in the development of the guideline. This guideline provides recommendations on the clinical and public health management of tuberculosis in children and adults in settings in which mycobacterial cultures, molecular and phenotypic drug susceptibility tests, and radiographic studies, among other diagnostic tools, are available on a routine basis. For all recommendations, literature reviews were performed, followed by discussion by an expert committee according to the Grading of Recommendations, Assessment, Development and Evaluation methodology. Given the public health implications of prompt diagnosis and effective management of tuberculosis, empiric multidrug treatment is initiated in almost all situations in which active tuberculosis is suspected. Additional characteristics such as presence of comorbidities, severity of disease, and response to treatment influence management decisions. Specific recommendations on the use of case management strategies (including directly observed therapy), regimen and dosing selection in adults and children (daily vs intermittent), treatment of tuberculosis in the presence of HIV infection (duration of tuberculosis treatment and timing of initiation of antiretroviral therapy), as well as treatment of extrapulmonary disease (central nervous system, pericardial among other sites) are provided. The development of more potent and better-tolerated drug regimens, optimization of drug exposure for the component drugs, optimal management of tuberculosis in special populations, identification of accurate biomarkers of treatment effect, and the assessment of new strategies for implementing regimens in the field remain key priority areas for research. See the full-text online version of the document for detailed discussion of the management of tuberculosis and recommendations for practice
Characteristics of Pregnant Women With Syphilis and Factors Associated With Congenital Syphilis at a Chicago Hospital
No full textBACKGROUND: Congenital syphilis incidence has more than tripled in recent years, in parallel with the resurgence of syphilis among reproductive-aged women. An understanding of risk factors associated with maternal syphilis infection can guide prevention of congenital syphilis through prenatal diagnosis and treatment. We aimed to describe factors associated with maternal syphilis and congenital syphilis at a public medical center in Chicago, Illinois. METHODS: Maternal syphilis diagnoses were identified using a database for local health department reporting. Medical records were reviewed for infant congenital syphilis diagnoses, sociodemographic information, medical history, and other behavioral factors. Maternal characteristics associated with congenital syphilis were assessed using logistic regression. RESULTS: Of 106 maternal syphilis diagnoses between 2014 and 2018, 76 (72%) had a known pregnancy outcome; of these, 8 (11%) delivered an infant with congenital syphilis. Women with psychiatric illness and noninjection substance use each had a >5-fold increased odds of having an infant with congenital syphilis. Cases with congenital syphilis were more likely to have late or scant prenatal care and initiated treatment nearly 3 months later in pregnancy. None were human immunodeficiency virus positive or reported incarceration, intravenous substance use, sex work, or having sex with men who have sex with men. CONCLUSIONS: Maternal psychiatric illness and substance use may have complicated prenatal care and delayed syphilis treatment, describing a population in need of public health intervention. Women experiencing such barriers to care may benefit from closer follow-up after a prenatal syphilis diagnosis to prevent congenital transmission
Repeated assessments of informed consent comprehension among HIV-infected participants of a three-year clinical trial in Botswana.
No full textBackgroundInformed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while even fewer conduct interim assessments once a trial is underway.Methods and findingsWe assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adults in Botswana (2004-2009). Quizzes were offered in both Setswana and English. To enroll in the TB trial, participants were required to have ≥ 16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The participants' highest education levels were: 28% primary, 59% secondary, 9% tertiary and 7% no formal education. Eighty percent of participants passed the enrollment quiz (Quiz1) on their first attempt and the remainder passed on their second attempt. Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt (adjusted odds ratios and 95% confidence intervals, 3.1 (2.4-4.0) and 1.5 (1.2, 1.9), respectively). The trial's purpose or procedures were understood by 90-100% of participants, while 44-77% understood randomization, placebos, or risks. Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial. Pass rates improved with quiz re-administration in subsequent years.ConclusionsAdministration of a comprehension quiz at enrollment and during follow-up was feasible in a large, international collaboration and efficiently determined IC comprehension by trial participants. Strategies to improve understanding of concepts like placebos and randomization are needed. Comprehension assessments throughout a study may reinforce key concepts
Brief Report: Yield of Repeat Tuberculin Skin Testing for People Living With HIV in Brazil
No full textOBJECTIVES: In Brazil, annual tuberculin skin tests (TST) are recommended for people living with HIV (PLWH) with CD4>350, with tuberculosis preventive therapy (TPT) provided upon test conversion. We aimed to determine the yield of repeat TST for PLWH. DESIGN: Secondary analysis of the stepped-wedge, cluster-randomized THRio trial for isoniazid preventive therapy (IPT) to prevent tuberculosis (TB). METHODS: We analyzed data from newly registered PLWH with negative baseline TST results. We calculated the number of TST conversions after 1 and/or 2 years among patients eligible for follow-up TSTs; the proportion of converters initiating IPT; and incidence of TB/death. RESULTS: Among 1,770 PLWH with a negative baseline TST, 679 (38%) were female and median age was 36 years (IQR 29–43). Eighty-six (5%) developed TB or died within 1 year. Among 1,684 eligible for a follow-up 1-year TST, 582 (35%) were tested and 53 (9%) were positive. Forty-nine (92%) converters started IPT. Of 529 patients with a negative 1-year TST, 7 (1%) developed TB or died over the following year. Of 522 patients eligible for a 2-year TST, 158 (30%) were tested and 13 (8%) were positive. Ten (77%) converters started IPT. Of 1,102 patients who did not receive a 1-year TST, 33 (3%) developed TB or died. Of the 1,069 patients eligible for a 2-year TST, 259 (24%) were tested and 34 (13%) were positive. Thirty (88%) converters started IPT. CONCLUSIONS: In this cohort of PLWH in Brazil, TST conversion was high among those re-tested, but only 48% received a follow-up TST within 2 years
CD4+ cell count stratification to guide tuberculosis preventive therapy for people living with HIV
No full textObjectives: In 2018, Brazilian guidelines changed to recommend tuberculosis (TB) preventive therapy for all people with HIV and a CD4þ cell count 350 cells/ml or less, but only for those with a positive tuberculin skin test (TST) if CD4þ cell count is than 350 cells/ml. We determined the potential effectiveness of CD4þ-based guidelines for TB testing and preventive therapy. Design: Secondary analysis of the stepped-wedge, cluster-randomized THRio trial for isoniazid preventive therapy (IPT).
Methods: We analyzed data from 4114 newly registered patients with HIV in 29 clinics followed until TB diagnosis, death, or administrative censoring. We compared incidence rates of TB and TB/death between CD4þ, TST, IPT, and antiretroviral therapy categories. Results: Initial CD4þ cell count was 350 cells/ml or less in 2138 (52%) and more than 350 cells/mlin 1976 (48%) patients. TST was performed for 2922 (71%), ofwhom657(16%)
were TST-positive [278 (13%) CD4þ 350 vs. 379 (19%) CD4þ > 350]. A total of 619 (15%) received IPT and 2806 (68%) received antiretroviral therapy. For patients with CD4þ cellcount 350 cells/mlor less who did not receive IPT, the incidence rate of TB was 1.79/100 person-years (pys) and TB/death was 3.89/100 pys. For patients with CD4þ cell count more than 350 who did not receive IPT, the incidence rates of TB and TB/death were 0.57/100 and 1.49/100 pys for TST-negatives, and 1.05/100 and 1.64/100 pys for TST-unknowns. Conclusion: TB incidence was high among all patients who did not receive IPT, including those with CD4þ cell count more than 350 cells/ml and negative or unknown TST results. TB preventive therapy should be provided to all people living with HIV in medium burden settings, regardless of CD4þ cell count and TST status.2051-01-0
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Elevated Mortality Among People Experiencing Homelessness With COVID-19.
No full textWe reviewed publicly available data from major US health jurisdictions to compare severe acute respiratory syndrome coronavirus 2 case fatality rates in people experiencing homelessness with the general population. The case fatality rate among people experiencing homelessness was 1.3 times (95% CI, 1.1-1.5) that of the general population, suggesting that people experiencing homelessness should be prioritized for vaccination
Diabetes is a Strong Predictor of Mortality During Tuberculosis Treatment: A Prospective Cohort Study Among Tuberculosis Patients from Mwanza, Tanzania.
No full textStrong evidence suggests diabetes may be associated with tuberculosis (TB) and could influence TB treatment outcomes. We assessed the role of diabetes on sputum culture conversion and mortality among patients undergoing TB treatment. A total of 1250 Tanzanian TB patients were followed prospectively during TB treatment with sputum culture after 2 and 5 months. Survival status was assessed at least 1 year after initiation of treatment. At baseline, all participants underwent testing for diabetes and HIV, and the serum concentration of the acute phase reactant alpha-1 glycoprotein (AGP) was determined. There were no differences between participants with and without diabetes regarding the proportion of positive cultures at 2 (3.8% vs. 5.8%) and 5 (1.3% vs. 0.9%) months (P > 0.46). However, among patients with a positive TB culture, relatively more patients with diabetes died before the 5-month follow-up. Within the initial 100 days of TB treatment, diabetes was associated with a fivefold increased risk of mortality (RR 5.09, 95% CI 2.36; 11.02, P < 0.001) among HIV uninfected, and a twofold increase among HIV co-infected patient (RR 2.33 95% CI 1.20; 4.53, P = 0.012), while diabetes was not associated with long-term mortality. Further adjustment with AGP did not change the estimates. Diabetes considerably increases risk of early mortality during TB treatment. The effect may not be explained by increased severity of TB, but could be due to impaired TB treatment response. Research is needed to clarify the mechanism and to assess whether glycaemic control improves survival
Tuberculosis screening improves preventive therapy uptake (TB SCRIPT) trial among people living with HIV in Uganda: a study protocol of an individual randomized controlled trial
No full textBACKGROUND: People living with HIV (PLHIV) have an increased risk of developing active tuberculosis (TB). To reduce the burden of TB among PLHIV, the World Health Organization (WHO) recommends systematic TB screening followed by (1) confirmatory TB testing for all who screen positive and (2) TB preventive therapy (TPT) for all TPT-eligible PLHIV who screen negative. Symptom-based screening remains the standard of care in most high TB burden settings, including Uganda. Despite having high sensitivity for active TB among antiretroviral-naïve PLHIV, symptom screening has poor specificity; as such, many high-risk PLHIV without active TB are not referred for TPT. C-reactive protein (CRP) is a promising alternative strategy for TB screening that has comparable sensitivity and higher specificity than symptom screening, and was endorsed by WHO in 2021. However, the impact of CRP-based TB screening on TB burden for PLHIV remains unclear. METHODS: TB SCRIPT (TB Screening Improves Preventive Therapy Uptake) is a phase 3, multi-center, single-blinded, individual (1:1) randomized controlled trial evaluating the effectiveness of CRP-based TB screening on clinical outcomes of PLHIV. The trial aims to compare the effectiveness of a TB screening strategy based on CRP levels using a point-of-care (POC) assay on 2-year TB incidence and all-cause mortality (composite primary trial endpoint) and prevalent TB case detection and uptake of TPT (intermediate outcomes), relative to symptom-based TB screening (current practice). DISCUSSION: This study will be critical to improving selection of eligible PLHIV for TPT and helping guide the scale-up and integration of TB screening and TPT activities. This work will enable the field to improve TB screening by removing barriers to TPT initiation among eligible PLHIV, and provide randomized evidence to inform and strengthen WHO guidelines. TRIAL REGISTRATION: ClinicalTrials.gov NCT04557176. Registered on September 21, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06371-0
Odds of answering comprehension quiz questions 1–20 correctly at Quizzes 2–5 compared to enrollment quiz.
No full text<p>Odds of answering comprehension quiz questions 1–20 correctly at Quizzes 2–5 compared to enrollment quiz.</p
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