Eric Pevzner

Insights from the Ebola response to address HIV and tuberculosis

276 www.thelancet.com/infection Vol 16 March 2016 NICE also considered that no evidence showed the eff ectiveness of antibiotic prophylaxis. Although no randomised trial has been done, various observational clinical studies show a benefi t in high-risk groups and data from animal studies show that a single dose of amoxicillin can prevent streptococcal bacteraemia and infective endocarditis. In a 2014 study, 277 prescriptions of antibiotic prophylaxis were needed to prevent one case of infective endocarditis. Numerous studies show a background increase in the incidence of infective endocarditis. However, the above-mentioned 2014 study, showed that the slope of this increase rose in the UK in the years after introduction of the NICE guidance in March, 2008. There has been subsequent debate about the timing of the change in slope and whether the data are better fi tted with a curve than a straight line, but there has been no disagreement about the existence of the change. The study was limited by the absence of microbiological information, and that infective endocarditis-related mortality did not rise in parallel with incidence is surprising. However, the mortality of infective endocarditis caused by oral streptococci is lower than that caused by other organisms, and a US study has shown a rise in infective endocarditis caused by streptococci in the same time period. NICE guidance might seem to simplify dental practice. However, the nature of informed consent obliges dentists to make patients aware of the diff erent guidelines, especially if a patient is at high clinical risk or has a particular concern about antibiotic prophylaxis or infective endocarditis. The dentist would then need to let the patient decide whether or not to receive antibiotic prophylaxis. This process would therefore be much simpler if all guidelines were in agreement. We suggest that the recently updated European Society of Cardiology guidance, remains clinically the most appropriate.

Implementing an isoniazid preventive therapy program for people living with HIV in Thailand

Treatment of people living with HIV (PLHIV) with latent tuberculosis (TB) infection using isoniazid preventive therapy (IPT) can reduce the risk of TB disease, however, the scale-up of IPT among PLHIV in Thailand and worldwide has been slow. To hasten the implementation of IPT in Thailand, we developed IPT implementation training curricula and tools for health care providers and implemented IPT services in seven large government hospitals. Of the 659 PLHIV enrolled, 272 (41.3%) reported symptoms of TB and 39 (14.3% of those with TB symptoms) were diagnosed with TB. A total of 346 (52.4%) participants were eligible for IPT; 318 (91.9%) of these participants opted to have a tuberculin skin test (TST) and 52 (16.3% of those who had a TST) had a positive TST result. Among the 52 participants with a positive TST, 46 (88.5%) initiated and 39 (75.0%) completed 9 months of IPT: physicians instructed three participants to stop IPT, two participants were lost to follow-up, one chose to stop therapy, and one developed TB. IPT can be implemented among PLHIV in Thailand and could reduce the burden of TB in the country.

Providers' Perspectives on Program Collaboration and Service Integration for Persons Who Use Drugs.

The structure and process of health care financing, delivery, and organization result in challenges for providers seeking to offer comprehensive and integrated care for persons who use drugs. The Affordable Care Act (ACA) is increasing coverage for mental health and substance abuse treatment as part of the Essential Health Benefits for Medicaid expansion and many private health plans. Community groups and scholars predict that increasing access to care under the ACA will likely require program collaboration among providers and integration of services in community health

Programmatic Evaluation of an Algorithm for Intensified Tuberculosis Case Finding and Isoniazid Preventive Therapy for People Living With HIV in Thailand and Vietnam

Background: Tuberculosis (TB) screening affords clinicians the opportunity to diagnose or exclude TB disease and initiate isoniazid preventive therapy (IPT) for people living with HIV (PLHIV). Methods: We implemented an algorithm to diagnose or rule out TB among PLHIV in 11 HIV clinics in Thailand and Vietnam. We assessed algorithm yield and uptake of IPT and factors associated with TB disease among PLHIV. Results: A total of 1448 PLHIV not yet on antiretroviral therapy (ART) were enrolled and screened for TB. Overall, 634 (44%) screened positive and 119 (8%) were diagnosed with TB; of these, 40% (48/119) were diagnosed by a positive culture following a negative sputum smear microscopy. In total, 55% of those eligible (263/477) started on IPT and of those, 75% (196/263) completed therapy. The prevalence of TB disease we observed in this study was 8.2% (8218 per 100,000 persons): 46 and 25 times the prevalence of TB in the general population in Thailand and Vietnam, respectively. Several factors were independently associated with TB disease including being underweight [aOR (95% CI): 2.3 (1.2 to 2.6)] and using injection drugs [aOR (95% CI): 2.9 (1.3 to 6.3)]. Conclusions: The high yield of TB disease diagnosed among PLHIV screened with the algorithm, and higher burden among PLHIV who inject drugs, underscores the need for innovative, tailored approaches to TB screening and prevention. As countries adopt test-and-start for antiretroviral therapy, TB screening, sensitive TB diagnostics, and IPT should be included in differentiated-care models for HIV to improve diagnosis and prevention of TB among PLHIV.

Operating Characteristics of a Tuberculosis Screening Tool for People Living with HIV in Out-Patient HIV Care and Treatment Services, Rwanda.

Background The World Health Organization (WHO) 2010 guidelines for intensified tuberculosis (TB) case finding (ICF) among people living with HIV (PLHIV) includes a recommendation that PLHIV receive routine TB screening. Since 2005, the Rwandan Ministry of Health has been using a five-question screening tool. Our study objective was to assess the operating characteristics of the tool designed to identify PLHIV with presumptive TB as measured against a composite reference standard, including bacteriologically confirmed TB. Methods In a cross-sectional study, the TB screening tool was routinely administered at enrolment in outpatient HIV care and treatment services at seven public health facilities. From March to September 2011, study enrollees were examined for TB disease irrespective of TB screening outcome. The examination consisted of a chest radiograph (CXR), three sputum smears (SS), sputum culture (SC) and polymerase chain reaction line-probe assay (Hain test). PLHIV were classified as having “laboratory-confirmed TB” with positive results on SS for acid-fast bacilli, SC on Lowenstein-Jensen medium, or a Hain test. Results Overall, 1,767 patients were enrolled and screened of which; 1,017 (57.6%) were female, median age was 33 (IQR, 27–41), and median CD4+ cell count was 385 (IQR, 229–563) cells/mm3. Of the patients screened, 138 (7.8%) were diagnosed with TB of which; 125 (90.5%) were laboratory-confirmed pulmonary TB. Of 404 (22.9%) patients who screened positive and 1,363 (77.1%) who screened negative, 79 (19.5%) and 59 (4.3%), respectively, were diagnosed with TB. For laboratory-confirmed TB, the tool had a sensitivity of 54.4% (95% CI 45.3–63.3), specificity of 79.5% (95% CI 77.5–81.5), PPV of 16.8% and NPV of 95.8%. Conclusion TB prevalence among PLHIV newly enrolling into HIV care and treatment was 65 times greater than the overall population prevalence. However, the performance of the tool was poorer than the predicted performance of the WHO recommended TB screening questions.

Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial

Background: Ethical principles obligate researchers to maximize study participants’ comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. Methods: Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. Results: ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24–42). Median ICAT scores were 80% (IQR: 67–93) for comprehension and 89% (IQR: 78–100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. Conclusions: Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials.