Faculty Bibliography

BACKGROUND:There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease. METHODS:In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat. RESULTS:Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [-3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = -0.2 [-0.9, 0.5]), ALT (AMD [95% CI] = -7 [-20, 7]) and AST (AMD [95% CI] = -4 [-15, 7]) at week 24 compared to TAU. CONCLUSION/CONCLUSIONS:ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.

Background. Influenza (flu) and other respiratory viruses circulate regularly throughout healthcare systems, often placing healthcare personnel (HCP) at high risk for illness. Hemagglutination inhibition (HAI) titers are associated with protection from flu illness, though few studies have characterized HAI in HCP. The Respiratory Protection Effectiveness Clinical Trial (ResPECT), provided HAI titers and data to assess infection risk based on four flu seasons. Participants from multiple outpatient settings wore respiratory protection within six feet of symptomatic patients. Methods. Serological samples obtained at the beginning and end of each season and anterior nasopharyngeal swabs were taken randomly and when participants reported respiratory symptoms were assessed. Our primary outcome was PCRconfirmed influenza. Results. During 5,180 participant-seasons of observation, 128 PCR-confirmed influenza A infections (20 H1N1, 108 H3N2) and 34 PCR-confirmed influenza B infections. 4,041 (78%) reported receiving an annual influenza vaccine. Each log base 2 increase in titer subtype-specific titer reduced the hazard of influenza infection with A/ H3N2 by 18%(Relative Risk (RR) 0.82 95% CI 0.72,0.94), by 28% for influenza B (RR 0.72 95% CI 0.56,0.92 and by 25% for influenza A H1N1 (RR 0.75 95% CI 0.57-1.0). After adjusting for HAI titers, age was not significantly associated with risk for any of the subtypes. Conclusion. In this prospective cohort of monitored HCPs, these findings support the current literature demonstrating that HAI titers are associated with protection from influenza infection. The relationship between HAI titers, influenza, and vaccination is complex, however. Vaccination was not shown to be associated with infection outcome in our model, though their effect may be difficult to separate from their effect on HAI titers

Background. Healthcare personnel (HCP) knowledge and attitudes toward Infection Prevention and Control (IPC) measures are important determinants of practices that can protect them from acquisition of infectious diseases from patients. We aimed to describe HCP knowledge and attitudes concerning IPC measures over time in the context of a clinical trial. Methods. ResPECT was a multi-center, multi-season cluster randomized clinical trial designed to compare the effectiveness of medical masks (MM) and N95 respirators (N95) for preventing acute respiratory illnesses in HCP employed in outpatient clinical settings. At the beginning of each respiratory virus season, participants completed a survey instrument to measure IPC knowledge. At the beginning and end of each season participants completed a survey to assess attitudes and beliefs about IPC measures, especially MM and N95. Results. A pre-study and post-study survey pair was available for 88.1% of participant seasons. There were no significant differences in demographic variables or job assignment between survey respondents and nonrespondents for each participant season. Participants correctly identified 59.8% to 63.4% of IPC measures that should be used by HCP when exposed to patients with symptoms of acute respiratory illness, or at high risk of infection. There was modest improvement in the knowledge score over time among providers who participated for multiple years in the study. In the first pre-study survey of IPC attitudes and beliefs, 88.5% and 87.9% of participants identified at least one reason to avoid using either MM and N95, respectively (Figure 1). At the post-season survey, the proportion of participants reporting a reason to avoid MM fell to 39.6% (IRR for pre- vs. post-season 0.15, 95% CI 0.13-0.17) and 53.6% reported a reason to avoid N95 (IRR 0.57, 95% CI 0.51-0.66). Conclusion. HCPknowledge of IPC precautions was poor, suggesting a need for better IPC education and accountability in the outpatient setting. When given incentives to comply with processes toward which they had negative attitudes at baseline, HCP realized that medical masks and N95 respirators were comfortable enough to wear for patient encounters and interfered with their work processes less than expected

Background. Healthcare personnel (HCP) are exposed to many individuals with respiratory illness while providing care. Because children more frequently present for care with respiratory infections compared with older individuals, we hypothesized that HCP working in pediatric settings might experience greater risks of respiratory infection than HCP working in adult settings. The Respiratory Protection Effectiveness Clinical Trial (ResPECT) prospectively compared respiratory protection among HCP at seven health systems across the United States between 2011 and 2015. Methods. Swabs were collected from asymptomatic participants twice each respiratory season. Swabs were collected from symptomatic HCP within 24 hours of self-reported respiratory symptoms and again if participants were still symptomatic after 7 days. PCR confirmation for 13 viruses was done by a single laboratory. We compared hazards of multiple outcomes associated with respiratory infections among HCP working in pediatric clinics and HCP working in clinics that care for adults. Results. The main outcomes were risk factors for symptomatic and asymptomatic viral respiratory infections. A total of 5,180 participant-seasons were evaluated from 2011-2015, 1,130 of which worked solely with children. There were 403 and 1,162 incidents of asymptomatic and symptomatic PCR-confirmed respiratory infection, respectively. Risk factors associated with respiratory infection in the entire cohort included age, race, vaccination status, smoking status, wearing contacts, total household members, study site, and age of patient population. HCP working exclusively with pediatric patients had 1.5 (95% CI 1.2-1.8) times the rate of respiratory virus infection compared with HCP working only with adults. HCP who worked with both populations had 1.4 times (95% CI: 1.2-1.7) the rate of infection with respiratory viruses. Conclusion. The risk of respiratory infections was increased among HCP that saw children. This risk was not mitigated by working only part-time with children and extended to those who identified as working with both adult and pediatric populations. Our findings highlight the need to target interventions in pediatric settings to decrease HCP acquisition of respiratory infections

Importance/UNASSIGNED:Clinical studies have been inconclusive about the effectiveness of N95 respirators and medical masks in preventing health care personnel (HCP) from acquiring workplace viral respiratory infections. Objective/UNASSIGNED:To compare the effect of N95 respirators vs medical masks for prevention of influenza and other viral respiratory infections among HCP. Design, Setting, and Participants/UNASSIGNED:A cluster randomized pragmatic effectiveness study conducted at 137 outpatient study sites at 7 US medical centers between September 2011 and May 2015, with final follow-up in June 2016. Each year for 4 years, during the 12-week period of peak viral respiratory illness, pairs of outpatient sites (clusters) within each center were matched and randomly assigned to the N95 respirator or medical mask groups. Interventions/UNASSIGNED:Overall, 1993 participants in 189 clusters were randomly assigned to wear N95 respirators (2512 HCP-seasons of observation) and 2058 in 191 clusters were randomly assigned to wear medical masks (2668 HCP-seasons) when near patients with respiratory illness. Main Outcomes and Measures/UNASSIGNED:The primary outcome was the incidence of laboratory-confirmed influenza. Secondary outcomes included incidence of acute respiratory illness, laboratory-detected respiratory infections, laboratory-confirmed respiratory illness, and influenzalike illness. Adherence to interventions was assessed. Results/UNASSIGNED:Among 2862 randomized participants (mean [SD] age, 43 [11.5] years; 2369 [82.8%]) women), 2371 completed the study and accounted for 5180 HCP-seasons. There were 207 laboratory-confirmed influenza infection events (8.2% of HCP-seasons) in the N95 respirator group and 193 (7.2% of HCP-seasons) in the medical mask group (difference, 1.0%, [95% CI, -0.5% to 2.5%]; P = .18) (adjusted odds ratio [OR], 1.18 [95% CI, 0.95-1.45]). There were 1556 acute respiratory illness events in the respirator group vs 1711 in the mask group (difference, -21.9 per 1000 HCP-seasons [95% CI, -48.2 to 4.4]; P = .10); 679 laboratory-detected respiratory infections in the respirator group vs 745 in the mask group (difference, -8.9 per 1000 HCP-seasons, [95% CI, -33.3 to 15.4]; P = .47); 371 laboratory-confirmed respiratory illness events in the respirator group vs 417 in the mask group (difference, -8.6 per 1000 HCP-seasons [95% CI, -28.2 to 10.9]; P = .39); and 128 influenzalike illness events in the respirator group vs 166 in the mask group (difference, -11.3 per 1000 HCP-seasons [95% CI, -23.8 to 1.3]; P = .08). In the respirator group, 89.4% of participants reported "always" or "sometimes" wearing their assigned devices vs 90.2% in the mask group. Conclusions and Relevance/UNASSIGNED:Among outpatient health care personnel, N95 respirators vs medical masks as worn by participants in this trial resulted in no significant difference in the incidence of laboratory-confirmed influenza. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT01249625.

BACKGROUND:We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among patients living with HIV and alcohol use disorder. METHODS:In this multisite, randomised controlled trial, conducted in five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment. Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence. Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study. Using a web-based clinical trial management system, we randomly assigned participants (1:1) to receive ISAT or treatment as usual; patients, investigators, and clinicians were unmasked to allocation. ISAT involved three steps: step 1, addiction physician management, comprising eight sessions; step 2, addiction physician management plus motivational enhancement therapy, comprising four sessions; and step 3, specialty referral. Participants were stepped up at weeks 4 and 12 if they exceeded a priori drinking criteria. Treatment as usual involved referral to substance use treatment services. The primary outcome was number of drinks per week over the past 30 days at week 24 by use of the timeline followback method, assessed in the intention-to-treat population. Adverse events were tracked throughout the study period in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, number NCT01410123. FINDINGS/RESULTS:Between Jan 28, 2013, and July 14, 2017, 128 of 351 patients assessed for eligibility were eligible and randomly assigned to receive ISAT (n=63) or treatment as usual (n=65). Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black. 25 (20%) were lost to follow-up. In the ISAT group, of 57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3. 32 (51%) of 63 participants assigned to ISAT versus 17 (26%) of 65 assigned to treatment as usual received at least one alcohol treatment medication (p=0·004). Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11). One adverse event occurred that was possibly related to treatment occurred in the ISAT group (headache). INTERPRETATION/CONCLUSIONS:ISAT increases the receipt of alcohol treatment medications and counselling without changes in drinking at week 24. Strategies to implement and enhance ISAT are needed. Future efforts should focus on promoting ISAT with attention to enhancing patient engagement and retention in alcohol-related care. FUNDING/BACKGROUND:US National Institute on Alcohol Abuse and Alcoholism.

Background. Respiratory protection (RP) for healthcare personnel (HCP) is controversial and clinical studies are inconclusive about the effectiveness of N95 respirators (N95) and medical masks (MM) for protecting HCP from workplace viral respiratory infections and illnesses (VRII). Methods. We conducted a cluster-randomized, investigator-blinded, multisite effectiveness study comparing N95 to MM in geographically diverse, high exposure outpatient settings between 2011 and 2016. Each year during VRII season, participants wore assigned devices when within 6 feet of patients with known or suspected respiratory illness. Respiratory swabs were collected from symptomatic and asymptomatic participants. Diaries detailed VRII exposures, influenza vaccination, adherence to RP and hand hygiene, and manifestations of illness. The primary and secondary outcomes were the incidence of laboratory-confirmed influenza (LCI) using polymerase chain reaction (PCR) and hemagglutinin inhibition assays (HAI), and acute respiratory illness (ARI), influenza-like illness (ILI), laboratory-confirmed respiratory illness (LCRI), and laboratory-detected respiratory infection (LDRI) (figure). Intervention protective effects were estimated using unadjusted odds and incidence rate ratios. Results. 5,180 HCP seasons enrolled and randomized (2,243 to N95 and 2,446 to MM), with 4,689 (91%) completing the study. In the intention-to-treat cohort (ITT), among participants in the N95 and MM groups, respectively, 207 (8.2%) and 193 (7.2%) were diagnosed with LCI (odds ratio [OR] 1.14, 95% confidence interval [CI] 0.93-1.40); 1,556 (61.9%) and 1711 (64.1%) were diagnosed with ARI (relative risk (RR) 0.99, CI 0.92-1.06); 128 (5.1%) and 166 (6.2%) were diagnosed with ILI (RR 0.87, CI 0.68-1.10), 371 (14.8%) and 417 (15.6%) were diagnosed with LCRI (RR 0.97, CI 0.84-1.12); and 679 (27.0%) and 745 (27.9%) were diagnosed with LDRI (RR 0.99, CI 0.89-1.09). The adjusted ITT and per-protocol analyses yielded similar results. Conclusion. In this outpatient-based, cluster-randomized, controlled trial, neither N95 nor MM resulted in superior protection from LCI or VRII

OBJECTIVE To determine the effect of mandatory and nonmandatory influenza vaccination policies on vaccination rates and symptomatic absenteeism among healthcare personnel (HCP). DESIGN Retrospective observational cohort study. SETTING This study took place at 3 university medical centers with mandatory influenza vaccination policies and 4 Veterans Affairs (VA) healthcare systems with nonmandatory influenza vaccination policies. PARTICIPANTS The study included 2,304 outpatient HCP at mandatory vaccination sites and 1,759 outpatient HCP at nonmandatory vaccination sites. METHODS To determine the incidence and duration of absenteeism in outpatient settings, HCP participating in the Respiratory Protection Effectiveness Clinical Trial at both mandatory and nonmandatory vaccination sites over 3 viral respiratory illness (VRI) seasons (2012-2015) reported their influenza vaccination status and symptomatic days absent from work weekly throughout a 12-week period during the peak VRI season each year. The adjusted effects of vaccination and other modulating factors on absenteeism rates were estimated using multivariable regression models. RESULTS The proportion of participants who received influenza vaccination was lower each year at nonmandatory than at mandatory vaccination sites (odds ratio [OR], 0.09; 95% confidence interval [CI], 0.07-0.11). Among HCP who reported at least 1 sick day, vaccinated HCP had lower symptomatic days absent compared to unvaccinated HCP (OR for 2012-2013 and 2013-2014, 0.82; 95% CI, 0.72-0.93; OR for 2014-2015, 0.81; 95% CI, 0.69-0.95). CONCLUSIONS These data suggest that mandatory HCP influenza vaccination policies increase influenza vaccination rates and that HCP symptomatic absenteeism diminishes as rates of influenza vaccination increase. These findings should be considered in formulating HCP influenza vaccination policies. Infect Control Hosp Epidemiol 2018;1-10.