Concordance of Ethyl Glucuronide, Blood Alcohol Content, and Self-Reported Alcohol Use in Russian Women with HIV and Hepatitis C Virus Co-Infection.

Problematic alcohol use is prevalent in Russia and is deleterious for individuals with HIV and Hepatitis C Virus (HCV). Ethyl glucuronide (EtG) and blood alcohol content (BAC) provide objective biomarkers of drinking that can be compared to self-reported alcohol use. This paper describes patterns of alcohol use measured by biomarkers and self-report along with concordance across measures. Participants were Russian women with HIV and HCV co-infection (N = 200; Mean age = 34.9) from two Saint Petersburg comprehensive HIV care centers enrolled in an alcohol reduction intervention clinical trial. Measures were: (a) urine specimen analyzed for EtG; (b) breathalyzer reading of BAC; and (c) self-reported frequency of drinking, typical number of drinks consumed, and number of standard drinks consumed in the past month. At baseline, 64.0% (n = 128) had a positive EtG (> 500 ng/mL) and 76.5% (n = 153) had a positive breathalyzer reading (non-zero reading). There was agreement between EtG and BAC (kappa = 0.66, p < .001; Phi coefficient = 0.69, p < .001); self-reported alcohol measures were positively correlated with positive EtG and BAC (p's < 0.001). There was concordance between EtG and BAC measures, which have differing alcohol detection windows. Most participants endorsed frequent drinking at high quantities, with very few reporting no alcohol consumption in the past month. Concordance between biomarkers and self-reported alcohol use suggests that underreporting of alcohol use was minimal. Results highlight the need for alcohol screening within HIV care. Implications for alcohol assessment within research and clinical contexts are discussed.

Development and Cultural Adaptation of a Computer-Delivered and Multi-Component Alcohol Reduction Intervention for Russian Women Living with HIV and HCV.

BACKGROUND: There is elevated prevalence of problem drinking among Russian women living with HIV and HCV co-infection. This paper describes the development and cultural adaptation of a multi-component alcohol reduction intervention incorporating a brief, computer-delivered module for Russian women living with HIV and HCV co-infection. METHODS: The format and content of the intervention were adapted to be linguistic-, cultural-, and gender-appropriate using the ADAPT-ITT framework. A computer-delivered module and brief clinician-delivered individual and telephone sessions were developed. RESULTS: We describe the theoretical foundations of the intervention, the cultural adaptation of the intervention, and overview the content of the intervention's multiple components. DISCUSSION: Interventions to reduce alcohol use that can be integrated within Russian HIV treatment centers are urgently needed. If efficacious, the culturally-adapted intervention offers the promise of a cost-effective, easily disseminated intervention approach for Russian women living with HIV/HCV co-infection engaging in problematic alcohol use.

Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial.

BACKGROUND: Russia has a high prevalence of human immunodeficiency virus (HIV) infections. In 2018, over one million persons were living with HIV (PLWH); over a third were women. A high proportion of HIV-infected women are co-infected with hepatitis C virus (HCV), and many consume alcohol, which adversely affects HIV and HCV treatment and prognosis. Despite the triple epidemics of alcohol use, HIV and HCV, and the need for interventions to reduce alcohol use among HIV/HCV co-infected women, evidence-based alcohol reduction interventions for this vulnerable population are limited. To address this gap, we developed a clinical trial to evaluate the efficacy of a computer-based intervention to reduce alcohol consumption among HIV/HCV co-infected women in clinical care. METHODS: In this two-arm parallel randomized controlled trial, we propose to evaluate the efficacy of a culturally adapted alcohol reduction intervention delivered via a computer for HIV/HCV co-infected Russian women. The study population consists of women 21-45 years old with confirmed HIV/HCV co-infection who currently use alcohol. Intervention efficacy is assessed by a novel alcohol biomarker, ethyl glucuronide (EtG), and biomarkers of HIV and HCV disease progression. Women are randomized to trial conditions in a 1:1 allocation ratio, using a computer-generated algorithm to develop the assignment sequence and concealment of allocation techniques to minimize assignment bias. Women are randomized to either (1) the computer-based alcohol reduction intervention or (2) the standard-of-care control condition. We will use an intent-to-treat analysis and logistic and linear generalized estimating equations to evaluate intervention efficacy, relative to the standard of care, in enhancing the proportion of women with a laboratory-confirmed negative EtG at each research study visit over the 9-month follow-up period. Additional analyses will evaluate intervention effects on HIV (viral load and CD4+ levels) and HCV markers of disease progression (FibroScan). DISCUSSION: The proposed trial design and analysis provides an appropriate conceptual and methodological framework to assess the efficacy of the computer-based intervention. We propose to recruit 200 participants. The intervention, if efficacious, may be an efficient and cost-effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated into clinical care in Russia to reduce women's alcohol consumption and enhance HIV/HCV prognosis. TRIAL REGISTRATION: ClinicalTrials.gov NCT03362476 . Registered on 5 December 2017.

Safety of influenza A (H1N1) 2009 live attenuated monovalent vaccine in pregnant women.

OBJECTIVE: To characterize maternal and infant outcomes for pregnant women who received live H1N1 influenza vaccine and had no reported adverse events. METHODS: We identified Vaccine Adverse Event Reporting System reports, which described receipt of live H1N1 vaccine during pregnancy without an indication of an adverse event at the time of the report during October 2009 to June 2010. We reviewed the initial reports and obtained pregnancy outcome and infant data through 6 months of age from medical records. We reviewed the numbers and characteristics of pregnancy complications and infant outcomes including major birth defects and medically important infant conditions. Rates of spontaneous abortion, preterm birth, and major birth defects and their 95% confidence intervals were calculated. RESULTS: The Vaccine Adverse Event Reporting System received 113 reports stating receipt of live H1N1 vaccine during pregnancy with no adverse events reported. We obtained follow-up maternal records on 95 of the 113 (84%) live H1N1 reports (40.2% were vaccinated in the first trimester) and found: 87 live births (two twin pregnancies) and no maternal deaths occurred. Number and rates of pregnancy-specific adverse events included: 10 (10.5%, 5.8-18.3) spontaneous abortions; four (4.7%, 1.8-11.4) preterm deliveries at 35-36 weeks of gestation; three (3.4%, 1.2-9.7) infants had one or more major birth defects noted at birth: one cleft palate, one cleft lip, and one microtia (underdeveloped or absent external ear). Seven neonates and infants were hospitalized for medically important conditions. One infant death occurred in a 2.5-month-old boy as a result of pertussis. CONCLUSION: Rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates. No concerning patterns of medical conditions in infants were identified. LEVEL OF EVIDENCE: : III.

Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women.

OBJECTIVE: We sought to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women who received tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap). STUDY DESIGN: We searched VAERS for reports of pregnant women who received Tdap from Jan. 1, 2005, through June 30, 2010. We conducted a clinical review of reports and available medical records. RESULTS: We identified 132 reports of Tdap administered to pregnant women; 55 (42%) described no adverse event (AE). No maternal or infant deaths were reported. The most frequent pregnancy-specific AE was spontaneous abortion in 22 (16.7%) reports. Injection site reactions were the most frequent non-pregnancy-specific AE found in 6 (4.5%) reports. One report with a major congenital anomaly (gastroschisis) was identified. CONCLUSION: During a time when Tdap was not routinely recommended in pregnancy, review of reports to VAERS in pregnant women after Tdap did not identify any concerning patterns in maternal, infant, or fetal outcomes.