27 results on '"Bendiks S"'
Search Results
2. Evolution of illicit opioids used among people with HIV in St. Petersburg, Russia, in the period 2004–2015
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Blokhina, E., Krupitsky, E.M., Cheng, D.M., Walley, A.Y., Toussova, O., Yaroslavtseva, T., Gnatienko, N., Bridden, C., Forman, L.S., Bendiks, S., and Samet, J.H.
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Adult ,Analgesics, Opioid ,Cohort Studies ,Heroin ,Male ,Young Adult ,mental disorders ,Humans ,Female ,HIV Infections ,Substance Abuse, Intravenous ,Article ,Russia - Abstract
OBJECTIVES: In the late 1990s, when the current Russian opioid epidemic began, illicit opioids used in Russia consisted almost exclusively of heroin. The type of opioids used has evolved in the early 21(st) century. The objective of this study was to describe the evolution of illicit opioid use among people living with HIV (PLWH) reporting recent opioid use in St. Petersburg, Russia. METHODS: We examined baseline data from four research studies conducted in the period 2004 to 2015 that included PLWH who used opioids [Partnership to Reduce the Epidemic Via Engagement in Narcology Treatment (PREVENT; 2004–2005; n = 17), HIV Evolution in Russia–Mitigating Infection Transmission and Alcoholism in a Growing Epidemic (HERMITAGE; 2007–2010; n = 281), Linking Infectious and Narcology Care (LINC; 2013–2014; n = 119) and Russia Alcohol Research Collaboration on HIV/AIDS (Russia ARCH; 2012–2015; n = 121)] and describe recent use of heroin and other opioids. RESULTS: Although these studies spanned more than a decade, the participants represented similar birth cohorts, the mean age was 24.5 years in 2004 and 33.3 in 2014. The use of opioid types however, evolved across cohorts with the use of any illicit drugs other than heroin increasing from 6% (95% CI: 0.002, 0.29) in PREVENT (2004–2005) to 30% (95% CI: 0.25, 0.36) in HERMITAGE (2007–2010) to 70% (95% CI: 0.61, 0.78) in LINC (2013–2014) to 77% in ARCH (2012–2015) (95% CI: 0.68, 0.84). Any heroin use consistently decreased over the ten-year period in the cohorts from 100% (95% CI: 0.8, 1.0) in 2004–2005 to 54% (95% CI: 0.44, 0.63) in 2012–2015. CONCLUSIONS: Among PLWH who use opioids from St. Petersburg, Russia, illicit use of opioids other than heroin appears to be more common than heroin use.
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- 2019
3. Evolution of illicit opioid use among people with HIV infection in St Petersburg, Russia, in the period 2004–2015
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Blokhina, E, primary, Krupitsky, EM, additional, Cheng, DM, additional, Walley, AY, additional, Toussova, O, additional, Yaroslavtseva, T, additional, Gnatienko, N, additional, Bridden, C, additional, Forman, LS, additional, Bendiks, S, additional, and Samet, JH, additional
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- 2019
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4. Nieuwe periferie in de polycentrische stad
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Salet, W., Janssen-Jansen, L., Bendiks, S., Degros, A., Vegt, H. van der, and Planning, Institutions and Transforming Spaces (AMIDST, FMG)
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- 2009
5. Associations of discomfort intolerance, discomfort avoidance, and cannabis and alcohol use among persons with chronic pain receiving prescription buprenorphine for opioid use disorder.
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Haley DF, Stein MD, Bendiks S, Karzhevsky S, Pierce C, Dunn A, Herman DS, Anderson B, and Weisberg RB
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Background: Chronic pain and non-prescribed substance use are associated with lower retention in opioid use disorder (OUD) treatment. We examined the associations of perceived capacity to tolerate uncomfortable physical sensations (discomfort intolerance and discomfort avoidance) and cannabis and alcohol use among persons with chronic pain receiving prescription buprenorphine for OUD., Methods: This study utilizes baseline data from 163 persons with chronic pain receiving prescription buprenorphine for OUD enrolled in the Treating Opioid use, Persistent Pain, and Sadness (TOPPS) intervention trial. We used negative-binomial regression models, adjusted for age, education, gender, race/ethnicity, pain interference, depression, generalized anxiety disorder, and average cigarettes smoked/day to estimate the associations of discomfort tolerance and discomfort avoidance with frequency of cannabis and alcohol use., Results: Participants (n=163) were on average 45 years old (standard deviation=10.6) and predominantly White (86 %, n=141). Forty-one percent (n=66) used cannabis and 24 % (n=30) used alcohol use in the past 30 days. In adjusted models, discomfort intolerance was positively associated with days of cannabis use (IRR = 1.11, p =.016) and days of alcohol use (IRR = 1.14, p =.022). Discomfort avoidance was not associated with cannabis or alcohol use., Conclusion: Individuals with chronic pain receiving prescribed buprenorphine for treatment of OUD with lower tolerance for physical discomfort may augment pain management with cannabis and alcohol. Given the intersections between substance use and retention in care for OUD, future work should extend this preliminary work by exploring these relationships over time and in experimental settings. Clinical Trial # NCT03698669., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Risa B. Weisberg reports a relationship with RealizedCare that includes: employment. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)
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- 2024
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6. Study protocol for the Treating Opioid Patients' Pain and Sadness (TOPPS) study - A randomized control trial to lower depression and chronic pain interference, and increase care retention among persons receiving buprenorphine.
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Stein MD, Bendiks S, Karzhevsky S, Pierce C, Dunn A, Majeski A, Herman DS, and Weisberg RB
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- Humans, Opiate Substitution Treatment methods, Male, Retention in Care, Behavior Therapy methods, Adult, Female, Health Education organization & administration, Health Education methods, Middle Aged, Buprenorphine therapeutic use, Buprenorphine administration & dosage, Chronic Pain drug therapy, Opioid-Related Disorders drug therapy, Opioid-Related Disorders therapy, Depression drug therapy, Depression therapy, Depression epidemiology, Analgesics, Opioid therapeutic use, Analgesics, Opioid administration & dosage
- Abstract
Background: Persons receiving prescription buprenorphine for opioid use disorder experience high rates of comorbid conditions such as chronic pain and depression, which present barriers to buprenorphine care retention. This paper describes the protocol of the TOPPS (Treating Opioid Patients' Pain and Sadness) study, which compares a values-based, behavioral activation intervention with a health education contact-control condition, with the aim of decreasing chronic pain and depression, and increasing buprenorphine care retention for persons with opioid use disorder., Methods: This randomized controlled trial (RCT) enrolls and randomizes up to 250 participants currently being treated with buprenorphine to receive three months of either TOPPS, a six-session phone-based behavioral intervention, or a health education (HE) control condition. We compare the TOPPS intervention to HE on the following outcomes: 1) pain interference and pain severity over the 3-month treatment phrase; 2) depressive symptoms over the 3-month treatment phase; and 3) sustained improvements in pain interference, depressive symptoms, and buprenorphine treatment retention over the 12-month study period. We also examine mechanisms by which the intervention may reduce pain interference., Discussion: This RCT explores a novel intervention to address chronic pain and depression for individuals receiving buprenorphine in office-based settings. TOPPS may lead to improved pain, depression, and substance use outcomes, and can utilize providers available within buprenorphine programs, broadening the disseminability of this intervention and heightening its public health impact., Clinical Trial: #NCT03698669., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Risa Weisberg is currently the Chief Clinical Officer for RealizedCare, a digital therapeutics-based healthcare company. RealizedCare manufactures and sells behavioral health products including those for chronic pain and opioid use., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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7. Is Abstinence from Alcohol and Smoking Associated with Less Anxiety and Depressive Symptoms Among People with HIV?
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Freibott CE, Biondi BE, Rao SR, Blokhina E, Dugas JN, Patts G, Bendiks S, Krupitsky E, Chichetto NE, Samet JH, Freiberg MS, Stein MD, and Tindle HA
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- Humans, Depression epidemiology, Tobacco Use Cessation Devices, Smoking epidemiology, Smoking therapy, Varenicline therapeutic use, Ethanol, Anxiety epidemiology, Smoking Cessation psychology, HIV Infections complications, HIV Infections epidemiology, HIV Infections drug therapy
- Abstract
Achieving abstinence from alcohol, tobacco, or both may improve mental health, but is understudied in people with HIV (PWH). The St PETER HIV randomized clinical trial compared varenicline, cytisine, and nicotine replacement therapy on alcohol and smoking behavior among 400 PWH in Russia. The primary exposure was thirty-day point prevalence abstinence (PPA) from (1) alcohol, (2) smoking, (3) both, or (4) neither and was assessed at 1, 3, 6 and 12-months as were the study outcomes of anxiety (GAD-7) and depressive (CES-D) symptoms. The primary aim was to examine the association between smoking and/or alcohol abstinence and subsequent symptoms of depression and anxiety. Primary analysis used repeated measures generalized linear modeling to relate PPA with mental health scores across time. In secondary analyses, Kruskal-Wallis tests related PPA with mental health scores at each timepoint. Primary analyses did not identify significant differences in anxiety or depressive symptoms between exposure groups over time. Secondary analyses found CES-D scores across PPA categories were similar at 1-month (11, 10, 11, 11) and 6-months (10, 10, 11, 11) but differed at 3-months (9, 11, 10, 12; p = 0.035) and 12-months (10, 6, 11, 10; p = 0.019). GAD-7 scores did not vary across PPA categories at any time point. While abstinence was associated with fewer depressive symptoms at times, findings were not consistent during follow-up, perhaps reflecting intermittent relapse. PWH with polysubstance use and mental health comorbidity are complex, and larger samples with sustained abstinence would further elucidate effects of abstinence on mental health., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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8. Pilot RCT comparing low-dose naltrexone, gabapentin and placebo to reduce pain among people with HIV with alcohol problems.
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Tsui JI, Rossi SL, Cheng DM, Bendiks S, Vetrova M, Blokhina E, Winter M, Gnatienko N, Backonja M, Bryant K, Krupitsky E, and Samet JH
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- Adult, Female, Humans, Male, Double-Blind Method, Gabapentin therapeutic use, Naltrexone therapeutic use, Pain Management, Treatment Outcome, Middle Aged, Alcohol-Related Disorders, Chronic Pain complications, Chronic Pain drug therapy, HIV Infections complications, HIV Infections drug therapy
- Abstract
Background: To estimate the effects on pain of two medications (low-dose naltrexone and gabapentin) compared to placebo among people with HIV (PWH) with heavy alcohol use and chronic pain., Methods: We conducted a pilot, randomized, double-blinded, 3-arm study of PWH with chronic pain and past-year heavy alcohol use in 2021. Participants were recruited in St. Petersburg, Russia, and randomized to receive daily low-dose naltrexone (4.5mg), gabapentin (up to 1800mg), or placebo. The two primary outcomes were change in self-reported pain severity and pain interference measured with the Brief Pain Inventory from baseline to 8 weeks., Results: Participants (N = 45, 15 in each arm) had the following baseline characteristics: 64% male; age 41 years (SD±7); mean 2 (SD±4) heavy drinking days in the past month and mean pain severity and interference were 3.2 (SD±1) and 3.0 (SD±2), respectively. Pain severity decreased for all three arms. Mean differences in change in pain severity for gabapentin vs. placebo, and naltrexone vs. placebo were -0.27 (95% confidence interval [CI] -1.76, 1.23; p = 0.73) and 0.88 (95% CI -0.7, 2.46; p = 0.55), respectively. Pain interference decreased for all three arms. Mean differences in change in pain interference for gabapentin vs. placebo, and naltrexone vs. placebo was 0.16 (95% CI -1.38, 1.71; p = 0.83) and 0.40 (95% CI -1.18, 1.99; p = 0.83), respectively., Conclusion: Neither gabapentin nor low-dose naltrexone appeared to improve pain more than placebo among PWH with chronic pain and past-year heavy alcohol use., Clinical Trial Registration: ClinicalTrials.gov (NCT4052139)., Competing Interests: Employees of the funder NIH (K. Bryant and M. Backonja) are co-authors on this manuscript and helped guide analysis, interpretation and presentation of data and participated in the decision to submit the manuscript for publication. The funder provided support in the form of salaries for authors [K. Bryant, M. Backonja], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section. D. Cheng serves on Data Safety Monitoring Boards for Janssen Research & Development. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The remaining authors report no conflicts of interest., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)
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- 2024
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9. Healthcare Utilization Among Persons with HIV and Unhealthy Alcohol Use in St. Petersburg, Russia.
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Biondi BE, Freibott CE, Cheng DM, Blokhina E, Lioznov D, Rateau L, Patts GJ, Bendiks S, Gnatienko N, Tindle HA, Freiberg MS, Krupitsky E, Samet JH, and Stein MD
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- Humans, Alcohol Drinking epidemiology, Delivery of Health Care, Patient Acceptance of Health Care, Russia epidemiology, Randomized Controlled Trials as Topic, HIV Infections epidemiology, HIV Infections complications
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Few studies have examined the association between healthcare utilization and heavy alcohol use in Russia among persons with HIV (PWH), a group with high healthcare needs. This study analyzed the association between unhealthy alcohol use (defined as AUDIT score ≥ 8) and healthcare utilization among PWH with heavy alcohol use and daily smoking in St. Petersburg, Russia. This secondary analysis used data from a randomized controlled trial addressing alcohol use. The primary outcome was seeing an infectionist for HIV care in the past year. Outcomes were measured at baseline, 6 months, and 12 months. We assessed the association between unhealthy alcohol use and healthcare utilization outcomes with a repeated measures logistic regression model, controlling for relevant covariates. Nearly all (96.0%) participants had unhealthy alcohol use at baseline, and 90.0% had seen an infectionist for HIV care in the past year. In adjusted analyses, unhealthy alcohol use was associated with a 36% decrease in seeing an infectionist for HIV care (aOR = 0.64, 95% CI 0.43-0.95). Participants reported low levels of emergency department visits and hospitalizations. Understanding how to engage this population in alcohol use disorder treatment and HIV care is an important next step for improving health outcomes for this population., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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10. Association of Alcohol Consumption With CD4 Recovery After Antiretroviral Therapy Initiation in St. Petersburg, Russia.
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McLaughlin A, Lin N, Jiang W, Lodi S, Lioznov D, Patts G, Gnatienko N, Blokhina E, Bendiks S, Freiberg MS, Tindle HA, Krupitsky E, Hahn JA, Samet JH, and So-Armah K
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- Adult, Female, Humans, Male, Ethanol, Retrospective Studies, Russia epidemiology, Alcohol Drinking adverse effects, Alcohol Drinking immunology, CD4 Lymphocyte Count, HIV Infections complications, HIV Infections drug therapy, Anti-Retroviral Agents adverse effects, Anti-Retroviral Agents immunology, CD4 Antigens immunology
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Background: Delayed CD4 recovery after initiating antiretroviral therapy (ART) is a novel potential mechanism by which alcohol consumption leads to increased morbidity and mortality in people with HIV. We hypothesized that alcohol consumption at ART initiation is associated with slower CD4 recovery., Methods: We retrospectively analyzed 2 pooled longitudinal alcohol/HIV cohorts (2014-2019) in St. Petersburg, Russia. Eligible participants initiated the first ART during parent studies; had alcohol consumption assessed by the blood biomarker, phosphatidylethanol (PEth), at the last research visit before ART initiation; and had ≥1 CD4 count measurement before and after initiating ART. Participants were stratified by low, moderate, and high PEth (<8, 8-80, and >80 ng/mL, respectively). We used random-effects piecewise linear regression models to estimate CD4 recovery, defined as CD4 count change per 30 days after ART initiation, by the alcohol group., Results: Of 60 eligible participants, median age was 34 years and 28% were female. The median pre-ART PEth in the low, moderate, and high PEth groups were <8, 23, and 232 ng/mL, respectively. After starting ART, the CD4 count increased by 13.60 cells/mm3/mo (95% CI: 0.33 to 26.87) with low PEth, 0.93 cells/mm3/mo (95% CI: -6.18 to 8.04) with moderate PEth, and 2.33 cells/mm3/mo (95% CI: -3.44 to 8.09) with high PEth., Conclusions: Among Russians with HIV, we observed faster CD4 recovery after ART initiation in those with low alcohol consumption compared with those with moderate and high alcohol consumption, as assessed by PEth. This analysis provides further evidence for the possible value of alcohol reduction interventions for people with HIV who are initiating ART., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2023
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11. Pilot study of tolerability and safety of opioid receptor antagonists as novel therapies for chronic pain among persons living with HIV with past year heavy drinking: a randomized controlled trial.
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Bendiks S, Cheng DM, Blokhina E, Vetrova M, Verbitskaya E, Gnatienko N, Bryant K, Krupitsky E, Samet JH, and Tsui JI
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- Humans, Narcotic Antagonists therapeutic use, Naltrexone therapeutic use, Pilot Projects, Treatment Outcome, Alcoholism, Chronic Pain drug therapy, HIV Infections complications, HIV Infections drug therapy
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Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03278886.
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- 2023
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12. An acceptance-based, intersectional stigma coping intervention for people with HIV who inject drugs-a randomized clinical trial.
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Luoma JB, Rossi SL, Sereda Y, Pavlov N, Toussova O, Vetrova M, Bendiks S, Kiriazova T, Krupitsky E, Lioznov D, Blokhina E, Lodi S, and Lunze K
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Background: People with HIV who inject drugs experience intersecting forms of stigma that adversely impact care access. This RCT aimed to evaluate effects of a behavioral intersectional stigma coping intervention on stigma and care utilization., Methods: We recruited 100 participants with HIV and past-30-day injection drug use at a non-governmental harm reduction organization in St. Petersburg, Russia, and randomized them 1:2 to receive usual services only or an additional intervention of three weekly 2-h group sessions. Primary outcomes were change in HIV and substance use stigma scores at one month after randomization. Secondary outcomes were initiation of antiretroviral treatment (ART), substance use care utilization, and changes in frequency of past-30-days drug injection at six months. The trial was registered as NCT03695393 at clinicaltrials.gov., Findings: Participant median age was 38.1 years, 49% were female. Comparing 67 intervention and 33 control group participants recruited October 2019-September 2020, the adjusted mean difference (AMD) in change in HIV and substance use stigma scores one month after baseline were 0.40, (95% CI: -0.14 to 0.93, p = 0.14) and -2.18 (95% CI: -4.87 to 0.52, p = 0.11), respectively. More intervention participants than control participants initiated ART (n = 13, 20% vs n = 1, 3%, proportion difference 0.17, 95% CI: 0.05-0.29, p = 0.01) and utilized substance use care (n = 15, 23% vs n = 2, 6%, proportion difference 0.17, 95% CI: 0.03-0.31, p = 0.02). The adjusted median difference in change in injecting drug use frequency 6 months after baseline was -3.33, 95% CI: -8.51 to 1.84, p = 0.21). Five not intervention-related serious adverse events (7.5%) occurred in the intervention group, one (3.0%) serious adverse event in the control group., Interpretation: This brief stigma-coping intervention did not change stigma manifestations or drug use behaviors in people with HIV and injection drug use. However, it seemed to reduce stigma's impact as an HIV and substance use care barrier., Funding: R00DA041245, K99DA041245, P30AI042853., Competing Interests: We declare no conflicts of interests., (© 2023 The Author(s).)
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- 2023
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13. Virally Suppressed People Living with HIV Who Use Opioids Have Diminished Latency Reversal.
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Basukala B, Rossi S, Bendiks S, Gnatienko N, Patts G, Krupitsky E, Lioznov D, So-Armah K, Sagar M, Cheng C, and Henderson AJ
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- Humans, Analgesics, Opioid pharmacology, Leukocytes, Mononuclear, Virus Latency, Proviruses genetics, HIV Infections drug therapy, HIV-1
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Of the 12 million people who inject drugs worldwide, 13% live with HIV. Whether opioid use impacts HIV pathogenesis and latency is an outstanding question. To gain insight into whether opioid use influences the proviral landscape and latent HIV reservoir, we performed intact proviral DNA assays (IPDA) on peripheral blood mononuclear cells (PBMCs) from antiretroviral therapy (ART)-suppressed people living with HIV (PWH) with or without current opioid use. No differences were observed between PWH with and without opioid use in the frequency of HIV intact and defective proviral genomes. To evaluate the latent reservoir, we activated PBMCs from ART-suppressed PWH with or without opioid use and assessed the induction of HIV RNA. PWH using opioids had diminished responses to ex vivo HIV reactivation, suggesting a smaller reversible reservoir of HIV-1 latently infected cells. However, in vitro studies using primary CD4+ T cells treated with morphine showed no effect of opioids on HIV-1 infection, replication or latency establishment. The discrepancy in our results from in vitro and clinical samples suggests that while opioids may not directly impact HIV replication, latency and reactivation in CD4+ T cells, opioid use may indirectly shape the HIV reservoir in vivo by modulating general immune functions.
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- 2023
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14. Correlates of Intersectional HIV and Substance Use Stigma Affecting People with HIV and Substance Use in St. Petersburg, Russia.
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Lodi S, Rossi SL, Bendiks S, Gnatienko N, Lloyd-Travaglini C, Vetrova M, Toussova O, Bushara N, Blokhina E, Krupitsky E, Ekstrand ML, Lioznov D, Samet JH, and Lunze K
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- Humans, Social Stigma, Russia epidemiology, Substance Abuse, Intravenous complications, Substance Abuse, Intravenous epidemiology, Substance Abuse, Intravenous psychology, HIV Infections psychology, Substance-Related Disorders epidemiology, Substance-Related Disorders complications, Alcoholism complications
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People with HIV (PWH) who inject drugs often experience coexisting HIV- and substance use-related stigma manifestations. We assessed correlates of HIV stigma (Berger HIV stigma scale), substance use stigma (Substance Abuse Self-stigma scale) and intersectional HIV and substance use stigma in a cohort of PWH with a lifetime history of drug use in St. Petersburg, Russia. Intersectional stigma was defined as having a score greater than the median for both forms of stigma. Of the 208 participants, 56 (27%) had intersectional stigma. Depressive symptoms and alcohol dependence were significantly associated with a higher HIV and substance stigma score, but not with intersectional stigma. Individual and community interventions to reduce the impact of HIV stigma and substance use stigma affecting PWH who inject drugs should consider assessing and addressing mental health and unhealthy substance use. Further work with longitudinal data is needed to understand mechanisms leading to intersectional stigma., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2023
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15. Impulsivity and linkage to HIV Care among People living with HIV in St. Petersburg, Russia.
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Dey AK, Ennis N, Cheng DM, Blokhina E, Raj A, Quinn E, Bendiks S, Palfai T, Dunne EM, Cook RL, Krupitsky E, and Samet JH
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- Adult, Male, Humans, Female, CD4 Lymphocyte Count, Impulsive Behavior, Russia epidemiology, Substance Abuse, Intravenous diagnosis, HIV Infections epidemiology, HIV Infections therapy, HIV Infections diagnosis, Substance-Related Disorders complications, Substance-Related Disorders epidemiology, Substance-Related Disorders therapy
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This study evaluated the association between impulsivity and linkage to HIV care among Russians living with HIV recruited from an inpatient narcology hospital. Linking Infectious and Narcology Care (LINC) study participants who completed the Barratt Impulsiveness Scale (BIS) were included in these analyses. The primary independent variable was impulsivity score which was categorized as high impulsivity (BIS score > 71) vs. low impulsivity (BIS score < = 71). The primary outcome, linkage to care post recruitment, was defined as one or more HIV medical care visits at 12-month follow-up. Multiple logistic regression models were used to evaluate the association between high impulsivity and linkage to HIV care controlling for potential confounders. Participants (N = 227) were adults with a mean age of 34 years (SD = 5), and the majority were male (74%). We did not detect a significant association between impulsivity and linkage to HIV care after adjusting for respondents' age, gender, CD4 cell count, and depression score. We also found that substance use and hazardous drinking did not appear to confound the relationship. Although our study was unable to detect an association between impulsivity and linkage to HIV care, it may provide direction for future research exploring the associations between impulsivity and HIV care., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2022
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16. Police abuse and care engagement of people with HIV who inject drugs in Ukraine.
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Schoenberger SF, Idrisov B, Sereda Y, Kiriazova T, Makarenko O, Bendiks S, Ahuja N, Dutta A, Flanigan T, Gillani FS, and Lunze K
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- Male, Female, Humans, Police, Ukraine epidemiology, Cross-Sectional Studies, Anti-Retroviral Agents therapeutic use, Substance Abuse, Intravenous complications, Substance Abuse, Intravenous epidemiology, HIV Infections drug therapy, HIV Infections epidemiology
- Abstract
Police abuse affects people who inject drugs (PWID), including those with HIV, and negatively impacts care engagement. This cross-sectional study evaluated police abuse among PWID receiving MOUD (medication for opioid use disorder) living with HIV and associations with HIV treatment adherence and receipt of NGO services. We assessed lifetime and past six-month rates of police abuse among a cohort of Ukrainian PWID with HIV receiving MOUD ( n = 190) from August to September 2017. Logistic regression models evaluated associations between past six-month police abuse and past 30-day antiretroviral therapy (ART) adherence, and past six-month NGO service receipt. Almost all (90%) participants reported lifetime police abuse: 77% reported physical violence and 75% reported paying the police to avoid arrest. One in four females (25%) reported police-perpetrated sexual violence. Recent police abuse was reported by 16% of males and 2% of females and was not associated with ART adherence (aOR: 1.1; 95% CI:0.3-5.0) or NGO service receipt (aOR: 3.4; 95% CI:0.6-18.3). While lifetime police abuse rates were high, few participants reported recent police abuse, which was not linked to care engagement. These trends should encourage the Ukrainian government for public health-public safety partnerships and legal interventions to eliminate human rights violations against PWID living with HIV.
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- 2022
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17. Effectiveness of Varenicline and Cytisine for Alcohol Use Reduction Among People With HIV and Substance Use: A Randomized Clinical Trial.
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Tindle HA, Freiberg MS, Cheng DM, Gnatienko N, Blokhina E, Yaroslavtseva T, Bendiks S, Patts G, Hahn J, So-Armah K, Stein MD, Bryant K, Lioznov D, Krupitsky E, and Samet JH
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- Adult, Alkaloids, Azocines, Benzazepines therapeutic use, Female, Humans, Male, Nicotine, Nicotinic Agonists therapeutic use, Quinolizines, Tobacco Use Cessation Devices, Varenicline therapeutic use, Alcoholism, HIV Infections complications, HIV Infections drug therapy, Smoking Cessation
- Abstract
Importance: Cigarette smoking and risky alcohol consumption co-occur and are undertreated. Nicotine receptor partial agonists and nicotine replacement therapy (NRT) treat smoking but are unproven for alcohol, and clinical trials rarely include individuals with HIV, substance use, and mental health conditions., Objective: To compare the effects on drinking and smoking of nicotinic acetylcholine receptor partial agonists varenicline and cytisine with those of NRT., Design, Setting, and Participants: This 4-group randomized, double-blinded, placebo-controlled clinical trial was conducted from July 2017 to December 2020 in St Petersburg, Russia. Included participants were 400 individuals with HIV who engaged in risky drinking (≥5 prior-month heavy-drinking days [HDDs]) and daily smoking; they were followed up for 12 months after enrollment. Data were analyzed from May 2021 through June 2022., Interventions: Participants received alcohol and tobacco counseling, 1 active medication, and 1 placebo in 1 of 4 groups: active varenicline and placebo NRT (group 1), placebo varenicline and active NRT (group 2), active cytisine and placebo NRT (group 3), or placebo cytisine and active NRT (group 4)., Main Outcomes and Measures: The primary outcome was number of prior-month HDDs at 3 months. Secondary outcomes included biochemically validated abstinence from alcohol at 3 months and smoking at 6 months., Results: Among 400 participants (263 [65.8%] men; mean [SD] age, 39 [6] years), 97 individuals (24.3%) used opioids and 156 individuals (39.1%) had depressive symptoms. These individuals had a mean (SD) CD4 count of 391 (257) cells/mm3, smoked a mean (SD) of 21 [8] cigarettes/d, and reported a mean (SD) of 9.3 (5.8) HDDs in the prior 30 days. At 3 months, the mean (SD) number of HDDs was decreased vs baseline across all groups (group 1: 2.0 [3.8] HDDs vs. 9.5 [6.1] HDDs; group 2: 2.1 [4.3] HDDs vs 9.3 [5.7] HDDs; group 3: 1.5 [3.3] HDDs vs 8.9 [5.0] HDDs; group 4: 2.4 [5.2] HDDs vs 9.6 [6.3] HDDs). There were no significant differences at 3 months between groups in mean (SD) HDDs, including group 1 vs 2 (incident rate ratio [IRR], 0.94; 95% CI, 0.49-1.79), 3 vs 4 (IRR, 0.60; 95% CI, 0.30-1.18), and 1 vs 3 (IRR, 1.29; 95% CI, 0.65-2.55). There were no significant differences at 6 months between groups in smoking abstinence, including group 1 vs 2 (15 of 100 individuals [15.0%] vs 17 of 99 individuals [17.2%]; odds ratio [OR],0.89; 95% CI, 0.38-2.08), 3 vs 4 (19 of 100 individuals [19.0%] vs 19 of 101 individuals [18.8%]; OR, 1.00; 95% CI, 0.46-2.17), and 1 vs 3 (OR, 0.79; 95% CI, 0.35-1.78). Post hoc analyses suggested lower mean (SD) HDDs (eg, at 3 months: 0.7 [1.8] HDDs vs 2.3 [4.6] HDDs) and higher alcohol abstinence (eg, at 3 months: 30 of 85 individuals [35.3%] vs 54 of 315 individuals [17.1%]) among those who quit vs continued smoking., Conclusions and Relevance: This study found that among individuals with HIV who engaged in risky drinking and smoking, varenicline and cytisine were not more efficacious than NRT to treat risky drinking and smoking but that behavior change rates were high in all groups., Trial Registration: ClinicalTrials.gov Identifier: NCT02797587.
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- 2022
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18. Stigma and ART initiation among people with HIV and a lifetime history of illicit drug use in Saint-Petersburg, Russia-A prospective cohort analysis.
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Vetrova M, Lodi S, Rateau L, Patts G, Blokhina E, Palatkin V, Yaroslavtseva T, Toussova O, Bushara N, Bendiks S, Gnatienko N, Krupitsky E, Lioznov D, Samet JH, and Lunze K
- Subjects
- Adult, Cohort Studies, Female, Humans, Male, Prospective Studies, HIV Infections complications, HIV Infections drug therapy, HIV Infections epidemiology, Illicit Drugs, Substance Abuse, Intravenous complications, Substance Abuse, Intravenous epidemiology, Substance-Related Disorders complications
- Abstract
Background: HIV-positive people who inject drugs (PWID) are stigmatized and face more challenges in accessing ART. The natural course of stigma and its role on ART initiation in this population is unclear. We examined 1] whether HIV stigma changes over time and 2] whether HIV and substance use stigma are associated with ART initiation in a prospective cohort of HIV-positive PWID in St. Petersburg, Russia., Methods: We used data from 165 HIV-positive PWID who were ART-naïve at enrollment andgeneralized estimating equations to assess changes in HIV stigma between baseline, 12- and 24-month study visits. Logistic regression estimated associations of HIV stigma and substance use stigma with ART initiation. All models were adjusted for gender, age, CD4 count, duration of HIV diagnosis, recent (past 30-day) drug use and depressive symptoms., Results: Participants characteristics were the following: median age of 34 (Q1; Q3: 30; 37) years; 30% female; 28% with CD4 count <350; 44% reported recent drug use. During the study period, 31% initiated ART and the median time between HIV diagnosis and ART initiation was 8.5 years (Q1; Q3: 4.68; 13.61). HIV stigma scores decreased yearly by 0.57 (95% CI -1.36, 0.22). More than half (27/47 [57.4%]) of participants who were eligible for ART initiation per local ART guidelines did not initiate therapy. Total HIV stigma and substance use stigma scores were not associated with ART initiation (AOR 0.99, 95%CI 0.94-1.04; AOR 1.01, 95%CI 0.96-1.05, respectively)., Conclusion: In this Russian cohort of HIV-positive, ART-naïve PWID, stigma did not change over time and was not associated with ART initiation. Addressing stigma alone is unlikely to increase ART initiation rates in this population. Reducing further existing structural barriers, e.g., by promoting equal access to ART and the value of substance-use treatment for ART treatment success should complement stigma-reduction approaches., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022. Published by Elsevier B.V.)
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- 2022
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19. Addressing intersectional stigma as a care barrier for HIV-positive people who inject drugs: Design of an RCT in St. Petersburg, Russia.
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Rossi SL, Sereda Y, Luoma JB, Pavlov N, Toussova O, Vasileva J, Abramova K, Bendiks S, Kiriazova T, Vetrova M, Blokhina E, Krupitsky E, Lioznov D, Lodi S, and Lunze K
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Background: HIV-positive people who inject drugs (PWID) experience stigma related to their substance use and HIV, with adverse consequences to their health care utilization and mental health. To help affected individuals cope with their intersectional stigma and reduce its negative impact on health and health care, we adapted a behavioral stigma coping intervention for this HIV key population., Objective: To conduct a randomized controlled trial (RCT) testing the 'Stigma Coping to Reduce HIV risks and Improve substance use Prevention and Treatment' (SCRIPT) intervention, a community-based, adapted form of Acceptance and Commitment Therapy (ACT), for PWID living with HIV in St. Petersburg, Russia., Methods: We recruited 100 PWID living with HIV from civil society organizations (CSO) delivering harm reduction and HIV prevention services in St. Petersburg, Russia. We randomized participants 2:1 to receive either the intervention (three adapted ACT sessions in a group format over one month and usual CSO care) or usual CSO care alone. ACT aims to help affected individuals cope with stigma by increasing their psychological flexibility to handle stigma-related negative expectations, emotions and experiences. The primary outcomes were satisfaction with the intervention, and changes in HIV and substance use stigma scores., Conclusions: Stigma coping interventions targeting HIV-positive PWID outside of formal health care settings may help them confront negativities in their lives originating from intersectional stigma and reduce stigma's impact as a health care barrier., (© 2021 The Author(s).)
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- 2021
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20. Linking HIV-positive people in addiction care to HIV services in St. Petersburg, Russia - Mixed-methods implementation study of strengths-based case management.
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Lunze K, Kiriazova T, Blokhina E, Bushara N, Bridden C, Gnatienko N, Bendiks S, Quinn E, Krupitsky E, Raj A, and Samet JH
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- Case Management, Humans, Russia, Social Stigma, HIV Infections drug therapy, Substance Abuse, Intravenous complications
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Access to HIV services for HIV-positive patients in addiction care is challenging in Russia, because both care systems are organised independently from each other. Strengths-based case management is an effective strategy to connect people with HIV (PHIV) to HIV care. This mixed-methods study's objective was to investigate implementation of a case management intervention in St. Petersburg, Russia, designed to connect PHIV who inject drugs to HIV care. We analysed survey data from 118 HIV-positive patients in addiction care and conducted six focus groups (n=38). Quantitative analyses of fidelity and satisfaction outcomes and qualitative text analysis assessed intervention implementation. Participants who linked to HIV services embraced empowerment and motivation resulting from case management as supporting self-efficacy and linkage to services. Among participants who did not link to care, drug use impeded their care engagement. Main levers to implementation were empowerment to cope with challenges of a fragmented health system and persistent stigma. Those who connected to HIV services credited case managers for facilitating linkage; those who did not link attributed it to personal issues. Implementation of case management for HIV care in Russia should focus on effective substance use treatment and empowerment, motivation and support in addressing personal and system factors.
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- 2021
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21. HIV and Substance Use Stigma, Intersectional Stigma and Healthcare Among HIV-Positive PWID in Russia.
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Vetrova MV, Cheng DM, Bendiks S, Gnatienko N, Lloyd-Travaglini C, Jiang W, Luoma J, Blokhina E, Krupitsky E, Lioznov D, Ekstrand ML, Raj A, Samet JH, and Lunze K
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- Delivery of Health Care, Health Facilities, Humans, Russia epidemiology, Social Stigma, HIV Infections epidemiology, Substance Abuse, Intravenous epidemiology
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Little is known about the intersection of HIV stigma and substance use stigma. Using data from 188 HIV-positive people who inject drugs (PWID) in Russia, we examined the associations of these stigmas and their interaction with access and utilization of healthcare. While substance use stigma was significantly associated with poor access to care (AOR 2.31, 95%CI 1.50-3.57), HIV stigma was not. HIV stigma was associated with lower inpatient care utilization (AOR 0.32, 95%CI 0.14-0.65), while substance use stigma was not. We did not detect a significant interaction between the two forms of stigma for either of the primary outcomes. However, those with high levels of both substance use stigma and HIV stigma had higher odds of poor general access to healthcare (AOR 1.86, 95%CI 1.19-2.92), and lower odds of recent general outpatient (AOR 0.52, 95%CI 0.32-0.85) and any inpatient (AOR 0.48, 95%CI 0.22-0.99) care utilization compared to those with low levels of both types of stigma. Interventions addressing both substance use and HIV stigma in general healthcare settings might improve care in this HIV key population., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature.)
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- 2021
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22. The Hepatitis C Continuum of Care Among HIV-Positive Persons with Heavy Alcohol Use in St. Petersburg, Russia.
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Corcorran MA, Ludwig-Baron N, Cheng DM, Lioznov D, Gnatienko N, Patts G, So-Armah K, Blokhina E, Bendiks S, Krupitsky E, Samet JH, and Tsui JI
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- Continuity of Patient Care, Hepacivirus, Humans, Russia epidemiology, Coinfection epidemiology, HIV Infections complications, HIV Infections drug therapy, HIV Infections epidemiology, Hepatitis C complications, Hepatitis C epidemiology
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This study describes the self-reported prevalence of hepatitis C virus (HCV) coinfection and the HCV care continuum among persons enrolled in the St PETER HIV Study, a randomized controlled trial of medications for smoking and alcohol cessation in HIV-positive heavy drinkers and smokers in St. Petersburg, Russia. Baseline health questionnaire data were used to calculate proportions and 95% confidence intervals for self-reported steps along the HCV continuum of care. The cohort included 399 HIV-positive persons, of whom 387 [97.0% (95% CI 95.3-98.7%)] reported a prior HCV test and 315 [78.9% (95% CI 74.9-82.9%)] reported a prior diagnosis of HCV. Among those reporting a diagnosis of HCV, 43 [13.7% (95% CI 9.9-17.4%)] had received treatment for HCV, and 31 [9.8% (95% CI 6.6-13.1%)] had been cured. Despite frequent HCV testing in this HIV-positive Russian cohort, the proportion reporting prior effective HCV treatment was strikingly low. Increased efforts are needed to scale-up HCV treatment among HIV-positive Russians in St. Petersburg.
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- 2021
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23. Violence, HIV Risks, and Polysubstance Use Among HIV-Positive People Who Inject Drugs in Ukraine.
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Lee JO, Yoon Y, Idrisov B, Kiriazova T, Makarenko O, Sereda Y, Bendiks S, Cody K, Schoenberger SF, Nurius PS, Halim N, Flanigan T, Samet JH, Liebschutz J, and Lunze K
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- Boston, Female, Humans, Prevalence, Risk Factors, Sexual Partners, Ukraine epidemiology, Violence, HIV Infections complications, HIV Infections epidemiology, Intimate Partner Violence, Pharmaceutical Preparations
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Violence experience has been consistently associated with HIV risks and substance use behaviors. Although many studies have focused on intimate partner violence (IPV), the role of violence at a structural level (i.e., police abuse) remains relevant for people who inject drugs. This study evaluated the association of IPV and police-perpetrated violence experiences with HIV risk behaviors and substance use in a cohort of HIV-positive people who inject drugs in Ukraine. We also evaluated possible moderation effects of gender and socioeconomic status in the links between violence exposure and HIV risk and polysubstance use behaviors. Data came from the Providence/Boston-CFAR-Ukraine Study involving 191 HIV-positive people who inject drugs conducted at seven addiction treatment facilities in Ukraine. Results from logistic regressions suggest that people who inject drugs and experienced IPV had higher odds of polysubstance use than those who did not experience IPV. Verbal violence and sexual violence perpetrated by police were associated with increased odds of inconsistent condom use. The odds of engaging in polysubstance use were lower for women in relation to police physical abuse. We found no evidence supporting socioeconomic status moderations. Violence experiences were associated with substance use and sexual HIV risk behaviors in this cohort of HIV-positive people who inject drugs in Ukraine. Trauma-informed prevention approaches that consider both individual and structural violence could improve this population's HIV risks.
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- 2021
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24. Design of a randomized controlled trial of smoking cessation medications for alcohol reduction among HIV-positive heavy drinkers and daily smokers in St. Petersburg, Russia.
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Tindle HA, Freiberg MS, Gnatienko N, Blokhina E, Cheng DM, Yaroslavtseva T, Bendiks S, Winter M, Krupitsky E, and Samet JH
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Background: HIV, heavy drinking, and smoking are all pro-inflammatory and increase risk for coronary heart disease (CHD). Interventions that reduce alcohol use, smoking, or both in HIV-positive people could lower inflammation, CHD and death risk. Varenicline and cytisine are proven therapies for smoking cessation and may also reduce alcohol consumption. The comparative efficacy of varenicline and cytisine to reduce alcohol consumption has not been tested, nor has their comparative effectiveness been reported for smoking., Objective: This paper describes the protocol of the Studying Partial agonists for Ethanol and Tobacco Elimination in Russians with HIV (St PETER HIV), a four-arm parallel-group randomized controlled trial comparing effects of varenicline, cytisine, and nicotine replacement therapy (NRT)., Methods: The study is recruiting four hundred HIV-positive heavy drinking smokers interested in cutting down on alcohol and/or tobacco in St. Petersburg, Russia. Participants are randomly assigned to receive either active varenicline + NRT placebo, varenicline placebo + active NRT, active cytisine + NRT placebo, cytisine placebo + active NRT. All participants receive evidence-based counseling for alcohol and tobacco use, one active medication, and one placebo. Outcomes are: 1) % heavy drinking days in the past month (primary study outcome at three months) and alcohol craving; 2) cigarettes per day (primary smoking outcome at 3 months) and 7-day point prevalence abstinence and; 3) inflammation, CHD risk, and mortality risk., Conclusion: St PETER HIV addresses the paucity of randomized controlled trial data to guide treatment of alcohol consumption and smoking in HIV-positive heavy drinking smokers., Competing Interests: Dr. Tindle has provided scientific input into the design of a phase III trial for cytisine to be considered for approval by the United States Food and Drug Administration to aid in smoking cessation. In this capacity she has served as an unpaid consultant to Achieve Life Sciences. She is also the principal investigator of an NIH-supported study that has received donated varenicline medication from the manufacturer (Pfizer) for smokers with cancer. The remaining authors report no declarations of interest., (© 2020 Published by Elsevier Inc.)
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- 2020
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25. Stigma and quality of co-located care for HIV-positive people in addiction treatment in Ukraine: a cross-sectional study.
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Sereda Y, Kiriazova T, Makarenko O, Carroll JJ, Rybak N, Chybisov A, Bendiks S, Idrisov B, Dutta A, Gillani FS, Samet JH, Flanigan T, and Lunze K
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- Adult, Analgesics, Opioid therapeutic use, Cross-Sectional Studies, Female, HIV Infections complications, HIV Infections drug therapy, Humans, Male, Middle Aged, Substance Abuse, Intravenous complications, Ukraine, Young Adult, Delivery of Health Care, HIV Infections psychology, Social Stigma
- Abstract
Introduction: Co-located treatment for HIV and opioid use disorder has been shown to improve care outcomes for HIV-positive people who inject drugs (PWID) in Ukraine. However, patients continue to be stigmatized for both HIV and substance use. This study aimed to assess whether co-located care for HIV-positive PWID receiving opioid agonist treatment (OAT) services in Ukraine is associated with less stigma and better perceived quality of HIV services., Methods: This cross-sectional study enrolled 191 HIV-positive PWID who received OAT services at three healthcare facilities providing substance use treatment (OAT only) and at four facilities that provided co-located care (both OAT and HIV treatment) in six regions in Ukraine during July-September, 2017. Primary outcomes were HIV stigma (Berger scale), substance use stigma (Substance Abuse Stigma Scale) and intersectional stigma (both stigma forms above 75th percentile). Secondary outcome was quality of HIV care, a composite score based on a package of received services. Linear and ordinal regressions were used to assess the predictors of selected outcomes., Results: Study participants were 75% male, mean age 40 ± 7 years; 47% received co-located care, and 10.5% had both high HIV and substance use stigma. Co-located care was neither associated with HIV nor substance use stigma but it was linked to better quality of HIV care (adjusted odds ratio: 4.13; 95% CI: 2.31, 7.54). HIV stigma was associated with suicide attempts (adjusted beta (aβ): 5.90; 95% CI: 2.05, 9.75), and substance use stigma was linked to poor mental health (aβ: -0.26; 95% CI: -0.44, -0.08) and lower likelihood of receipt of services from non-governmental organization (NGO; aβ: -6.40; 95% CI: -10.23, -2.57)., Conclusion: One in ten people with HIV in this cohort who received OAT services experienced high levels of both HIV and substance use stigma, which was associated with poorer mental health and less NGO support. Co-located HIV and OAT services were linked to better perceived quality of HIV care, but did not seem to reduce stigma for this key population. Stigma interventions for PWID, possibly delivered involving NGOs, may be an approach to mitigate this challenge., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)
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- 2020
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26. Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia.
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Gnatienko N, Lioznov D, Raj A, Blokhina E, Rosen S, Cheng DM, Lunze K, Bendiks S, Truong V, Bushara N, Toussova O, Quinn E, Krupitsky E, and Samet JH
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- Humans, CD4 Lymphocyte Count, Drug Implants, Patient Compliance, Russia epidemiology, Viral Load, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Anti-HIV Agents administration & dosage, Anti-HIV Agents therapeutic use, Case Management organization & administration, HIV Infections drug therapy, HIV Infections epidemiology, Narcotic Antagonists therapeutic use, Opioid-Related Disorders drug therapy, Opioid-Related Disorders epidemiology, Substance Abuse, Intravenous drug therapy, Substance Abuse, Intravenous epidemiology
- Abstract
Background: If Russia is to achieve the UNAIDS 90-90-90 HIV targets, better approaches to engage, effectively treat, and retain patients in care are needed. This paper describes the protocol of a randomized controlled trial (RCT) testing the effectiveness of LINC-II, a strength-based case management program for HIV-positive people who inject drugs (PWID) to increase rates of HIV viral suppression, ART initiation, and opioid abstinence., Methods: This RCT will enroll and randomize 240 participants, recruited from a narcology (addiction care) hospital in St. Petersburg, Russia. Participants are randomized to the intervention or control arms. Those in the intervention arm receive: (1) strengths-based HIV case management supporting coordinated care; (2) rapid ART initiation; and (3) pharmacotherapy for opioid use disorder. We will evaluate the intervention's effectiveness compared to standard of care on the following outcomes: (1) undetectable HIV viral load at 12 months (primary); (2) initiation of ART within 28 days of randomization; (3) change in CD4 count from baseline to 12 months; (4) retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods); (5) undetectable HIV viral load at 6 months; and (6) past 30-day opioid abstinence (at 6 and at 12 months)., Discussion: This RCT will assess the LINC-II intervention in an urban Russian setting. If effective, it will offer a new approach for increasing the uptake of both HIV and opioid use disorder treatment and coordination of these modalities in standard Eastern European clinical settings. Trial registration This study was registered with ClinicalTrials.gov through the National Institutes of Health, NCT03290391. Registered 19 September 2017, https://clinicaltrials.gov/ct2/show/NCT03290391.
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- 2020
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27. Design of a randomized controlled trial of zinc supplementation to improve markers of mortality and HIV disease progression in HIV-positive drinkers in St. Petersburg, Russia.
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Gnatienko N, Freiberg MS, Blokhina E, Yaroslavtseva T, Bridden C, Cheng DM, Chaisson CE, Lioznov D, Bendiks S, Koerbel G, Coleman SM, Krupitsky E, and Samet JH
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- Adolescent, Adult, Aged, Alcoholism mortality, Bacterial Translocation drug effects, Cardiovascular Diseases epidemiology, Disease Progression, Double-Blind Method, Female, HIV Infections mortality, Humans, Inflammation pathology, Male, Middle Aged, Placebos administration & dosage, Risk Assessment, Russia, Surveys and Questionnaires, Survival Analysis, Treatment Outcome, Young Adult, Alcoholism complications, Alcoholism therapy, Dietary Supplements, HIV Infections complications, HIV Infections therapy, Zinc administration & dosage
- Abstract
Background Russia continues to have an uncontrolled HIV epidemic and its per capita alcohol consumption is among the highest in the world. Alcohol use among HIV-positive individuals is common and is associated with worse clinical outcomes. Alcohol use and HIV each lead to microbial translocation, which in turn results in inflammation. Zinc supplementation holds potential for lowering levels of biomarkers of inflammation, possibly as a consequence of its impact on intestinal permeability. This paper describes the protocol of a double-blinded randomized placebo-controlled trial of zinc supplementation in St. Petersburg, Russia. Methods Participants (n = 254) were recruited between October 2013 and June 2015 from HIV and addiction clinical care sites, and non-clinical sites in St. Petersburg, Russia. Participants were randomly assigned, to receive either zinc (15 mg for men; 12 mg for women) or placebo, daily for 18 months. The following outcomes were assessed at 6, 12, and 18 months: (1) mortality risk (primary outcome at 18 months); (2) HIV disease progression; (3) cardiovascular risk; and (4) microbial translocation and inflammation. Adherence was assessed using direct (riboflavin) and indirect (pill count, self-report) measures. Conclusion Given the limited effectiveness of current interventions to reduce alcohol use, zinc supplementation merits testing as a simple, low-cost intervention to mitigate the consequences of alcohol use in HIV-positive persons despite ongoing drinking.
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- 2018
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