542 results on '"Springer, Sandra A"'
Search Results
202. Design and implementation of a prospective cohort study of persons living with and without HIV infection who are initiating medication treatment for opioid use disorder
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Biondi, Breanne E., Mohanty, Subhasis, Wyk, Brent Vander, Montgomery, Ruth R., Shaw, Albert C., and Springer, Sandra A.
- Abstract
Opioid use disorder (OUD) negatively impacts the HIV continuum of care for persons living with HIV. Medication treatment for OUD (MOUD) may have differential biological effects in individuals with HIV and OUD. To address the question of modulation of immune responses by MOUDs, we describe state of the art systems biology approaches to carry out the first prospective, longitudinal study of persons with and without HIV infection with OUD initiating MOUD.
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- 2021
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203. Self-reported antiretroviral therapy adherence and viral load in criminal justice-involved populations.
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Cunningham, William E., Nance, Robin M., Golin, Carol E., Flynn, Patrick, Knight, Kevin, Beckwith, Curt G., Kuo, Irene, Spaulding, Anne, Taxman, Faye S., Altice, Fredrick, Delaney, Joseph A., Crane, Heidi M., and Springer, Sandra A.
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VIRAL load ,ANTIRETROVIRAL agents ,LOGISTIC regression analysis ,CD4 lymphocyte count ,CONTINUUM of care - Abstract
Background: Self-reported antiretroviral therapy (ART) adherence measures that are associated with plasma viral load (VL) are valuable to clinicians and researchers, but are rarely examined among groups vulnerable to dropping out of care. One-seventh of all those living with HIV pass through incarceration annually and criminal-justice (CJ) involved people living with HIV (PLH) are vulnerable to falling out of care. We examined the association of self-reported ART adherence with VL in a criminal-justice sample compared to a routine-care sample.Methods: Samples: We examined data from a multisite collaboration of studies addressing the continuum of HIV care among CjJ involved persons in the Seek, Test, Treat, and Retain cohort. Data pooled from seven CJ- studies (n = 414) were examined and compared with the routine-care sample from the Centers for AIDS Research Network of Integrated Clinical Systems' seven sites (n = 11,698).Measures: In both samples, data on self-reported percent ART doses taken were collected via the visual analogue scale adherence measure. Viral load data were obtained by blood-draw.Analysis: We examined the associations of adherence with VL in both cohorts using mixed effects linear regression of log-VL, and mixed effects logistic regression of binary VL (≥ 200 copies/mL) outcomes. Interactions by CD4 count and self-reported health status were also tested.Results: Among the CJ sample, the coefficient for log-VL was - 0.31 (95% CI = - 0.43, - 0.18; P < 0.01) and that in the routine-care sample was - 0.42 (95% CI = - 0.45, - 0.38; P < 0.01). For the logistic regression of binary detectable VL on 10% increments of adherence we found the coefficient was - 0.26 (95% CI = - 0.37, - 0.14; P < 0.01) and in the routine-care sample it was - 0.38 (95% CI = - 0.41, - 0.35; P < 0.01). There was no significant interaction by CD4 count level in the CJ sample, but there was in the routine-care sample. Conversely, there was a significant interaction by self-reported health status level in the criminal-justice sample, but not in the routine-care sample.Conclusions: The visual analogue scale is valid and useful to measure ART adherence, supporting treatment for CJ- involved PLH vulnerable to falling out of care. Research should examine adherence and VL in additional populations. [ABSTRACT FROM AUTHOR]- Published
- 2019
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204. Risk behaviors and HIV care continuum outcomes among criminal justice-involved HIV-infected transgender women and cisgender men: Data from the Seek, Test, Treat, and Retain Harmonization Initiative
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Beckwith, Curt G., Kuo, Irene, Fredericksen, Rob J., Brinkley-Rubinstein, Lauren, Cunningham, William E., Springer, Sandra A., Loeliger, Kelsey B., Franks, Julie C., Christopoulos, Katerina, Lorvick, Jennifer, Kahana, Shoshana Y., Young, Rebekah, Seal, David W., Zawitz, Chad, Delaney, Joseph A., Crane, Heidi M., and Biggs, Mary L.
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HIV-positive persons--Care ,Transgender people ,Prisoners--Health and hygiene ,5. Gender equality ,Continuum of care ,Medicine ,3. Good health - Abstract
Background Transgender persons are highly victimized, marginalized, disproportionately experience incarceration, and have alarmingly increased rates of HIV infection compared to cis-gender persons. Few studies have examined the HIV care continuum outcomes among transgender women (TW), particularly TW who are involved with the criminal justice (CJ) system. Methods To improve our understanding of HIV care continuum outcomes and risk behaviors among HIV-infected TW who are involved with the CJ system, we analyzed data from the National Institute on Drug Abuse-supported Seek, Test, Treat, Retain (STTR) Data Harmonization Initiative. Baseline data were pooled and analyzed from three U.S. STTR studies to examine HIV risk and care continuum indicators among CJ-involved HIV-infected TW compared to cisgender men (CM), matched on age (within 5 years) and study at a ratio of 1:5. Results Eighty-eight TW and 440 CM were included in the study. Among matched participants, TW were more likely to report crack and cocaine use compared to CM (40%,16% respectively, p
205. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults 2022 Recommendations of the International Antiviral Society-USA Panel
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Gandhi, Rajesh T., Bedimo, Roger, Hoy, Jennifer F., Landovitz, Raphael J., Smith, Davey M., Eaton, Ellen F., Lehmann, Clara, Springer, Sandra A., Sax, Paul E., Thompson, Melanie A., Benson, Constance A., Buchbinder, Susan P., del Rio, Carlos, Eron, Joseph J., Jr., Guenthard, Huldrych F., Molina, Jean-Michel, Jacobsen, Donna M., Saag, Michael S., Gandhi, Rajesh T., Bedimo, Roger, Hoy, Jennifer F., Landovitz, Raphael J., Smith, Davey M., Eaton, Ellen F., Lehmann, Clara, Springer, Sandra A., Sax, Paul E., Thompson, Melanie A., Benson, Constance A., Buchbinder, Susan P., del Rio, Carlos, Eron, Joseph J., Jr., Guenthard, Huldrych F., Molina, Jean-Michel, Jacobsen, Donna M., and Saag, Michael S.
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Importance Recent advances in treatment and prevention of HIV warrant updated recommendations to guide optimal practice.Objective Based on a critical evaluation of new data, to provide clinicians with recommendations on use of antiretroviral drugs for the treatment and prevention of HIV, laboratory monitoring, care of people aging with HIV, substance use disorder and HIV, and new challenges in people with HIV, including COVID-19 and monkeypox virus infection.Evidence Review A panel of volunteer expert physician scientists were appointed to update the 2020 consensus recommendations. Relevant evidence in the literature (PubMed and Embase searches, which initially yielded 7891 unique citations, of which 834 were considered relevant) and studies presented at peer-reviewed scientific conferences between January 2020 and October 2022 were considered.Findings Initiation of antiretroviral therapy (ART) is recommended as soon as possible after diagnosis of HIV. Barriers to care should be addressed, including ensuring access to ART and adherence support. Integrase strand transfer inhibitor-containing regimens remain the mainstay of initial therapy. For people who have achieved viral suppression with a daily oral regimen, long-acting injectable therapy with cabotegravir plus rilpivirine given as infrequently as every 2 months is now an option. Weight gain and metabolic complications have been linked to certain antiretroviral medications; novel strategies to ameliorate these complications are needed. Management of comorbidities throughout the life span is increasingly important, because people with HIV are living longer and confronting the health challenges of aging. In addition, management of substance use disorder in people with HIV requires an evidence-based, integrated approach. Options for preexposure prophylaxis include oral medications (tenofovir disoproxil fumarate or tenofovir alafenamide plus emtricitabine) and, for the first time, a long-acting injectable agent, cabo
206. Dosimetric benefits of daily treatment plan adaptation for prostate cancer stereotactic body radiotherapy.
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Eckl, Miriam, Sarria, Gustavo R., Springer, Sandra, Willam, Marvin, Ruder, Arne M., Steil, Volker, Ehmann, Michael, Wenz, Frederik, and Fleckenstein, Jens
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STEREOTACTIC radiotherapy , *PROSTATE cancer , *IMAGE-guided radiation therapy , *STRUCTURAL optimization , *DRUG dosage - Abstract
Background: Hypofractionation is increasingly being applied in radiotherapy for prostate cancer, requiring higher accuracy of daily treatment deliveries than in conventional image-guided radiotherapy (IGRT). Different adaptive radiotherapy (ART) strategies were evaluated with regard to dosimetric benefits.Methods: Treatments plans for 32 patients were retrospectively generated and analyzed according to the PACE-C trial treatment scheme (40 Gy in 5 fractions). Using a previously trained cycle-generative adversarial network algorithm, synthetic CT (sCT) were generated out of five daily cone-beam CT. Dose calculation on sCT was performed for four different adaptation approaches: IGRT without adaptation, adaptation via segment aperture morphing (SAM) and segment weight optimization (ART1) or additional shape optimization (ART2) as well as a full re-optimization (ART3). Dose distributions were evaluated regarding dose-volume parameters and a penalty score.Results: Compared to the IGRT approach, the ART1, ART2 and ART3 approaches substantially reduced the V37Gy(bladder) and V36Gy(rectum) from a mean of 7.4cm3 and 2.0cm3 to (5.9cm3, 6.1cm3, 5.2cm3) as well as to (1.4cm3, 1.4cm3, 1.0cm3), respectively. Plan adaptation required on average 2.6 min for the ART1 approach and yielded doses to the rectum being insignificantly different from the ART2 approach. Based on an accumulation over the total patient collective, a penalty score revealed dosimetric violations reduced by 79.2%, 75.7% and 93.2% through adaptation.Conclusion: Treatment plan adaptation was demonstrated to adequately restore relevant dose criteria on a daily basis. While for SAM adaptation approaches dosimetric benefits were realized through ensuring sufficient target coverage, a full re-optimization mainly improved OAR sparing which helps to guide the decision of when to apply which adaptation strategy. [ABSTRACT FROM AUTHOR]- Published
- 2021
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207. Does Counseling Increase Sustained Benefit of HAART among Prison Inmates after Release to the Community?
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Altice, Frederick L., Springer, Sandra A., and Pesanti, Edward
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LETTERS to the editor , *HIV-positive persons - Abstract
Presents a letter to the editor about the effectiveness of HAART after release of HIV-infected inmates treated in prison.
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- 2005
208. High rates of depressive symptomatology among injecting drug users in Saskatoon, Canada.
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Springer, Sandra A.
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- 2012
209. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2022 Recommendations of the International Antiviral Society-USA Panel.
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Gandhi, Rajesh T., Bedimo, Roger, Hoy, Jennifer F., Landovitz, Raphael J., Smith, Davey M., Eaton, Ellen F., Lehmann, Clara, Springer, Sandra A., Sax, Paul E., Thompson, Melanie A., Benson, Constance A., Buchbinder, Susan P., del Rio, Carlos, Eron Jr, Joseph J., Günthard, Huldrych F., Molina, Jean-Michel, Jacobsen, Donna M., Saag, Michael S., and Eron, Joseph J Jr
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HIV prevention , *PRE-exposure prophylaxis , *ANTIRETROVIRAL agents , *HIV infections , *ADULTS , *VIRUS diseases - Abstract
Importance: Recent advances in treatment and prevention of HIV warrant updated recommendations to guide optimal practice.Objective: Based on a critical evaluation of new data, to provide clinicians with recommendations on use of antiretroviral drugs for the treatment and prevention of HIV, laboratory monitoring, care of people aging with HIV, substance use disorder and HIV, and new challenges in people with HIV, including COVID-19 and monkeypox virus infection.Evidence Review: A panel of volunteer expert physician scientists were appointed to update the 2020 consensus recommendations. Relevant evidence in the literature (PubMed and Embase searches, which initially yielded 7891 unique citations, of which 834 were considered relevant) and studies presented at peer-reviewed scientific conferences between January 2020 and October 2022 were considered.Findings: Initiation of antiretroviral therapy (ART) is recommended as soon as possible after diagnosis of HIV. Barriers to care should be addressed, including ensuring access to ART and adherence support. Integrase strand transfer inhibitor-containing regimens remain the mainstay of initial therapy. For people who have achieved viral suppression with a daily oral regimen, long-acting injectable therapy with cabotegravir plus rilpivirine given as infrequently as every 2 months is now an option. Weight gain and metabolic complications have been linked to certain antiretroviral medications; novel strategies to ameliorate these complications are needed. Management of comorbidities throughout the life span is increasingly important, because people with HIV are living longer and confronting the health challenges of aging. In addition, management of substance use disorder in people with HIV requires an evidence-based, integrated approach. Options for preexposure prophylaxis include oral medications (tenofovir disoproxil fumarate or tenofovir alafenamide plus emtricitabine) and, for the first time, a long-acting injectable agent, cabotegravir. Recent global health emergencies, like the SARS-CoV-2 pandemic and monkeypox virus outbreak, continue to have a major effect on people with HIV and the delivery of services. To address these and other challenges, an equity-based approach is essential.Conclusions and Relevance: Advances in treatment and prevention of HIV continue to improve outcomes, but challenges and opportunities remain. [ABSTRACT FROM AUTHOR]- Published
- 2023
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210. Evaluation of the Impact of HIV Serostatus on the Hepatitis C Virus Care Cascade and Injection Drug Use Among Persons Initiating Medication Treatment for Opioid Use Disorder.
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Lier, Audun J, Wyk, Brent Vander, Paola, Angela Di, and Springer, Sandra A
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OPIOID abuse , *DRUG abuse , *HEPATITIS C virus , *HIV status , *OPIOIDS , *NEEDLE exchange programs - Abstract
Background Persons who inject drugs are at increased risk for acquiring hepatitis C virus (HCV). Medications for opioid use disorder (MOUD) are associated with reduced injection drug use (IDU) frequency among persons with opioid use disorder (OUD). However, whether HCV treatment uptake or changes in IDU frequency differ by HIV serostatus among persons receiving MOUD is incompletely understood. Methods A secondary analysis was performed of data collected from 2 prospective cohort studies of participants with (PWH) or without HIV with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition–diagnosed OUD who were initiated on methadone, buprenorphine, or naltrexone. Results Of 129 participants, 78 (60.5%) were HCV antibody positive. PWH underwent increased HCV viral load testing (76.7% vs 43.3%; P =.028), but HCV treatment rates did not differ (17.6% vs 10.0%; P =.45) by HIV status. Participants without HIV reported a greater reduction in mean opioid IDU at 90 days (10.7 vs 2.0 fewer days out of 30; P <.001), but there were no group differences at 90 days. Stimulant use did not differ between groups. Urine opioid positivity declined from baseline to 90 days among the entire cohort (61.4% to 38.0%; P <.001) but did not differ by HIV serostatus. Conclusions PWH who received MOUD underwent higher rates of follow-up HCV testing, but HCV treatment rates did not significantly differ by HIV serostatus. Participants without HIV on MOUD reported a greater reduction in opioid IDU. Improved integration of concomitant OUD with HCV and HIV screening, linkage to care, and treatment are needed for persons without HIV. [ABSTRACT FROM AUTHOR]
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- 2022
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211. Gender differences among persons entering medication treatment for opioid use disorder in the community.
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Di Paola, Angela, Taweh, Noor, Biondi, Breanne E., Forray, Ariadna, Frank, Cynthia A., Shaw, Albert, and Springer, Sandra A.
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Background and Objectives: We evaluated gender differences among persons initiating medications for opioid use disorder (MOUD). Methods: Analyses of baseline assessments for a study evaluating the impact of MOUD on outcomes included: demographics, DSM‐5 diagnoses, depression severity, quality of life (QoL), and medication history (N = 125). Results: When compared to men, women had a greater prevalence of generalized anxiety and posttraumatic stress disorders; and worse psychological QoL. Women were less likely to be prescribed psychiatric medications. Discussion and Conclusions: Women may benefit from tailored multidisciplinary programs with MOUD. Scientific Significance: This study identified that women with OUD seeking MOUD in the community had greater sedative hypnotic nonprescribed medication use and psychiatric comorbidity than men, all of which can contribute to poorer retention on MOUD and higher risk of morbidity and mortality. Thus, concurrent psychiatric disorder screening and treatment integrated with MOUD may improve retention on MOUD, opioid relapse and overdose for women. [ABSTRACT FROM AUTHOR]
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- 2022
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212. Perspectives on benefits and risks of creation of an "injection drug use" billing code.
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Sundaram, Gayathri, Sato, Taisuke, Goodman-Meza, David, Haddad, Marwan, Thakarar, Kinna, Feinberg, Judith, Springer, Sandra A., Barton, Kerri, Butler, Nikki, Eaton, Ellen F., and Wurcel, Alysse G.
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HEALTH services accessibility , *INTRAVENOUS drug abuse , *HEALTH insurance reimbursement , *MEDICAL coding , *EARLY diagnosis , *INTRAVENOUS drug abusers , *PSYCHOSOCIAL factors , *NOSOLOGY , *HEALTH care rationing - Abstract
People with substance use disorder (SUD) face barriers to prevention and treatment services, increasing risk for hospitalization and death. Injection drug use (IDU) can lead to an increased risk of overdose and infections. However, identifying people who inject drugs (PWID) within healthcare systems is challenging. International Classification of Disease (ICD-10) codes are used for billing and tracking healthcare utilization. In this commentary, experts in the field weigh the benefits and risks of creating an IDU-specific ICD-10 code. Potential benefits include earlier identification, better access to health services, and improved systems of resource allocation. Potential risks include further stigmatization of PWID and, if not tied to financial reimbursement, low rates of code utilization. As the current systems of identifying PWID are lacking, we feel that a guided operationalization of an ICD code to identify PWID could improve quantitative and epidemiological research accuracy and, therefore, support the health and well-being of PWID. [ABSTRACT FROM AUTHOR]
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- 2024
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213. Feasibility of a community‐based delivery model for HIV pre‐exposure prophylaxis among bar patrons in rural South Africa.
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Grammatico, Megan A., Moll, Anthony P., Choi, Koeun, Springer, Sandra A., and Shenoi, Sheela V.
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PRE-exposure prophylaxis , *ALCOHOLISM , *HUMAN sexuality , *HIV , *ALCOHOL drinking , *LOGISTIC regression analysis - Abstract
Introduction: South Africa, home to the world's largest HIV epidemic, has made great strides in improving access to HIV services, but specific groups, particularly young men, remain difficult to engage in the HIV care cascade. Alcohol use disorder, prevalent in South Africa, further complicates engagement. Congregate settings where alcohol is served, known as shebeens, are an ideal place to engage young people for HIV testing, treatment and prevention, including pre‐exposure prophylaxis (PrEP). Here, we characterize the uptake of PrEP in shebeen patrons and explore the effect of alcohol consumption on PrEP uptake by piloting a community‐based delivery model. Methods: In the rural Kwazulu‐Natal province (KZN) of South Africa, a field team made up of all men offered screenings outside of shebeens at 27 events over 6 months in 2020. Screenings included rapid HIV testing and Alcohol Use Disorder Identification Test (AUDIT). Participants who tested negative for HIV were offered PrEP as once daily oral tenofovir disoproxil fumarate/emtricitabine. Short‐term retention was determined. Logistic regression was performed to identify predictors of PrEP uptake, including unadjusted and adjusted odds ratios (OR) with 95% confidence interval. Results: One hundred and sixty‐two shebeen patrons were screened, and 136 (84%) were eligible for PrEP. Among those eligible, 37 (27%) completed clinical evaluation and initiated PrEP. Among PrEP initiators, 91.9% were men, median age was 26.0 years (interquartile range 21–31), 32.4% were employed, 18.9% had running water and 70.3% had AUDIT scores indicating hazardous drinking. Among 37 initiators, 25 (68%) were retained at 1 month, and 19 (51%) were retained at 4 months. Independent predictors of PrEP uptake among all bar patrons, and only men (108 screened and 34 initiators), included younger age (OR 0.92 [0.88–0.97]) and lifetime number of sexual partners (OR 1.07 [1.02–1.13]). Conclusions: Community‐based PrEP delivery after engagement at shebeens in rural South Africa is a feasible and novel approach to reach a traditionally difficult‐to‐engage population, particularly young men. In this small sample, sexual risk behaviours predicted PrEP uptake. Hazardous drinking was not a barrier to PrEP initiation. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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214. A Systematic Review and Meta-Analysis of Studies Evaluating the Effect of Medication Treatment for Opioid Use Disorder on Infectious Disease Outcomes.
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McNamara, Katelyn F, Biondi, Breanne E, Hernández-Ramírez, Raúl U, Taweh, Noor, Grimshaw, Alyssa A, and Springer, Sandra A
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OPIOID abuse , *HEPATITIS B , *COMMUNICABLE diseases , *OPIOID epidemic , *OPIOIDS - Abstract
The opioid epidemic has fueled infectious disease epidemics. We determined the impact of medications for opioid use disorder (MOUD) on treatment outcomes of opioid use disorder (OUD)-associated infectious diseases: antiretroviral therapy (ART) adherence, human immunodeficiency virus (HIV) viral suppression, hepatitis C virus (HCV) sustained virologic response, HCV reinfection, new hepatitis B virus infections, and infectious endocarditis-related outcomes. Manuscripts reporting on these infectious disease outcomes in adults with OUD receiving MOUD compared with those with OUD "not" receiving MOUD were included. Initial search yielded 8169 papers; 9 were included in the final review. The meta-analysis revealed that MOUD was associated with greater ART adherence (odds ratio [OR] = 1.55; 95% confidence interval [CI] = 1.12–2.15) and HIV viral suppression (OR = 2.19; 95% CI = 1.88–2.56). One study suggested a positive association between MOUD and HCV sustained virologic response. There is significant support for integrating MOUD with HIV treatment to improve viral suppression among persons with HIV (PWH) and OUD. Treatment of OUD among PWH should be a priority to combat the opioid and HIV epidemics. [ABSTRACT FROM AUTHOR]
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- 2021
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215. Brief Report: Reduced Use of Illicit Substances, Even Without Abstinence, Is Associated With Improved Depressive Symptoms Among People Living With HIV.
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Delaney, Joseph A., Nance, Robin M., Whitney, Bridget M., Altice, Frederick L., Dong, Xinyuan, Trejo, Maria Esther Perez, Matsuzaki, Mika, Taxman, Faye S., Chander, Geetanjali, Kuo, Irene, Fredericksen, Rob, Strand, Lauren N., Eron, Joseph J., Geng, Elvin, Kitahata, Mari M., Mathews, William C., Mayer, Kenneth, Moore, Richard D., Saag, Michael S., and Springer, Sandra
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Supplemental Digital Content is Available in the Text. Purpose: Substance use is linked with poor outcomes among people living with HIV (PLWH) and is associated with mental health disorders. This analysis examines the impact of decreasing substance use, even without abstinence, on depressive symptoms among PLWH. Methods: Data are from PLWH enrolled in the Centers for AIDS Research Network of Integrated Clinical Sites cohort. Participants completed longitudinal assessments of substance use (modified ASSIST) and depressive symptoms (PHQ-9). Changes in substance use frequency were categorized as abstinence, reduced use, and nondecreasing use. Adjusted linear mixed models with time-updated change in substance use frequency and depressive symptom scores were used to examine associations between changes in the use of individual substances and depressive symptoms. Analyses were repeated using joint longitudinal survival models to examine associations with a high (PHQ-9 ≥10) score. Results: Among 9905 PLWH, 728 used cocaine/crack, 1016 used amphetamine-type substances (ATS), 290 used illicit opiates, and 3277 used marijuana at baseline. Changes in ATS use were associated with the greatest improvements in depressive symptoms: stopping ATS led to a mean decrease of PHQ-9 by 2.2 points (95% CI: 1.8 to 2.7) and a 61% lower odds of PHQ-9 score ≥10 (95% CI: 0.30 to 0.52), and decreasing ATS use led to a mean decrease of 1.7 points (95% CI: 1.2 to 2.3) and a 62% lower odds of PHQ-9 score ≥10 (95% CI: 0.25 to 0.56). Stopping and reducing marijuana and stopping cocaine/crack use were also associated with improvement in depressive symptoms. Conclusions: We demonstrated that both substance use reduction and abstinence are associated with improvements in depressive symptoms over time. [ABSTRACT FROM AUTHOR]
- Published
- 2018
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216. Corrigendum to 'Maintenance on extended-release naltrexone is associated with reduced injection opioid use among justice-involved persons with opioid use disorder' [J. Subst. Abuse Treat. vol. 142 (2022)/108852].
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Lier, Audun J., Seval, Nikhil, Vander Wyk, Brent, Di Paola, Angela, and Springer, Sandra A.
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NALTREXONE , *SUBSTANCE abuse , *INTRAVENOUS drug abuse , *CONTROLLED release preparations - Published
- 2023
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217. Chapter 14 - HIV in the Correctional Facility
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Altice, Frederick L. and Springer, Sandra A.
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218. Maintenance on extended-release naltrexone is associated with reduced injection opioid use among justice-involved persons with opioid use disorder.
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Lier, Audun J., Seval, Nikhil, Vander Wyk, Brent, Di Paola, Angela, and Springer, Sandra A.
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OPIOID abuse , *DRUG abuse , *NALTREXONE , *OPIOIDS , *HEPATITIS C virus , *METHADONE treatment programs , *CONTROLLED release drugs , *HIV infections , *RESEARCH , *NARCOTIC antagonists , *BUPRENORPHINE , *SUBSTANCE abuse treatment , *RESEARCH methodology , *HEPATITIS C , *RNA , *SOCIAL justice , *EVALUATION research , *INTRAMUSCULAR injections , *COMPARATIVE studies , *RANDOMIZED controlled trials , *DISEASE complications - Abstract
Introduction: Opioid use disorder (OUD) and injection drug use (IDU) place justice-involved individuals at increased risk for acquiring or transmitting HIV or hepatitis C virus (HCV). Methadone and buprenorphine have been associated with reduced opioid IDU; however, the effect of extended-release naltrexone (XR-NTX) on this behavior is incompletely studied.Methods: This study examined injection opioid use and shared injection equipment behavior from a completed double-blind placebo-controlled trial of XR-NTX among 88 justice-involved participants with HIV and OUD. Changes in participants' self-reported daily injection opioid use and shared injection equipment was evaluated pre-incarceration, during incarceration, and monthly post-release for 6 months. The study also assessed differences in time to first opioid injection post-release. The research team performed intention to treat and "as treated" (high treatment versus low treatment) analyses.Results: Fifty-eight of 88 participants (69.5 %) endorsed IDU and 26 (29.5 %) reported sharing injection equipment in the 30 days pre-incarceration; 2 participants (2.2 %) reported IDU during incarceration; 19 (21.6 %) reported IDU one month post-release from prison or jail. Fifty-four (61.4 %) participants had an HIV RNA below 200 copies/mL and 62 (70.5 %) were baseline HCV antibody positive. The 6-month follow-up rate was 49.5 % and 50.5 % for those who received XR-NTX and placebo, respectively, which was not significantly different (p = 0.822). Participants in the XR-NTX and placebo groups had similar low mean opioid injection use post-release and time to first injection opioid use in the Intention-to-treat analysis. In the as-treated analysis, participants in the high treatment group had significantly lower mean proportion of days injecting opioids (13.8 % high treatment versus 22.8 % low treatment, p = 0.02) by month 1, which persisted up to 5 months post-release (0 % high treatment vs 24.3 % low treatment, p < 0.001) and experienced a longer time to first opioid injection post-release (143.8 days high treatment vs 67.4 days low treatment, p < 0.001).Conclusions: Injection opioid use was low during incarceration and remained low post-release in this justice-involved population. Retention on XR-NTX was associated with reduced intravenous opioid use, which has important implications for reducing transmission of HIV and HCV. [ABSTRACT FROM AUTHOR]- Published
- 2022
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219. Combination comet/micronucleus assay validation performed by BioReliance under the JaCVAM initiative.
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Pant, Kamala, Krsmanovic, Ljubica, Bruce, Shannon Wilson, Kelley, Tawney, Arevalo, Mirna, Atta-Safoh, Samuel, Debelie, Fekadu, La Force, Michelle L. Klug, Springer, Sandra, Sly, Jamie, Paranjpe, Madhav, Lawlor, Timothy, and Aardema, Marilyn
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DNA damage , *NUCLEOLUS , *GEL electrophoresis , *DICHLOROPROPANE , *BUSULFAN , *ORAL drug administration - Abstract
In the international validation study of the in vivo rat alkaline comet assay (comet assay), the Japanese Center for the Validation of Alternative Methods (JaCVAM) provided three coded chemicals to BioReliance, 1,3-dichloropropene, ethionamide and busulfan, to be tested in a combined in vivo comet/micronucleus assay. Induction of DNA damage (comet) in liver, stomach and jejunum (1,3-dichloropropene only) cells, and induction of MNPCEs in bone marrow, were examined in male Sprague–Dawley (Hsd:SD) rats following oral administration of the test chemical for three consecutive days. A dose range finding (DRF) test was performed with each chemical to determine the maximum tolerated dose (MTD). Based on the results of the DRF test; 1,3-dichloropropene was tested at 50, 100 and 200 mg/kg/day; ethionamide was tested at 125, 250 and 500 mg/kg/day, and busulfan was tested at 10, 20 and 40 mg/kg/day. The results indicated that 1,3-dichloropropene induced DNA damage only in liver cells at all three test article doses, while no effects were observed in the stomach and jejunum cells. Additionally, it did not increase MNPCEs in the bone marrow. 1,3-Dichloropropene was concluded to be negative in the MN assay but positive in the comet assay. Ethionamide did not induce DNA damage in liver. However, in stomach, statistically significant decreases (although still within historical range) in % tail DNA at all test article doses compared to the vehicle control were observed. There was no increase in MNPCEs in the bone marrow. Thus, ethionamide was concluded to be negative in the comet/MN combined assay. Busulfan did not induce DNA damage in any of the organs tested (liver and stomach) but it did induce a significant increase in MNPCEs in the bone marrow. Busulfan was concluded to be negative in the comet assay but positive in the MN assay. [ABSTRACT FROM AUTHOR]
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- 2015
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220. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community.
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Di Paola, Angela, Lincoln, Thomas, Skiest, Daniel J., Desabrais, Maureen, Altice, Frederick L., and Springer, Sandra A.
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HIV infections , *THERAPEUTICS , *NALTREXONE , *OPIOID abuse , *BLIND experiment , *RANDOMIZED controlled trials , *PLACEBOS - Abstract
Background People with opioid dependence and HIV are concentrated within criminal justice settings (CJS). Upon release, however, drug relapse is common and contributes to poor HIV treatment outcomes, increased HIV transmission risk, reincarceration and mortality. Extended-release naltrexone (XR-NTX) is an evidence-based treatment for opioid dependence, yet is not routinely available for CJS populations. Methods A randomized, double-blind, placebo-controlled trial of XR-NTX for HIV-infected inmates transitioning from correctional to community settings is underway to assess its impact on HIV and opioid-relapse outcomes. Results We describe the methods and early acceptability of this trial. In addition we provide protocol details to safely administer XR-NTX near community release and describe logistical implementation issues identified. Study acceptability was modest, with 132 (66%) persons who consented to participate from 199 total referrals. Overall, 79% of the participants had previously received opioid agonist treatment before this incarceration. Thus far, 65 (49%) of those agreeing to participate in the trial have initiated XR-NTX or placebo. Of the 134 referred patients who ultimately did not receive a first injection, the main reasons included a preference for an alternative opioid agonist treatment (37%), being ineligible (32%), not yet released (10%), and lost upon release before receiving their injection (14%). Conclusions Study findings should provide high internal validity about HIV and opioid treatment outcomes for HIV-infected prisoners transitioning to the community. The large number of patients who ultimately did not receive the study medication may raise external validity concerns due to XR-NTX acceptability and interest in opioid agonist treatments. Clinical Trial number: NCT01246401 [ABSTRACT FROM AUTHOR]
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- 2014
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221. Linking criminal justice-involved individuals to HIV, Hepatitis C, and opioid use disorder prevention and treatment services upon release to the community: Progress, gaps, and future directions.
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Taweh, Noor, Schlossberg, Esther, Frank, Cynthia, Nijhawan, Ank, Kuo, Irene, Knight, Kevin, and Springer, Sandra A.
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HIV-positive persons , *HEPATITIS C , *OPIOID abuse , *CRIMINAL justice system , *COMMUNICABLE diseases , *HEPATITIS C prevention , *HIV prevention , *HIV infections , *SUBSTANCE abuse , *HEPATITIS viruses , *CRIMINOLOGY , *DISEASE complications - Abstract
Improving HIV and Hepatitis C Virus (HCV) management among people involved in the criminal justice (CJ) system who use drugs, in particular those with opioid use disorder (OUD), requires effective approaches to screening, linkage, and adherence to integrated prevention and treatment services across correctional and community agencies and providers. This manuscript reviews the literature to explore gaps in HIV, Hepatitis C, and OUD prevention, treatment, and delivery cascades of care for persons involved in the CJ system. Specifically, we compare two models of linkage to prevention and treatment services: Peer/Patient Navigation (PN) wherein the PN links CJ-involved individuals to community-based infectious disease (ID) and substance use prevention and treatment services, and Mobile Health Units (MHU) wherein individuals are linked to a MHU within their community that provides integrated ID and substance use prevention and treatment services. The most notable finding is a gap in the literature, with few to no comparisons of models linking individuals recently released from the CJ system to integrated HIV, Hepatitis C, and OUD prevention and treatment and other harm reduction services. Further, few published studies address the geographical distinctions that affect service implementation and their effects on these substance use, ID and harm reduction care cascades. This manuscript makes specific recommendations to fill this gap through a detailed evaluation of PN and MHU linkage models to co-located and integrated HIV, Hepatitis C, and OUD prevention and treatment services across different communities within the U.S. [ABSTRACT FROM AUTHOR]
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- 2021
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222. Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder.
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Seval, Nikhil, Frank, Cynthia A., Litwin, Alain H., Roth, Prerana, Schade, Meredith A., Pavlicova, Martina, Levin, Frances R., Brady, Kathleen T., Nunes, Edward V., and Springer, Sandra A.
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OPIOID abuse , *THERAPEUTICS , *COMMUNICABLE diseases , *DRUG abuse , *RANDOMIZED controlled trials , *DRUG overdose - Abstract
Hospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge. A randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose. We describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial. Study findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population. [ABSTRACT FROM AUTHOR]
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- 2021
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223. Plans to end HIV should address substance use.
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Springer SA
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Competing Interests: SAS has provided paid scientific consultation to Alkermes and received in-kind study drug donations from Alkermes and Indivior Pharmaceutical Company for NIH-funded research in the USA and received funding from the US National Institute on Drug Abuse (NIDA DP1DA056106).
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- 2024
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224. Antiretroviral Drugs for Treatment and Prevention of HIV in Adults: 2024 Recommendations of the International Antiviral Society-USA Panel.
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Gandhi RT, Landovitz RJ, Sax PE, Smith DM, Springer SA, Günthard HF, Thompson MA, Bedimo RJ, Benson CA, Buchbinder SP, Crabtree-Ramirez BE, Del Rio C, Eaton EF, Eron JJ Jr, Hoy JF, Lehmann C, Molina JM, Jacobsen DM, and Saag MS
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Importance: New data and new antiretroviral drugs and formulations continue to become available for the prevention and management of HIV infection., Objective: To provide updated recommendations for HIV treatment and clinical management and HIV prevention., Methods: A panel of volunteer expert physician scientists were appointed to provide updated consensus recommendations for 2024. Relevant evidence in the literature since the last report was identified from PubMed and Embase searches (which initially yielded 3998 unique citations, of which 249 were considered relevant); from ongoing monitoring of the literature by the panel members; from data submitted by product manufacturers; and from studies presented at peer-reviewed scientific conferences between June 2022 and October 2024., Findings: Antiretroviral therapy continues to be recommended for all individuals with HIV. For most people with HIV, initial regimens composed of an integrase strand transfer inhibitor (InSTI), specifically bictegravir or dolutegravir, with 2 (and in some cases 1) nucleoside or nucleotide reverse transcriptase inhibitors are recommended. Recommendations are made for those with particular clinical circumstances, such as pregnancy and active opportunistic diseases, as well as for those unable to take InSTIs. Regimens may need to be changed for virologic failure, adverse effects, convenience, or cost, among other reasons. Long-acting injectable therapy is available for those who prefer not to take daily oral medications and for people struggling with adherence to daily therapy. Recommendations are provided for laboratory monitoring, management of substance use disorders and weight changes, as well as use of statins for cardiovascular disease prevention. For HIV prevention, oral (daily or intermittent) and injectable long-acting medications are effective options for people at increased likelihood of HIV exposure. Further, new tools for maintaining health and well-being among people with HIV, such as doxycycline postexposure prophylaxis to avert sexually transmitted infection, and strategies to treat substance use disorders, are recommended. Disparities in HIV acquisition and care access are discussed and solutions proposed., Conclusions: New approaches for treating and preventing HIV offer additional tools to help end the HIV epidemic, but achieving this goal depends on addressing disparities and inequities in access to care.
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- 2024
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225. Commentary on Gregory et al.: Fear of precipitated opioid withdrawal should not prevent buprenorphine initiation.
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Springer SA
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- 2025
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226. HIV and Substance Use Disorders.
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Lier AJ, Tarfa A, Shenoi SV, Kuo I, and Springer SA
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- Humans, Risk Factors, HIV Infections drug therapy, HIV Infections epidemiology, HIV Infections complications, Substance-Related Disorders complications, Substance-Related Disorders epidemiology
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Over 1.2 million Americans aged 13 years and older have been diagnosed with human immunodeficiency virus (HIV). While HIV incidence has been declining since 2017, the risk of HIV acquisition and transmission persists among persons who use drugs via injection drug use and unprotected sexual intercourse associated with substance use. Untreated substance use disorder (SUD) is associated with poor adherence to HIV antiretroviral therapy, poor HIV outcomes, and increased risk for HIV acquisition. Herein, we describe the intertwined syndemic of HIV and SUD, as well as treatment strategies and evidence-based public health efforts to engage and retain persons who use drugs into care., Competing Interests: Disclosure Author S.A. Springer has provided paid scientific consultation to Alkermes Inc. S.A. Springer has received in-kind study drug donations from Alkermes Inc and Indivior Pharmaceutical Company for NIH-funded research. Work related to this manuscript was funded by National Institute on Drug Abuse, United States (NIDA; DP1DA056106, Springer). The funder was not involved in the research design, analysis or interpretation of the data or the decision to publish the manuscript., (Published by Elsevier Inc.)
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- 2024
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227. Considerations when prescribing opioid agonist therapies for people living with HIV.
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Tarfa A, Lier AJ, Shenoi SV, and Springer SA
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- Humans, Delayed-Action Preparations, Health Services Accessibility, United States, Delivery of Health Care organization & administration, Pre-Exposure Prophylaxis methods, Anti-HIV Agents administration & dosage, Anti-HIV Agents pharmacology, Opioid-Related Disorders drug therapy, HIV Infections drug therapy, Buprenorphine administration & dosage, Opiate Substitution Treatment methods, Narcotic Antagonists administration & dosage, Methadone administration & dosage, Naltrexone administration & dosage, Drug Interactions, Analgesics, Opioid administration & dosage
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Introduction: Medications for opioid use disorder (MOUD) include opioid agonist therapies (OAT) (buprenorphine and methadone), and opioid antagonists (extended-release naltrexone). All forms of MOUD improve opioid use disorder (OUD) and HIV outcomes. However, the integration of services for HIV and OUD remains inadequate. Persistent barriers to accessing MOUD underscore the immediate necessity of addressing pharmacoequity in the treatment of OUD in persons with HIV (PWH)., Areas Covered: In this review article, we specifically focus on OAT among PWH, as it is the most commonly utilized form of MOUD. Specifically, we delineate the intersection of HIV and OUD services, emphasizing their integration into the United States Ending the HIV Epidemic (EHE) plan by offering comprehensive screening, testing, and treatment for both HIV and OUD. We identify potential drug interactions of OAT with antiretroviral therapy (ART), address disparities in OAT access, and present the practical benefits of long-acting formulations of buprenorphine, ART, and pre-exposure prophylaxis for improving HIV prevention and treatment and OUD management., Expert Opinion: Optimizing OUD outcomes in PWH necessitates careful attention to diagnosing OUD, initiating OUD treatment, and ensuring medication retention. Innovative approaches to healthcare delivery, such as mobile pharmacies, can integrate both OUD and HIV and reach underserved populations.
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- 2024
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228. HIV Risk and Interest in Preexposure Prophylaxis in Justice-Involved Persons.
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Nijhawan AE, Pulitzer Z, Torres B, Noreen N, Schultheis A, Frank C, Colon R, Brooks R, Proffitt R, Pankow J, Bennett A, Salyards M, Kuo I, Knight K, and Springer SA
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- Female, Humans, Male, Hispanic or Latino, Homosexuality, Male, Risk Factors, United States, White, Black or African American, HIV Infections epidemiology, HIV Infections prevention & control, Pre-Exposure Prophylaxis
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Preexposure prophylaxis (PrEP) is underused in persons who use drugs and justice-involved persons. In an ongoing randomized controlled trial in 4 US locations comparing patient navigation versus mobile health unit on time to initiation of HIV medication or PrEP for justice-involved persons who use stimulants or opioids and who are at risk for or living with HIV, we assessed HIV risk factors, perceived HIV risk, and interest in PrEP. Participants without HIV (n = 195) were 77% men, 65% White, 23% Black, and 26% Hispanic; 73% reported a recent history of condomless sex, mainly with partners of unknown HIV status. Of 34% (67/195) reporting injection drug use, 43% reported sharing equipment. Despite risk factors, many persons reported their risk for acquiring HIV as low (47%) or no (43%) risk, although 51/93 (55%) with PrEP indications reported interest in PrEP. Justice-involved persons who use drugs underestimated their HIV risk and might benefit from increased PrEP education efforts.
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- 2024
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229. Integrated Care Models: HIV and Substance Use.
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Hill K, Kuo I, Shenoi SV, Desruisseaux MS, and Springer SA
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- Humans, Health Services, HIV Infections drug therapy, HIV Infections epidemiology, Opioid-Related Disorders epidemiology, Opioid-Related Disorders therapy, Delivery of Health Care, Integrated
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Purpose of Review: Behaviors and practices associated with substance use contribute to lack of HIV virologic suppression and onward transmission. In the USA, many recent HIV outbreaks have been connected with substance use. Evidence-based strategies for integrating care of those at risk for and living with HIV and who use substances continue to evolve. This review, based on scientific and medical literature through March 2023, provides an overview and evaluation of initiatives for integrated care aimed to serve patients at risk for and with HIV and a substance use disorder., Recent Findings: Integrated care services can improve health outcomes for patients at risk for and with HIV and a substance use disorder; for instance, treatment for an opioid use disorder can help improve HIV viral suppression. Brick-and-mortar facilities can provide successful care integration with appropriate clinic leadership to support multidisciplinary care teams, up-to-date provider training, and sufficient pharmacy stock for substance use treatment. Delivering healthcare services to communities (e.g., mobile healthcare clinics and pharmacies, telehealth) may prove to be an effective way to provide integrated services for those with or at risk of HIV and substance use disorders. Incorporating technology (e.g., mobile phone applications) may facilitate integrated care. Other venues, including harm reduction programs and carceral settings, should be targets for integrated services. Venues providing healthcare should invest in integrated care and support legislation that increases access to services related to HIV and substance use., (© 2023. 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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230. Ending the HIV Epidemic for Persons Who Use Drugs: the Practical Challenges of Meeting People Where They Are.
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Springer SA
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- Humans, HIV Infections drug therapy, HIV Infections epidemiology, HIV Infections prevention & control, Epidemics prevention & control
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- 2023
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231. Validation of Two Diagnostic Assessments for Opioid and Stimulant Use Disorder for Use by Non-Clinicians.
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Di Paola A, Farabee D, and Springer SA
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Objective: The United States is in the fourth wave of the opioid epidemic marked by the increase in fentanyl and co-occurring stimulant use related overdose deaths. Measures are needed to quickly diagnose opioid and stimulant use disorders, yet current traditional diagnostic assessments pose barriers to providing rapid diagnoses., Methods: This study aimed to (1) validate an updated version of the Rapid Opioid Dependence Screen (RODS) from DSM-IV criteria for opioid dependence to the now DSM-5 moderate-to-severe opioid use disorder, the Rapid Opioid Use Disorder Assessment (ROUDA); and (2) create and validate the Rapid Stimulant Use Disorder Assessment to DSM-5 stimulant use disorder (RSUDA) when compared to the substance use disorder module from the DSM-5 version of the Mini International Neuropsychiatric Interview., Results: One-hundred and fifty adults completed study assessments, 122 reported opioid misuse and 140 reported stimulant misuse within their lifetime. The ROUDA had a sensitivity of 82.5% (95% confidence interval [CI] 75.7, 89.2), specificity of 100.0% (95% CI: 100, 100), and strong internal consistency α = 0.94. The RSUDA had similarly high sensitivity (83.8%, 95% CI: 77.7, 89.9), specificity (91.4%, 95% CI: 86.8, 96.1), and internal consistency α = 0.87. The ROUDA and RSUDA are efficient and valid measures that can be administered in various settings by non-clinical staff to rapidly diagnose opioid and stimulant use disorders and allow for immediate treatment and harm reduction interventions., Conclusions: The ROUDA and RSUDA are efficient and valid measures that can be administered by non-clinicians to rapidly diagnose opioid and stimulant use disorders., (© 2023 The Authors. Psychiatric Research and Clinical Practice published by Wiley Periodicals LLC on behalf of American Psychiatric Association.)
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- 2023
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232. Inpatient Low-dose Transitions From Full Agonist Opioids Including Methadone Onto Long-acting Depot Buprenorphine: Case Series From a Multicenter Clinical Trial.
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Seval N, Nunez J, Roth P, Schade M, Strong M, Frank CA, Litwin AH, Levin FR, Brady KT, Nunes EV, and Springer SA
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- Humans, Analgesics, Opioid, Inpatients, Methadone, Opiate Substitution Treatment, Pain drug therapy, Buprenorphine therapeutic use, Opioid-Related Disorders drug therapy
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Objectives: Persons with opioid use disorder (OUD) suffer disproportionately from morbidity and mortality related to serious addiction-related infections requiring hospitalization. Long-acting buprenorphine (LAB) is an underused medication for OUD that may facilitate linkage to care and treatment retention when administered before hospital discharge. Transition onto buprenorphine in the inpatient setting is often complicated by pain, active infection management, potential surgical interventions, and risk of opioid withdrawal in transition from full agonists to a partial agonist., Methods: The COMMIT Trial is a randomized controlled trial evaluating LAB administered by infectious disease physicians and hospitalists compared with treatment as usual for persons with OUD hospitalized with infections. We report a case series of participants on full agonist opioids including methadone who were transitioned to sublingual buprenorphine using low-dose ( microdosing ) strategies followed by LAB injection., Results: Seven participants with current opioid use disorder and life-threatening infections, all with significant concurrent pain and many requiring surgical intervention, underwent low-dose transitions starting at buccal buprenorphine doses ranging from 225 μg to 300 μg 3 times a day on the first day. All were well tolerated with average time to LAB injection of 7.5 days (range, 5-10 days)., Conclusions: Inpatient low-dose buprenorphine transition from full agonist opioids including methadone onto LAB is feasible even in those with complex hospitalizations for concurrent infections and/or surgery. This strategy facilitates dosing of LAB before hospital discharge when risk of opioid relapse and overdose are significant., Competing Interests: Dr Springer has provided scientific consultation to Alkermes Inc and received NIH and VA grant funding. She has received in-kind study drug donations from Alkermes Inc and Indivior Pharmaceutical Company for NIH-funded research. Dr Levin receives grant support from the NIDA, SAMHSA, and from Aelis Pharmaceuticals. She also receives medication from Indivior for research. In addition, she served as a nonpaid member of a Scientific Advisory Board for Alkermes, Indivior, Novartis, Teva, and US WorldMeds and is a consultant to Major League Baseball. Dr Brady has provided scientific consultation to Alkermes, Indivior, Sage, and Jazz Pharmaceuticals. She has received grant funding from NIH and in-kind study drug from US World Meds. Dr Nunes has served as a consultant without compensation for Alkermes, Camurus, Indivior, and Pear Therapeutics and received in-kind study drug or digital therapeutic donations for NIH funded studies from Alkermes, Indivior, Braeburn-Camurus, Pear Therapeutics, and CHESS Health. Dr Litwin has served as on advisory boards with Gilead Sciences and AbbVie, and has received research grants from NIDA, NSF, SAMHSA, HRSA, and Gilead Sciences. The authors alone are responsible for the content and writing of this paper. No conflicts of interest declared for the remaining authors., (Copyright © 2023 American Society of Addiction Medicine.)
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- 2023
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233. The relationship between reincarceration and treatment of opioid use disorder with extended-release naltrexone among persons with HIV.
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Parchinski K, Di Paola A, Wilson AP, and Springer SA
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Background: In the United States, a disproportionate number of persons with HIV (PWH) and opioid use disorder (OUD) are involved in the justice system. Medications for OUD (MOUD) can reduce convictions and incarceration time in persons with OUD. Extended-release naltrexone (XR-NTX) has been shown to reduce craving of opioids, recurrence of use, and overdose and help achieve or maintain HIV viral suppression in PWH with OUD involved with the justice system., Objectives: This retrospective study aimed to describe factors associated with reincarceration and to evaluate if XR-NTX was associated with reduced reincarceration among PWH and OUD who were released to the community from incarceration., Methods: Data from participants released to the community from incarceration from a completed randomized controlled trial was analyzed using a generalized linear model to estimate odds ratios associated with reincarceration and a Kaplan-Meier survival analysis to determine time to reincarceration and non-reincarcerated individuals were compared., Results: Of the 77 participants, 41 (53.2%) were reincarcerated during the 12-month study period. The mean time to reincarceration was 190 days (SD=108.3). Compared with participants who remained in the community, reincarcerated participants were more likely to have major depressive disorder at study baseline, increased opioid cravings, longer mean lifetime incarceration, and a higher physical quality of life score. XR-NTX was not significantly associated statistically with reincarceration in this analysis., Conclusion: Reducing reincarceration is a public health priority, given the high proportion of PWH and OUD in the U.S. justice system as well as high degrees of persons returning to the community and having care interrupted due to reincarceration. This analysis determined that potentially identifying depression in recently released individuals could improve HIV outcomes, decrease recurrence of opioid use, and reduce reincarceration., Competing Interests: Author Sandra Springer, MD has provided paid scientific consultation to Alkermes Inc. Sandra Springer, MD has received in-kind study drug donations from Alkermes Inc and Indivior Pharmaceutical Company for NIH-funded research. The authors alone are responsible for the content and writing of this paper.
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- 2023
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234. The impact of COVID-19 on the treatment of opioid use disorder in carceral facilities: a cross-sectional study.
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Saunders EC, Satcher MF, Monico LB, McDonald RD, Springer SA, Farabee D, Gryczynski J, Nyaku A, Reeves D, Kunkel LE, Schultheis AM, Schwartz RP, Lee JD, Marsch LA, and Waddell EN
- Abstract
While the COVID-19 pandemic disrupted healthcare delivery everywhere, persons with carceral system involvement and opioid use disorder (OUD) were disproportionately impacted and vulnerable to severe COVID-associated illness. Carceral settings and community treatment programs (CTPs) rapidly developed protocols to sustain healthcare delivery while reducing risk of COVID-19 transmission. This survey study assessed changes to OUD treatment, telemedicine use, and re-entry support services among carceral and CTPs participating in the National Institute on Drug Abuse (NIDA)-funded study, Long-Acting Buprenorphine vs. Naltrexone Opioid Treatments in Criminal Justice System-Involved Adults (EXIT-CJS) study. In December 2020, carceral sites (n = 6; median pre-COVID 2020 monthly census = 3468 people) and CTPs (n = 7; median pre-COVID 2020 monthly census = 550 patients) participating in EXIT-CJS completed a cross-sectional web-based survey. The survey assessed changes pre- (January-March 2020) and post- (April-September 2020) COVID-19 in OUD treatment, telemedicine use, re-entry supports and referral practices. Compared to January-March 2020, half of carceral sites (n = 3) increased the total number of persons initiating medication for opioid use disorder (MOUD) from April-September 2020, while a third (n = 2) decreased the number of persons initiated. Most CTPs (n = 4) reported a decrease in the number of new admissions from April-September 2020, with two programs stopping or pausing MOUD programs due to COVID-19. All carceral sites with pre-COVID telemedicine use (n = 5) increased or maintained telemedicine use, and all CTPs providing MOUD (n = 6) increased telemedicine use. While expansion of telemedicine services supported MOUD service delivery, the majority of sites experienced challenges providing community support post-release, including referrals to housing, employment, and transportation services. During the COVID-19 pandemic, this small sample of carceral and CTP sites innovated to continue delivery of treatment for OUD. Expansion of telemedicine services was critical to support MOUD service delivery. Despite these innovations, sites experienced challenges providing reintegration supports for persons in the community. Pre-COVID strategies for identifying and engaging individuals while incarcerated may be less effective since the pandemic. In addition to expanding research on the most effective telemedicine practices for carceral settings, research exploring strategies to expand housing and employment support during reintegration are critical., (© 2022. The Author(s).)
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- 2022
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235. Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons.
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Springer SA, Nijhawan AE, Knight K, Kuo I, Di Paola A, Schlossberg E, Frank CA, Sanchez M, Pankow J, Proffitt RP, Lehman W, Pulitzer Z, Thompson K, Violette S, and Harding KK
- Subjects
- Analgesics, Opioid therapeutic use, Anti-Retroviral Agents therapeutic use, Humans, Randomized Controlled Trials as Topic, Acquired Immunodeficiency Syndrome drug therapy, HIV Infections drug therapy, HIV Infections epidemiology, HIV Infections prevention & control, Hepatitis C drug therapy, Hepatitis C epidemiology, Hepatitis C prevention & control, Pre-Exposure Prophylaxis methods, Sexually Transmitted Diseases complications, Substance-Related Disorders complications
- Abstract
Background: Persons involved in the justice system are at high risk for HIV and drug overdose upon release to the community. This manuscript describes a randomized controlled trial of two evidence-based linkage interventions for provision of HIV prevention and treatment and substance use disorder (SUD) services in four high risk communities to assess which is more effective at addressing these needs upon reentry to the community from the justice system., Methods: This is a 5-year hybrid type 1 effectiveness-implementation randomized controlled trial that compares two models (Patient Navigation [PN] or Mobile Health Unit [MHU] service delivery) of linking justice-involved individuals to the continuum of community-based HIV and SUD prevention and treatment service cascades of care. A total of 864 justice-involved individuals in four US communities with pre-arrest histories of opioid and/or stimulant use who are living with or at-risk of HIV will be randomized to receive either: (a) PN, wherein patient navigators will link study participants to community-based service providers; or (b) services delivered via an MHU, wherein study participants will be provided integrated HIV prevention/ treatment services and SUD services. The six-month post-release intervention will focus on access to pre-exposure prophylaxis (PrEP) for those without HIV and antiretroviral treatment (ART) for people living with HIV (PLH). Secondary outcomes will examine the continuum of PrEP and HIV care, including: HIV viral load, PrEP/ ART adherence; HIV risk behaviors; HCV testing and linkage to treatment; and sexually transmitted infection incidence and treatment. Additionally, opioid and other substance use disorder diagnoses, prescription, receipt, and retention on medication for opioid use disorder; opioid and stimulant use; and overdose will also be assessed. Primary implementation outcomes include feasibility, acceptability, sustainability, and costs required to implement and sustain the approaches as well as to scale-up in additional communities., Discussion: Results from this project will help inform future methods of delivery of prevention, testing, and treatment of HIV, HCV, substance use disorders (particularly for opioids and stimulants), and sexually transmitted infections for justice-involved individuals in the community., Trial Registration: Clincialtrials.gov NCT05286879 March 18, 2022., (© 2022. The Author(s).)
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- 2022
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236. Factors associated with retention on medications for opioid use disorder among a cohort of adults seeking treatment in the community.
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Biondi BE, Vander Wyk B, Schlossberg EF, Shaw A, and Springer SA
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- Adult, Analgesics, Opioid therapeutic use, Female, Humans, Male, Methadone therapeutic use, Naltrexone therapeutic use, Opiate Substitution Treatment, Pain drug therapy, Prospective Studies, Buprenorphine therapeutic use, Drug Overdose drug therapy, Opioid-Related Disorders drug therapy
- Abstract
Background: Medication treatment for opioid use disorder (OUD) (MOUD; buprenorphine and methadone) reduces opioid use and overdose. Discontinuation of MOUD can quickly lead to relapse, overdose and death. Few persons who initiate MOUD are retained on treatment, thus it is critical to identify factors associated with retention., Methods: Evaluated data was from an ongoing prospective cohort study of adults aged 18 or older with DSM-5 moderate to severe OUD seeking MOUD in the community and followed for 6 months. Participants were considered retained on MOUD through 6 months if they reported taking MOUD at every study interview without discontinuation. A high dose of MOUD was defined as a methadone dose > 85 mg or buprenorphine dose ≥ 16 mg. Multivariable logistic regression was conducted to assess factors associated with 6-month MOUD retention., Results: A total of 118 participants (73% male, 58% white, 36% with HIV) were included. Buprenorphine was initiated by 58% and 42% started methadone. MOUD retention was 49% and 58% among buprenorphine and methadone, respectively, at 6-months. In adjusted models, a high MOUD dose (OR = 4.71, 95% CI 2.05-10.84) and higher pain interference (OR = 1.59, 95% CI 1.15-2.19) was associated with MOUD retention., Conclusions: Adequate dosing of MOUD leads to improved retention on MOUD. Further, persons with high pain interference at baseline had higher odds of retention on MOUD. Both methadone and buprenorphine have analgesic effects, thus those with high pain interference could have dual benefits of MOUD for treating OUD and pain. Interventions should be tailored to improve adequate MOUD dosing to improve retention on MOUD., (© 2022. The Author(s).)
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- 2022
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237. Commentary on Murphy et al.: What will it take to prescribe extended-release naltrexone to treat alcohol use disorder?
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Springer SA
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- Alcohol Drinking, Humans, Naltrexone therapeutic use, Narcotic Antagonists therapeutic use, Alcohol Deterrents therapeutic use, Alcoholism drug therapy
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- 2022
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238. Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans.
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Petrakis I, Springer SA, Davis C, Ralevski E, Gu L, Lew R, Hermos J, Nuite M, Gordon AJ, Kosten TR, Nunes EV, Rosenheck R, Saxon AJ, Swift R, Goldberg A, Ringer R, and Ferguson R
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- Humans, Narcotic Antagonists therapeutic use, SARS-CoV-2, Buprenorphine therapeutic use, COVID-19, Opioid-Related Disorders drug therapy, Veterans
- Abstract
Background: To address the US opioid epidemic, there is an urgent clinical need to provide persons with opioid use disorder (OUD) with effective medication treatments for OUD (MOUD). Formulations of sublingual buprenorphine/naloxone (SL-BUP/NLX) are considered the standard of care for OUD including within the Veterans Healthcare Administration (VHA). However, poor retention on MOUD undermines its effectiveness. Long-acting injectable monthly buprenorphine (INJ-BUP) (e.g., Sublocade®) has the potential to improve retention and therefore reduce opioid use and overdose. Designing and conducting studies for OUD pose unique challenges. The strategies and solutions to some of these considerations in designing Cooperative Studies Program (CSP) 2014, Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE), a randomized, 20-site, clinical effectiveness trial comparing INJ-BUP to SL-BUP/NLX conducted within the VHA may provide valuable guidance for others confronted with similar investigation challenges., Methods: This 52-week, parallel group, open-label, randomized controlled trial (RCT) evaluates the comparative effectiveness of two current FDA-approved formulations of buprenorphine: (1) daily SL-BUP/NLX vs. (2) monthly (28-day) INJ-BUP for Veterans with moderate to severe OUD (n = 952). The primary outcomes are (1) retention in MOUD and (2) opioid abstinence. Secondary outcomes include measures of other drug use, psychiatric symptoms, medical outcomes including prevalence rates of HIV, hepatitis B and C as well as social outcomes (housing instability, criminal justice involvement), service utilization and cost-effectiveness. Special considerations in conducting a comparative effectiveness trial with this population and during COVID-19 pandemic were also included., Discussion: The evaluation of the extended-release formulation of buprenorphine compared to the standard sublingual formulation in real-world VHA settings is of paramount importance in addressing the opioid epidemic. The extent to which this new treatment facilitates retention, decreases opioid use, and prevents severe sequelae of OUD has not been studied in any long-term trial to date. Positive findings in this trial could lead to widespread adoption of MOUD, and, if proven superior INJ-BUP, by clinicians throughout the VHA and beyond. This treatment has the potential to reduce opioid use among Veterans, improve medical, psychological, and social outcomes, and save lives at justifiable cost. Trial registration Registered at Clinicaltrials.gov NCT04375033., (© 2022. The Author(s).)
- Published
- 2022
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239. Hepatitis C in the United States: One Step Forward, Two Steps Back.
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Rio CD and Springer SA
- Subjects
- Humans, United States epidemiology, Hepacivirus, Hepatitis C epidemiology
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- 2021
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240. Hazardous alcohol use, antiretroviral therapy receipt, and viral suppression in people living with HIV who inject drugs in the United States, India, Russia, and Vietnam.
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Wagman JA, Wynn A, Matsuzaki M, Gnatienko N, Metsch LR, Del Rio C, Feaster DJ, Nance RM, Whitney BM, Delaney JAC, Kahana SY, Crane HM, Chandler RK, Elliott JC, Altice F, Lucas GM, Mehta SH, Hirsch-Moverman Y, El-Sadr WM, Vu Q, Nguyen Thanh B, Springer SA, Tsui JI, and Samet JH
- Subjects
- Adult, Cross-Sectional Studies, Female, Humans, India epidemiology, Male, Middle Aged, Russia epidemiology, United States, Vietnam epidemiology, Viral Load, Alcohol-Related Disorders epidemiology, Alcohol-Related Disorders virology, Anti-Retroviral Agents administration & dosage, HIV Infections drug therapy, HIV Infections epidemiology, HIV Infections virology, Substance Abuse, Intravenous epidemiology, Substance Abuse, Intravenous virology
- Abstract
Objectives: In high-income countries, hazardous alcohol use is associated with reduced receipt of antiretroviral therapy (ART) and viral suppression among people living with HIV (PLHIV) who inject drugs. These associations are less understood in lower middle-income countries (LMIC) and upper middle-income countries., Design: We examined associations between hazardous alcohol use, ART receipt, and viral suppression among PLHIV who reported current or former injection drug use. Participants were from nine studies in the United States (high-income country), India (LMIC), Russia (upper middle-income country), and Vietnam (LMIC)., Methods: Hazardous alcohol use was measured via Alcohol Use Disorders Identification Test. Outcomes were HIV viral suppression (viral load of <1000 RNA copies/ml) and self-reported ART receipt. Logistic regression assessed associations between hazardous alcohol use and both outcome variables, controlling for age and sex, among participants with current and former injection drug use., Results: Among 2790 participants, 16% were women, mean age was 37.1 ± 9.5 years. Mean Alcohol Use Disorders Identification Test scores were 4.6 ± 8.1 (women) and 6.2 ± 8.3 (men); 42% reported ART receipt; 40% had viral suppression. Hazardous alcohol use was significantly associated with reduced ART receipt in India (adjusted odds ratio = 0.59, 95% confidence interval: 0.45-0.77, P < 0.001); and lower rates of viral suppression in Vietnam (adjusted odds ratio = 0.51, 95% confidence interval: 0.31-0.82, P = 0.006)., Conclusion: Associations between hazardous alcohol use, ART receipt, and viral suppression varied across settings and were strongest in LMICs. Addressing hazardous alcohol use holds promise for improving HIV continuum of care outcomes among PLHIV who inject drugs. Specific impact and intervention needs may differ by setting.
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- 2020
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241. Preventing HIV outbreaks among people who inject drugs in the United States: plus ça change, plus ça même chose.
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Strathdee SA, Kuo I, El-Bassel N, Hodder S, Smith LR, and Springer SA
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- Continuity of Patient Care, HIV Infections psychology, Humans, Pre-Exposure Prophylaxis, Substance Abuse, Intravenous epidemiology, United States epidemiology, Disease Outbreaks prevention & control, HIV Infections epidemiology, HIV Infections prevention & control, Substance Abuse, Intravenous complications, Substance Abuse, Intravenous psychology, Substance-Related Disorders psychology
- Abstract
: This editorial review covers current trends in the epidemiology of HIV among people who inject drugs (PWID) in the United States, including four recent HIV outbreaks. We discuss gaps in the prevention and treatment cascades for HIV and medications for opioid disorder and propose lessons learned to prevent future HIV outbreaks. Over the last decade, North America has been in the throes of a major opioid epidemic, due in part to over-prescribing of prescription opiates, followed by increasing availability of cheap heroin, synthetic opioids (e.g. fentanyl), and stimulants (e.g. methamphetamine). Historically, HIV infection among PWID in the US had predominantly affected communities who were older, urban and Black. More recently, the majority of these infections are among younger, rural or suburban and Caucasian PWID. All four HIV outbreaks were characterized by a high proportion of women who inject drugs and underlying socioeconomic drivers such as homelessness and poverty. We contend that the US response to the HIV epidemic among PWID has been fractured. A crucial lesson is that when evidence-based responses to HIV prevention are undermined or abandoned because of moral objections, untold humanitarian and financial costs on public health will ensue. Restructuring a path forward requires that evidence-based interventions be integrated and brought to scale while simultaneously addressing underlying structural drivers of HIV and related syndemics. Failing to do so will mean that HIV outbreaks among PWID and the communities they live in will continue to occur in a tragic and relentless cycle.
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- 2020
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242. Lessons Learned from the Response to the Human Immunodeficiency Virus Epidemic that Can Inform Addressing the Opioid Epidemic.
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Springer SA and Rio CD
- Subjects
- HIV Infections drug therapy, HIV Infections mortality, Humans, Opioid-Related Disorders drug therapy, Opioid-Related Disorders mortality, United States epidemiology, Analgesics, Opioid therapeutic use, HIV Infections epidemiology, Opioid Epidemic, Opioid-Related Disorders epidemiology
- Abstract
The lessons learned from the response to the human immunodeficiency virus (HIV) epidemic are important to quell the opioid use disorder epidemic in the United States. This article identifies similar barriers to treatment and care that persons living with HIV experienced in the 1980s and early 1990s that are currently being experienced by persons living with opioid use disorder. In addition, this article reviews the ways in which those barriers were overcome to reduce the mortality and morbidity from HIV and highlights similar strategies that can also help persons living with opioid use disorder in this country., Competing Interests: Disclosure S.A. Springer has provided scientific consulting to Alkermes Inc. and received NIH funding for research grants. C. del Rio has received research grants from NIH. This research was funded by the National Institute on Drug Abuse (K02 DA032322 for Springer’s career development). The funders were not involved in the research design, analysis, or interpretation of the data, or the decision to publish the article. The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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243. The Impact of Medications for Opioid Use Disorder on Hepatitis C Incidence Among Incarcerated Persons: A Systematic Review.
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Seval N, Wurcel A, Gunderson CG, Grimshaw A, and Springer SA
- Subjects
- Hepatitis C drug therapy, Hepatitis C etiology, Humans, Incidence, Opioid-Related Disorders drug therapy, Prevalence, Prisoners, Prisons, Risk, Substance Abuse, Intravenous drug therapy, Analgesics, Opioid adverse effects, Hepatitis C epidemiology, Opioid-Related Disorders complications, Substance Abuse, Intravenous complications
- Abstract
Hepatitis C virus (HCV) is highly prevalent in the criminal justice system and in persons who inject drugs, particularly opioids. Data on the impact of medications for opioid use disorder (MOUD) are abundant for infectious and noninfectious outcomes but are limited for justice-involved settings. This systematic review and meta-analysis focuses on the impact of MOUD on HCV incidence for persons in prisons and jails. Six studies were included in the qualitative synthesis, of which four were included for meta-analysis. A varied MOUD effect on HCV incidence was observed in part due to wide variability in prison and jail risk environments., Competing Interests: Conflicts of interest All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Author S.A. Springer discloses receiving monetary compensation for scientific consultation from Alkermes Inc and receives research funding from the National Institutes of Health (NIH)., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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244. A Call to Action to Combat the Opioid Epidemic Among Women.
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Springer SA, Biondi BE, Frank C, and El-Bassel N
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- Female, Humans, Opioid Epidemic, Social Stigma, United States epidemiology, Analgesics, Opioid adverse effects, Opioid-Related Disorders drug therapy, Opioid-Related Disorders epidemiology
- Abstract
: Acknowledging the needs and challenges of women with opioid use disorder is an essential step to reduce the opioid epidemic in the United States. Efforts that can help women include increasing psychosocial services to address trauma, increasing access to medication treatment for opioid use disorder, reducing barriers and stigma that impede access to and retention on treatment, and addressing structural and policy barriers. This commentary discusses the reasons why women-focused treatment for opioid use disorder is necessary and makes specific recommendations for interventions, treatment, services, and policies that can reduce barriers to care and improve treatment and retention among women.
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- 2020
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245. Pregnancy, Substance Use, and Research: How do We Protect Women While Increasing Their Participation in Research?
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Biondi BE, Frank C, and Springer SA
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- Female, Humans, Pregnancy, Behavioral Research, Biomedical Research, Patient Selection, Pregnant Women, Substance-Related Disorders, Women's Health
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- 2020
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246. Medications for Treatment of Opioid Use Disorder among Persons Living with HIV.
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Fanucchi L, Springer SA, and Korthuis PT
- Subjects
- HIV Infections drug therapy, HIV Infections etiology, Humans, Treatment Outcome, Buprenorphine therapeutic use, Methadone therapeutic use, Naltrexone therapeutic use, Opioid-Related Disorders drug therapy
- Abstract
Purpose of Review: Recent HIV outbreaks have occurred as a result of the current US opioid epidemic. Providing medications for opioid use disorder (MOUD) with methadone, buprenorphine, and extended-release naltrexone is essential to achieving optimal HIV treatment outcomes including viral suppression and retention in treatment. This review describes the pharmacology of MOUD with specific attention to interactions with antiretroviral therapy, and to the effect of MOUD on HIV treatment outcomes., Recent Findings: Methadone and buprenorphine both improve HIV viral suppression, adherence to antiretroviral therapy, and overall mortality for persons with opioid use disorder (OUD). Extended-release naltrexone has been most extensively studied in persons with HIV leaving incarcerated settings, and improves HIV viral suppression in that context. Strategies that integrate MOUD and HIV treatment are crucial to optimize viral suppression. The differing pharmacokinetic and delivery characteristics of these MOUD offer diverse options. Given the chronic and relapsing nature of both HIV and OUD, long-term approaches are required.
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- 2019
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247. Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community: Results From a Double-Blind, Placebo-Controlled Trial.
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Springer SA, Di Paola A, Barbour R, Azar MM, and Altice FL
- Subjects
- Adult, Alcoholism complications, Double-Blind Method, Female, HIV Infections complications, HIV-1 genetics, HIV-1 isolation & purification, Humans, Male, Opioid-Related Disorders complications, Placebos, RNA, Viral blood, Alcohol Deterrents administration & dosage, Alcoholism drug therapy, Delayed-Action Preparations administration & dosage, HIV Infections virology, Naltrexone administration & dosage, Narcotic Antagonists administration & dosage, Opioid-Related Disorders drug therapy, Prisoners, Viral Load
- Abstract
Objective: To determine whether extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among incarcerated individuals with HIV and alcohol use disorders (AUDs) transitioning to the community., Design: A randomized, double-blind, placebo-controlled trial was conducted among incarcerated individuals with HIV and AUDs transitioning to the community from 2010 through 2016., Methods: Eligible participants (N = 100) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n = 67) or placebo (n = 33) starting at release and continued for 6 months. The primary and secondary outcomes were the proportion that maintained or improved VS at <200 and <50 copies per milliliter from baseline to 6 months, respectively, using an intention-to-treat analysis., Results: Participants allocated to XR-NTX improved VS from baseline to 6 months for <200 copies per milliliter (48.0%-64.2%, P = 0.024) and for <50 copies per milliliter (31.0%-56.7%, P = 0.001), whereas the placebo group did not (<200 copies/mL: 64%-42.4%, P = 0.070; <50 copies/mL: 42.0%-30.3%, P = 0.292). XR-NTX participants were more likely to achieve VS than the placebo group at 6 months (<200 copies/mL: 64.2% vs. 42.4%; P = 0.041; <50 copies/mL: 56.7% vs. 30.3%; P = 0.015). XR-NTX independently predicted VS [<200 copies/mL: adjusted odds ratio (aOR) = 2.68, 95% confidence interval (CI) = 1.01 to 7.09, P = 0.047; <50 copies/mL: aOR = 4.54; 95% CI = 1.43 to 14.43, P = 0.009] as did receipt of ≥3 injections (<200 copies/mL: aOR = 3.26; 95% CI = 1.26 to 8.47, P = 0.010; <50 copies/mL: aOR = 6.34; 95% CI = 2.08 to 19.29, P = 0.001). Reductions in alcohol consumption (aOR = 1.43, 95% CI = 1.03 to 1.98, P = 0.033) and white race (aOR = 5.37, 95% CI = 1.08 to 27.72, P = 0.040) also predicted VS at <50 copies per milliliter., Conclusions: XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV and AUDs.
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- 2018
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248. Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community: Results of a Double-Blind, Placebo-Controlled Randomized Trial.
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Springer SA, Di Paola A, Azar MM, Barbour R, Biondi BE, Desabrais M, Lincoln T, Skiest DJ, and Altice FL
- Subjects
- Adult, Criminal Law, Delayed-Action Preparations, Double-Blind Method, Female, Follow-Up Studies, HIV Infections complications, HIV-1, Humans, Injections, Intramuscular, Male, Middle Aged, Multivariate Analysis, Naltrexone administration & dosage, Naltrexone adverse effects, Narcotic Antagonists administration & dosage, Narcotic Antagonists adverse effects, Opioid-Related Disorders complications, Prospective Studies, RNA, Viral, Research Design, Time Factors, Treatment Outcome, Viral Load, HIV Infections drug therapy, Naltrexone therapeutic use, Narcotic Antagonists therapeutic use, Opioid-Related Disorders drug therapy, Prisoners
- Abstract
Objective: To determine whether extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among prisoners or jail detainees with HIV and opioid use disorder (OUD) transitioning to the community., Design: A 4-site, prospective randomized double-blind, placebo-controlled trial was conducted among prison and jail inmates with HIV and OUD transitioning to the community from September 2010 through March 2016., Methods: Eligible participants (N = 93) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n = 66) or placebo (n = 27) starting at release and observed for 6 months. The primary outcome was the proportion that maintained or improved VS (<50 copies/mL) from baseline to 6 months., Results: Participants allocated to XR-NTX significantly improved to VS (<50 copies/mL) from baseline (37.9%) to 6 months (60.6%) (P = 0.002), whereas the placebo group did not (55.6% at baseline to 40.7% at 6 months P = 0.294). There was, however, no statistical significant difference in VS levels at 6 months between XR-NTX (60.6%) vs. placebo (40.7%) (P = 0.087). After controlling for other factors, only allocation to XR-NTX (adjusted odds ratio = 2.90; 95% confidence interval = 1.04 to 8.14, P = 0.043) was associated with the primary outcome. Trajectories in VS from baseline to 6 months differed significantly (P = 0.017) between treatment groups, and the differences in the discordant values were significantly different as well (P = 0.041): the XR-NTX group was more likely than the placebo group to improve VS (30.3% vs. 18.5%), maintain VS (30.3% vs. 27.3), and less likely to lose VS (7.6% vs. 33.3%) by 6 months., Conclusions: XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV with OUD.
- Published
- 2018
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249. Gender Differences in HIV Risk Behaviors Among Persons Involved in the U.S. Criminal Justice System and Living with HIV or at Risk for HIV: A "Seek, Test, Treat, and Retain" Harmonization Consortium.
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Loeliger KB, Biggs ML, Young R, Seal DW, Beckwith CG, Kuo I, Gordon MS, Altice FL, Ouellet LJ, Cunningham WE, Young JD, and Springer SA
- Subjects
- Adult, Female, Health Services Accessibility, Humans, Logistic Models, Male, Middle Aged, Sex Factors, Sexual Partners, United States epidemiology, Young Adult, Criminal Law, HIV Infections epidemiology, HIV Infections prevention & control, Prisons, Risk-Taking, Sexual Behavior statistics & numerical data, Substance Abuse, Intravenous epidemiology
- Abstract
The U.S. female criminal justice (CJ) population is rapidly growing, yet large-scale studies exploring gender-specific HIV risk behaviors in the CJ population are lacking. This analysis uses baseline data on adults with a CJ history from eight U.S. studies in an NIH-funded "Seek, Test, Treat, Retain" harmonization consortium. Data were collected using a standardized HIV risk behavior assessment tool and pooled across studies to describe participants' characteristics and risk behaviors. Multilevel mixed-effects logistic regression models were used to test for gender-based behavior differences. Among 784 HIV-positive (21.4% female) and 5521 HIV-negative (8.5% female) participants, HIV-positive women had higher odds than HIV-positive men of engaging in condomless sexual intercourse (AOR 1.84 [1.16-2.95]) with potentially sero-discordant partners (AOR 2.40 [1.41-4.09]) and of sharing injection equipment (AOR 3.36 [1.31-8.63]). HIV risk reduction interventions targeting CJ-involved women with HIV are urgently needed as this population may represent an under-recognized potential source of HIV transmission.
- Published
- 2017
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250. The Impact of Alcohol Use and Related Disorders on the HIV Continuum of Care: a Systematic Review : Alcohol and the HIV Continuum of Care.
- Author
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Vagenas P, Azar MM, Copenhaver MM, Springer SA, Molina PE, and Altice FL
- Subjects
- Drug Administration Schedule, Humans, Alcohol Drinking, Alcoholism, Anti-HIV Agents therapeutic use, HIV Infections complications, HIV Infections drug therapy
- Abstract
Alcohol use is highly prevalent globally with numerous negative consequences to human health, including HIV progression, in people living with HIV (PLH). The HIV continuum of care, or treatment cascade, represents a sequence of targets for intervention that can result in viral suppression, which ultimately benefits individuals and society. The extent to which alcohol impacts each step in the cascade, however, has not been systematically examined. International targets for HIV treatment as prevention aim for 90 % of PLH to be diagnosed, 90 % of them to be prescribed with antiretroviral therapy (ART), and 90 % to achieve viral suppression; currently, only 20 % of PLH are virally suppressed. This systematic review, from 2010 through May 2015, found 53 clinical research papers examining the impact of alcohol use on each step of the HIV treatment cascade. These studies were mostly cross-sectional or cohort studies and from all income settings. Most (77 %) found a negative association between alcohol consumption on one or more stages of the treatment cascade. Lack of consistency in measurement, however, reduced the ability to draw consistent conclusions. Nonetheless, the strong negative correlations suggest that problematic alcohol consumption should be targeted, preferably using evidence-based behavioral and pharmacological interventions, to indirectly increase the proportion of PLH achieving viral suppression, to achieve treatment as prevention mandates, and to reduce HIV transmission.
- Published
- 2015
- Full Text
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