Socioeconomic Status and CD4 Count Among People with HIV Who Inject Drugs in St. Petersburg, Russia.

Lack of access to resources is a "fundamental cause" of poor HIV outcomes across the care cascade globally and may have the greatest impact on groups with co-existing marginalized identities. In a sample of people living with HIV (PWH) who inject drugs and were not on antiretroviral therapy (ART), we explored associations between access to resources and HIV severity. Fundamental Cause Theory (FCT) sees socioeconomic status/access to resources as a root cause of disease and emphasizes that individuals with limited resources have fewer means to mitigate health risks and implement protective behaviors, which ultimately generates disparities in health outcomes. Guided by the FCT, we hypothesized that resource depletion (primary aim) and lower income (secondary aim) were associated with increased HIV severity. Using baseline data from the Linking Infectious and Narcology Care (LINC-II) trial of ART-naive PWH who inject drugs in St. Petersburg, Russia (n = 225), we examined the association between "past year resource runout" (yes vs. no) and "low-income (< 300 USD a month)" and the outcome HIV severity (CD4 count, continuous). We fit two separate linear regression models adjusted for gender, age, time since HIV diagnosis, and prior ART use. Participants had a mean age of 37.5 years and were 60% male. Two thirds (66%) reported resource depletion, and 30% had income below 300 USD a month. Average CD4 count was 416 cells/mm3 (SD 285). No significant association was identified between either resource depletion or low-income and HIV severity (adjusted mean difference in CD4 count for resource depletion: - 4.16, 95% CI - 82.93, 74.62; adjusted mean difference in CD4 count for low-income: 68.13, 95% CI - 15.78, 152.04). Below-average income and running out of resources were common among PWH who inject drugs and are not on ART in St. Petersburg, Russia. Resource depletion and low-income were not significantly associated with HIV disease severity as captured by CD4 count. The nuanced relationship between socioeconomic status and HIV severity among people with HIV who inject drugs and not on ART merits further examination in a larger sample.

Effect of the Communities that HEAL intervention on receipt of behavioral therapies for opioid use disorder: A cluster randomized wait-list controlled trial.

BACKGROUND: The U.S. opioid overdose crisis persists. Outpatient behavioral health services (BHS) are essential components of a comprehensive response to opioid use disorder and overdose fatalities. The Helping to End Addiction Long-Term® (HEALing) Communities Study developed the Communities That HEAL (CTH) intervention to reduce opioid overdose deaths in 67 communities in Kentucky, Ohio, New York, and Massachusetts through the implementation of evidence-based practices (EBPs), including BHS. This paper compares the rate of individuals receiving outpatient BHS in Wave 1 intervention communities (n = 34) to waitlisted Wave 2 communities (n = 33). METHODS: Medicaid data included individuals ≥18 years of age receiving any of five BHS categories: intensive outpatient, outpatient, case management, peer support, and case management or peer support. Negative binomial regression models estimated the rate of receiving each BHS for Wave 1 and Wave 2. Effect modification analyses evaluated changes in the effect of the CTH intervention between Wave 1 and Wave 2 by research site, rurality, age, sex, and race/ethnicity. RESULTS: No significant differences were detected between intervention and waitlisted communities in the rate of individuals receiving any of the five BHS categories. None of the interaction effects used to test the effect modification were significant. CONCLUSIONS: Several factors should be considered when interpreting results-no significant intervention effects were observed through Medicaid claims data, the best available data source but limited in terms of capturing individuals reached by the intervention. Also, the 12-month evaluation window may have been too brief to see improved outcomes considering the time required to stand-up BHS. TRIAL REGISTRATION: Clinical Trials.gov http://www. CLINICALTRIALS: gov: Identifier: NCT04111939.

Comparative costs and potential affordability of a multifaceted intervention to improve treatment outcomes among people with HIV who inject drugs in Russia: economic evaluation of the LINC-II randomized controlled trial.

INTRODUCTION: The LINC-II randomized controlled trial in St. Petersburg, Russia for HIV-positive adults who inject drugs found that a multi-component intervention including initiation of antiretroviral therapy (ART) during admission to an addiction hospital, strengths-based case management and naltrexone significantly increased 12-month HIV viral suppression and ART retention. We conducted a comparative cost analysis to determine if the 12-month cost of the intervention is affordable within the current Russian health system. METHODS: We used LINC-II trial records and questionnaire responses to calculate the resources utilized by each participant in the study, including inpatient days, medications, laboratory tests, outpatient consultations, case manager interactions and opioid medication treatment. Quantities of resources utilized were multiplied by unit costs for each resource estimated from the service fee or price lists used by the study facilities for each specific service delivered. We report the average cost/study primary (viral suppression at 12 months) or secondary (retention in care at 12 months) outcome/participant in 2021 USD and compare costs between study arms. RESULTS: The trial enrolled 225 participants (111 intervention, 114 control) between September 2018 and December 2020. Viral suppression, non-suppression and missing suppression results were 28% and 14%, 49% and 37%, and 31% and 41% for the control and intervention arms, respectively. Retention results were 35% and 51% for the control and intervention arms, respectively. The average cost per study participant was $2714 in the control arm and $4342 in the intervention arm. The average cost per participant virally suppressed at 12 months was $3662 (control) and $6355 (intervention). The average cost per participant retained at 12 months was $4050 (control) and $5448 (intervention). For those retained, the cost difference between the arms was comprised of opioid treatment (35%), case management (31%), outpatient visits (18%) and additional days of ART (12%). CONCLUSIONS: The LINC-II intervention increased the cost of care for HIV-positive people who inject drugs in Russia significantly, but some components of the intervention, particularly earlier initiation of ART and case management, may be justifiable due to their success in reaching a challenging subgroup of the population in need. CLINICAL TRIAL NUMBER: NCT03290391.

Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial.

Importance: Buprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined. Objective: To determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing. Design, Setting, and Participants: This prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list-controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022. Intervention: Waiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity. Main Outcomes and Measures: The rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100 000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed. Results: A total of 8 166 963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10). Conclusions and Relevance: In this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder. Trial Registration: ClinicalTrials.gov Identifier: NCT04111939.

Pilot RCT comparing low-dose naltrexone, gabapentin and placebo to reduce pain among people with HIV with alcohol problems.

BACKGROUND: To estimate the effects on pain of two medications (low-dose naltrexone and gabapentin) compared to placebo among people with HIV (PWH) with heavy alcohol use and chronic pain. METHODS: We conducted a pilot, randomized, double-blinded, 3-arm study of PWH with chronic pain and past-year heavy alcohol use in 2021. Participants were recruited in St. Petersburg, Russia, and randomized to receive daily low-dose naltrexone (4.5mg), gabapentin (up to 1800mg), or placebo. The two primary outcomes were change in self-reported pain severity and pain interference measured with the Brief Pain Inventory from baseline to 8 weeks. RESULTS: Participants (N = 45, 15 in each arm) had the following baseline characteristics: 64% male; age 41 years (SD±7); mean 2 (SD±4) heavy drinking days in the past month and mean pain severity and interference were 3.2 (SD±1) and 3.0 (SD±2), respectively. Pain severity decreased for all three arms. Mean differences in change in pain severity for gabapentin vs. placebo, and naltrexone vs. placebo were -0.27 (95% confidence interval [CI] -1.76, 1.23; p = 0.73) and 0.88 (95% CI -0.7, 2.46; p = 0.55), respectively. Pain interference decreased for all three arms. Mean differences in change in pain interference for gabapentin vs. placebo, and naltrexone vs. placebo was 0.16 (95% CI -1.38, 1.71; p = 0.83) and 0.40 (95% CI -1.18, 1.99; p = 0.83), respectively. CONCLUSION: Neither gabapentin nor low-dose naltrexone appeared to improve pain more than placebo among PWH with chronic pain and past-year heavy alcohol use. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT4052139).

Is Abstinence from Alcohol and Smoking Associated with Less Anxiety and Depressive Symptoms Among People with HIV?

Achieving abstinence from alcohol, tobacco, or both may improve mental health, but is understudied in people with HIV (PWH). The St PETER HIV randomized clinical trial compared varenicline, cytisine, and nicotine replacement therapy on alcohol and smoking behavior among 400 PWH in Russia. The primary exposure was thirty-day point prevalence abstinence (PPA) from (1) alcohol, (2) smoking, (3) both, or (4) neither and was assessed at 1, 3, 6 and 12-months as were the study outcomes of anxiety (GAD-7) and depressive (CES-D) symptoms. The primary aim was to examine the association between smoking and/or alcohol abstinence and subsequent symptoms of depression and anxiety. Primary analysis used repeated measures generalized linear modeling to relate PPA with mental health scores across time. In secondary analyses, Kruskal-Wallis tests related PPA with mental health scores at each timepoint. Primary analyses did not identify significant differences in anxiety or depressive symptoms between exposure groups over time. Secondary analyses found CES-D scores across PPA categories were similar at 1-month (11, 10, 11, 11) and 6-months (10, 10, 11, 11) but differed at 3-months (9, 11, 10, 12; p = 0.035) and 12-months (10, 6, 11, 10; p = 0.019). GAD-7 scores did not vary across PPA categories at any time point. While abstinence was associated with fewer depressive symptoms at times, findings were not consistent during follow-up, perhaps reflecting intermittent relapse. PWH with polysubstance use and mental health comorbidity are complex, and larger samples with sustained abstinence would further elucidate effects of abstinence on mental health.

Healthcare Utilization Among Persons with HIV and Unhealthy Alcohol Use in St. Petersburg, Russia.

Few studies have examined the association between healthcare utilization and heavy alcohol use in Russia among persons with HIV (PWH), a group with high healthcare needs. This study analyzed the association between unhealthy alcohol use (defined as AUDIT score ≥ 8) and healthcare utilization among PWH with heavy alcohol use and daily smoking in St. Petersburg, Russia. This secondary analysis used data from a randomized controlled trial addressing alcohol use. The primary outcome was seeing an infectionist for HIV care in the past year. Outcomes were measured at baseline, 6 months, and 12 months. We assessed the association between unhealthy alcohol use and healthcare utilization outcomes with a repeated measures logistic regression model, controlling for relevant covariates. Nearly all (96.0%) participants had unhealthy alcohol use at baseline, and 90.0% had seen an infectionist for HIV care in the past year. In adjusted analyses, unhealthy alcohol use was associated with a 36% decrease in seeing an infectionist for HIV care (aOR = 0.64, 95% CI 0.43-0.95). Participants reported low levels of emergency department visits and hospitalizations. Understanding how to engage this population in alcohol use disorder treatment and HIV care is an important next step for improving health outcomes for this population.

Mobile treatment for opioid use disorder: Implementation of community-based, same-day medication access interventions.

BACKGROUND: Medications for Opioid Use Disorder (MOUD) are lifesaving, but <20 % of individuals in the US who could benefit receive them. As part of the NIH-supported HEALing Communities Study (HCS), coalitions in several communities in Massachusetts and Ohio implemented mobile MOUD programs to overcome barriers to MOUD receipt. We defined mobile MOUD programs as units that provide same-day access to MOUD at remote sites. We aimed to (1) document the design and organizational structure of mobile programs providing same-day or next-day MOUD, and (2) explore the barriers and facilitators to implementation as well as the successes and challenges of ongoing operation. METHODS: Program staff from five programs in two states (n = 11) participated in semi-structured interviews. Two authors conducted thematic analysis of the transcripts based on the domains of the social-ecological model and the semi-structured interview guide. RESULTS: Mobile MOUD units sought to improve immediate access to MOUD ("Our answer is pretty much always, 'Yes, we'll get you started right here, right now,'"), advance equity ("making sure that we have staff who speak other languages, who are on the unit and have some resources that are in different languages,"), and decrease opioid overdose deaths. Salient program characteristics included diverse staff, including staff with lived experience of substance use ("She just had that personal knowledge of where we should be going"). Mobile units offered harm reduction services, broad medical services (in particular, wound care), and connection to transportation programs and incorporated consistency in service provision and telemedicine access. Implementation facilitators included trusting relationships with partner organizations (particularly pharmacies and correctional facilities), nuanced understanding of local politics, advertising, protocol flexibility, and on-unit prescriber hours. Barriers included unclear licensing requirements, staffing shortages and competing priorities for staff, funding challenges due to inconsistency in grant funding and low reimbursement ("It's not really possible that billing in and of itself is going to be able to sustain it"), and community stigma toward addiction services generally. CONCLUSIONS: Despite organizational, community, and policy barriers, participants described mobile MOUD units as an innovative way to expand access to life-saving medications, promote equity in MOUD treatment, and overcome stigma.

Alcohol Consumption and Illicit Drug Use: Associations With Fall, Fracture, and Acute Health Care Utilization Among People With HIV Infection.

BACKGROUND: Given alcohol and/or other drug (AOD) use occurs among people with HIV (PWH), we examined its association with falls and fall-related outcomes and whether frailty moderates the association. SETTING: Northeastern US city. METHODS: We analyzed an observational cohort of PWH with current or past AOD use. Alcohol measures were any past 14-day heavy use, average alcohol/day, and days with heavy use. Drug use measures were past 30-day illicit use of cocaine, opioids, and sedatives. Repeated cross-sectional associations were estimated with separate multivariable generalized estimating equation regression models for each fall-related outcome. RESULTS: Among PWH (n = 251; mean age 52 [SD = 10]), 35% reported heavy alcohol use, 24% cocaine, 16% illicit opioids, 13% illicit sedatives, and 35% any fall; 27% were frail. Heavy alcohol use was associated with a fall (AOR = 1.49, 95% CI: 1.08 to 2.07), multiple falls (AOR = 1.55 95% CI: 1.10 to 2.19), and fall/fracture-related emergency department visit or hospitalization (AOR = 1.81, 95% CI: 1.10 to 2.97). Higher average alcohol/day and more heavy drinking days were associated with multiple falls. Illicit sedative use was associated with a fall, multiple falls, and emergency department visit/hospitalization and opioid use with fracture. Frailty moderated the association of heavy alcohol use and a fall (AOR = 2.26, 95% CI: 1.28 to 4.01 in those frail) but not in those not frail. CONCLUSION: The effect of AOD use on falls and fall-related outcomes was most pronounced with alcohol, particularly among frail PWH. Heavy alcohol, illicit sedative, and illicit opioid use are high-priority targets for preventing falls and fall-related consequences for PWH.

Stigma and other correlates of sharing injection equipment among people with HIV in St. Petersburg, Russia.

Stigma that people with HIV who inject drugs experience negatively impacts HIV and substance use care, but stigma's association with sharing injection equipment is not known. This is a cross-sectional analysis of data from two studies of people with HIV reporting drug injection (N = 319) in St. Petersburg, Russia (September 2018-December 2020). We used logistic regression to examine associations between HIV stigma and substance use stigma scores (categorised into quartiles) and past 30-day equipment sharing, adjusting for demographic and clinical characteristics. Secondary analyses examined associations of arrest history and social support with sharing equipment. Almost half (48.6%) of participants reported sharing injection equipment. Among groups who did and did not share, mean HIV stigma (2.3 vs 2.2) and substance use stigma (32 vs 31) scores were similar. Adjusted analyses detected no significant associations between HIV stigma quartiles (global p-value = 0.85) or substance use stigma quartiles (global p-value = 0.51) and sharing equipment. Neither arrest history nor social support were significantly associated with sharing equipment. In this cohort, sharing injection equipment was common and did not vary based on stigma, arrest history, or social support. To reduce equipment sharing, investments in sterile injection equipment access in Russia should be prioritised over interventions to address stigma.

Influence of patient trust in provider and health literacy on receipt of guideline-concordant chronic opioid therapy in HIV care settings.

OBJECTIVE: Persons with HIV (PWH) frequently receive opioids for pain. Health literacy and trust in provider may impact patient-provider communication, and thus receipt of guideline-concordant opioid monitoring. We analyzed baseline data of HIV-positive patients on chronic opioid therapy (COT) in a trial to improve guideline-concordant COT in HIV clinics. DESIGN: Retrospective cohort study. SETTING: Two hospital-based safetynet HIV clinics in Boston and Atlanta. PATIENTS AND PARTICIPANTS: A cohort of patients who were ≥18 years, HIV-positive, had received ≥ 3 opioid prescriptions from a study site ≥21 days apart within a 6-month period during the prior year and had ≥1 visit at the HIV clinic in the prior 18 months. MAIN OUTCOME MEASURES: Adjusted logistic regression models examined whether health literacy and trust in provider (scale scored 11-55, higher indicates more trust) were associated with: (1) ≥ 2 urine drug tests (UDTs) and (2) presence of an opioid treatment agreement. RESULTS: Among 166 PWH, mean trust in provider was 47.4 (SD 6.6); 117 (70 percent) had adequate health literacy. Fifty patients (30 percent) had ≥ 2 UDTs and 20 (12 percent) had a treatment agreement. The adjusted odds ratio (aOR) for a one-point increase in trust in provider was 0.97 for having ≥ 2 UDTs (95 percent CI 0.92-1.02) and 1.03 for opioid treatment agreement (95 percent CI 0.95-1.12). The aOR for adequate health literacy was 0.89 for having ≥ 2 UDTs (95 percent CI 0.42-1.88) and 1.66 for an opioid treatment agreement (95 percent CI 0.52-5.31). CONCLUSIONS: Health literacy and trust in provider were not associated with chronic opioid therapy quality outcomes.

Association of Alcohol Consumption With CD4 Recovery After Antiretroviral Therapy Initiation in St. Petersburg, Russia.

BACKGROUND: Delayed CD4 recovery after initiating antiretroviral therapy (ART) is a novel potential mechanism by which alcohol consumption leads to increased morbidity and mortality in people with HIV. We hypothesized that alcohol consumption at ART initiation is associated with slower CD4 recovery. METHODS: We retrospectively analyzed 2 pooled longitudinal alcohol/HIV cohorts (2014-2019) in St. Petersburg, Russia. Eligible participants initiated the first ART during parent studies; had alcohol consumption assessed by the blood biomarker, phosphatidylethanol (PEth), at the last research visit before ART initiation; and had ≥1 CD4 count measurement before and after initiating ART. Participants were stratified by low, moderate, and high PEth (<8, 8-80, and >80 ng/mL, respectively). We used random-effects piecewise linear regression models to estimate CD4 recovery, defined as CD4 count change per 30 days after ART initiation, by the alcohol group. RESULTS: Of 60 eligible participants, median age was 34 years and 28% were female. The median pre-ART PEth in the low, moderate, and high PEth groups were <8, 23, and 232 ng/mL, respectively. After starting ART, the CD4 count increased by 13.60 cells/mm3/mo (95% CI: 0.33 to 26.87) with low PEth, 0.93 cells/mm3/mo (95% CI: -6.18 to 8.04) with moderate PEth, and 2.33 cells/mm3/mo (95% CI: -3.44 to 8.09) with high PEth. CONCLUSIONS: Among Russians with HIV, we observed faster CD4 recovery after ART initiation in those with low alcohol consumption compared with those with moderate and high alcohol consumption, as assessed by PEth. This analysis provides further evidence for the possible value of alcohol reduction interventions for people with HIV who are initiating ART.

Trends in buprenorphine dosage and days supplied for new treatment episodes for opioid use disorder, 2010-2019.

BACKGROUND: Buprenorphine reduces risk of opioid overdose mortality. However, its benefits are limited by low retention, particularly in early treatment. Optimizing initial dosage may impact retention. However, little is known about the prescription characteristics of new buprenorphine treatment episodes. METHODS: In a US sample of commercial and employer-sponsored pharmacy claims, we identified new buprenorphine treatment episodes (days 1-30) from individuals ≥16 years following 90 days without buprenorphine from 2010 to 2019. Outcomes included first prescription average days supplied, first prescription average daily dosage, and average dosage on days 2, 8, 15 and 30. RESULTS: We identified 117,793 new episodes among 96,451 unique individuals. Episodes per 10,000 person-years decreased slightly over time. Stratifying by age, sex and region demonstrated decreasing episodes among individuals ≤34 years and increasing episodes among individuals ≥35 years. From 2010-2019, first prescription average days supplied and daily dosage decreased from 17.1 to 15.3 days and 13.6mg to 11.6mg, respectively. Simultaneously, the proportion of episodes without possession and with dosages <16mg increased across all days and years. By day 30, episodes without buprenorphine possession grew from 27.9% to 30.8% and episodes involving dosages of <16mg grew from 26.4% to 33.4%. CONCLUSIONS: We found that buprenorphine dosage and days supplied for new treatment episodes decreased from 2010 to 2019 while buprenorphine possession worsened. Further investigation examining the relationship between buprenorphine dosage and retention in the early treatment period is needed.

Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial.

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. Objective: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization. Design, Setting, and Participants: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system's randomization date through 2 years after. Intervention: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine. Main Outcomes and Measures: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up. Results: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70). Conclusions and Relevance: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT03407638.

Methamphetamine use and illicit opioid use during buprenorphine treatment.

Introduction: Although methamphetamine use is rising in the United States, its impacts on patient outcomes among persons undergoing treatment for opioid use disorder (OUD) remain unclear. This study aims to assess the association between baseline methamphetamine/amphetamine (MA/A) use and subsequent illicit opioid use among patients with OUD initiating buprenorphine in an office-based setting. Methods: We conducted a secondary analysis of a pilot randomized controlled trial of a behavioral mobile health intervention for buprenorphine adherence conducted over a 12-week study period at two clinic sites. The study defined baseline MA/A use by a positive urine drug test (UDT) and/or self-report of use within the past 30-days. Separate Poisson regression models with robust standard errors evaluated associations between MA/A and: i) illicit opioid use measured by weekly UDT (primary) and ii) self-reported past 30-day use at end of study (secondary). Other secondary outcomes included buprenorphine positive UDTs throughout the study and retention in OUD treatment at both weeks 12 and 24 post-randomization. Results: At baseline, 28 (36%) of the 78 participants had MA/A use and use was associated with a statistically significant increase in risk of testing positive for illicit opioids on UDT during the study follow-up period (adjusted relative risk (aRR)=1.54; 95% CI=1.09-2.17; p=0.015), as well as an increased risk for reported past 30-day illicit opioid use at week 12 (aRR=3.86; 95% CI=1.47-10.18; P=0.006). The study found no significant associations between MA/A use and buprenorphine positive UDT or retention in OUD treatment. Conclusions: In this sample of patients initiating buprenorphine, methamphetamine/amphetamine use at baseline was associated with illicit opioid use over a 12-week period. These findings demonstrate how co-use of methamphetamine can impede attainment of ideal OUD treatment outcomes.

Applied risk mapping and spatial analysis of address-level decedent data to inform opioid overdose interventions: The Massachusetts HEALing Communities Study.

BACKGROUND: Death certificate data provide powerful and sobering records of the opioid overdose crisis. In Massachusetts, where address-level decedent data are publicly available upon request, mapping and spatial analysis of fatal overdoses can provide valuable insights to inform prevention interventions. We describe how we used this approach to support a community-level intervention to reduce opioid-involved overdose mortality. METHODS: We developed a method to clean and geocode decedent data that substituted injury locations (the likely location of fatal overdoses) for deaths recorded in hospitals. After geomasking for greater privacy protection, we created maps to visualize the spatial distribution of decedent residence addresses, alone and juxtaposed with drive and walk-time distances to opioid treatment programs (OTPs), and place of death by overdose address. We used spatial statistical analyses to identify locations with significant clusters of overdoses. RESULTS: In the 8 intervention communities, 785 individuals died from opioid-involved overdoses between 2017 and 2020. We found that 19.7% of fatal overdoses were recorded in hospitals, 50.2% occurred at the decedent's residence, and 30.1% at another location. We identified overdose hotspots in study communities. By juxtaposing decedent residence data with drive- and walk-time analyses, we highlighted actionable spatial gaps in access to OTP treatment. CONCLUSION: To better understand local fatal opioid overdose risk environments and inform the development of community-level prevention interventions, we used publicly available address-level decedent data to conduct nuanced spatial analyses. Our approach can be replicated in other jurisdictions to inform overdose prevention responses.

Rapid access to antiretroviral therapy, receipt of naltrexone, and strengths-based case management versus standard of care for HIV viral load suppression in people with HIV who inject drugs in Russia (LINC-II): an open-label, randomised controlled trial.

BACKGROUND: Antiretroviral therapy (ART) coverage in Russia is low for people with HIV who inject drugs. HIV and addiction treatment in Russia are not well integrated. We aimed to evaluate an intervention to link people with HIV in addiction treatment to HIV care to achieve HIV viral load suppression. METHODS: LINC-II was a two-arm, open-label, randomised controlled trial at the City Addiction Hospital, Saint Petersburg, Russia. Eligible participants were aged 18 years or older, had a positive HIV status, were not currently on ART, were admitted to a narcology hospital, and had a current diagnosis of opioid use disorder. Participants were randomly assigned (1:1) to a multicomponent intervention (ie, rapid access to ART, naltrexone for opioid use disorder, and strengths-based case management) or standard of care. Blocked randomisation was stratified by history of ART use. The primary outcome was undetectable HIV viral load at 12 months, defined as less than 40 copies per mL. The trial was conducted and analysed according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, NCT03290391. FINDINGS: Between Sept 19, 2018, and Dec 25, 2020, 953 individuals were screened for eligibility, 225 of whom were randomly assigned to the intervention (n=111) or standard of care (n=114). 136 (60%) participants were male and 89 (40%) were female. Participants in the intervention group had higher odds of HIV viral load suppression at 12 months compared with participants in the standard-of-care group (52 [47%] vs 26 [23%]; adjusted odds ratio 3·0 [95% CI 1·4-6·4]; p=0·0039). 21 adverse events (18 in the intervention group and three in the standard-of-care group)and 14 deaths (four in the intervention group and ten in the standard-of-care group) were reported in the study. INTERPRETATION: Given the effectiveness of the LINC-II intervention, scaling up this model could be one strategy to advance the UNAIDS goal of ending the HIV epidemic. FUNDING: National Institute on Drug Abuse and Providence/Boston Center for AIDS Research.

Provider-patient experiences and HIV care utilization among people living with HIV who inject drugs in St. Petersburg, Russia.

Providers' disrespect and abuse of patients is a recognized but understudied issue affecting quality of care and likely affecting healthcare utilization. Little research has examined this issue among people living with HIV (PWH) who inject drugs, despite high stigmatization of this population. No research has examined this issue in the context of Russia. This study assesses patients' reports of disrespect and abuse from providers as a barrier to healthcare and examines the association between these reports and HIV care outcomes.We conducted a cross-sectional analysis of the associations between disrespect/abuse from health providers as a barrier to care and the following HIV care outcomes: (i) anti-retroviral treatment (ART) uptake ever, (ii) past 6-month visit to HIV provider, and (iii) CD4 count. Participants (N = 221) were people living with HIV who injected drugs and were not on ART at enrollment.Two in five participants (42%) reported a history disrespect/abuse from a healthcare provider that they cited as a barrier to care. Those reporting this concern had lower odds of ever use of ART (adjusted odds ratio 0.46 [95% CI 0.22, 0.95]); we found no significant associations for the other HIV outcomes. We additionally found higher representation of women among those reporting prevalence of disrespect/abuse from provider as a barrier to care compared to those not reporting this barrier (58.1% versus 27.3%).Almost half of this sample of PWH who inject drugs report disrespect/abuse from a provider as a barrier to healthcare, and this is associated with lower odds of receipt of ART but not with other HIV outcomes studied. There is need for improved focus on quality of respectful and dignified care from providers for PWH who inject drugs, and such focus may improve ART uptake in Russia.

Use of Video Directly Observed Therapy and Characteristics Associated With Use Among Patients Treated With Buprenorphine in an Office-based Setting.

OBJECTIVES: Video directly observed therapy (video DOT) is a tool for confirming buprenorphine adherence that could complement the use of urine toxicology; research is needed to characterize the patients who are receptive and able to use this technology. We aimed to describe video DOT utilization and assess participant characteristics associated with use. METHODS: We performed a secondary analysis of data from a pilot randomized controlled trial of adults who recently initiated sublingual buprenorphine in office-based programs, restricting to intervention arm participants, which consisted of 12 weeks of video DOT via a mobile health technology platform. Participants were instructed to record at least 1 daily video of buprenorphine self-administration. Poisson regression models with robust standard errors were used to measure associations between participant characteristics and frequency of submitted videos. RESULTS: The sample included 39 participants. Of 3276 possible videos, 1002 (31%) were submitted. Age ≥40 years (relative risk [RR], 2.54 [95% confidence interval {CI}, 1.31-4.91]) and once-daily buprenorphine dosing (RR, 3.10 [95% CI, 1.76-5.48]) were positively associated with video submissions. Non-White race (RR, 0.43 [95% CI, 0.19-0.97]), less than high school education (RR, 0.27 [95% CI, 0.10-0.74]), history of previous buprenorphine treatment (RR, 0.50 [95% CI, 0.25-0.97]), and ≥3 previous treatment attempts (RR, 0.16 [95% CI, 0.07-0.37]) were negatively associated. CONCLUSIONS: Video DOT utilization resulted in about a third of expected videos, although there were differences in use according to age, race, buprenorphine treatment factors, and educational status. Such differences underscore that mobile-health interventions such as video DOT may not be equally used by all patients.Trial Registration : ClinicalTrails.gov , NCT03779997 , registered on December 19, 2018.

Buprenorphine adherence and illicit opioid use among patients in treatment for opioid use disorder.

Background: Buprenorphine is a partial mu opioid agonist medication that has been shown to decrease non-prescribed opioid use, cravings, and opioid related morbidity and mortality. There is an assumption that full adherence is needed to achieve ideal treatment outcomes, and that non-adherence is associated with ongoing opioid use. However, literature documenting the strength of that assertion is lacking.Objectives: Evaluate the association between daily buprenorphine adherence and illicit opioid use.Methods: Secondary analysis of a 12-week randomized controlled trial of adults with opioid use disorder who recently initiated buprenorphine. Weekly study visits included self-report of daily buprenorphine adherence over the past 7 days (Timeline Follow Back method) and urine drug tests (UDT). A log-linear regression model accounting for clustering by participant was used to assess the association between buprenorphine adherence and illicit opioid use. Buprenorphine adherence was measured as a continuous variable (0-7 days).Results: Among 78 participants (56 men, 20 women, 2 nonbinary) with 737 visits, full 7-day adherence was reported at 70% of visits. The predominant form of non-adherence was missed doses (92% of cases). Each additional day of adherence was associated with an 8% higher rate of negative UDT for illicit opioids (RR = 1.08; 95% CI:1.03-1.13, p = .0002).Conclusion: In this sample of participants starting buprenorphine, missed doses were not uncommon. Fewer missed days was significantly associated with a lower risk of illicit opioid use. These findings suggest that efforts to minimize the number of missed days of buprenorphine are beneficial for treatment outcomes.