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Since the discovery of the secondary preventive benefits of antiretroviral therapy, national and international governing bodies have called for countries to reach 90% diagnosis, ART engagement and viral suppression among people living with HIV/AIDS. The US HIV epidemic is dispersed primarily across large urban centers, each with different underlying epidemiological and structural features. We selected six US cities, including Atlanta, Baltimore, Los Angeles, Miami, New York, and Seattle, with the objective of demonstrating the breadth of epidemiological and structural differences affecting the HIV/AIDS response across the US. We synthesized current and publicly-available surveillance, legal statutes, entitlement and discretionary funding, and service location data for each city. The vast differences we observed in each domain reinforce disparities in access to HIV treatment and prevention, and necessitate targeted, localized strategies to optimize the limited resources available for each city's HIV/AIDS response.

BackgroundOpioid dependence is associated with high levels of morbidity, yet sparse data exists regarding the health-related quality of life (HRQoL) of individuals with opioid dependence, particularly following treatment initiation. To inform cost-effectiveness analyses of treatment modalities, this study investigates short-term changes in HRQoL following enrollment into opioid agonist treatment (OAT), across treatment modalities and patient subgroups.MethodsData was analyzed from the Starting Treatment with Agonist Replacement Therapies (START) and Prescription Opioid Addiction Treatment Studies (POATS) randomized controlled trials. Participants included individuals dependent on prescription opioids (POs) or heroin, receiving limited-term or time-unlimited treatment. PO- or heroin-users in START received buprenorphine/naloxone (BUP/NX) or methadone (MET) over 24 weeks. PO-users in POATS received psychosocial care and short-term (4-week) taper with BUP/NX, with non-responders offered subsequent extended (12-week) stabilization and taper. HRQoL was assessed using the short-form SF-6D while in and out of OAT, with distinction between MMT and BUP/NX in START. Linear mixed effects regression models were fitted to determine the independent effects of OAT on HRQoL and characterize HRQoL trajectories.ResultsTreatment had a similar immediate and modest positive association with HRQoL in each patient subgroup. The association of OAT on HRQoL was statistically significant in each model, with effect sizes between 0.039 (heroin-users receiving BUP/NX) and 0.071 (PO-users receiving MET). After initial improvement, HRQoL decreased slightly, or increased at a diminished rate.ConclusionsOAT, whether delivered in time-limited or unlimited form, using BUP/NX or MET, is associated with modest immediate HRQoL improvements, with diminishing benefits thereafter.

The antiretroviral protease inhibitor atazanavir inhibits hepatic uridine diphosphate glucuronosyltransferase (UGT) 1A1, thereby preventing the glucuronidation and elimination of bilirubin. Resultant indirect hyperbilirubinemia with jaundice can cause premature discontinuation of atazanavir. Risk for bilirubin-related discontinuation is highest among individuals who carry two UGT1A1 decreased function alleles ( UGT1A1*28 or *37). We summarize published literature that supports this association and provide recommendations for atazanavir prescribing when UGT1A1 genotype is known (updates at ). [ABSTRACT FROM AUTHOR]

A case-cohort study was used to determine the effect of baseline nonnucleoside reverse-transcriptase inhibitor (NNRTI) resistance, as assessed by viral genotyping, on the response to efavirenz-containing regimens in AIDS Clinical Trials Group A5095. The sample included a random cohort of efavirenz-treated subjects plus unselected subjects who experienced virologic failure. Of 220 subjects in the random cohort, 57 (26%) had virologic failure. The prevalence of baseline NNRTI resistance was 5%. The risk of virologic failure for subjects with baseline NNRTI resistance was higher than that for subjects without such resistance (hazard ratio 2.27 [95% confidence interval], 1.15-4.49; P = .018). These results support resistance testing before starting antiretroviral therapy. Copyright © 2008 Infectious Diseases Society of America [ABSTRACT FROM AUTHOR]

Objective: We sought to project the lifetime cost of medical care for human immunodefiency virus (HIV)-infected adults using current antiretroviral therapy (ART) standards.Methods: Medical visits and hospitalizations for any reason were from the HIV Research Network, a consortium of high-volume HIV primary care sites. HIV treatment drug regimen efficacies were from clinical guidelines and published sources; data on other drugs used were not available. In a computer simulation model, we projected HIV medical care costs in 2004 U.S. dollars.Results: From the time of entering HIV care, per person projected life expectancy is 24.2 years, discounted lifetime cost is Dollars 385,200, and undiscounted cost is Dollars 618,900 for adults who initiate ART with CD4 cell count < 350/microL. Seventy-three percent of the cost is antiretroviral medications, 13% inpatient care, 9% outpatient care, and 5% other HIV-related medications and laboratory costs. For patients who initiate ART with CD4 cell count < 200/microL, projected life expectancy is 22.5 years, discounted lifetime cost is Dollars 354,100 and undiscounted cost is Dollars 567,000. Results are sensitive to drug manufacturers' discounts, ART efficacy, and use of enfuvirtide for salvage. If costs are discounted to the time of infection, the discounted lifetime cost is Dollars 303,100.Conclusions: Effective ART regimens have substantially improved survival and have increased the lifetime cost of HIV-related medical care in the U.S. [ABSTRACT FROM AUTHOR]

Context: Three-drug antiretroviral regimens are standard of care for initial treatment of human immunodeficiency virus 1 (HIV-1) infection, but a 4-drug regimen could improve antiretroviral activity and be more effective than a 3-drug regimen.Objective: To compare the safety/efficacy of 3-drug vs 4-drug regimens for initial treatment of HIV-1 infection.Design: The AIDS Clinical Trials Group (ACTG) A5095 study, a randomized, double-blind, placebo-controlled study with enrollment and follow-up conducted from March 22, 2001, to March 1, 2005, and enrolling treatment-naive, HIV-1-infected patients with HIV-1 RNA levels of 400 copies/mL or greater from US clinical trials units of the ACTG.Interventions: Zidovudine/lamivudine plus efavirenz (3-drug regimen) vs zidovudine/lamivudine/abacavir plus efavirenz (4-drug regimen).Main Outcome Measures: Time to virologic failure (defined as time to first of 2 successive HIV-1 RNA levels > or =200 copies/mL at or after week 16), CD4 cell count changes, and grade 3 or 4 adverse events. HIV-1 RNA data were intent-to-treat, regardless of treatment changes.Results: Seven hundred sixty-five patients with a baseline mean HIV-1 RNA level of 4.86 log10 (72,444) copies/mL and CD4 cell count of 240 cells/mm3 were randomized. After a median 3-year follow-up, 99 (26%) of 382 and 94 (25%) of 383 patients receiving the 3-drug and 4-drug regimens, respectively, reached protocol-defined virologic failure; time to virologic failure was not significantly different (hazard ratio, 0.95; 97.5% confidence interval, 0.69-1.33; P = .73). In planned subgroup analyses, increased risk for virologic failure was seen in non-Hispanic black patients (adjusted hazard ratio, 1.66; 95% confidence interval, 1.18-2.34; P = .003). At 3 years, the HIV-1 RNA level was less than 200 copies/mL in 152 (90%) of 169 and 143 (92%) of 156 patients receiving the 3-drug and 4-drug regimens, respectively (P = .59), and less than 50 copies/mL in 144 (85%) of 169 and 137 (88%) of 156 patients (P = .39). CD4 cell count increases and grade 3 or 4 adverse events were not significantly different.Conclusions: In treatment-naive patients, there were no significant differences between the 3-drug and 4-drug antiretroviral regimens; overall, at least approximately 80% of patients had HIV-1 RNA levels less than 50 copies/mL through 3 years. These results support current guidelines recommending 2 nucleosides plus efavirenz for initial treatment of HIV-1 infection; adding abacavir as a fourth drug provided no additional benefit.Clinical Trials Registration: clinicaltrials.gov Identifier: NCT00013520. [ABSTRACT FROM AUTHOR]

Background: Epidemiologic studies have demonstrated substantial variations in per capita rates of many surgical procedures, including rotator cuff repair. The purpose of the current study was to characterize orthopaedic surgeons' attitudes concerning medical decision-making about rotator cuff surgery and to investigate the associations between these beliefs and reported surgical volumes.Methods: A survey was mailed to randomly selected orthopaedic surgeons listed in the American Academy of Orthopaedic Surgeons directory. Only individuals who had treated patients for a rotator cuff tear, or had referred patients for such treatment, within the previous year were asked to complete the two-page survey. The survey comprised fifteen questions regarding clinical opinion, including four regarding hypothetical cases. Clinical agreement was defined as >80% of the respondents answering similarly.Results: Of the 1100 surveys that were mailed, 539 were returned (a response rate of 49%). Of the 539 respondents, 316 (58.6%) had treated or referred patients with a rotator cuff tear in the previous year. There was a significant negative correlation between the surgeon's estimation of the failure rate of cuff repairs in the United States and that surgeon's procedure volume (r = -0.21, p = 0.0003), indicating that surgeons with a lower procedure volume are more pessimistic about the results of surgery than are those with a higher procedure volume. Arthroscopic, mini-open, and open cuff repairs were preferred by 14.5%, 46.2%, and 36.6% of the respondents, respectively. Surgeons who performed a higher volume of procedures were less likely to perform open surgery (p < 0.0001). There was clinical agreement regarding only four of the nine clinical questions and none of the four questions about the hypothetical vignettes.Conclusions: We found significant variation in surgical decision-making and a lack of clinical agreement among orthopaedic surgeons about rotator cuff surgery. There was a positive correlation between the volume of procedures performed by the surgeon and the surgeon's perception of outcome, with surgeons who had a higher procedure volume being more enthusiastic about rotator cuff surgery than those who had a lower procedure volume. [ABSTRACT FROM AUTHOR]

Abstract Background We determined direct medical costs, overhead costs, societal costs, and personnel requirements for the provision of antiretroviral therapy (ART) to patients with AIDS in Haiti. Methods We examined data from 218 treatment-naïve adults who were consecutively initiated on ART at the GHESKIO Center in Port-au-Prince, Haiti between December 23, 2003 and May 20, 2004 and calculated costs and personnel requirements for the first year of ART. Results The mean total cost of treatment per patient was $US 982 including $US 846 in direct costs, $US 114 for overhead, and $US 22 for societal costs. The direct cost per patient included generic ART medications $US 355, lab tests $US 130, nutrition $US 117, hospitalizations $US 62, pre-ART evaluation $US 58, labor $US 51, non-ART medications $US 39, outside referrals $US 31, and telephone cards for patient retention $US 3. Higher treatment costs were associated with hospitalization, change in ART regimen, TB treatment, and survival for one year. We estimate that 1.5 doctors and 2.5 nurses are required to treat 1000 patients in the first year after initiating ART. Conclusion Initial ART treatment in Haiti costs approximately $US 1,000 per patient per year. With generic first-line antiretroviral drugs, only 36% of the cost is for medications. Patients who change regimens are significantly more expensive to treat, highlighting the need for less-expensive second-line drugs. There may be sufficient health care personnel to treat all HIV-infected patients in urban areas of Haiti, but not in rural areas. New models of HIV care are needed for rural areas using assistant medical officers and community health workers.

Abstract We conducted a survey to examine whether reimbursement levels are associated with the quality of adolescent substance use treatment programs in the United States. Between March and September 2005, telephone and written surveys were administered to program, clinical, and finance directors of previously surveyed highly regarded programs. Differences in quality scores were compared for programs with above versus below median reimbursement levels and examined in multivariate regression models constructed separately for programs offering residential and outpatient treatment. In residential treatment multivariate regression models, higher quality scores were associated with higher reimbursement, but this relationship was not observed for outpatient treatment. Even the highest level of outpatient reimbursement received may be too low to support quality improvement initiatives. Our results suggest that higher reimbursement may be a necessary component of quality improvement for residential adolescent drug treatment programs, and emphasize the need for further research to determine what levels of reimbursement and insurance coverage policies will encourage the expansion of high quality outpatient programs.

Background and Aims: During the COVID-19 pandemic, there was a surge in opioid overdose deaths (OODs) in Massachusetts, USA, particularly among Black and Hispanic/Latinx populations. Despite the increasing racial and ethnic disparities in OODs, there was no compensatory increase in naloxone distributed to these groups. We aimed to evaluate two community-based naloxone expansion strategies, with the objective of identifying approaches that could mitigate mortality and racial and ethnic disparities in OODs., Design: Individual-based simulation model. We measured naloxone availability using naloxone kits per OOD and evaluated scenarios of achieving higher benchmarks for naloxone availability (i.e. 40, 60 and 80 kits per OOD) from 2022 levels (overall: 26.0, White: 28.8, Black: 17.3, Hispanic/Latinx: 18.9). We compared two naloxone distribution strategies: (1) proportional distribution: achieving the benchmark ratio at the overall population level while distributing additional kits proportional to the 2022 level for each racial/ethnic group (at 40 kits per OOD benchmark: overall: 40, White: 44.3, Black: 26.6, Hispanic/Latinx: 29.1), and (2) equity-focused distribution: achieving the benchmark ratio among each racial/ethnic group (at 40 kits per OOD benchmark: 40 for all groups)., Setting: Massachusetts, United States., Participants: People at risk of OOD., Measurements: Annual number and rate of OODs, total healthcare costs of increasing naloxone availability., Findings: Both naloxone distribution strategies yielded comparable predicted reductions in total OODs in 2025 and incurred similar incremental costs. However, the relative reduction in the rate of OODs differed across groups. For achieving an 80 kits per OOD benchmark, proportional distribution resulted in a projected 6.7%, 6.5% and 7.1% reduction in annual OODs in 2025 among White, Black and Hispanic/Latinx populations, respectively. In contrast, equity-focused distribution achieved a reduction of 5.7%, 11.3% and 10.2% in the respective groups. In all scenarios, the cost per OOD averted was lower than the generally accepted thresholds for cost per life saved., Conclusions: An equity-focused naloxone distribution strategy designed to reduce racial and ethnic disparities in naloxone availability could improve health equity among racial and ethnic groups while potentially improving overall population health at lower healthcare costs per opioid overdose death averted than a proportional distribution strategy., (© 2024 The Author(s). Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Importance: Overdose is the leading cause of death among people experiencing homelessness (PEH), but engagement in medication treatment is low in this population. Shelter-based buprenorphine may be a strategy for increasing initiation and retention on lifesaving medications., Objective: To estimate clinical outcomes and conduct an economic analysis of statewide shelter-based opioid treatment in Massachusetts., Design, Setting, and Participants: This economic evaluation study in Massachusetts used a cohort state-transition simulation model. Two cohorts were modeled starting in 2013, including (1) a closed cohort of a fixed population of PEH with history of high-risk opioid use over their lifetimes and (2) an open cohort in which membership could change over time, allowing assessment of population-level trends over a 10-year period. Data analysis occurred from January 2023 to April 2024., Exposures: Model exposures included (1) no shelter-based buprenorphine (status quo) and (2) offering buprenorphine in shelters statewide., Main Outcomes and Measures: Outcomes included overdose deaths, quality-adjusted life-years (QALYs) gained, and health care and modified societal perspective costs. Sensitivity analyses were conducted on key parameters., Results: In the closed cohort analysis of 13 800 PEH (mean [SD] age, 40.4 [13.1] years; 8749 male [63.4%]), shelter-based buprenorphine was associated with an additional 65.4 person-weeks taking buprenorphine over an individual's lifetime compared with status quo. Shelter-based buprenorphine was cost saving when compared with the status quo, with a discounted lifetime cost savings from the health sector perspective of $1300 per person, and 0.2 additional discounted QALYs per person and 0.9 additional life-years per person. In the population-level simulation, 254 overdose deaths were averted over the 10-year period with the shelter-based buprenorphine strategy compared with the status quo (a 9.2% reduction of overdose deaths among PEH in Massachusetts). Overdose-related and other health care utilization undiscounted costs decreased by $3.0 million and $66.4 million, respectively. Shelter-based opioid treatment generated $44.7 million in additional medication and clinical costs, but saved $69.4 million in overdose and other health costs., Conclusions and Relevance: In this economic evaluation of clinical and economic outcomes among PEH, shelter-based buprenorphine was associated with fewer overdose deaths and was cost saving. These findings suggest that broad rollout of shelter-based buprenorphine may be an important tool in addressing the overdose crisis.

Background: Expanding public naloxone access is a key strategy to reduce opioid overdose fatalities. We describe tailored community-engaged, data-driven approaches to install and maintain naloxone housing units (naloxone boxes) in New York State and estimate the cost of these approaches., Methods: Guided by the Consolidated Framework for Implementation Research, we collected data from administrative records and key informant interviews that documented the unique processes employed by four counties enrolled in the HEALing Communities Study to install and maintain naloxone housing units. We conducted a prospective micro-costing analysis to estimate the cost of each naloxone housing unit strategy from the community perspective., Results: While all counties used a coalition to guide action planning for naloxone distribution, we identified unique approaches to implementing naloxone housing units: 1) County-led with technology expansion; 2) County-led grassroots; 3) Small-scale rural opioid overdose prevention program (OOPP) contract and 4) Comprehensive OOPP contract including overdose education and naloxone distribution (OEND) to individuals. The first two county-led approaches had lower cost per naloxone dose disbursed ($28-$38) compared to outsourcing to an OOPP ($183-$266); costs depended on services added to installing and maintaining units, such as OEND. Barriers included competing demands on public health resources (i.e., COVID-19) and stigma toward naloxone and opioid use disorder. Geographic access was a barrier in rural areas whereas existing infrastructure was a facilitator in urban counties. The policy landscape in New York State, which provides free naloxone kits and financial support to OOPPs, facilitated implementation in all counties., Conclusions: If a community has the resources, installing and maintaining naloxone housing units in-house can be less expensive than contracting with an outside partner. However, contracts that include OEND may be more effective at reaching target populations. Financial support from health departments and legislative authorization are important facilitators to making naloxone available in public settings., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Missouri's Overdose Field Report (ODFR) is a community-based reporting system which intends to capture overdoses which may not be otherwise recorded. Objectives: Describe the factors related to non-fatal overdoses reported to Missouri's ODFR. Methods: This study used a descriptive epidemiological approach to examine the demographics and circumstances of overdoses reported to the ODFR. We used binary logistic regression to evaluate factors associated with survival and ordinal logistic regression to evaluate factors associated with number of doses used. Factors were chosen based on their relevance to overdose education and survival, and naloxone distribution. Results: Between 2018 and 2022, 12,225 overdoses (67% male; 78% White) were reported through the ODFR, with a 96% (n = 11,225) survival rate. Overdose survival (ps < .02) was associated with younger age (OR = .58), no opioid and stimulant co-involvement (OR = .61), and private location (OR = .48). Intramuscular naloxone in particular was associated with a significantly higher odds of survival compared to nasal naloxone (OR = 2.11). An average of 1.6 doses of naloxone per incident were administered. Additional doses were associated (ps < .02) with being older (OR = .45), female (OR = .90), nasal naloxone (versus intravenous) (OR = .65), and the belief fentanyl was present (OR = 1.49). Conclusion: Our reporting form provides a comprehensive picture of the events surrounding reported overdoses, including factors associated with survival, how much naloxone was used, and the effects of respondents believing fentanyl was involved. Missouri's report can provide support for current naloxone dosing, contextualize refusing post-overdose transport, and can be used to improve overdose response by community and first responders.

Objectives: Overdose prevention centers (OPCs) provide a safe place where people can consume preobtained drugs under supervision so that a life-saving medical response can be provided quickly in the event of an overdose. OPCs are programs that are established in Canada and have recently become legally sanctioned in only a few United States jurisdictions., Methods: We conducted a systematic review that summarizes and identifies gaps of economic evidence on establishing OPCs in North America to guide future expansion of OPCs., Results: We included 16 final studies that were evaluated with the Consolidated Health Economic Evaluation Reporting Standards and Drummond checklists. Eight studies reported cost-effectiveness results (eg, cost per overdose avoided or cost per quality-adjusted life-year), with 6 also including cost-benefit; 5 reported only cost-benefit results, and 3 cost offsets. Health outcomes primarily included overdose mortality outcomes or HIV/hepatitis C virus infections averted. Most studies used mathematical modeling and projected OPC outcomes using the experience of a single facility in Vancouver, BC., Conclusions: OPCs were found to be cost-saving or to have favorable cost-effectiveness or cost-benefit ratios across all studies. Future studies should incorporate the experience of OPCs established in various settings and use a greater diversity of modeling designs., Competing Interests: Author Disclosures Author disclosure forms can be accessed in the Supplemental Material section. The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the funding agencies or the US government., (Copyright © 2024. Published by Elsevier Inc.)

Importance: Many US states are substantially increasing community-based naloxone distribution, supported in part through settlements from opioid manufacturers and distributors., Objectives: To evaluate the potential impact of increased naloxone availability on opioid overdose deaths (OODs) and explore strategies to enhance this impact by integrating interventions to address solitary drug use., Design, Setting, and Participants: This decision analytical modeling study used PROFOUND (Prevention and Rescue of Fentanyl and Other Opioid Overdoses Using Optimized Naloxone Distribution Strategies), a previously published simulation model, to forecast annual OODs between January 2023 and December 2025. The simulated study population included individuals from Rhode Island who misused opioids and stimulants and were at risk for opioid overdose., Exposures: The study modeled expanded naloxone distribution supported by the state's opioid settlement (50 000 naloxone nasal spray kits each year). Two approaches to expanding naloxone distribution were evaluated: one based on historical spatial patterns of naloxone distribution (supply-based approach) and one based on the spatial distribution of individuals at risk (demand-based approach). In addition, hypothetical interventions to enhance the likelihood of witnessed overdoses in private or semiprivate settings were considered., Main Outcomes and Measures: Annual number of OODs and ratio of fatal to nonfatal opioid overdoses., Results: Modeling results indicated that distributing more naloxone supported by the state's opioid settlement could reduce OODs by 6.3% (95% simulation interval [SI], 0.3%-13.7%) and 8.8% (95% SI, 1.8%-17.5%) in 2025 with the supply-based and demand-based approaches, respectively. However, increasing witnessed overdoses by 20% to 60% demonstrated greater potential for reducing OODs, ranging from 8.5% (95% SI, 0.0%-20.3%) to 24.1% (95% SI, 8.6%-39.3%). Notably, synergistic associations were observed when combining both interventions: increased naloxone distribution with the 2 approaches and a 60% increase in witnessed overdoses could reduce OODs in 2025 by 33.5% (95% SI, 17.1%-50.4%) and 37.4% (95% SI, 19.6%-56.3%), respectively., Conclusions and Relevance: These findings suggest that interventions to address solitary drug use are needed to maximize the impact of continued efforts to increase community-based naloxone distribution, which may be particularly important for jurisdictions that have strong community-based naloxone distribution programs.

Background: Communities That HEAL (CTH) is a novel, data-driven community-engaged intervention designed to reduce opioid overdose deaths by increasing community engagement, adoption of an integrated set of evidence-based practices, and delivering a communications campaign across healthcare, behavioral-health, criminal-legal, and other community-based settings. The implementation of such a complex initiative requires up-front investments of time and other expenditures (i.e., start-up costs). Despite the importance of these start-up costs in investment decisions to stakeholders, they are typically excluded from cost-effectiveness analyses. The objective of this study is to report a detailed analysis of CTH start-up costs pre-intervention implementation and to describe the relevance of these data for stakeholders to determine implementation feasibility., Methods: This study is guided by the community perspective, reflecting the investments that a real-world community would need to incur to implement the CTH intervention. We adopted an activity-based costing approach, in which resources related to hiring, training, purchasing, and community dashboard creation were identified through macro- and micro-costing techniques from 34 communities with high rates of fatal opioid overdoses, across four states-Kentucky, Massachusetts, New York, and Ohio. Resources were identified and assigned a unit cost using administrative and semi-structured-interview data. All cost estimates were reported in 2019 dollars., Results: State-level average and median start-up cost (representing 8-10 communities per state) were $268,657 and $175,683, respectively. Hiring and training represented 40%, equipment and infrastructure costs represented 24%, and dashboard creation represented 36% of the total average start-up cost. Comparatively, hiring and training represented 49%, purchasing costs represented 18%, and dashboard creation represented 34% of the total median start-up cost., Conclusion: We identified three distinct CTH hiring models that affected start-up costs: hospital-academic (Massachusetts), university-academic (Kentucky and Ohio), and community-leveraged (New York). Hiring, training, and purchasing start-up costs were lowest in New York due to existing local infrastructure. Community-based implementation similar to the New York model may have lower start-up costs due to leveraging of existing infrastructure, relationships, and support from local health departments., (© 2024. The Author(s).)

Background and Aims: The onset of the coronavirus disease 2019 (COVID-19) pandemic was associated with a surge in opioid overdose deaths in Massachusetts, particularly affecting racial and ethnic minority communities. We aimed to compare the impact of the pandemic on opioid overdose fatalities and naloxone distribution from community-based programs across racial and ethnic groups in Massachusetts., Design: Interrupted time-series., Setting and Cases: Opioid overdose deaths (OODs) among non-Hispanic White, non-Hispanic Black, Hispanic and non-Hispanic other race people in Massachusetts, USA (January 2016 to June 2021)., Measurements: Rate of OODs per 100 000 people, rate of naloxone kits distributed per 100 000 people and ratio of naloxone kits per opioid overdose death as a measure of naloxone availability. We applied five imputation strategies using complete data in different periods to account for missingness of race and ethnicity for naloxone data., Findings: Before COVID-19 (January 2016 to February 2020), the rate of OODs declined among non-Hispanic White people [0.2% monthly reduction (95% confidence interval = 0.0-0.4%)], yet was relatively constant among all other population groups. The rate of naloxone kits increased across all groups (0.8-1.2% monthly increase) and the ratio of naloxone kits per OOD death among non-Hispanic White was 1.1% (0.8-1.4%) and among Hispanic people was 1.0% (0.2-1.8%). After the onset of the pandemic (March 2020+), non-Hispanic Black people experienced an immediate increase in the rate of OODs [63.6% (16.4-130%)], whereas rates among other groups remained similar. Trends in naloxone rescue kit distribution did not substantively change among any groups, and the ratio of naloxone kits per OOD death for non-Hispanic Black people did not compensate for the surge in OODs deaths in this group., Conclusions: With the onset of the COVID-19 pandemic, there was a surge in opioid overdose deaths among non-Hispanic Black people in Massachusetts, USA with no compensatory increase in naloxone rescue kit distribution. For non-Hispanic White and Hispanic people, opioid overdose deaths remained stable and naloxone kit distribution continued to increase., (© 2023 Society for the Study of Addiction.)

Importance: Magnetic resonance imaging (MRI) and potential MRI-guided biopsy enable enhanced identification of clinically significant prostate cancer. Despite proven efficacy, MRI and potential MRI-guided biopsy remain costly, and there is limited evidence regarding the cost-effectiveness of this approach in general and for different prostate-specific antigen (PSA) strata., Objective: To examine the cost-effectiveness of integrating annual MRI and potential MRI-guided biopsy as part of clinical decision-making for men after being screened for prostate cancer compared with standard biopsy., Design, Setting, and Participants: Using a decision analytic Markov cohort model, an economic evaluation was conducted projecting outcomes over 10 years for a hypothetical cohort of 65-year-old men in the US with 4 different PSA strata (<2.5 ng/mL, 2.5-4.0 ng/mL, 4.1-10.0 ng/mL, >10 ng/mL) identified by screening through Monte Carlo microsimulation with 10 000 trials. Model inputs for probabilities, costs in 2020 US dollars, and quality-adjusted life-years (QALYs) were from the literature and expert consultation. The model was specifically designed to reflect the US health care system, adopting a federal payer perspective (ie, Medicare)., Exposures: Magnetic resonance imaging with potential MRI-guided biopsy and standard biopsy., Main Outcomes and Measures: Incremental cost-effectiveness ratios (ICERs) using a willingness-to-pay threshold of $100 000 per QALY was estimated. One-way and probabilistic sensitivity analyses were performed., Results: For the 3 PSA strata of 2.5 ng/mL or greater, the MRI and potential MRI-guided biopsy strategy was cost-effective compared with standard biopsy (PSA 2.5-4.0 ng/mL: base-case ICER, $21 131/QALY; PSA 4.1-10.0 ng/mL: base-case ICER, $12 336/QALY; PSA >10.0 ng/mL: base-case ICER, $6000/QALY). Results varied depending on the diagnostic accuracy of MRI and potential MRI-guided biopsy. Results of probabilistic sensitivity analyses showed that the MRI and potential MRI-guided biopsy strategy was cost-effective at the willingness-to-pay threshold of $100 000 per QALY in a range between 76% and 81% of simulations for each of the 3 PSA strata of 2.5 ng/mL or more., Conclusions and Relevance: This economic evaluation of a hypothetical cohort suggests that an annual MRI and potential MRI-guided biopsy was a cost-effective option from a US federal payer perspective compared with standard biopsy for newly eligible male Medicare beneficiaries with a serum PSA level of 2.5 ng/mL or more.

Objective: Alcohol use among people living with HIV (PLWH) can reduce adherence and worsen health outcomes. We evaluated the economic cost of an effective smartphone application (HealthCall) to reduce drinking and improve antiretroviral adherence among heavy-drinking PLWH participating in a randomized trial., Method: Participants were randomized to receive a brief drinking-reduction intervention, either (a) the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Clinician's Guide (CG-only, n = 37), (b) CG enhanced by HealthCall to monitor daily alcohol consumption (CG+HealthCall, n = 38), or (c) motivational interviewing delivered by a nonclinician enhanced by HealthCall (MI+HealthCall, n = 39). We used micro-costing techniques to evaluate start-up costs and incremental costs per participant incurred from the health care sector perspective in 2018 U.S. dollars. We also investigated potential cost offsets using participant-reported health care utilization., Results: Participants attended three intervention visits, and each visit cost on average $29 for CG-only, $32 for CG+HealthCall, and $15 for MI+HealthCall. The total intervention cost per participant was $94 for CG-only, $114 for CG+HealthCall, and $57 for MI+HealthCall; the incremental cost of CG+HealthCall compared with CG-only was $20 per participant, and the incremental savings of MI+HealthCall compared with CG-only was $37 per participant. No significant differences in health care utilization occurred among the three groups over 12 months., Conclusions: The cost of enhancing CG with the HealthCall application for heavy-drinking PLWH was modestly higher than using the CG alone, whereas MI enhanced with HealthCall delivered by a nonclinician had a lower cost than CG alone. HealthCall may be a low-cost enhancement to brief interventions addressing alcohol use and antiretroviral adherence among PLWH., Competing Interests: The authors have no conflicts of interest to declare.

Introduction: We evaluated racial/ethnic differences in the receipt of naloxone distributed by opioid overdose prevention programs (OOPPs) in New York City (NYC)., Methods: We used naloxone recipient racial/ethnic data collected by OOPPs from April 2018 to March 2019. We aggregated quarterly neighborhood-specific rates of naloxone receipt and other covariates to 42 NYC neighborhoods. We used a multilevel negative binomial regression model to assess the relationship between neighborhood-specific naloxone receipt rates and race/ethnicity. Race/ethnicity was stratified into four mutually exclusive groups: Latino, non-Latino Black, non-Latino White, and non-Latino Other. We also conducted racial/ethnic-specific geospatial analyses to assess whether there was within-group geographic variation in naloxone receipt rates for each racial/ethnic group., Results: Non-Latino Black residents had the highest median quarterly naloxone receipt rate of 41.8 per 100,000 residents, followed by Latino residents (22.0 per 100,000), non-Latino White (13.6 per 100,000) and non-Latino Other residents (13.3 per 100,000). In our multivariable analysis, compared with non-Latino White residents, non-Latino Black residents had a significantly higher receipt rate, and non-Latino Other residents had a significantly lower receipt rate. In the geospatial analyses, both Latino and non-Latino Black residents had the most within-group geographic variation in naloxone receipt rates compared to non-Latino White and Other residents., Conclusions: This study found significant racial/ethnic differences in naloxone receipt from NYC OOPPs. We observed substantial variation in naloxone receipt for non-Latino Black and Latino residents across neighborhoods, indicating relatively poorer access in some neighborhoods and opportunities for new approaches to address geographic and structural barriers in these locations., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Importance: In 2017, the US Food and Drug Administration (FDA) approved a monthly injectable form of buprenorphine, extended-release buprenorphine; published data show that extended-release buprenorphine is effective compared with no treatment, but its current cost is higher and current retention is lower than that of transmucosal buprenorphine. Preliminary research suggests that extended-release buprenorphine may be an important addition to treatment options, but the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine remains unclear., Objective: To evaluate the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine., Design, Setting, and Participants: This economic evaluation used a state transition model starting in 2019 to simulate the lifetime of a closed cohort of individuals with OUD presenting for evaluation for opioid agonist treatment with buprenorphine. The data sources used to estimate model parameters included cohort studies, clinical trials, and administrative data. The model relied on pharmaceutical costs from the Federal Supply Schedule and health care utilization costs from published studies. Data were analyzed from September 2021 to January 2023., Interventions: No treatment, treatment with transmucosal buprenorphine, or treatment with extended-release buprenorphine., Main Outcomes and Measures: Mean lifetime costs per person, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs)., Results: The simulated cohort included 100 000 patients with OUD receiving (61% male; mean [SD] age, 38 [11] years) or not receiving medication treatment (58% male, mean [SD] age, 48 [18] years). Compared with no medication treatment, treatment with transmucosal buprenorphine yielded an ICER of $19 740 per QALY. Compared with treatment with transmucosal buprenorphine, treatment with extended-release buprenorphine yielded lower effectiveness by 0.03 QALYs per person at higher cost, suggesting that treatment with extended-release buprenorphine was dominated and not preferred. In probabilistic sensitivity analyses, treatment with transmucosal buprenorphine was the preferred strategy 60% of the time. Treatment with extended-release buprenorphine was cost-effective compared with treatment with transmucosal buprenorphine at a $100 000 per QALY willingness-to-pay threshold only after substantial changes in key parameters., Conclusions and Relevance: In this economic evaluation of extended-release buprenorphine compared with transmucosal buprenorphine for the treatment of OUD, extended-release buprenorphine was not associated with efficient allocation of limited resources when transmucosal buprenorphine was available. Future initiatives should aim to improve retention rates or decrease costs associated with extended-release buprenorphine.

Introduction: The economic burden of substance use disorder (SUD) is significant, comprising costs of health care and social services, criminal justice resources, loss of productivity, and premature mortality. This study assembles and synthesizes two decades of evidence describing the benefits of SUD treatment across five main outcome domains; 1) health care utilization; 2) self-reported criminal activity by offense type; 3) criminal justice involvement collected from administrative records or self-reported; 4) productivity assessed through working hours or wages earned; and 5) social services (e.g., a day spent in transitional housing)., Methods: This review included studies if they reported the monetary value of the intervention outcomes, most commonly through a cost-benefit or cost-effectiveness framework. The search included studies from 2003 to the present day as of this writing (up to October 15, 2021). Summary cost estimates were adjusted using the US Consumer Price Index (CPI) to reflect the 12-month benefits per client in USD 2021. We followed the PRISMA methodology for study selection and assessed quality using the Checklist for Health Economic Evaluation Reporting Standards (CHEERS)., Results: The databases yielded 729 studies after removing duplicates, and we ultimately selected 12 for review. Studies varied widely regarding analytical approaches, time horizons, outcome domains, and other methodological factors. Among the ten studies that found positive economic benefits, reductions in criminal activity or criminal justice costs represented the largest or second largest component of these benefits (range $621 to $193,440 per client)., Conclusions: Consistent with previous findings, a reduction in criminal activity costs is driven by the relatively high societal cost per criminal offense, notably for violent crimes, such as aggravated assault and rape/sexual assault. Accepting the economic rationale for increased investment in SUD interventions will require recognizing that more benefits accrue to individuals by avoiding being victims of a crime than to governments through budget offsets resulting from savings in non-SUD program expenses. Future studies should explore individually tailored interventions to optimize care management, which may yield unexpected economic benefits to services utilization, and criminal activity data to estimate economic benefits across a broad range of interventions., Competing Interests: Declaration of competing interest None., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Importance: Buprenorphine is an effective and cost-effective medication to treat opioid use disorder (OUD), but is not readily available to many people with OUD in the US. The current cost-effectiveness literature does not consider interventions that concurrently increase buprenorphine initiation, duration, and capacity., Objective: To conduct a cost-effectiveness analysis and compare interventions associated with increased buprenorphine treatment initiation, duration, and capacity., Design and Setting: This study modeled the effects of 5 interventions individually and in combination using SOURCE, a recent system dynamics model of prescription opioid and illicit opioid use, treatment, and remission, calibrated to US data from 1999 to 2020. The analysis was run during a 12-year time horizon from 2021 to 2032, with lifetime follow-up. A probabilistic sensitivity analysis on intervention effectiveness and costs was conducted. Analyses were performed from April 2021 through March 2023. Modeled participants included people with opioid misuse and OUD in the US., Interventions: Interventions included emergency department buprenorphine initiation, contingency management, psychotherapy, telehealth, and expansion of hub-and-spoke narcotic treatment programs, individually and in combination., Main Outcomes and Measures: Total national opioid overdose deaths, quality-adjusted life years (QALYs) gained, and costs from the societal and health care perspective., Results: Projections showed that contingency management expansion would avert 3530 opioid overdose deaths over 12 years, more than any other single-intervention strategy. Interventions that increased buprenorphine treatment duration initially were associated with an increased number of opioid overdose deaths in the absence of expanded treatment capacity. With an incremental cost- effectiveness ratio of $19 381 per QALY gained (2021 USD), the strategy that expanded contingency management, hub-and-spoke training, emergency department initiation, and telehealth was the preferred strategy for any willingness-to-pay threshold from $20 000 to $200 000/QALY gained, as it was associated with increased treatment duration and capacity simultaneously., Conclusion and Relevance: This modeling analysis simulated the effects of implementing several intervention strategies across the buprenorphine cascade of care and found that strategies that were concurrently associated with increased buprenorphine treatment initiation, duration, and capacity were cost-effective.

Background: Despite evidence that eHealth approaches can be effective in reducing HIV risk, their implementation requirements for public health scale up are not well established, and effective strategies to bring these programs into practice are still unknown. Keep It Up! (KIU!) is an online program proven to reduce HIV risk among young men who have sex with men (YMSM) and ideal candidate to develop and evaluate novel strategies for implementing eHealth HIV prevention programs. KIU! 3.0 is a Type III Hybrid Effectiveness-Implementation cluster randomized trial designed to 1) compare two strategies for implementing KIU!: community-based organizations (CBO) versus centralized direct-to-consumer (DTC) recruitment; 2) examine the effect of strategies and determinants on variability in implementation success; and 3) develop materials for sustainment of KIU! after the trial concludes. In this article, we describe the approaches used to achieve these aims., Methods: Using county-level population estimates of YMSM, 66 counties were selected and randomized 2:1 to the CBO and DTC approaches. The RE-AIM model was used to drive outcome measurements, which were collected from CBO staff, YMSM, and technology providers. Mixed-methods research mapped onto the domains of the Consolidated Framework for Implementation Research will examine determinants and their relationship with implementation outcomes., Discussion: In comparing our implementation recruitment models, we are examining two strategies which have shown effectiveness in delivering health technology interventions in the past, yet little is known about their comparative advantages and disadvantages in implementation. The results of the trial will further the understanding of eHealth prevention intervention implementation., Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests., (Copyright © 2023. Published by Elsevier Inc.)

Background: Syringe service programs (SSPs) deliver critical harm reduction services to people who inject drugs (PWID). Some SSPs in New York State received enhanced funding to provide additional services to combat opioid overdose fatalities. These SSPs, known as Drug User Health Hubs, provide buprenorphine for the treatment of opioid use disorder and other health-related services in addition to their syringe services. While the COVID-19 pandemic posed widespread challenges to the delivery of health services nationwide, the effect of the pandemic on SSPs uniquely impacts PWID. This study examines the impact of COVID-19 on service delivery of Drug User Health Hubs and stand-alone SSPs in New York State., Methods: Between July 2020 and September 2020, we performed eleven semi-structured virtual interviews with staff from three Health Hub SSPs and three stand-alone SSPs. The interviews explored the effect of the COVID-19 pandemic on SSPs and their clients as well as the changes implemented in response. Interviews were recorded and transcribed. We performed content analysis to identify emerging themes from the data., Results: Due to the COVID-19 pandemic, some SSPs temporarily shut down while others limited their hours of operation. SSPs modified their service delivery to maintain syringe services and naloxone distribution over other services such as STI and HCV testing. They virtualized components of their services, including telemedicine for the provision of buprenorphine. While SSPs found virtualization to be important for maintaining their services, it negatively impacted the intimate nature of client interactions. Participants also described the impact of the pandemic on the well-being of PWID, including isolation, worsened mental health challenges, and increased drug overdoses., Conclusions: In response to the COVID-19 pandemic, SSPs demonstrated innovation, adaptability, and togetherness. Despite the challenges posed by the pandemic, SSPs continued to be key players in maintaining access to sterile supplies, buprenorphine, and other services for PWID. In addition to adapting to COVID-19 restrictions, they also responded to the dynamic needs of their clients. Sustainable funding and recognition of the critical role of SSPs in supporting PWID can help to improve outcomes for PWID., (© 2023. The Author(s).)

Background: We explored syringe service program (SSP) perspectives on barriers, readiness, and programmatic needs to support coronavirus disease 2019 (COVID-19) vaccine uptake among people who use drugs., Methods: We conducted an exploratory qualitative study, leveraging an existing sample of SSPs in the United States. Semistructured, in-depth interviews were conducted with SSP staff between February and April 2021. Interviews were analyzed using a Rapid Assessment Process, an intensive, iterative process that allows for rapid analysis of time-sensitive qualitative data., Results: Twenty-seven SSPs completed a qualitative interview. Many SSP respondents discussed that COVID-19 vaccination was not a priority for their participants because of competing survival priorities, and respondents shared concerns that COVID-19 had deepened participant mistrust of health care. Most SSPs wanted to participate in COVID-19 vaccination efforts; however, they identified needed resources, including adequate space, personnel, and training, to implement successful vaccine programs., Conclusions: Although SSPs are trusted resources for people who use drugs, many require additional structural and personnel support to address barriers to COVID-19 vaccination among their participants. Funding and supporting SSPs in the provision of COVID-19 prevention education and direct vaccine services should be a top public health priority., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 American Society of Addiction Medicine.)

Background: Co-located hepatitis C treatment at syringe service programs (SSP) is an emerging model of care for people who inject drugs (PWID). Implementation of these models can be informed by understanding the program costs., Methods: We conducted an economic evaluation of a hepatitis C treatment intervention at an SSP in New York City implemented as one arm of a randomized trial from 2017 to 2021. Start-up and operating costs were determined from the treatment program's perspective using micro-costing and were compared to potential Medicaid reimbursement. We applied nationally representative unit costs and wage rates. Results are reported in 2020 USD., Results: The treatment program was staffed by one physician and one care coordinator. Participants were offered hepatitis C clinical evaluation and treatment, a 45-min reinfection prevention education session, and additional care coordination as needed. The trial enrolled 84 PWID with hepatitis C in the intervention arm; 64 initiated treatment and 55 achieved sustained virological response. Start-up costs including training and equipment totaled $4677. Overhead costs including rent, utilities and software totaled $2229 per month. Clinical and care coordination totaled $4867 per participant, of which $3722 was care coordination. The total cost excluding startup was $6035 per enrolled participant and $7921 per treated participant; estimated potential reimbursement was $628 per enrolled participant., Conclusion: Our results provide insight to US-based SSPs seeking to provide co-located hepatitis C care and highlight the intensive care coordination services provided. Successful implementation likely requires funding sources beyond health insurers or substantial changes to insurance reimbursement for care coordination., Competing Interests: Conflicts of Interest Drs Kapadia,Eckhardt and Marks report research grants paid to their institutions from Gilead Sciences Inc, unrelated to the current study. Dr Aponte-Melendez reports research grants paid to their institution from Abbvie Inc, unrelated to the current study. All other authors report no potential conflicts of interest.

Background: Racial/ethnic minorities have experienced disproportionate opioid-related overdose death rates in recent years. In this context, we examined inequities in community-based naloxone access across racial/ethnic groups in Massachusetts., Methods: We used data from: the Massachusetts Department of Public Health on community-based overdose education and naloxone distribution (OEND) programs; the Massachusetts Office of the Chief Medical Examiner on opioid-related overdose deaths, and; the United States Census American Community Survey for regional demographic/socioeconomic details to estimate community populations by race/ethnicity and racial segregation between African American/Black and white residents. Race/ethnicity groups included in the analysis were African American/Black (non-Hispanic), Hispanic, white (non-Hispanic), and "other" (non-Hispanic). We evaluated racial/ethnic differences in naloxone distribution across regions in Massachusetts and neighborhoods in Boston descriptively and spatially, plotting the race/ethnicity-specific number of kits per opioid-related overdose death per jurisdiction. Lastly, we constructed generalized estimating equations models with a negative binomial distribution to compare the race/ethnicity-specific naloxone distribution rate by OEND programs., Results: From 2016-2019, the median annual rate of naloxone kits received from OEND programs in Massachusetts per racial/ethnicity group ranged between 160 and 447 per 100,000. In a multivariable analysis, we found that the naloxone distribution rates for racial/ethnic minorities were lower than the rate for white residents. We also found naloxone was more likely to be distributed in racially segregated communities than non-segregated communities., Conclusion: We identified racial/ethnic inequities in naloxone receipt by individuals in Massachusetts. Additional resources focused on designing and implementing OEND programs for racial/ethnic minorities are warranted to ensure equitable access to naloxone., Competing Interests: Conflict of Interest No conflict declared., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Syringe services programs (SSPs) provide critical evidence-based public health services that decrease harms from drug use for people who use drugs (PWUD). Many SSPs have experienced significant and evolving COVID-19-related disruptions. We aimed to characterize the impacts of COVID-19 on SSP operations in the United States approximately one year into the pandemic., Methods: Participating sites, selected from a national sample of SSPs, completed a semi-structured interview via teleconference and brief survey evaluating the impacts of COVID-19 on program operations. Data collection explored aspects of program financing, service delivery approaches, linkages to care, and perspectives on engaging PWUD in services one year into the pandemic. Interview data were analyzed qualitatively using Rapid Assessment Process. Survey data were analyzed using descriptive statistics and triangulated with qualitative findings., Results: 27 SSPs completed study-related interviews and surveys between February 2021 - April 2021. One year into the pandemic, SSPs reported continuing to adapt approaches to syringe distribution in response to COVID-19, and identified multiple barriers that hindered their ability to engage program participants in services, including 1) isolation and decreased connectivity with participants, 2) resource restrictions that limit responsiveness to participant needs, 3) reduced capacity to provide on-site HIV/HCV testing and treatment linkages, and 4) changing OUD treatment modalities that were a "double-edged sword" for PWUD. Quantitative survey responses aligned with qualitative findings, highlighting increases in the number of syringes distributed, increases in mobile and home delivery services, and reductions in on-site HIV and HCV testing., Conclusion: These data illuminate persistent and cascading risks of isolation, reduced access to services, and limited engagement with program participants that resulted from COVID-19 and continue to create barriers to the delivery of critical harm reduction services. Findings emphasize the need to ensure SSPs have the resources and capacity to adapt to changing public health needs, particularly as the COVID-19 pandemic continues to evolve., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier B.V.)

Importance: In 2021, the state of Rhode Island distributed 10 000 additional naloxone kits compared with the prior year through partnerships with community-based organizations., Objective: To compare various strategies to increase naloxone distribution through community-based programs in Rhode Island to identify one most effective and efficient strategy in preventing opioid overdose deaths (OODs)., Design, Setting, and Participants: In this decision analytical model study conducted from January 2016 to December 2022, a spatial microsimulation model with an integrated decision tree was developed and calibrated to compare the outcomes of alternative strategies for distributing 10 000 additional naloxone kits annually among all individuals at risk for opioid overdose in Rhode Island., Interventions: Distribution of 10 000 additional naloxone kits annually, focusing on people who inject drugs, people who use illicit opioids and stimulants, individuals at various levels of risk for opioid overdose, or people who misuse prescription opioids vs no additional kits (status quo). Two expanded distribution implementation approaches were considered: one consistent with the current spatial distribution patterns for each distribution program type (supply-based approach) and one consistent with the current spatial distribution of individuals in each of the risk groups, assuming that programs could direct the additional kits to new geographic areas if required (demand-based approach)., Main Outcomes and Measures: Witnessed OODs, cost per OOD averted (efficiency), geospatial health inequality measured by the Theil index, and between-group variance for OOD rates., Results: A total of 63 131 simulated individuals were estimated to be at risk for opioid overdose in Rhode Island based on current population data. With the supply-based approach, prioritizing additional naloxone kits to people who use illicit drugs averted more witnessed OODs by an estimated mean of 18.9% (95% simulation interval [SI], 13.1%-30.7%) annually. Expanded naloxone distribution using the demand-based approach and focusing on people who inject drugs had the best outcomes across all scenarios, averting an estimated mean of 25.3% (95% SI, 13.1%-37.6%) of witnessed OODs annually, at the lowest mean incremental cost of $27 312 per OOD averted. Other strategies were associated with fewer OODs averted at higher costs but showed similar patterns of improved outcomes and lower unit costs if kits could be reallocated to areas with greater need. The demand-based approach reduced geospatial inequality in OOD rates in all scenarios compared with the supply-based approach and status quo., Conclusions and Relevance: In this decision analytical model study, variations in the effectiveness, efficiency, and health inequality of the different naloxone distribution expansion strategies and approaches were identified. Future efforts should be prioritized for people at highest risk for overdose (those who inject drugs or use illicit drugs) and redirected toward areas with the greatest need. These findings may inform future naloxone distribution priority settings.

Many syringe services programs (SSPs) have established trusting, long-term relationships with their clients and are well situated to provide COVID-19 vaccinations. We examined characteristics and practices of SSPs in the United States that reported providing COVID-19 vaccinations to their clients and obstacles to vaccinating people who inject drugs (PWID). We surveyed SSPs in September 2021 to examine COVID-19 vaccination practices through a supplement to the 2020 Dave Purchase Memorial survey. Of 153 SSPs surveyed, 73 (47.7%) responded to the supplement; 24 of 73 (32.9%) reported providing on-site COVID-19 vaccinations. Having provided hepatitis and influenza vaccinations was significantly associated with providing COVID-19 vaccinations (70.8% had provided them vs 28.6% had not; P = .002). Obstacles to providing vaccination included lack of appropriate facilities, lack of funding, lack of trained staff, and vaccine hesitancy among PWID. SSPs are underused as vaccination providers. Many SSPs are well situated to provide COVID-19 vaccinations to PWID, and greater use of SSPs as vaccination providers is needed.

Background: US overdose deaths have reached a record high. Syringe services programs (SSPs) play a critical role in addressing this crisis by providing multiple services to people who use drugs (PWUD) that help prevent overdose death. This study examined the perspectives of leadership and staff from a geographically diverse sample of US SSPs on factors contributing to the overdose surge, their organization's response, and ongoing barriers to preventing overdose death., Methods: From 2/11/2021 to 4/23/2021, we conducted semi-structured interviews with leadership and staff from 27 SSPs sampled from the North American Syringe Exchange Network directory. Interviews were transcribed and qualitatively analyzed using a Rapid Assessment Process., Results: Respondents reported that increased intentional and unintentional fentanyl use (both alone and combined with other substances) was a major driver of the overdose surge. They also described how the COVID-19 pandemic increased solitary drug use and led to abrupt increases in use due to life disruptions and worsened mental health among PWUD. In response to this surge, SSPs have increased naloxone distribution, including providing more doses per person and expanding distribution to people using non-opioid drugs. They are also adapting overdose prevention education to increase awareness of fentanyl risks, including for people using non-opioid drugs. Some are distributing fentanyl test strips, though a few respondents expressed doubts about strips' effectiveness in reducing overdose harms. Some SSPs are expanding education and naloxone training/distribution in the broader community, beyond PWUD and their friends/family. Respondents described several ongoing barriers to preventing overdose death, including not reaching certain groups at risk of overdose (PWUD who do not inject, PWUD experiencing homelessness, and PWUD of color), an inconsistent naloxone supply and lack of access to intranasal naloxone in particular, inadequate funding, underestimates of overdoses, legal/policy barriers, and community stigma., Conclusions: SSPs remain essential in preventing overdose deaths amid record numbers likely driven by increased fentanyl use and COVID-19-related impacts. These findings can inform efforts to support SSPs in this work. In the face of ongoing barriers, support for SSPs-including increased resources, political support, and community partnership-is urgently needed to address the worsening overdose crisis., (© 2022. The Author(s).)

Background and Aims: Opioid-related overdose death rates continue to rise in the United States, especially in racial/ethnic minority communities. Our objective was to determine if US municipalities with high percentages of non-white residents have equitable access to the overdose antidote naloxone distributed by community-based organizations., Methods: We used community-based naloxone data from the Massachusetts Department of Public Health and the Rhode Island non-pharmacy naloxone distribution program for 2016-18. We obtained publicly available opioid-related overdose death data from Massachusetts and the Office of the State Medical Examiners in Rhode Island. We defined the naloxone coverage ratio as the number of community-based naloxone kits received by a resident in a municipality divided by the number of opioid-related overdose deaths among residents, updated annually. We used a Poisson regression with generalized estimating equations to analyze the relationship between the municipal racial/ethnic composition and naloxone coverage ratio. To account for the potential non-linear relationship between naloxone coverage ratio and race/ethnicity we created B-splines for the percentage of non-white residents; and for a secondary analysis examining the percentage of African American/black and Hispanic residents. The models were adjusted for the percentage of residents in poverty, urbanicity, state and population size., Results: Between 2016 and 2018, the annual naloxone coverage ratios range was 0-135. There was no difference in naloxone coverage ratios among municipalities with varying percentages of non-white residents in our multivariable analysis. In the secondary analysis, municipalities with higher percentages of African American/black residents had higher naloxone coverage ratios, independent of other factors. Naloxone coverage did not differ by percentage of Hispanic residents., Conclusions: There appear to be no municipal-level racial/ethnic inequities in naloxone distribution in Rhode Island and Massachusetts, USA., (© 2021 Society for the Study of Addiction.)

Background: Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes., Methods: The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial (M 2 HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated., Discussion: The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings., Trial Registration: Clinicaltrials.gov NCT03981445 . Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201., (© 2022. The Author(s).)

Background: Using data from a randomized trial, we evaluated the cost of HCV care facilitation that supports moving along the continuum of care for HIV/HCV co-infected individuals with substance use disorder., Methods: Participants were HIV patients residing in the community, initially recruited from eight US hospital sites. They received HCV care facilitation (n = 51) or treatment as usual (n = 62) for up to six months. We used micro-costing methods to evaluate costs from the healthcare sector and patient perspectives in 2017 USD. We conducted sensitivity analyses varying care facilitator caseloads and examined offsetting savings using participant self-reported healthcare utilization., Results: The average site start-up cost was $6320 (site range: $4320-$7000), primarily consisting of training. The mean weekly cost per participant was $20 (site range: $4-$30) for care facilitation visits and contacts, $360 (site range: $130- $700) for supervision and client outreach, and $70 (site range: $20-$180) for overhead. In sensitivity analyses applying a weekly caseload of 10 participants per care facilitator (versus 1-6 observed in the trial), the total mean weekly care facilitation cost from the healthcare sector perspective decreased to $110. Weekly participant time and travel costs averaged $7. There were no significant differences in other healthcare service costs between participants in the intervention and control arms., Conclusion: Weekly HCV care facilitation costs were approximately $450 per participant, but approximately $110 at a real-world setting maximum caseload of 10 participants per week. No healthcare cost offsets were identified during the trial period, although future savings might result from successful HCV treatment., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Objectives: This study describes harm reduction and health services provided by U.S syringe services programs (SSPs) in 2019 and changes in provision of those services in 2020., Methods: SSPs were invited to participate in the Dave Purchase Memorial survey in August 2020. We collected programmatic data on services provided in 2019 and at the time of the survey in 2020. We conducted descriptive analyses using Chi-square and McNemar's tests., Results: At the time of the survey, > 60% of SSPs reported increased monthly syringe and naloxone distribution and expansion of home-based and mail-based naloxone delivery in Fall 2020 compared to 2019. Approximately three-quarters of SSPs decreased or stopped providing on-site HIV and HCV testing. Nearly half of SSPs offering on-site medications for opioid use disorder (MOUD) in 2019 increased provision of MOUD in 2020. The proportion of SSPs offering on-site mental health care services and primary care services statistically significantly decreased from 2019 to Fall 2020, but telehealth offerings of these services increased., Conclusions: Many SSPs that offered health services in 2019 and remained operational in 2020 increased telehealth provision of mental health and primary care services, increased MOUD provision, and expanded harm reduction services, but most SSPs reduced or stopped on-site HIV and HCV testing. Sustaining SSP growth and innovation is paramount for preventing overdose deaths and HIV/HCV outbreaks after the deadliest year of the opioid epidemic in 2020., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Understanding the sources of HIV transmission provides a basis for prioritizing HIV prevention resources in specific geographic regions and populations. This study estimated the number, proportion, and rate of HIV transmissions attributable to individuals along the HIV care continuum within different HIV transmission risk groups in 6 US cities., Methods: We used a dynamic, compartmental HIV transmission model that draws on racial behavior-specific or ethnic behavior-specific and risk behavior-specific linkage to HIV care and use of HIV prevention services from local, state, and national surveillance sources. We estimated the rate and number of HIV transmissions attributable to individuals in the stage of acute undiagnosed HIV, nonacute undiagnosed HIV, HIV diagnosed but antiretroviral therapy (ART) naïve, off ART, and on ART, stratified by HIV transmission group for the 2019 calendar year., Results: Individuals with undiagnosed nonacute HIV infection accounted for the highest proportion of total transmissions in every city, ranging from 36.8% (26.7%-44.9%) in New York City to 64.9% (47.0%-71.6%) in Baltimore. Individuals who had discontinued ART contributed to the second highest percentage of total infections in 4 of 6 cities. Individuals with acute HIV had the highest transmission rate per 100 person-years, ranging from 76.4 (58.9-135.9) in Miami to 160.2 (85.7-302.8) in Baltimore., Conclusion: These findings underline the importance of both early diagnosis and improved ART retention for ending the HIV epidemic in the United States. Differences in the sources of transmission across cities indicate that localized priority setting to effectively address diverse microepidemics at different stages of epidemic control is necessary., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: To respond to the U.S. opioid crisis, new models of healthcare delivery for opioid use disorder treatment are essential. We used a qualitative approach to describe the implementation of a low-threshold buprenorphine treatment program in an independent, community-based medical practice in Ithaca, NY., Methods: We conducted 17 semi-structured interviews with program staff, leadership, and external stakeholders. Then we analyzed these data using content analysis. We used purposeful sampling aiming for variation in job title for program staff, and in organizational affiliation for external stakeholders., Results: We found that opening an independent medical practice allowed for low-threshold buprenorphine treatment with less regulatory oversight, but state-certification was ultimately required to ensure financial sustainability. Relying on health insurance reimbursement alone led to funding shortfalls and additional funding sources were also required. The practice's ability to build relationships with licensed substance use treatment programs, community organizations, the legal system, and government agencies in the region differed depending on how much these entities supported a harm reduction philosophy compared to abstinence-based treatment. Finally, expanding the practice to a second location in a different region, co-located with a syringe service program, required adapting to a new cultural and political environment., Conclusion: The results from this study provide insight about the challenges that independent medical practices might face in delivering low-threshold buprenorphine treatment. They support policy efforts to address the financial burdens associated with providing low-threshold buprenorphine therapy and inform the external relationships that other providers would need to consider when delivering novel treatment models.

Background: Naloxone is an opioid antagonist medication that can be administered by lay people or medical professionals to reverse opioid overdoses and reduce overdose mortality. Cost was identified as a potential barrier to providing expanded overdose education and naloxone distribution (OEND) in New York City (NYC) in 2017. We estimated the cost of delivering OEND for different types of opioid overdose prevention programs (OOPPs) in NYC. Methods : We interviewed naloxone coordinators at 11 syringe service programs (SSPs) and 10 purposively sampled non-SSPs in NYC from December 2017 to September 2019. The samples included diverse non-SSP program types, program sizes, and OEND funding sources. We calculated one-time start up costs and ongoing operating costs using micro-costing methods to estimate the cost of personnel time and materials for OEND activities from the program perspective, but excluding naloxone kit costs. Results : Implementing an OEND program required a one-time median startup cost of $874 for SSPs and $2,548 for other programs excluding overhead, with 80% of those costs attributed to time and travel for training staff. SSPs spent a median of $90 per staff member trained and non-SSPs spent $150 per staff member. The median monthly cost of OEND program activities excluding overhead was $1,579 for SSPs and $2,529 for non-SSPs. The costs for non-SSPs varied by size, with larger, multi-site programs having higher median costs compared to single-site programs. The estimated median cost per kit dispensed excluding and including overhead was $19 versus $25 per kit for SSPs, and $36 versus $43 per kit for non-SSPs, respectively. Conclusions : OEND operating costs vary by program type and number of sites. Funders should consider that providing free naloxone to OEND programs does not cover full operating costs. Further exploration of cost-effectiveness and program efficiency should be considered across different types of OEND settings.

Background and Aims: In a US randomized-effectiveness trial comparing extended-release naltrexone (XR-NTX) with buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse among participants recruited during inpatient detoxification (CTN-0051), the requirement to complete opioid detoxification prior to initiating XR-NTX resulted in lower rates of initiation of XR-NTX (72% XR-NTX versus 94% BUP-NX)., Design: This was a retrospective secondary analysis of CTN-0051 trial data, including follow-up data over 24-36 weeks., Setting: Eight community-based, inpatient-detoxification and follow-up outpatient treatment facilities in the United States., Participants: A total of 283 participants randomized to receive XR-NTX., Measurements: Efficiency was estimated using a multivariable generalized structural equation model to explore simultaneous determinants of XR-NTX induction and induction duration (detoxification + residential days). Cost-effectiveness was estimated from the health-care sector perspective and included expected costs and quality-adjusted life-years (QALYs)., Findings: Treatment site was the only modifiable factor that simultaneously increased the likelihood of XR-NTX induction and decreased induction duration. Incorporating the higher predicted probability of XR-NTX induction, and fewer predicted days of detoxification and subsequent residential treatment into the cost-effectiveness framework, reduced the incremental average 24-week total cost of XR-NTX treatment from $5317 more than that of BUP-NX (P = 0.01) to a non-statistically-significant difference of $1016 (P = 0.63). QALYs gained remained similar across arms., Conclusion: Adopting an efficient model of extended-release naltrexone initiation could result in extended-release naltrexone and buprenorphine-naloxone being of comparable economic value from the health-care sector perspective over 24-36 weeks for patients seeking treatment for opioid use disorder at an inpatient detoxification facility., (© 2021 Society for the Study of Addiction.)

Background: Rates of fatal opioid overdose in Massachusetts (MA) and Rhode Island (RI) far exceed the national average. Community-based opioid education and naloxone distribution (OEND) programs are effective public health interventions to prevent overdose deaths. We compared naloxone distribution and opioid overdose death rates in MA and RI to identify priority communities for expanded OEND., Methods: We compared spatial patterns of opioid overdose fatalities and naloxone distribution through OEND programs in MA and RI during 2016 to 2019 using public health department data. The county-level ratio of naloxone kits distributed through OEND programs per opioid overdose death was estimated and mapped to identify potential gaps in naloxone availability across geographic regions and over time., Results: From 2016 to 2019, the statewide community-based naloxone distribution to opioid overdose death ratio improved in both states, although more rapidly in RI (from 11.8 in 2016 to 35.6 in 2019) than in MA (from 12.3 to 17.2), driven primarily by elevated and increasing rates of naloxone distribution in RI. We identified some urban/non-urban differences, with higher naloxone distribution relative to opioid overdose deaths in more urban counties, and we observed some counties with high rates of overdose deaths but low rates of naloxone kits distributed through OEND programs., Conclusions: We identified variations in spatial patterns of opioid overdose fatalities and naloxone availability, and these disparities appeared to be widening in some areas over time. Data on the spatial distribution of naloxone distribution and opioid overdose deaths can inform targeted, community-based naloxone distribution strategies that optimize resources to prevent opioid overdose fatalities., Competing Interests: Declarations of Interest The authors have no conflicts of interest to declare., (Copyright © 2021. Published by Elsevier B.V.)