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With changing drug supplies and associated drug consumption behaviors, HIV transmission has increased among people who inject drugs in the United States. HIV testing and referrals to effective prevention and treatment services are critical for individual and population health, yet multilevel barriers limit access to HIV testing for this population, even within syringe services programs (SSPs). In this organizational-level interrupted time series randomized controlled trial, we will assess the effectiveness and cost-effectiveness of an implementation strategy, the Systems Analysis and Improvement Approach (SAIA), in optimizing HIV testing and referrals to appropriate clinical services among U.S. SSPs. From 01/12/2023 to 01/07/2025, we will recruit a diverse sample of 32 SSPs nationally that directly provide HIV testing to participants. SSPs will be randomized to the active implementation arm (i.e., SAIA-SSP-HIV) or an implementation-as-usual arm (n = 16 organizations per arm). SAIA-SSP-HIV is a flexible, data-driven implementation strategy designed to help optimize SSPs’ delivery of HIV testing and referrals to appropriate clinical services for HIV prevention (e.g., pre-exposure prophylaxis) and treatment. In the active implementation arm, trained SAIA specialists will guide SSPs through three cyclical steps over 12 months: (1) process mapping to identify organization-specific needs, (2) cascade analysis and prioritization of areas for improvement, and (3) testing solutions through continuous quality improvement. In both arms, we will collect outcome data over 21 months (3-month lead-in period, 12-month implementation period, 6-month sustainment period). We will assess the initial and sustained effectiveness of SAIA and calculate its cost and cost-effectiveness. This trial presents a novel opportunity to test the effectiveness of an organization-level implementation strategy for optimizing the delivery of HIV screening and referrals in community settings that are frequented by an at-risk population. If successful, SAIA-SSP-HIV could be adapted for other infectious or chronic disease care cascades within SSPs. Trial registration: ClinicalTrials.gov: NCT06025435 .

Background More than half a million Americans died of an opioid-related overdose between 1999 and 2020, the majority occurring between 2015 and 2020. The opioid overdose mortality epidemic disproportionately impacts Black, Indigenous, and people of color (BIPOC): since 2015, overdose mortality rates have increased substantially more among Black (114%) and Latinx (97%) populations compared with White populations (32%). This is in part due to disparities in access to naloxone, an opioid antagonist that can effectively reverse opioid overdose to prevent death. Our recent pilot work determined that many barriers to naloxone access can be identified and addressed by syringe service programs (SSPs) using the Systems Analysis and Improvement Approach to Naloxone distribution (SAIA-Naloxone). This randomized controlled trial will test SAIA-Naloxone’s ability to improve naloxone distribution in general and among BIPOC specifically. Methods We will conduct a trial with 32 SSPs across California, randomly assigning 16 to the SAIA-Naloxone arm and 16 to receive implementation as usual. SAIA-Naloxone is a multifaceted, multilevel implementation strategy through which trained facilitators work closely with SSPs to (1) assess organization-level barriers, (2) prioritize barriers for improvement, and (3) test solutions through iterative change cycles until achieving and sustaining improvements. SSPs receiving SAIA-Naloxone will work with a trained facilitator for a period of 12 months. We will test SAIA-Naloxone’s ability to improve SSPs’ naloxone distribution using an interrupted time series approach. Data collection will take place during a 3-month lead-in period, the 12-month active period, and for an additional 6 months afterward to determine whether impacts are sustained. We will use a structured approach to specify SAIA-Naloxone to ensure strategy activities are clearly defined and to assess SAIA-Naloxone fidelity to aid in interpreting study results. We will also assess the costs associated with SAIA-Naloxone and its cost-effectiveness. Discussion This trial takes a novel approach to improving equitable distribution of naloxone amid the ongoing epidemic and associated racial disparities. If successful, SAIA-Naloxone represents an important organizational-level solution to the multifaceted and multilevel barriers to equitable naloxone distribution.

Background Medications to treat opioid use disorder (OUD) including buprenorphine products are evidence-based and cost-effective tools for combating the opioid crisis. However, limited availability to buprenorphine is pervasive in the United States (US) and may serve to exacerbate the deadly epidemic. Although prior research points to rural counties as especially needy of strategies that improve buprenorphine availability, it is important to investigate the availability of waivered providers according to treatment need as defined by the county-level rate of opioid-overdose deaths (OOD). This study examined differences in buprenorphine provider availability relative to treatment need among rural and urban counties in the US. Methods Buprenorphine provider availability relative to need in each county was defined as the number of waivered providers divided by the rate of OODs (i.e., number of OODs/100,000 population), according to 2018 data. Counties with ratios in the bottom tertile of their state were classified as buprenorphine undersupplied. We estimated logit models to statistically test the association of rurality and state main effects and their interaction terms (independent variables) and the county classified as buprenorphine undersupplied (dependent variable). Results A total of 38 states and 2595 counties had sufficient non-suppressed data to remain in the analysis. A larger percent of urban counties (36.43%) than rural counties (32.01%) were classified as buprenorphine undersupplied (p  = 0.001). The likelihood of a rural county being undersupplied varied considerably by state (Chi Square  = 82.88, p  = 0.000). All states with significant (p  < 0.05 or p  < 0.10) interaction terms showed lower likelihood of buprenorphine undersupply in rural counties. Conclusions The rural–urban distribution in undersupply of waivered buprenorphine providers relative to need varied markedly by state. Strategies for improving access to buprenorphine-waivered providers should be state-centric and informed by county-specific indicators of need.

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.

ObjectiveTo understand the importance of electronic nicotine delivery systems (ENDS) product attributes to adult consumers in the USA by age and gender.DesignCross-sectional survey with a discrete choice experiment (best–worst, case 2, scaling) of 19 choice tasks in which participants answered what would make them most want to use and least want to use an ENDS product.Setting and participantsA national sample of adults (aged 18+ years) in the USA who had tried an ENDS product at least once.MeasuresWe included 9 ENDS attributes with levels that varied across 19 choice tasks. We performed a multinomial logistic regression to obtain overall importance scores, attribute-level part-worth utilities and most important attribute.ResultsOf 660 participants, 81% were white, 51% women and 37% had at least a 4-year college degree with an average age of 42.0 years (SD ±19.4). The attributes had the following importance: harms of use 17.6%; general effects 14.1%; cessation aid 12.6%; purchase price 12.1%; monthly cost 12.0%; nicotine content 11.4%; flavour availability 8.4%; device design 7.2%; modifiability 4.6%. Harms of use was the most important attribute for all ages and genders (p<0.05); variation in other important attributes existed by age though not by gender.ConclusionThis study identified the importance of nine ENDS attributes. Perceived harms of use of ENDS use appeared most important, and modifiability was least important. Variation by consumer group existed, which may allow for targeted interventions to modify ENDS use.

BackgroundThe World Health Organization (WHO) categorizes alcohol consumption according to grams consumed into low-, medium-, high-, and very-high-risk drinking levels (RDLs). Although abstinence has been considered the ideal outcome of alcohol treatment, reductions in WHO RDLs have been proposed as primary outcomes for alcohol use disorder (AUD) trials.ObjectiveThe current study examines the stability of WHO RDL reductions and the association between RDL reductions and long-term functioning for up to 3 years following treatment.Design and ParticipantsSecondary data analysis of patients with AUD enrolled in the COMBINE Study and Project MATCH, two multi-site, randomized AUD clinical trials, who were followed for up to 3 years post-treatment (COMBINE: n = 694; MATCH: n = 806).MeasuresAlcohol use was measured via calendar-based methods. We estimated all models in the total sample and among participants who did not achieve abstinence during treatment.Key ResultsOne-level RDL reductions were achieved by 84% of patients at the end of treatment, with 84.9% of those individuals maintaining that reduction at a 3-year follow-up. Two-level RDL reductions were achieved by 68% of patients at the end of treatment, with 77.7% of those individuals maintaining that reduction at a 3-year follow-up. One- and two-level RDL reductions at the end of treatment were associated with significantly better mental health, quality of life (including physical quality of life), and fewer drinking consequences 3 years after treatment (p < 0.05), as compared to no change or increased drinking.ConclusionAUD patients can maintain WHO RDL reductions for up to 3 years after treatment. Patients who had WHO RDL reductions functioned significantly better than those who did not reduce their drinking. These findings are consistent with prior reports suggesting that drinking reductions, short of abstinence, yield meaningful improvements in patient health, well-being, and functioning.

Prior authorization requirements may be a barrier to accessing medications for opioid use disorder treatment and may, therefore, be associated with poor health care outcomes. To determine the association of prior authorization with use of buprenorphine-naloxone and health care outcomes. This comparative interrupted time series analysis examined enrollment and insurance claims data from Medicare beneficiaries with an opioid use disorder diagnosis or who filled a prescription for an opioid use disorder medication between 2012 and 2017. Over this period, 775 874 members were in 1479 Part D plans that always required prior authorization, 113 286 members were in 206 plans that removed prior authorization, 189 461 members were in 489 plans that never required prior authorization, and 619 919 members were in 485 plans that added prior authorization. Data analysis was performed from April 2019 to February 2020. Removal or addition of prior authorization and new prescriptions filled for buprenorphine-naloxone. Buprenorphine-naloxone use, inpatient admissions, emergency department visits, and prescription drug and medical expenditures. The study population in 2012 included 949 206 Medicare beneficiaries (mean [SD] age, 57 [15] years; 550 445 women [58%]). Removal of prior authorization was associated with an increase of 17.9 prescriptions (95% CI, 1.1 to 34.7 prescriptions) filled for buprenorphine-naloxone per plan per year, which is a doubling of the number of prescriptions, on average. Each prescription filled was associated with statistically significant decreases in adverse health care outcomes: substance use disorder-related inpatient admissions decreased by 0.1 admission per plan per year (95% CI, -0.2 to -0.1 admission per plan per year), and substance use disorder-related emergency department visits decreased by 0.1 visit per plan per year (95% CI, -0.13 to -0.03 visit per plan per year) (all P < .001). Combining these results, removal of prior authorization was associated with a reduction in substance use disorder-related inpatient admissions by 2.0 admissions per plan per year (95% CI, -4.3 to -0.1 admissions per plan per year) and substance use disorder-related emergency department visits by 1.4 visits per plan per year (95% CI, -3.2 to -0.1 visits per plan per year). Removing prior authorization for buprenorphine-naloxone was associated with an increase in the medication use and decreases in health care utilization and expenditures.

ObjectivePrevious research suggests that some adolescents are using e-cigarette devices to vaporise (‘vaping’) cannabis in the form of hash oil, tetrahydrocannabinol (THC) wax or oil, or dried cannabis buds or leaves. However, it is unclear how adolescents who vape cannabis use other tobacco products. This study examined the extent to which adolescents reported ever vaping cannabis and investigated how demographic variables and tobacco behaviours were associated with use.DesignWe used cross-sectional data from adolescents (total response rate 64.5%) who participated in the 2017 North Carolina Youth Tobacco Survey. SAS logistic regression survey procedures were used to account for the complex survey design and sampling weights.SettingNorth Carolina, USA.ParticipantsAdolescents in high school (n=2835).Primary outcome and measureAdolescents were asked to indicate whether they had ever used an e-cigarette device with marijuana, THC or hash oil, or THC wax.ResultsApproximately 1 in 10 high school students reported ever vaping cannabis in the overall sample (9.6%). In multivariable models, adolescents who reported using cigars (adjusted OR (aOR) 3.76, 95% CI 2.33 to 6.07), waterpipe (aOR 2.32, 95% CI 1.37 to 3.93) or e-cigarettes (aOR 3.18, 95% CI 2.38 to 4.25) in the past 30 days had higher odds of reporting ever vaping cannabis compared with their counterparts. There was no significant association between use of smokeless tobacco (aOR 0.89, 95% CI 0.42 to 1.91) or use of cigarettes (aOR 1.27, 95% CI 0.71 to 2.29) in the past 30 days and odds of reporting ever vaping cannabis.ConclusionsThese findings provide evidence that large numbers of high school students who use tobacco products have vaped cannabis. As tobacco control policies—such as communication campaigns or smoke-free laws—increasingly focus on e-cigarettes, attention to understanding how adolescents use e-cigarettes to vape substances other than nicotine is essential.

Only 63% of people living with HIV in the United States are achieving viral suppression. Structural and social barriers limit adherence to antiretroviral therapy which furthers the HIV epidemic while increasing health care costs. This study calculated the cost and cost-effectiveness of a contingency management intervention with cash incentives. People with HIV and detectable viral loads were randomized to usual care or an incentive group. Individuals could earn up to$3650 per year if they achieved and maintained an undetectable viral load. The average 1-year intervention cost, including incentives, was $ 4105 per patient. The average health care costs were$27,189 per patient in usual care and $ 35,853 per patient in the incentive group. We estimated a cost of $28,888 per quality-adjusted life-year (QALY) gained, which is well below accepted cost-per-QALY thresholds. Contingency management with cash incentives is a cost-effective intervention for significantly increasing viral suppression.

BACKGROUND:Persons appearing in trauma centers have a higher prevalence of unhealthy alcohol use than the general population. Screening and brief intervention (SBI) is designed to moderate drinking levels and avoid costly future readmissions, but few studies have examined the impact of SBI on hospital readmissions and health care costs in a trauma population. RESEARCH DESIGN:This study uses comparative interrupted time-series and the Arizona State Inpatient Database to estimate the effect of the American College of Surgeons Committee on Trauma SBI mandate on the probability of readmission and cost per readmission in Arizona trauma centers. We compare individuals with and without an alcohol diagnosis code before and after the mandate was implemented. RESULTS:The mandate resulted in a 2.2 percentage point reduction (44%) in the probability of readmission. Total health care and readmission costs were not affected by the mandate. CONCLUSIONS:The estimates are consistent with a differential effect of SBISBI reduces readmissions among those who present with a less serious alcohol-related problem. Persons with more serious alcohol problems are less likely to respond to SBI. These higher risk individuals likely have a higher cost, which may explain the lack of change in readmission costs. Our study is a macrolevel intent-to-treat analysis of SBI’s impact that corroborates the potential of SBI implied by efficacy studies in trauma centers and other settings. This study provides a framework for future research involving more states and health systems and evaluating other SBI policies.