Economic Evaluations of Establishing Opioid Overdose Prevention Centers in 12 North American Cities: A Systematic Review.

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.

Supporting treatment adherence for resilience and thriving (START): protocol for a mHealth randomized controlled trial.

BACKGROUND: Although behavioral interventions show some promise for reducing stimulant use and achieving durable viral suppression in sexual minority men (SMM) with HIV, scalable mHealth applications are needed to optimize their reach and cost-effectiveness. METHODS: Supporting Treatment Adherence for Resilience and Thriving (START) is a randomized controlled trial (RCT) testing the efficacy and cost-effectiveness of a mHealth application that integrates evidence-based positive affect regulation skills with self-monitoring of adherence and mood. The primary outcome is detectable HIV viral load (i.e., > 300 copies/mL) from self-collected dried blood spot (DBS) specimens at 6 months. Secondary outcomes include detectable DBS viral load at 12 months, self-reported stimulant use severity, anti-retroviral therapy (ART) adherence, and positive affect over 12 months. A national sample of up to 250 SMM with HIV who screen positive for stimulant use disorder and reporting suboptimal ART adherence is being recruited via social networking applications through April of 2024. After providing informed consent, participants complete a run-in period (i.e., waiting period) including two baseline assessments with self-report measures and a self-collected DBS sample. Those who complete the run-in period are randomized to either the START mHealth application or access to a website with referrals to HIV care and substance use disorder treatment resources. Participants provide DBS samples at baseline, 6, and 12 months to measure HIV viral load as well as complete self-report measures for secondary outcomes at quarterly follow-up assessments over 12 months. DISCUSSION: To date, we have paid $117,500 to advertise START on social networking applications and reached 1,970 eligible participants ($59.77 per eligible participant). Although we identified this large national sample of potentially eligible SMM with HIV who screen positive for a stimulant use disorder and report suboptimal ART adherence, only one-in-four have enrolled in the RCT. The run-in period has proven to be crucial for maintaining scientific rigor and reproducibility of this RCT, such that only half of consented participants complete the required study enrollment activities and attended a randomization visit. Taken together, findings will guide adequate resource allocation to achieve randomization targets in future mHealth research SMM with HIV who use stimulants. TRIAL REGISTRATION: This protocol was registered on clinicaltrials.gov (NCT05140876) on December 2, 2021.

Economic Evaluation Design within the HEAL Prevention Cooperative.

The rapid rise in opioid misuse, disorder, and opioid-involved deaths among older adolescents and young adults is an urgent public health problem. Prevention is a vital part of the nation's response to the opioid crisis, yet preventive interventions for those at risk for opioid misuse and opioid use disorder are scarce. In 2019, the National Institutes of Health (NIH) launched the Preventing Opioid Use Disorder in Older Adolescents and Young Adults cooperative as part of its broader Helping to End Addiction Long-term (HEAL) Initiative ( https://heal.nih.gov/ ). The HEAL Prevention Cooperative (HPC) includes ten research projects funded with the goal of developing effective prevention interventions across various settings (e.g., community, health care, juvenile justice, school) for older adolescent and young adults at risk for opioid misuse and opioid use disorder (OUD). An important component of the HPC is the inclusion of an economic evaluation by nine of these research projects that will provide information on the costs, cost-effectiveness, and sustainability of these interventions. The HPC economic evaluation is integrated into each research project's overall design with start-up costs and ongoing delivery costs collected prospectively using an activity-based costing approach. The primary objectives of the economic evaluation are to estimate the intervention implementation costs to providers, estimate the cost-effectiveness of each intervention for reducing opioid misuse initiation and escalation among youth, and use simulation modeling to estimate the budget impact of broader implementation of the interventions within the various settings over multiple years. The HPC offers an extraordinary opportunity to generate economic evidence for substance use prevention programming, providing policy makers and providers with critical information on the investments needed to start-up prevention interventions, as well as the cost-effectiveness of these interventions relative to alternatives. These data will help demonstrate the valuable role that prevention can play in combating the opioid crisis.

Economic Evaluations of Pharmacologic Treatment for Opioid Use Disorder: A Systematic Literature Review.

OBJECTIVE: The crisis of opioid use puts a strain on resources in the United States and worldwide. There are 3 US Food and Drug Administration-approved medications for treatment of opioid use disorder: methadone, buprenorphine, and injectable extended-release naltrexone (XR-NTX). The comparative effectiveness and cost vary considerably among these 3 medications. Economic evaluations provide evidence that help stakeholders efficiently allocate scarce resources. Our objective was to summarize recent health economic evidence of pharmacologic treatment of opioid use disorder interventions. METHODS: We searched PubMed for peer-reviewed studies in English from August 2015 through December 2019 as an update to a 2015 review. We used the Drummond checklist to evaluate and categorize economic evaluation study quality. We summarized results by economic evaluation methodology and pharmacologic treatment modality. RESULTS: We identified 105 articles as potentially relevant and included 21 (4 cost-offset studies and 17 cost-effectiveness/cost-benefit studies). We found strengthened evidence on buprenorphine and methadone, indicating that these treatments are economically advantageous compared with no pharmacotherapy, but found limited evidence on XR-NTX. Only half of the cost-effectiveness studies used a generic preference-based measure of effectiveness, limiting broad comparison across diseases/disorders. The disease/disorder-specific cost-effectiveness measures vary widely, suggesting a lack of consensus on the value of substance use disorder treatment. CONCLUSION: We found studies that provide new evidence supporting the cost-effectiveness of buprenorphine compared with no pharmacotherapy. We found a lack of evidence supporting superior economic value for buprenorphine versus methadone, suggesting that both are attractive alternatives. Further economic research is needed on XR-NTX, as well as other emerging pharmacotherapies, treatment modalities, and dosage forms.

Implementation and first-year operating costs of an academic medical center-based syringe services program.

BACKGROUND: Syringe services programs (SSPs) remain highly effective, cost-saving interventions for the prevention of blood-borne infections among people who inject drugs. However, there have been restrictions regarding financial resources allocated to these programs, particularly in the US South. This study aimed to provide cost data regarding the implementation and first-year operations of an academic-based SSP utilizing fixed and mobile strategies, including the integration of onsite wound care. METHODS: We conducted a micro-costing study that retrospectively collected detailed resource utilization and unit cost data for both the fixed and mobile SSP strategies, including onsite wound care, from both healthcare and societal perspectives. A three-step approach was used to identify, measure, and value intervention costs, and cost components were categorized into implementation, variable program, and time-dependent costs. Sensitivity analysis was performed to examine the impact of SSP operational changes (i.e., needs-based distribution and opt-out HIV/HCV testing) on the cost-per-participant. Cost data we presented as overall cost and cost-per-participant adjusted to 2017 US dollars. RESULTS: A total of 452 and 129 participants enrolled in fixed and mobile SSP services, respectively. The total cost associated with implementation and first year operations for the fixed site was $407,217.22 or $729.72 per participant and $311,625.52 or $2415.70 per participant for the mobile unit. The largest cost component for both modalities was time-dependent costs (personnel and overhead), while intervention materials (syringes, injection equipment, naloxone) were less than 15% of the total program cost. DISCUSSION/CONCLUSION: Implementation and operation of new SSP models continue to be low cost compared to treatment for the multitude of harms PWID face without access to evidence-based prevention. Future cost-effectiveness and cost-benefit analyses integrating a comprehensive SSP model within an academic institution, including onsite wound care and other medical services, will provide a more comprehensive understanding of this model, and state-level policy action must be taken to lift the prohibition of state and local funds for the implementation, sustainability, and maintenance of these programs in Florida.

Chronic condition patterns in the US population and their association with health related quality of life.

This study aims to identify chronic disease patterns and their relationship to health-related quality of life (HRQL) in the US population. This cross-sectional study used data from 86,745 participants aged 18 years and older of the Medical Expenditure Panel Survey (MEPS) 2010-2015, we employed latent class analysis (LCA) to identify subgroups of participants with different combinations of 23 chronic conditions which had medical utilization during the past 12 months. Derived chronic condition latent classes were used to predict the 12-Item Short Form Survey physical component score (PCS), mental component score (MCS) in addition to overall HRQL (SF-6D) while controlling for covariates. LCA identified five unique multi-morbidity groups: "healthy" (62.5%), "vascular risk" (18.9%), "anxiety" (12.2%), "heart disease" (2.9%), and "severely-impaired" (3.5%). Covariate-adjusted mean SF-6D scores varied significantly among classes: healthy (0.85), vascular risk (0.77), anxiety (0.67), heart disease group (0.65), and severely-impaired (0.56). The anxiety group, proportionately younger and female, had high PCS (46.3) but low MCS (41.9). The heart disease group, although older and in poor physical health (PCS = 33.2), had higher MCS scores (46.9). Our results demonstrate multi-morbidity significantly impacts HRQL. The relationship between physical and mental health functioning varied across different multi-morbidity groups, and the discordance was more pronounced in younger ages and females. Our research also identified an older age group that was mentally robust and maintained a strong HRQL. Findings can inform the development of targeted interventions to improve physical and mental health functioning in vulnerable populations.

Cost-Effectiveness of Buprenorphine-Naloxone Versus Extended-Release Naltrexone to Prevent Opioid Relapse.

Background: Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder. Objective: To evaluate the cost-effectiveness of buprenorphine-naloxone versus extended-release naltrexone. Design: Cost-effectiveness analysis alongside a previously reported randomized clinical trial of 570 adults in 8 U.S. inpatient or residential treatment programs. Data Sources: Study instruments. Target Population: Adults with opioid use disorder. Time Horizon: 24-week intervention with an additional 12 weeks of observation. Perspective: Health care sector and societal. Interventions: Buprenorphine-naloxone and extended-release naltrexone. Outcome Measures: Incremental costs combined with incremental quality-adjusted life-years (QALYs) and incremental time abstinent from opioids. Results of Base-Case Analysis: Use of the health care sector perspective and a willingness-to-pay threshold of $100 000 per QALY showed buprenorphine-naloxone to be preferable to extended-release naltrexone in 97% of bootstrap replications at 24 weeks and in 85% at 36 weeks. Similar results were obtained with incremental time abstinent from opioids as an outcome and with use of the societal perspective. Results of Sensitivity Analysis: The base-case results were sensitive to the cost of the 2 treatments and the success of randomized treatment initiation. Limitation: Relatively short follow-up for a chronic condition, substantial missing data, no information on patient out-of-pocket and social service costs. Conclusion: Buprenorphine-naloxone is preferred to extended-release naltrexone as first-line treatment when both options are clinically appropriate and patients require detoxification before initiating extended-release naltrexone. Primary Funding Source: National Institute on Drug Abuse, National Institutes of Health.

Unit Costs of Delinquent Acts for Use in Economic Evaluations.

BACKGROUND: Youth mental health interventions aimed at reducing substance use and delinquency in adolescents compete with other types of interventions for reimbursement from public funding. Within the youth mental health domain, delinquent acts impose high costs on society. These costs should be included in economic evaluations conducted from a societal perspective. Although the relevance of these costs is recognized, they are often left out because the unit costs of delinquent acts are unknown. AIMS OF THE STUDY: This study aims to provide a method for estimating the unit costs per perpetrator of 14 delinquent acts common in the Netherlands and included in self reported delinquency questionnaires: robbery/theft with violence, simple theft/pickpocketing, receiving stolen goods, destruction/vandalism of private or public property, disorderly conduct/discrimination, arson, cybercrime, simple and aggravated assault, threat, forced sexual contact, unauthorised driving, driving under the influence, dealing in soft drugs, and dealing in hard drugs. METHODS: Information on government expenditures and the incidence of crimes, number of perpetrators, and the percentage of solved and reported crimes was obtained from the national database on crime and justice of the Research and Documentation Centre of the Ministry of Justice and Security, Statistics Netherlands, and the Council for the Judiciary in the Netherlands. We applied a top-down micro costing approach to calculate the point estimate of the unit costs for each of the delinquent acts and, subsequently, estimated the mean (SD) unit costs for each of the delinquent acts by taking random draws from a triangular distribution while taking into account a 10% uncertainty associated with the associated point estimate. RESULTS: The mean (SD) unit costs per delinquent act per perpetrator ranged between EUR495 (EUR1.30) for "Driving under the influence" and EUR33,813 (EUR78.30) for a "Cybercrime". These unit costs may be considered as outliers as most unit costs ranged between EUR 2,600 and EUR 13,500 per delinquent act per perpetrator. DISCUSSION: This study is the first to estimate the unit costs per delinquent act per perpetrator in the Netherlands. The results of this study enable the inclusion of government expenditures associated with crime and justice in economic evaluations conducted from a societal perspective. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Youth mental health interventions aimed at reducing substance use and delinquency in adolescents are increasingly subjected to economic evaluations. These evaluations are used to inform decisions concerning the allocation of scarce healthcare resources and should cover all the costs and benefits for society, including those associated with delinquent acts. IMPLICATIONS FOR HEALTH POLICIES: The results of this study facilitate economic evaluations of youth mental health interventions aimed at reducing substance use and delinquency in adolescents, conducted from a societal perspective. IMPLICATIONS FOR FURTHER RESEARCH: Based on health-economic evaluations conducted in the field of youth mental health and the results of the current study, we recommend including the estimated unit costs in guidelines for health-economic evaluations conducted from a societal perspective. Future research could aim at examining whether these unit costs require regular updating. The methodology applied in this study allows for this.

Implementation of a nationwide health economic consultation service to assist substance use researchers: Lessons learned.

BACKGROUND: Health economic evaluation findings assist stakeholders in improving the quality, availability, scalability, and sustainability of evidence-based services, and in maximizing the efficiency of service delivery. The Center for Health Economics of Treatment Interventions for Substance Use Disorders, HCV, and HIV (CHERISH) is a NIDA-funded multi-institutional center of excellence whose mission is to develop and disseminate health-economic research on healthcare utilization, health outcomes, and health-related behaviors that informs substance use disorder treatment policy, and HCV and HIV care of people who use substances. METHODS: We designed a consultation service that is free to researchers whose work aligns with CHERISH's mission. The service includes up to six hours of consulting time. After prospective consultees submit their request online, they receive a screening call from the consultation service director, who connects them with a consultant with relevant expertise. Consultees and consultants complete web-based evaluations following the consultation; consultees also complete a six-month follow-up. We report on the status of the service from its inception in July 2015 through June 2017. RESULTS: We have received 28 consultation requests (54% Early Stage Investigators, 57% MD or equivalent, 28% PhD, 61% women) on projects typically related to planning a study or grant application (93%); 71% were HIV/AIDS-related. Leading topics included cost-effectiveness (43%), statistical-analysis/econometrics (36%), cost (32%), cost-benefit (21%), and quality-of-life (18%). All consultees were satisfied with their overall experience, and felt that consultation expectations and objectives were clearly defined and the consultant's expertise was matched appropriately with their needs. Results were similar for consultants, who spent a median of 3 hours on consultations. CONCLUSIONS: There is a need for health-economic methodological guidance among substance use, HCV, and HIV researchers. Lessons learned pertain to the feasibility of service provision, the need to implement systems to measure and improve service value, and strategies for service promotion.

Surgical versus Medical Treatment of Ocular Surface Squamous Neoplasia: A Cost Comparison.

PURPOSE: The objective of this study was to compare the cost associated with surgical versus interferon-alpha 2b (IFNα2b) treatment for ocular surface squamous neoplasia (OSSN). DESIGN: A matched, case-control study. PARTICIPANTS: A total of 98 patients with OSSN, 49 of whom were treated surgically and 49 of whom were treated medically. METHODS: Patients with OSSN treated with IFNα2b were matched to patients treated with surgery on the basis of age and date of treatment initiation. Financial cost to the patient was calculated using 2 different methods (hospital billing and Medicare allowable charges) and compared between the 2 groups. These fees included physician fees (clinic, pathology, anesthesia, and surgery), facility fees (clinic, pathology, and operating room), and medication costs. Time invested by patients was calculated in terms of number of visits to the hospital and compared between the 2 groups. Parking costs, transportation, caregiver wages, and lost wages were not considered in our analysis. MAIN OUTCOME MEASURES: Number of clinic visits and cost of therapy as represented by both hospital charges and Medicare allowable charges. RESULTS: When considering cost in terms of time, the medical group had an average of 2 more visits over 1 year compared with the surgical group. Cost as represented by hospital charges was higher in the surgical group (mean, $17 598; standard deviation [SD], $7624) when compared with the IFNα2b group (mean, $4986; SD, $2040). However, cost between the 2 groups was comparable when calculated on the basis of Medicare allowable charges (surgical group: mean, $3528; SD, $1610; medical group: mean, $2831; SD, $1082; P = 1.00). The highest cost in the surgical group was the excisional biopsy (hospital billing $17 598; Medicare allowable $3528), and the highest cost in the medical group was interferon ($1172 for drops, average 8.0 bottles; $370 for injections, average 5.4 injections). CONCLUSIONS: Our data in this group of patients previously demonstrated equal efficacy of surgical versus medical treatment. In this article, we consider costs of therapy and found that medical treatment involved two more office visits, whereas surgical treatment could be more or equally costly depending on insurance coverage.

The economic burden of disease by industry: Differences in quality-adjusted life years and associated costs.

BACKGROUND: This study compares differences in quality-adjusted life expectancy across the eight original National Occupational Research Agenda (NORA) industry sectors. METHODS: Data from the 1997 to 2012 National Health Interview Survey (NHIS) were used to estimate quality-adjusted life years (QALYs) for all workers and by NORA sector. Differences in QALYs were calculated and translated into economic values using estimates of the societal willingness-to-pay per QALY. RESULTS: Mean QALYs across workers was 29.17 years. Among NORA sectors, wholesale, and retail trade workers had the highest average QALYs remaining (35.88), while mining workers had the lowest QALYs (31.4). The economic value of this difference ranges from $604,843 to $1,155,287 per worker depending on the societal willingness-to-pay per QALY. CONCLUSION: The value of life lost within some industries is very high relative to others. Additional investments in occupational safety, benefits, and health promotion initiatives may reduce these losses, but experimental research is needed to assess the effectiveness of such programs.

Opportunity costs and financial incentives for Hispanic youth participating in a family-based HIV and substance use preventive intervention.

This paper presents results from a pilot study of the synergies between the opportunity costs incurred by research participants, participant compensation, and program attendance in a family-based substance use and HIV preventive intervention for Hispanic adolescents in Miami-Dade County, Florida. To estimate parent/caretaker cost per session and cost for the duration of the intervention, we administered the Caretaker Drug Abuse Treatment Cost Analysis Program to a random sample of 34 families who participated in a recent clinical trial of Familias Unidas. The total opportunity cost per parent/caretaker was under $40 per group session, under $30 per family session, and just over $570 for the duration of the intervention. Participants were compensated between $40 and $50 per session and attended more than 79% of family and group sessions. Parents and caretakers incurred a cost of approximately $30-40 per intervention session for which they were adequately compensated. Attendance was very good overall for this group (>79%) and significantly higher than attendance in a comparable uncompensated study group from another recent Familias Unidas trial that targeted similar youth. Findings suggest that incentives should be considered important for future implementations of Familias Unidas and similar family-based interventions that target minority and low-SES populations.

Economic Costs of a Postrelease Intervention for Incarcerated Female Substance Abusers: Recovery Management Checkups for Women Offenders (RMC-WO).

This study estimates the economic costs of Recovery Management Checkups for Women Offenders (RMC-WO), highlighting the unique mix of services and differential costs between two distinct phases of the intervention. Participants were randomly assigned to quarterly outcome monitoring (OM) only (n=242) or OM plus Recovery Management Checkups (OM-plus-RMC) (n=238). The OM-only condition has a total annual economic cost of $76,010, which equates to $81 quarterly per person. The average cost per OM interview completed is $86. OM-plus-RMC generates a total annual economic cost of $126,717, or $137 quarterly per person. The cost per interview completed is $147 and the cost per intervention session completed is $161. RMC-WO has a relatively modest additional cost compared with the average costs of post-release supervision, which can range from $3.42 ($1,250) per day (year) for probationers to $7.47 ($2,750) per day (year) for parolees. The clinical, economic, and policy implications of incorporating RMC-WO into existing corrections and/or community-based treatment settings are discussed.

Start-Up and Implementation Costs for the Trust Based Relational Intervention.

Capturing costs associated with prevention activities related to substance use disorders (SUD) and mental health (MH) is critical. In this study, Trust Based Relational Intervention (TBRI®), an attachment-based, trauma-informed intervention, is conceptualized as a preventive intervention to reduce substance and opioid use among youth involved with the legal system. When implemented alongside community reentry, TBRI leverages family systems as youth transition from secure residential care into communities through emotional guidance and role modeling. Activity-based cost (ABC) analysis was used to guide cost data collection and analysis for both start-up and implementation of the TBRI intervention. Start-up costs were estimated using data across eight sites during their start-up phase. All components, activities, personnel involved, and time associated with implementation of TBRI sessions according to protocol were defined. National wages were extracted from O*NET and utilized to calculate total costs for each TBRI component. Total and average TBRI intervention costs were calculated with a breakdown by TBRI sessions and number of staff and participants. A sensitivity analysis was conducted to estimate TBRI implementation costs with travel. The total cost for the TBRI intervention, representing 42 sessions, ranges from $6,927, without travel expenses or $12,298, with travel expenses. The average per family cost ranges from $1,385 (without travel) to $2,460 (with travel). Costs are primarily generated by time investments from primary interventionists. The sensitivity analysis shows costs for responsive coaching would double with travel costs included. Results aim to show that using ABC for prevention activities, like TBRI, to understand cost drivers can facilitate future intervention sustainability.Clinical Trail.gov ID: NCT04678960.

The 2023 Addiction Health Services Research Conference: Back in Person and Taking a Bite of the Big Apple.

The Addiction Health Services Research (AHSR) Conference has been held since 2002. This Conference brings together researchers, graduate students, policymakers, and treatment providers to focus improving the organization, distribution, and financing of healthcare resources for prevention/care of SUD. The AHSR 2023 Conference took place in New York City, October 18-20th, and was hosted by the Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV (CHERISH; cherishresearch.org). Attended by more than 300 participants, the Conference comprised several themes relating to the latest research on addiction health services delivery, financing, and impact. The agenda also included pre-conference workshops, distinguished plenary speakers, a multitude of networking opportunities, and career support for early-stage and minority investigators. AHSR 2023 featured 3 plenary sessions, 120 oral presentations, and 143 poster presentations from academics throughout the world. Overall, AHSR 2023 provided numerous opportunities to advance the field of addiction health services research. The state-of-the-art techniques and insights gained by attending scholars will position them to be change-agents in the addiction field going forward.

Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV, HCV and overdose risk in rural Appalachia.

INTRODUCTION: Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia. METHODS AND ANALYSIS: KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness. ETHICS AND DISSEMINATION: The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings. TRIAL REGISTRATION NUMBER: NCT05657106.

Cost of start-up activities to implement a community-level opioid overdose reduction intervention in the HEALing Communities Study.

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.

Economic benefits of substance use disorder treatment: A systematic literature review of economic evaluation studies from 2003 to 2021.

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.

Budget impact tool for the incorporation of medications for opioid use disorder into jail/prison facilities.

BACKGROUND: Given the personal and public consequences of untreated/undertreated OUD among persons involved in the justice system, an increasing number of jails and prisons are incorporating medication for opioid use disorder (MOUD) into their system. Estimating the costs of implementing and sustaining a particular MOUD program is vital to detention facilities, which typically face modest, fixed health care budgets. We developed a customizable budget impact tool to estimate the implementation and sustainment costs of numerous MOUD delivery models for detention facilities. METHODS: The aim is to describe the tool and present an application of a hypothetical MOUD model. The tool is populated with resources required to implement and sustain various MOUD models in detention facilities. We identified resources via micro-costing techniques alongside randomized clinical trials. The resource-costing method is used to assign values to resources. Resources/costs are categorized as (a) fixed, (b) time-dependent, and (c) variable. Implementation costs include (a), (b), and (c) over a specified timeframe. Sustainment costs include (b) and (c). The MOUD model example entails offering all three FDA-approved medications, with methadone and buprenorphine provided by vendors, and naltrexone by the jail/prison facility. RESULTS: Fixed resources/costs are incurred only once, including accreditation fees and trainings. Time-dependent resources/costs are recurring, but fixed over a given time-period; e.g., medication delivery and staff meetings. Variable resources/costs are those that are a direct function of the number of persons treated, such as the medication provided to each patient. Using nationally representative prices, we estimated fixed/sustainment costs to be $2919/patient, over 1 year. This article estimates annual sustainment costs to be $2885/patient. CONCLUSION: The tool will serve as a valuable asset to jail/prison leadership, policymakers, and other stakeholders interested in identifying/estimating the resources and costs associated with alternative MOUD delivery models, from the planning stages through sustainment.

Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs.

BACKGROUND: The resurgence of HIV outbreaks and rising prevalence among people who inject drugs (PWID) remain exigent obstacles to Ending the HIV Epidemic in the USA. Adapting a low threshold, comprehensive treatment model for PWID with HIV can leverage syringe services programs (SSPs) to increase availability and accessibility of antiretrovirals (ART), medications for opioid use disorder (MOUD), and hepatitis C cure. We developed Tele-Harm Reduction, a telehealth-enhanced, harm reduction intervention delivered within an SSP venue. METHODS: The T-SHARP trial is an open-label, multi-site, randomized controlled superiority trial with two parallel treatment arms. Participants (n=240) recruited from SSPs in Miami, Ft. Lauderdale, and Tampa, Florida, who are PWID with uncontrolled HIV (i.e., HIV RNA>200) will be randomized to Tele-Harm Reduction or off-site linkage to HIV care. The primary objective is to compare the efficacy of Tele-Harm Reduction for initiation of ART at SSPs vs. off-site linkage to an HIV clinic with respect to viral suppression across follow-up (suppression at 3, 6, and 12 months post randomization). Participants with HIV RNA<200 copies/ml will be considered virally suppressed. The primary trial outcome is time-averaged HIV viral suppression (HIV RNA <200 copies/ml) over 3-, 6-, and 12-month follow-up. Secondary outcomes include initiation of MOUD measured by urine drug screen and HCV cure, defined as achieving 12-week sustained virologic response (negative HCV RNA at 12 weeks post treatment completion). A cost-effectiveness analysis will be performed. DISCUSSION: The T-SHARP Trial will be the first to our knowledge to test the efficacy of an innovative telehealth intervention with PWID with uncontrolled HIV delivered via an SSP to support HIV viral suppression. Tele-Harm Reduction is further facilitated by a peer to support adherence and bridge the digital divide. This innovative, flipped healthcare model sets aside the traditional healthcare system, reduces multi-level barriers to care, and meets PWID where they are. The T-SHARP trial is a pragmatic clinical trial that seeks to transform the way that PWID access HIV care and improve HIV clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05208697. Trial registry name: Tele-Harm Reduction. Registration date: January 26, 2022.