Reducing perceived barriers to scaling up overdose education and naloxone distribution and medications for opioid use disorder in the United States in the HEALing (Helping End Addiction Long-Term®) communities study.

BACKGROUND: Scaling up overdose education and naloxone distribution (OEND) and medications for opioid use disorder (MOUD) is needed to reduce opioid overdose deaths, but barriers are pervasive. This study examines whether the Communities That HEAL (CTH) intervention reduced perceived barriers to expanding OEND and MOUD in healthcare/behavioral health, criminal-legal, and other/non-traditional venues. METHODS: The HEALing (Helping End Addiction Long-Term®) Communities Study is a parallel, wait-list, cluster randomized trial testing the CTH intervention in 67 communities in the United States. Surveys administered to coalition members and key stakeholders measured the magnitude of perceived barriers to scaling up OEND and MOUD in November 2019-January 2020, May-June 2021, and May-June 2022. Multilevel linear mixed models compared Wave 1 (intervention) and Wave 2 (wait-list control) respondents. Interactions by rural/urban status and research site were tested. RESULTS: Wave 1 respondents reported significantly greater reductions in mean scores for three outcomes: perceived barriers to scaling up OEND in Healthcare/Behavioral Health Venues (-0.26, 95% confidence interval, CI: -0.48, -0.05, p = 0.015), OEND in Other/Non-traditional Venues (-0.53, 95% CI: - 0.84, -0.22, p = 0.001) and MOUD in Other/Non-traditional Venues (-0.34, 95% CI: -0.62, -0.05, p = 0.020). There were significant interactions by research site for perceived barriers to scaling up OEND and MOUD in Criminal-Legal Venues. There were no significant interactions by rural/urban status. DISCUSSION: The CTH Intervention reduced perceived barriers to scaling up OEND and MOUD in certain venues, with no difference in effectiveness between rural and urban communities. More research is needed to understand facilitators and barriers in different venues.

Examining changes in pain interference via pandemic-induced isolation among patients receiving medication for opioid use disorder: a secondary data analysis.

BACKGROUND: Early in the pandemic, the United States population experienced a sharp rise in the prevalence rates of opioid use, social isolation, and pain interference. Given the high rates of pain reported by patients on medication for opioid use disorder (MOUD), the pandemic presented a unique opportunity to disentangle the relationship between opioid use, pain, and social isolation in this high-risk population. We tested the hypothesis that pandemic-induced isolation would partially mediate change in pain interference levels experienced by patients on MOUD, even when controlling for baseline opioid use. Such work can inform the development of targeted interventions for a vulnerable, underserved population. METHODS: Analyses used data from a cluster randomized trial (N = 188) of patients on MOUD across eight opioid treatment programs. As part of the parent trial, participants provided pre-pandemic data on pain interference, opioid use, and socio-demographic variables. Research staff re-contacted participants between May and June 2020 and 133 participants (71% response rate) consented to complete a supplemental survey that assessed pandemic-induced isolation. Participants then completed a follow-up interview during the pandemic that again assessed pain interference and opioid use. A path model assessed whether pre-pandemic pain interference had an indirect effect on pain interference during the pandemic via pandemic-induced isolation. RESULTS: Consistent with hypotheses, we found evidence that pandemic-induced isolation partially mediated change in pain interference levels among MOUD patients during the pandemic. Higher levels of pre-pandemic pain interference and opioid use were both significantly associated with higher levels of pandemic-induced isolation. In addition, pre-pandemic pain interference was significantly related to levels of pain interference during the pandemic, and these pain levels were partially explained by the level of pandemic-induced isolation reported. CONCLUSIONS: Patients on MOUD with higher use of opioids and higher rates of pain pre-pandemic were more likely to report feeling isolated during COVID-related social distancing and this, in turn, partially explained changes in levels of pain interference. These results highlight social isolation as a key risk factor for patients on MOUD and suggest that interventions promoting social connection could be associated with reduced pain interference, which in turn could improve patient quality of life. TRIAL REGISTRATION: NCT03931174 (Registered 04/30/2019).

Effective, but underused: lessons learned implementing contingency management in real-world practice settings in the United States.

Despite being one of the most effective adjunctive behavioral interventions in combination with medication for opioid use disorder, contingency management (CM) is one of the least available interventions in opioid treatment programs. This paradoxical state of affairs is perhaps the greatest example of the research-to-practice gap in the behavioral health field. Implementation science, a discipline that aims to identify replicable methods that can be used across settings and populations to bridge the gap between research and practice, can potentially help. Based on our team's experience implementing CM in opioid treatment programs, we detail five key lessons for researchers, clinicians, policy makers, and others seeking to implement and sustain CM in real-world settings. First, multiple barriers to CM implementation exist at both the counselor- and organization-levels, requiring multi-level solutions. Second, one-shot CM training alone is not sufficient for successful implementation: ongoing support is essential to achieve levels of intervention fidelity that will benefit patients. Third, assessing an organization's capacity for implementation prior to support provision can prevent costly mistakes. Fourth, implementors should plan for high staff turnover rates and expect the unexpected by developing detailed contingency plans. Finally, implementors should remember that the goal is to implement evidence-based CM and not simply incentives. We encourage colleagues to consider these lessons to increase the likelihood that CM can be implemented and sustained in a manner that improves the quality of care in opioid treatment programs.

The Prevalence and Negative Impacts of Substance Use Disorders among People with HIV in the United States: A Real-Time Delphi Survey of Key Stakeholders.

Although HIV and substance use disorders (SUDs) constitute a health syndemic, no research to date has examined the perceived negative impacts of different SUDs for people with HIV (PWH). In May 2019, 643 stakeholders in the U.S., representing clients of AIDS service organizations (ASOs), ASO staff, and HIV/AIDS Planning Council members, participated in an innovative Stakeholder-Engaged Real-Time Delphi (SE-RTD) survey focused on the prevalence and individual-level negative impact of five SUDs for PWH. The SE-RTD method has advantages over conventional survey methods by efficiently sharing information, thereby reducing the likelihood that between-group differences are simply due to lack of information, knowledge, and/or understanding. The population-level negative impacts were calculated by weighting each SUD's individual-level negative impact on indicators of the HIV Care Continuum and other important areas of life by the perceived prevalence of each SUD. Overall, we found these SUDs to have the greatest population-level negative impact scores (possible range 0-24): alcohol use disorder (population-level negative impact = 6.9; perceived prevalence = 41.9%), methamphetamine use disorder (population-level negative impact = 6.5; perceived prevalence = 3.2%), and opioid use disorder (population-level negative impact = 6.4; perceived prevalence = 34.6%). Beyond further demonstration of the need to better integrate SUD services within HIV settings, our findings may help inform how finite funding is allocated for addressing the HIV-SUD syndemic within the U.S. Based on our findings, such future efforts should prioritize the integration of evidence-based treatments that help address use disorders for alcohol, methamphetamine, and opioids.

Identifying Implementation Strategies That Address Barriers and Facilitate Implementation of Digital Interventions in HIV Primary Care Settings: Results from the Pilot Implementation of Positive Health Check.

We used the 1-month pilot implementation of Positive Health Check, a brief web-based video counseling intervention that supports patients with HIV attending HIV primary care clinics, to exemplify how studying implementation strategies earlier in the evidence-generation process can improve implementation outcomes in later pragmatic trials. We identified how implementation strategies were operationalized and the barriers and facilitators these strategies addressed using multiple data sources, including adapted implementation procedures and weekly structured interviews conducted with 9 key stakeholders in 4 HIV primary care clinics. Nineteen of 73 discrete implementation strategies for clinical innovations were used in the pilot implementation of Positive Health Check. Clinic staff reported 17 barriers and facilitators related to the clinic environment, patient population, intervention characteristics, and training and technical assistance. Identifying the link between strategies, barriers, and facilitators helped plan for a subsequent larger multisite pragmatic trial.

Overdose Education and Naloxone Distribution Within Syringe Service Programs - United States, 2019.

Syringe service programs (SSPs), which provide access to sterile syringes and other injection equipment and their safe disposal after use,* represent a highly successful human immunodeficiency virus (HIV) prevention intervention. SSPs are associated with a 58% reduction in the incidence of HIV infection among persons who inject drugs (1). In addition, SSPs have led efforts to prevent opioid overdose deaths by integrating evidence-based opioid overdose education and naloxone distribution (OEND) programs (2-4). OEND programs train laypersons to respond during overdose events and provide access to naloxone and directions for drug delivery (2-4). SSPs are ideal places for OEND because they provide culturally relevant services designed to reach persons at high risk for experiencing or observing an opioid overdose. A 2013 survey found that only 55% of SSPs in the United States had implemented OEND (5). To characterize current implementation of OEND among SSPs, and to describe the current reach (i.e., the ratio of persons who received naloxone per opioid overdose death and the ratio of naloxone doses distributed per opioid overdose death) of SSP-based OEND programs by U.S. Census division,† a survey of known U.S. SSPs was conducted in 2019, which found that 94% of SSPs had implemented OEND. In addition, the reach of SSP-based OEND programs varied by U.S. Census division. Scaling up of SSP-based OEND delivery programs could be a critical component for areas of the country with high opioid overdose death rates and low reach.

User-centered design of contingency management for implementation in opioid treatment programs: a qualitative study.

BACKGROUND: Contingency management (CM) is one of the only behavioral interventions shown to be effective for the treatment of opioid use disorders when delivered alone and in combination with pharmacotherapy. Despite extensive empirical support, uptake of CM in community settings remains abysmally low. The current study applied user-centered design principles to gather qualitative data on familiarity with CM, current clinical practice, and preferences regarding the implementation of CM in community-based opioid treatment programs. METHODS: Participants were 21 leaders and 22 front-line counselors from 11 community-based opioid treatment programs. Semi-structured interviews were about 45 min long. Transcripts from each interview were coded by independent raters and analyzed using a reflexive team approach. Frequencies of responses were tallied, and queries were run in NVivo to identify exemplar quotes for each code. RESULTS: Results indicated low familiarity with CM, with less than half of the respondents defining CM correctly and over 40% of respondents declining to answer/ did not know. Abstinence was the most commonly recommended CM target, yet over 70% of respondents indicated that urine screens only occurred monthly. Attendance was also a popular recommendation, with respondents suggesting a range of possible indices including counseling, dosing, and/or case management sessions. Regarding the ideal role to administer CM prizes, program directors and supervisors were most commonly recommended, closely followed by front-line counselors. The most commonly suggested strategies to afford CM incentives included soliciting community donations and offering non-financial incentives. CONCLUSIONS: User design principles to understand workflow constraints, target user needs, and simplify the intervention guided this qualitative investigation of CM implementation in opioid treatment programs. Findings highlighted the potential value of flexible, organization-specific definitions of CM attendance and non-financial incentives, as well as active involvement of clinical leaders and supervisors to promote buy in among staff/patients. Respondents were generally optimistic about their ability to fundraise or solicit donations to overcome cost-related barriers of CM. Implications for CM implementation strategies, including the use of targeted leadership coaching focused on sustainability, are explored.

Program Capacity to Eliminate Outcome Disparities in Addiction Health Services.

We evaluated program capacity factors associated with client outcomes in publicly funded substance abuse treatment organizations in one of the most populous and diverse regions of the United States. Using multilevel cross-sectional analyses of program data (n = 97) merged with client data from 2010 to 2011 for adults (n = 8,599), we examined the relationships between program capacity (leadership, readiness for change, and Medi-Cal payment acceptance) and client wait time and treatment duration. Acceptance of Medi-Cal was associated with shorter wait times, whereas organizational readiness for change was positively related to treatment duration. Staff attributes were negatively related to treatment duration. Overall, compared to low program capacity, high program capacity was negatively associated with wait time and positively related to treatment duration. In conclusion, program capacity, an organizational indicator of performance, plays a significant role in access to and duration of treatment. Implications for health care reform implementation in relation to expansion of public health insurance and capacity building to promote health equities are discussed.

A Behaviorally-Anchored Rating System to Monitor Treatment Integrity for Community Clinicians Using the Adolescent Community Reinforcement Approach.

This study evaluated a process for training raters to reliably rate clinicians delivering the Adolescent Community Reinforcement Approach (A-CRA) in a national dissemination project. The unique A-CRA coding system uses specific behavioral anchors throughout its 73 procedure components. Five randomly-selected raters each rated "passing" and "not passing" examples of the 19 A-CRA procedures. Ninety-four percent of the final ICCs were at least 'good' (≥.60) and 66.7% were 'excellent' (≥.75), and 95% of the ratings exceeded the 60% or better agreement threshold between raters and the gold standard. Raters can be trained to provide reliable A-CRA feedback for large-scale dissemination projects.

Organize and mobilize for implementation effectiveness to improve overdose education and naloxone distribution from syringe services programs: a randomized controlled trial.

BACKGROUND: The United States (US) continues to face decades-long increases in opioid overdose fatalities. As an opioid overdose reversal medication, naloxone can dramatically reduce opioid overdose mortality rates when distributed to people likely to experience or witness an opioid overdose and packaged with education on its use, known as overdose education and naloxone distribution (OEND). Syringe services programs (SSPs) are ideal venues for OEND with staff who are culturally competent in providing services for people who are at risk of experiencing or observing an opioid overdose. We carried out a randomized controlled trial of SSPs to understand the effectiveness of the organize and mobilize for implementation effectiveness (OMIE) approach at improving OEND implementation effectiveness within SSPs. METHODS: Using simple randomization, 105 SSPs were enrolled into the trial and assigned to one of two study arms - (1) dissemination of OEND best practice recommendations (Control SSPs) or the OMIE approach along with dissemination of the OEND best practice recommendations (i.e., OMIE SSPs). OMIE SSPs could participate in 60-min OMIE sessions once a month for up to 12 months. At 12-month post-baseline, 102 of 105 SSPs (97%) responded to the follow-up survey. RESULTS: The median number of sessions completed by OMIE SSPs was 10. Comparing OMIE SSPs to control SSPs, we observed significant increases in the number of participants receiving naloxone (incidence rate ratio: 2.15; 95% CI: 1.42, 3.25; p < 0.01) and the rate of naloxone doses distributed per SSP participant (adjusted incidence rate ratio: 1.97; 95% CI: 1.18, 3.30; p = 0.01). We observed no statistically significant difference in the number of adopted best practices between conditions (difference in means 0.2, 95% CI: - 0.7, 1.0; p = 0.68). We also observed a threshold effect where SSPs receiving a higher OMIE dose had greater effect sizes with regard to the number of people given naloxone and the number of naloxone doses distributed. CONCLUSIONS: In conclusion, the multifaceted OMIE approach was effective at increasing naloxone distribution from SSPs, despite substantial external shocks during the trial. These findings have major implications for addressing the overdose crisis, which has continued unabated for decades. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03924505 . Registered 19 April 2019.

Testing the incremental effectiveness of pay-for-performance to improve implementation of a motivational interviewing brief intervention for substance use disorders in HIV settings: Results of a parallel cluster-randomized type 3 hybrid trial.

Background: Substance use disorders (SUDs) have a serious adverse impact on the physical and mental well-being of people with HIV. Previously, using a 39-site dual-randomized type 2 hybrid trial design, findings from the Substance Abuse Treatment to HIV Care Project supported the Implementation and Sustainment Facilitation (ISF) strategy to improve implementation and effectiveness of a motivational interviewing brief intervention (MIBI) for SUD within HIV service settings across the United States (US). Building on this trial, this parallel cluster-randomized type 3 hybrid trial aimed to test the incremental effectiveness of a pay-for-performance (P4P), a form of the "alter incentive/allowance structures" strategy. Methods: Twenty-six HIV service organizations, their staff participants (N=87), and their client participants (N=341) were cluster-randomized to one of two implementation conditions. The control condition included staff-focused training, feedback, and consultation (TFC) and team-focused implementation and sustainment (ISF). The experimental condition included TFC+ISF as well as P4P (TFC+ISF+P4P). P4P used financial incentives to reward MIBI implementation (US$10 per MIBI delivered) and MIBI implementation at or above a pre-defined level of quality (US$10 per demonstration). In addition to these outcomes, past 4-week changes/reductions in client participant's days of primary substance use and anxiety symptoms were examined. Results: The addition of P4P had a large and significant effect on the number of MIBIs implemented (d=1.30, p<.05) and reduction in anxiety (d=-1.54), but there was no impact on days of substance use. P4P had large effects on MIBI quality (d=1.24) and MIBI implementation effectiveness (d=1.28), but these were not significant (p<.10). Conclusions: P4P is a form of the "alter incentive/allowance structures" strategy. Its function is to reward the implementation of a clinical innovation. Rewarding implementation is consistent with the theory of implementation effectiveness, which suggests implementation climate (i.e., the extent to which implementation is expected, supported, and rewarded) is a key antecedent of implementation effectiveness (i.e., the consistency and quality of implementation). We found that P4P had a significant, positive impact on MIBI implementation in HIV service settings, but client-level outcomes were mixed. Future research should examine the effectiveness of the P4P strategy to improve implementation and sustainment of other evidence-based innovations. Trial registration: ClinicalTrials.gov: NCT04687917. Registered 12/18/2020.

Examining Changes in Pain Interference via Pandemic-Induced Isolation Among Patients Receiving Medication for Opioid Use Disorder: A Secondary Data Analysis.

Background: Early in the pandemic, the United States population experienced a sharp rise in the prevalence rates of opioid use, social isolation, and pain interference. Given the high rates of pain reported by patients on medication for opioid use disorder (MOUD), the pandemic presented a unique opportunity to disentangle the relationship between opioid use, pain, and social isolation in this high-risk population. We tested the hypothesis that pandemic-induced isolation would partially mediate change in pain interference levels experienced by patients on MOUD, even when controlling for baseline opioid use. Such work can inform the development of targeted interventions for a vulnerable, underserved population. Methods: Analyses used data from a cluster randomized trial (N = 188) of patients on MOUD across eight opioid treatment programs. As part of the parent trial, participants provided pre-pandemic data on pain interference, opioid use, and socio-demographic variables. Research staff re-contacted participants between May and June 2020 and 133 participants (71% response rate) consented to complete a supplemental survey that assessed pandemic-induced isolation. Participants then completed a follow-up interview during the pandemic that again assessed pain interference and opioid use. A path model assessed whether pre-pandemic pain interference had an indirect effect on pain interference during the pandemic via pandemic-induced isolation. Results: Consistent with hypotheses, we found evidence that pandemic-induced isolation partially mediated change in pain interference levels among MOUD patients during the pandemic. Higher levels of pre-pandemic pain interference and opioid use were both significantly associated with higher levels of pandemic-induced isolation. In addition, pre-pandemic pain interference was significantly related to levels of pain interference during the pandemic, and these pain levels were partially explained by the level of pandemic-induced isolation reported. Conclusions: Patients on MOUD with higher use of opioids and higher rates of pain pre-pandemic were more likely to report feeling isolated during COVID-related social distancing and this, in turn, partially explained changes in levels of pain interference. These results highlight social isolation as a key risk factor for patients on MOUD and suggest that interventions promoting social connection could be associated with reduced pain interference, which in turn could improve patient quality of life.

Early COVID-Related pandemic impacts and subsequent opioid outcomes among persons receiving medication for opioid use disorder: a secondary data analysis of a Type-3 hybrid trial.

BACKGROUND: Opioid overdoses have continued to increase since the start of the COVID-19 pandemic. The pathways through which the COVID-19 pandemic has affected trajectories of opioid use and opioid-related problems are largely unknown. Using the Epidemic-Pandemic Impacts Inventory (EPII), a novel instrument that assess pandemic-related impacts across multiple life domains, we tested the hypothesis that COVID-related impacts (on e.g., interpersonal conflict, employment, infection exposure, and emotional health) experienced in the early months of the pandemic would predict changes in opioid use and opioid-related problems at follow-up. METHODS: This analysis was embedded within a cluster randomized type 3 implementation-effectiveness hybrid trial that had enrolled 188 patients across eight opioid treatments prior to the start of the pandemic. Participants had all been recently inducted on medication for opioid use disorder and were actively receiving treatment. Participants reported on their opioid use and opioid-related problems at baseline and 3-, 6-, and 9-month post-baseline assessments. Between May and August 2020, participants were sent an optional invitation to complete the EPII. RESULTS: One hundred thirty-three respondents completed the EPII and 129 had sufficient data to analyze the EPII and at least one subsequent follow-up. In logistic and zero-inflated negative binomial analyses adjusting for covariates, each endorsed pandemic impact in the interpersonal conflict domain was associated with 67% increased odds of endorsement of any opioid use, and each impact in the employment and infection exposure-domains was associated with 25% and 75% increases in number of endorsed opioid-related problems, respectively. CONCLUSIONS: Mitigating the effect of the pandemic on patients' interpersonal relationships and employment, and promoting greater infection control in opioid treatment programs, could be protective against negative opioid-related outcomes. Trial registration The present study describes secondary data analysis on a previously registered clinical trial: clinicaltrials.gov/ct2/show/NCT03931174.

Implementing contingency management for stimulant use in opioid treatment programs: protocol of a type III hybrid effectiveness-stepped-wedge trial.

BACKGROUND: Contingency management (CM) is an evidence-based intervention for stimulant use and is highly effective in combination with medication for opioid use disorder. Yet, uptake of CM in opioid treatment programs that provide medication for opioid use disorder remains low. This paradox in which CM is one of the most effective interventions, yet one of the least available, represents one of the greatest research-to-practice gaps in the addiction health services field. Multi-level implementation strategies are needed to address barriers to CM implementation at both the provider- and organization-level. This type III hybrid effectiveness-implementation trial was funded by the National Institute on Drug Abuse to evaluate whether a multi-level implementation strategy, the Science of Service Laboratory (SSL), can effectively promote CM implementation in opioid treatment programs. Specific aims will test the effectiveness of the SSL on implementation outcomes (primary aim) and patient outcomes (secondary aim), as well as test putative mediators of implementation outcomes (exploratory aim). METHODS: Utilizing a fully powered type III hybrid effectiveness-implementation trial with a stepped wedge design, we propose to randomize a cohort of 10 opioid treatment programs to receive the SSL across four steps. Each step, an additional 2-3 opioid treatment programs will receive the SSL implementation strategy, which has three core components: didactic training, performance feedback, and external facilitation. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on CM delivery and patient outcomes. Staff from each opioid treatment program will provide feedback on contextual determinants influencing implementation at three timepoints. DISCUSSION: Between planning of this protocol and receipt of funding, the landscape for CM in the USA changed dramatically, with multiple Departments of Health launching state-wide CM initiatives. We therefore accelerated the protocol timeline and offered some cursory training resources to all sites as a preparation activity. We also began partnering with multiple Departments of Health to evaluate their rollout of CM using the measures outlined in this protocol. TRIAL REGISTRATION: This study protocol is registered via ClinicalTrials.gov Identifier: NCT05702021. Date of registration: January 27, 2023.

Testing the incremental effectiveness of pay-for-performance to improve implementation of a motivational interviewing brief intervention for substance use disorders in HIV settings: Results of a cluster-randomized type 3 hybrid trial.

Background: Substance use disorders (SUDs) have a serious adverse impact on people living with HIV. Previously, using a 39-site dual-randomized type 2 hybrid trial design, findings from the Substance Abuse Treatment to HIV Care Project supported the Implementation and Sustainment Facilitation (ISF) strategy to improve implementation and effectiveness of a motivational interviewing brief intervention (MIBI) for SUD within HIV service settings across the United States (US). Building on this trial, this cluster-randomized type 3 hybrid trial aimed to test the incremental effectiveness of a pay-for-performance (P4P), a form of the "alter incentive/allowance structures" strategy. Methods: Twenty-six HIV service organizations, their staff participants (N=87), and their client participants (N=341) were cluster-randomized to one of two implementation conditions. The control condition included staff-focused training, feedback, and consultation (TFC) and team-focused implementation and sustainment (ISF). The experimental condition included TFC+ISF as well as P4P (TFC+ISF+P4P). P4P used financial incentives to reward MIBI implementation (US$10 per MIBI delivered) and MIBI implementation at or above a pre-defined level of quality (US$10 per demonstration). In addition to these outcomes, past 4-week changes/reductions in client participant's days of primary substance use and anxiety symptoms were examined. Results: The addition of P4P had a large and significant effect on the number of MIBIs implemented (d=1.30, p<.05) and reduction in anxiety (d=-1.54), but there was no impact on days of substance use. P4P had large effects on MIBI quality (d=1.24) and MIBI implementation effectiveness (d=1.28), but these were not significant (p<.10). Conclusions: P4P is a form of the "alter incentive/allowance structures" strategy Its function is to reward the implementation of a clinical innovation. Rewarding implementation is consistent with the theory of implementation effectiveness, which suggests implementation climate (i.e., the extent to which implementation is expected, supported, and rewarded) is a key antecedent of implementation effectiveness (i.e., the consistency and quality of implementation). We found that P4P had a significant, positive impact on MIBI implementation in HIV service settings, but client-level outcomes were mixed. Future research should examine the cost-effectiveness of this strategy, as well as to examine the effectiveness of P4P to improve the implementation of other evidence-based innovations. Trial registration: ClinicalTrials.gov: NCT04687917. Registered 12/18/2020.

From innovative applications of the effectiveness-implementation hybrid trial design to the dissemination, implementation, effectiveness, sustainment, economics, and level-of-scaling hybrid trial design.

To address the enduring gap between research and practice, there is a need to improve the speed and efficiency of research across the translational research spectrum. In 2012, the effectiveness-implementation hybrid trial design (HTD) was codified as a design with the potential to improve the speed and efficiency of translation, especially as part of T2 (clinical research) translational research. Building on this and other recent efforts to stimulate greater use of this novel HTD, the current article highlights an innovative application of each effectiveness-implementation HTD type. The completed application of the Type 1 effectiveness-implementation HTD tested the effectiveness of a clinical intervention for reducing HIV viral load and retaining people with HIV in care, as well as conducted a longitudinal mixed-methods examination to test for significant changes over time in three key measures of context, and economic evaluation of the clinical intervention. The completed application of the Type 2 effectiveness-implementation HTD used a dual-randomized design to simultaneously test the effectiveness of a clinical intervention for addressing substance use disorder among people with HIV and effectiveness of a blended strategy called the Implementation and Sustainment Facilitation (ISF) Strategy. This Type 2 hybrid trial was also innovative due to its focus on both sustainment and economic outcomes. The innovative Type 3 application (funded in 2008 and completed in 2012) tested the effectiveness and cost-effectiveness of using pay-for-performance to improve both implementation outcomes and client outcomes. This article also codifies a HTD called the Dissemination, Implementation, effectiveness, Sustainment, Economics, and Level-of-scaling (DIeSEL) HTD.

The implementation & sustainment facilitation (ISF) strategy: Cost and cost-effectiveness results from a 39-site cluster randomized trial integrating substance use services in community-based HIV service organizations.

Background: As part of the Substance Abuse Treatment to HIV Care Project, the Implementation & Sustainment Facilitation (ISF) strategy was found to be an effective adjunct to the Addiction Technology Transfer Center (ATTC) strategy for integrating a motivational interviewing-based brief intervention (MIBI) for substance use disorders. This study presents the cost and cost-effectiveness results. Methods: Thirty-nine HIV service organizations were randomized to receive the ATTC-only condition or the ATTC + ISF condition. Two staff from each organization received the ATTC-training. In ATTC + ISF organizations, the same two staff and additional support staff participated in facilitation sessions to support MIBI implementation. We estimated costs using primary data on the time spent in each strategy and the time spent delivering 409 MIBIs to clients. We estimated staff-level cost-effectiveness for the number of MIBIs delivered, average MIBI quality scores, and total client days abstinent per staff. We used sensitivity analyses to test how changes to key variables affect the results. Results: Adjusted per-staff costs were $2,915 for the ATTC strategy and $5,371 for ATTC + ISF, resulting in an incremental cost of $2,457. ATTC + ISF significantly increased the number of MIBIs delivered (3.73) and the average MIBI quality score (61.45), yielding incremental cost effectiveness ratios (ICERs) of $659 and $40. Client days abstinent increased by 59 days per staff with a quality-adjusted life-year ICER of $40,578 (95% confidence interval $29,795-$61,031). Conclusions: From the perspective of federal policymakers, ISF as an adjunct to the ATTC strategy may be cost-effective for improving the integration of MIBIs within HIV service organizations, especially if scaled up to reach more clients. Travel accounted for nearly half of costs, and virtual implementation may further increase value. We also highlight two considerations for cost-effectiveness analysis with hybrid trials: study protocols kept recruitment low and modeling choices affect how we interpret the effects on client-level outcomes.

Persons from racial and ethnic minority groups receiving medication for opioid use disorder experienced increased difficulty accessing harm reduction services during COVID-19.

INTRODUCTION: The COVID-19 pandemic collided with the opioid epidemic and longstanding health inequities to exacerbate the disproportionate harms experienced by persons with opioid use disorder (OUD) who self-identify as from racial and ethnic minority groups. Disrupted access to harm reduction services (e.g., naloxone, sterile syringes, recovery support) is one pathway whereby COVID-19 might exacerbate health disparities. We tested the hypothesis that persons receiving medication for opioid use disorder (MOUD) who self-identify as from racial/ethnic minority groups would experience more disruptions in access to harm reduction services than persons identifying as non-Hispanic White, even when controlling for severity of opioid use and sociodemographics (e.g., education, income, biological sex, age). METHODS: Analyses used data from a cluster randomized trial that had enrolled 188 patients, all of whom had provided baseline data on sociodemographics and severity of opioid use, across eight opioid treatment programs. Data collectors re-contacted participants between May and June 2020 and 133 (71% response rate) agreed to complete a survey about access to harm reduction services. RESULTS: Twenty-six respondents (20%) identified as from racial/ethnic minority groups (predominantly Black, Hispanic, and/or biracial). Between 7% and 27% of respondents reported disrupted access to harm reduction services. Logistic regressions indicated that persons identifying as from racial/ethnic minority groups were 8-10 times more likely than persons identifying as non-Hispanic White to report reduced access to naloxone and sterile syringes (p < .01), even when accounting for potential confounding variables. CONCLUSIONS: This report concludes with a discussion of potential outreach strategies and policies to advance more equitable access to essential harm reduction services.

A Longitudinal Mixed-Methods Examination of Positive Health Check: Implementation Results From a Type 1 Effectiveness-Implementation Hybrid Trial.

BACKGROUND: Positive Health Check is an evidence-based video doctor intervention developed for improving the medication adherence, retention in care, and viral load suppression of people with HIV receiving clinical care. SETTING: Four HIV primary care clinics within the United States. METHODS: As part of a type 1 hybrid trial, a mixed-methods approach was used to longitudinally assess the following 3 key implementation constructs over a 23-month period: innovation-values fit (ie, the extent to which staff perceive innovation use will foster the fulfillment of their values), organizational readiness for change (ie, the extent to which organizational members are psychologically and behaviorally prepared to implement organizational change), and implementation climate (ie, the extent to which implementation is expected, supported, and rewarded). Quantitative mixed-effects regression analyses were conducted to assess changes over time in these constructs. Qualitative analyses were integrated to help provide validation and understanding. RESULTS: Innovation-values fit and organizational readiness for change were found to be high and relatively stable. However, significant curvilinear change over time was found for implementation climate. Based on the qualitative data, implementation climate declined toward the end of implementation because of decreased engagement from clinic champions and differences in priorities between research and clinic staff. CONCLUSIONS: The Positive Health Check intervention was found to fit within HIV primary care service settings, but there were some logistical challenges that needed to be addressed. Additionally, even within the context of an effectiveness trial, significant and nonlinear change in implementation climate should be expected over time.

Virtual Training Is More Cost-Effective Than In-Person Training for Preparing Staff to Implement Contingency Management.

Behavior therapy implementation relies in part on training to foster counselor skills in preparation for delivery with fidelity. Amidst Covid-19, the professional education arena witnessed a rapid shift from in-person to virtual training, yet these modalities' relative utility and expense is unknown. In the context of a cluster-randomized hybrid type 3 trial of contingency management (CM) implementation in opioid treatment programs (OTPs), a multi-cohort design presented rare opportunity to compare cost-effectiveness of virtual vs. in-person training. An initial counselor cohort (n = 26) from eight OTPs attended in-person training, and a subsequent cohort (n = 31) from ten OTPs attended virtual training. Common training elements were the facilitator, learning objectives, and educational strategies/activities. All clinicians submitted a post-training role-play, independently scored with a validated fidelity instrument for which performances were compared against benchmarks representing initial readiness and advanced proficiency. To examine the utility and expense of in-person and virtual trainings, cohort-specific rates for benchmark attainment were computed, and per-clinician expenses were estimated. Adjusted between-cohort differences were estimated via ordinary least squares, and an incremental cost effectiveness ratio (ICER) was calculated. Readiness and proficiency benchmarks were attained at rates 12-14% higher among clinicians attending virtual training, for which aggregated costs indicated a $399 per-clinician savings relative to in-person training. Accordingly, the ICER identified virtual training as the dominant strategy, reflecting greater cost-effectiveness across willingness-to-pay values. Study findings document greater utility, lesser expense, and cost-effectiveness of virtual training, which may inform post-pandemic dissemination of CM and other therapies.