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.

Impacts of the COVID-19 pandemic on healthcare access among patients receiving medication for opioid use disorder.

BACKGROUND: The COVID-19 pandemic significantly altered treatment delivery for opioid treatment programs (OTPs) dispensing medications for opioid use disorder (MOUD). We aimed to identify patterns of substance use among MOUD patients and examine whether COVID-19-related impacts on access to healthcare varied across subgroups. METHODS: This analysis was embedded within a type 3 hybrid trial that enrolled patients across eight OTPs at the start of the pandemic. Enrolled patients reported on past-30 day use of multiple substances during their baseline assessment. Participants re-contacted in May-July 2020 completed a survey about COVID-19-related impacts on various life domains. Using latent class analysis we identified patient subgroups, and then examined group differences on a set of negative and positive COVID-19 impacts related to healthcare access. RESULTS: Of the 188 trial participants, 135 (72 %) completed the survey. Latent class analysis identified three MOUD patient subgroups: minimal use (class probability: 0.25); opioid use (class probability: 0.34); and polysubstance use (class probability: 0.41). Compared to the minimal use group, the polysubstance use group reported increased substance use and difficulty accessing sterile needles, naloxone, and preferred substance. The opioid use group reported increased substance use and difficulty accessing their preferred substance. There were no significant group differences related to accessing routine or specialized healthcare or medication; or paying attention to their health. CONCLUSIONS: During COVID-19, many MOUD patients reported challenges accessing care, particularly harm reduction services for patients with polysubstance use. Additional efforts, like providing wraparound support, may be necessary to serve the needs of MOUD patients.

The implementation and sustainment facilitation strategy improved implementation effectiveness and intervention effectiveness: Results from a cluster-randomized, type 2 hybrid trial.

Background: Substance use disorders (SUDs) among people with HIV are both prevalent and problematic. The Substance Abuse Treatment to HIV care project was funded to test the Implementation and Sustainment Facilitation (ISF) strategy as an adjunct to the Addiction Technology Transfer Center (ATTC) strategy for integrating a motivational interviewing-based brief intervention (MIBI) for SUDs within HIV community-based organizations. Methods: Using a cluster-randomized, type 2 hybrid trial design, 39 HIV organizations were randomized to either (1) ATTC (n = 19) or (2) ATTC + ISF (n = 20). Each HIV organization identified two staff members to be prepared to implement the MIBI (N = 78). Subsequently, during the implementation phase, HIV organizations in each condition randomized client participants (N = 824) to one of the two intervention conditions: usual care (UC; n = 415) or UC + MIBI (n = 409). Both staff-level outcomes and client-level outcomes were examined. Results: The ISF strategy had a significant impact on the implementation effectiveness (i.e., the consistency and the quality of implementation; ß = .65, p = .01) but not on time-to-proficiency (ß = -.02) or level-of-sustainment (ß = .09). In addition, the ISF strategy was found to have a significant impact on the intervention effectiveness (the effectiveness of the MIBI), at least in terms of significantly decreasing the odds (odds ratio = 0.11, p = .02) of clients using their primary substance daily during follow-up. Conclusion: The ISF strategy was found to be an effective adjunct to the ATTC strategy in terms of implementation effectiveness and intervention effectiveness. It is recommended that future efforts to integrate the project's MIBI for SUD within HIV organizations use the ATTC + ISF strategy. However, given the ISF strategy did not have a significant impact on level-of-sustainment, implementation research testing the extent to which the ATTC + ISF strategy can be significantly enhanced through effective sustainment strategies is warranted. Plain language abstract: Substance use among people living with HIV is associated with increased mental health problems, worse medication adherence, and worse HIV viral suppression. Increasing substance use-related services in HIV community-based organizations is an important public health need. The Substance Abuse Treatment to HIV care project tested two strategies for helping HIV organizations implement a brief intervention (BI) designed to motivate clients to decrease their substance use. The project also tested if receiving a BI improved clients' outcome. Two staff from each of the 39 participating organizations were taught how to deliver the BI using the Addiction Technology Transfer Center (ATTC) training strategy (online and in-person training, monthly feedback, and coaching). Half of the organizations also received the Implementation and Sustainment Facilitation (ISF) strategy, which included monthly meetings with an ISF coach for the two BI staff and one or more leadership staff from the organization. Organizations that received both the ATTC and ISF strategies delivered more BIs and higher quality BIs than organizations that only received the ATTC strategy. In addition, clients receiving BIs at organizations that received both strategies were more likely to decrease their substance use. However, receiving both strategies did not improve how quickly staff learned to deliver the BI or improve the number of BIs delivered during the project's 6-month sustainment phase. Future research focused on implementing BIs within HIV organizations should consider using the ATTC and ISF strategies while also seeking to enhance the strategies to improve sustainment.

Correction to: Testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to usual care in community-based AIDS service organizations: study protocol for a multisite randomized controlled trial.

Upon publication of the original article.

Testing the implementation and sustainment facilitation (ISF) strategy as an effective adjunct to the Addiction Technology Transfer Center (ATTC) strategy: study protocol for a cluster randomized trial.

BACKGROUND: Improving the extent to which evidence-based practices (EBPs)-treatments that have been empirically shown to be efficacious or effective-are integrated within routine practice is a well-documented challenge across numerous areas of health. In 2014, the National Institute on Drug Abuse funded a type 2 effectiveness-implementation hybrid trial titled the substance abuse treatment to HIV Care (SAT2HIV) Project. Aim 1 of the SAT2HIV Project tests the effectiveness of a motivational interviewing-based brief intervention (MIBI) for substance use as an adjunct to usual care within AIDS service organizations (ASOs) as part of its MIBI Experiment. Aim 2 of the SAT2HIV Project tests the effectiveness of implementation and sustainment facilitation (ISF) as an adjunct to the Addiction Technology Transfer Center (ATTC) model for training staff in motivational interviewing as part of its ISF Experiment. The current paper describes the study protocol for the ISF Experiment. METHODS: Using a cluster randomized design, case management and leadership staff from 39 ASOs across the United States were randomized to receive either the ATTC strategy (control condition) or the ATTC + ISF strategy (experimental condition). The ATTC strategy is staff-focused and includes 10 discrete strategies (e.g., provide centralized technical assistance, conduct educational meetings, provide ongoing consultation). The ISF strategy is organization-focused and includes seven discrete strategies (e.g., use an implementation advisor, organize implementation team meetings, conduct cyclical small tests of change). Building upon the exploration-preparation-implementation-sustainment (EPIS) framework, the effectiveness of the ISF strategy is examined via three staff-level measures: (1) time-to-proficiency (i.e., preparation phase outcome), (2) implementation effectiveness (i.e., implementation phase outcome), and (3) level of sustainment (i.e., sustainment phase outcome). DISCUSSION: Although not without limitations, the ISF experiment has several strengths: a highly rigorous design (randomized, hypothesis-driven), high-need setting (ASOs), large sample size (39 ASOs), large geographic representation (23 states and the District of Columbia), and testing along multiple phases of the EPIS continuum (preparation, implementation, and sustainment). Thus, study findings will significantly improve generalizable knowledge regarding the best preparation, implementation, and sustainment strategies for advancing EBPs along the EPIS continuum. Moreover, increasing ASO's capacity to address substance use may improve the HIV Care Continuum. Trial registration ClinicalTrials.gov: NCT03120598.

Testing the effectiveness of a motivational interviewing-based brief intervention for substance use as an adjunct to usual care in community-based AIDS service organizations: study protocol for a multisite randomized controlled trial.

BACKGROUND: In 2010, the first comprehensive National HIV/AIDS Strategy for the United States was released and included three goals: (1) reducing the number of people who become infected with HIV, (2) increasing access to care and improving health outcomes for people living with HIV, and (3) reducing HIV-related health disparities and health inequities. In 2013, as part of its effort to help address the National HIV/AIDS Strategy, the National Institute on Drug Abuse (NIDA) funded a type 2 effectiveness-implementation hybrid trial titled the Substance Abuse Treatment to HIV Care (SAT2HIV) Project. Aim 1 of the SAT2HIV Project tests the effectiveness of a motivational interviewing-based brief intervention (MIBI) for substance use as an adjunct to usual care within AIDS Service Organizations (ASOs) as part of its MIBI Experiment. Aim 2 of the SAT2HIV Project tests the effectiveness of implementation and sustainment facilitation (ISF) as an adjunct to the Addiction Technology Transfer Center (ATTC) model for training staff in motivational interviewing as part of its ISF Experiment. The current paper describes the study protocol for the MIBI Experiment. METHODS: As part of a multisite randomized controlled trial, individuals with comorbid HIV/AIDS and problematic substance use are randomized to receive either the ASOs' usual care (control condition) or usual care plus a MIBI for substance use (experimental condition) delivered by trained ASO case-management staff. Primary outcome measures are reductions in days of primary substance use, number of substance-related problems, times engaging in risky behaviors, days of non-adherence to HIV medications, and increases in substance use treatment. As part of this paper, we describe the trial protocol in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines. DISCUSSION: If successfully able to implement MIBI as an effective adjunct to usual care, the current trial may have a significant impact on increasing the capacity of ASOs to address problematic substance use among individuals living with HIV/AIDS. Reducing the prevalence of problematic substance use among individuals living with HIV/AIDS within the United States may lead to significant improvements on key performance measures (i.e., the HIV Care Continuum and the 90-90-90 target). Trial registration ClinicalTrials.gov: NCT02495402.

Behavioral characteristics and injection practices associated with skin and soft tissue infections among people who inject drugs: A community-based observational study.

BACKGROUND: People who inject drugs (PWID) are at increased risk for bacterial skin and soft tissue infections (SSTIs). Although SSTIs pose significant health risks, little is known about their prevalence and characteristics in the population of PWID in the United States. This study investigates whether behavioral factors related to skin and equipment hygiene and tissue-damaging injection practices are associated with recent SSTIs among PWID. METHODS: Active PWID were recruited using targeted sampling in San Francisco in 2011-2013. Interviewers collected information on behavioral risk factors of past-month self-reported SSTIs. Inferential analyses used multivariate logistic regression methods (i.e., generalized linear model) to characterize risk factors for past-month SSTIs. RESULTS: The self-reported prevalence of lifetime, past-year, and past-month SSTI was 70%, 29%, and 11%, respectively. Several factors were significantly associated with past-month SSTIs in bivariate analysis, including injecting nonpowder drugs (odds ratio [OR] = 3.57; 95% confidence interval [CI] = 1.23, 10.35; P = .01), needle-licking before injection (OR = 3.36; 95% CI = 1.28, 8.81; P = .01), injecting with someone else's preused syringe/needle (OR = 7.97; 95% CI = 2.46, 25.83; P < .001), being injected by another person (OR = 2.63; 95% CI = 1.02, 6.78; P = .04), infrequent skin cleaning before injection (OR = 2.47; 95% CI = 1.00, 6.10; P = .04), and frequent injections (P = .02). In multivariate analysis, only syringe/needle sharing (adjusted OR = 6.38; 95% CI = 1.90, 21.46) remained statistically significant. CONCLUSION: SSTIs are common among PWID. These data highlight the importance of clinical and public health screening efforts to reduce SSTIs. Needle exchange programs may be good venues for SSTIs screening and treatment.