Trends in Self-Reported Fentanyl and Other Illicit Substance Use in South Carolina Emergency Department Patients, 2020-2022.

BACKGROUND: Opioid-involved deaths are continuing to increase across the United States, exceeding 100,000 for the first time in 2021. Contamination with, and intentional use of, synthetic opioids such as fentanyl are a major driver of this increase. Utilizing self-report substance use data of patients being treated in the emergency department (ED) can be useful to determine which substances patients are intentionally seeking. OBJECTIVES: 1) Examine changes in self-reported illicit substance use (including fentanyl) over time; 2) Examine changes in the co-occurrence of self-reported fentanyl with other illicit substance use over time. METHODS: All patients presenting to the study EDs that answered anything other than "never" on the National Institute on Drug Abuse Quick Screen and were seen by a peer recovery specialist in the ED between July 1, 2020 and December 31, 2022 were included for analysis. The substance of use as reported by each patient was recorded by the peer recovery specialist. Differences in substance use by type over time were examined using chi-squared tests of proportions. RESULTS: There were 7568 patients that met inclusion criteria. Self-reported fentanyl (1760%; p < 0.0001) and cocaine (82%; p = 0.034) use increased, whereas heroin use (16%; p < 0.0001) decreased. CONCLUSIONS: Self-reported fentanyl and cocaine use has increased significantly in South Carolina ED patients between 2020 and 2022. Given the high morbidity and mortality associated with fentanyl and fentanyl analog use, further measures to identify these patients and provide harm reduction and treatment from the ED setting are warranted.

Retention in Treatment after Emergency Department-Initiated Buprenorphine.

BACKGROUND: Emergency department-initiated buprenorphine (EDIB) has been shown to be effective in connecting patients with opioid use disorder (OUD) to outpatient treatment. Five diverse emergency departments (EDs) have successfully implemented EDIB programs. OBJECTIVES: 1) To measure attendance at the first referral appointment and 30-day retention in treatment rates for patients receiving EDIB; 2) To describe demographic and opioid use characteristics of patients receiving EDIB; and 3) To determine average length of time in treatment after EDIB at the five participating EDs. METHODS: All patients receiving EDIB at the participating EDs (n = 522) were seen by a peer recovery specialist in the ED and demographic and opioid use characteristics were recorded. Patients were followed prospectively. The referral site was contacted and information regarding attendance at the first referral appointment and 30-day retention in treatment was obtained. All patients still in treatment at 30 days were continually followed at subsequent 30-day intervals until the referral site indicated the patient had ended treatment at their facility. RESULTS: The rate of attendance at the first referral appointment was 77.0% for patients receiving EDIB. At 30-day follow-up, 43.1% of patients were retained in treatment. The mean age of patient enrollment was 36.7 years, 58% of enrollees were male, 90.5% were white, and 73.4% had no medical insurance. Seventy-seven percent reported no substance use other than opioids. The mean time in treatment was 158 days. CONCLUSIONS: EDIB programs across diverse ED settings are effective at promoting attendance at the first referral appointment for OUD treatment; however, additional work is warranted to increase 30-day treatment retention rates, particularly among patients with nonprescription-only use profiles.

Delivery and implementation of an algorithm for smoking cessation treatment for people living with HIV and AIDS.

Compared to the general population, persons living with HIV (PLWH) have higher rates of tobacco use and an increased risk of morbidity from tobacco-related diseases. We conducted a single-arm pilot study of the real-world feasibility of integrating a smoking cessation decisional algorithm within routine clinic visits to engage non-treatment-seeking smokers in smoking cessation therapies. Smokers had an initial study visit during routine care followed by phone contacts at one and three months. Participants completed a baseline survey, followed by the algorithm which resulted in a recommendation for a smoking cessation medication, which was prescribed during the visit. Follow-up phone surveys assessed changes in smoking behavior and use of cessation medications at 1 and 3 months. Participants' (N = 60) self-reported smoking decreased from a baseline average of 14.4 cigarettes/day to 7.1 cigarettes/day at 3 months (p = .001). Nicotine dependence (FTND) decreased from 5.6 at baseline to 3.6 at 3 months (p < .001). Twenty-seven (45%) made a 24-h quit attempt and 39 (65%) used cessation medication. Insurance prior-authorization delayed medication receipt for seven participants and insurance denial occurred for one. Motivational status did not significantly influence outcomes. The algorithm was successful in engaging participants to use cessation medications and change smoking behaviors.

Rates of substance use disorder treatment seeking visits after emergency department-initiated buprenorphine.

BACKGROUND: Emergency department-initiated buprenorphine (EDIB) programs have been shown to improve treatment outcomes for patients with opioid use disorders (OUD); however, little is known about how EDIB implementation impacts the patient census at participating hospitals. OBJECTIVES: To determine if implementation of an EDIB program was associated with changes in the number of patients presenting to the ED seeking treatment for substance use disorder (SUD). METHODS: We conducted a retrospective evaluation at a single academic ED that began offering EDIB in December 2017. Data span the period of December 2016 to April 2019, All ED visits with a chief complaint of addiction problem, detoxification, drug/alcohol assessment, drug problem, or withdrawal charted by nursing at the time of triage were eligible for inclusion. Charts were reviewed to determine: (1) treatment status and (2) substance(s) for which the patient was seeking treatment. An interrupted time series analysis was used to compare the pre- and post-EDIB rates for all-substance, as well as opioid-specific, treatment-seeking visits. RESULTS: For all-substance visits, the predicted level change in the treatment-seeking rate after EDIB was implemented was positive but not significant (0.000497, p = 0.53); the trend change after EDIB was also not significant (-0.00004, p = 0.73). For visits involving opioids, the predicted level change was (0.000638, p = 0.21); and the trend change was (0.000047, p = 0.49). CONCLUSION: Implementation of an EDIB program was not associated with increased rates of presentation by patients requesting treatment for a substance use disorder in the participating ED setting.

Examining the Efficacy of HIV Risk-Reduction Counseling on the Sexual Risk Behaviors of a National Sample of Drug Abuse Treatment Clients: Analysis of Subgroups.

HIV counseling with testing has been part of HIV prevention in the U.S. since the 1980s. Despite the long-standing history of HIV testing with prevention counseling, the CDC released HIV testing recommendations for health care settings contesting benefits of prevention counseling with testing in reducing sexual risk behaviors among HIV-negatives in 2006. Efficacy of brief HIV risk-reduction counseling (RRC) in decreasing sexual risk among subgroups of substance use treatment clients was examined using multi-site RCT data. Interaction tests between RRC and subgroups were performed; multivariable regression evaluated the relationship between RRC (with rapid testing) and sex risk. Subgroups were defined by demographics, risk type and level, attitudes/perceptions, and behavioral history. There was an effect (p < .0028) of counseling on number of sex partners among some subgroups. Certain subgroups may benefit from HIV RRC; this should be examined in studies with larger sample sizes, designed to assess the specific subgroup(s).

Self-Reported HIV and HCV Screening Rates and Serostatus Among Substance Abuse Treatment Patients.

Substance users are at increased risk for HIV and HCV infection. Still, many substance use treatment programs (SUTP) fail to offer HIV/HCV testing. The present secondary analysis of screening data from a multi-site randomized trial of rapid HIV testing examines self-reported HIV/HCV testing patterns and serostatus of 2473 SUTP patients in 12 community-based sites that had not previously offered on-site testing. Results indicate that most respondents screened for the randomized trial tested more than a year prior to intake for HIV (52 %) and HCV (38 %). Prevalence rates were 3.6 and 30 % for HIV and HCV, respectively. The majority of participants that were HIV (52.2 %) and HCV-positive (40.5 %) reported having been diagnosed within the last 1-5 years. Multivariable logistic regression showed that members of high-risk groups were more likely to have tested. Bundled HIV/HCV testing and linkage to care issues are recommended for expanding testing in community-based SUTP settings.

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.

IMPORTANCE: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates. OBJECTIVE: To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients. DESIGN, SETTING, AND PARTICIPANTS: From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months. INTERVENTIONS: Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment. MAIN OUTCOMES AND MEASURES: The primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up. RESULTS: Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68). CONCLUSIONS AND RELEVANCE: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01612169.

Characterization of peer support services for substance use disorders in 11 US emergency departments in 2020: findings from a NIDA clinical trials network site selection process.

INTRODUCTION: Emergency departments (ED) are incorporating Peer Support Specialists (PSSs) to help with patient care for substance use disorders (SUDs). Despite rapid growth in this area, little is published regarding workflow, expectations of the peer role, and core components of the PSS intervention. This study describes these elements in a national sample of ED-based peer support intervention programs. METHODS: A survey was conducted to assess PSS site characteristics as part of site selection process for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) evaluating PSS effectiveness, Surveys were distributed to clinical sites affiliated with the 16 CTN nodes. Surveys were completed by a representative(s) of the site and collected data on the PSS role in the ED including details regarding funding and certification, services rendered, role in medications for opioid use disorder (MOUD) and naloxone distribution, and factors impacting implementation and maintenance of ED PSS programs. Quantitative data was summarized with descriptive statistics. Free-text fields were analyzed using qualitative content analysis. RESULTS: A total of 11 surveys were completed, collected from 9 different states. ED PSS funding was from grants (55%), hospital funds (46%), peer recovery organizations (27%) or other (18%). Funding was anticipated to continue for a mean of 16 months (range 12 to 36 months). The majority of programs provided "general recovery support (81%) Screening, Brief Intervention, and Referral to Treatment (SBIRT) services (55%), and assisted with naloxone distribution to ED patients (64%). A minority assisted with ED-initiated buprenorphine (EDIB) programs (27%). Most (91%) provided services to patients after they were discharged from the ED. Barriers to implementation included lack of outpatient referral sources, barriers to initiating MOUD, stigma at the clinician and system level, and lack of ongoing PSS availability due to short-term grant funding. CONCLUSIONS: The majority of ED-based PSSs were funded through time-limited grants, and short-term grant funding was identified as a barrier for ED PSS programs. There was consistency among sites in the involvement of PSSs in facilitation of transitions of SUD care, coordination of follow-up after ED discharge, and PSS involvement in naloxone distribution.

Effect of risk-reduction counseling with rapid HIV testing on risk of acquiring sexually transmitted infections: the AWARE randomized clinical trial.

IMPORTANCE: To increase human immunodeficiency virus (HIV) testing rates, many institutions and jurisdictions have revised policies to make the testing process rapid, simple, and routine. A major issue for testing scale-up efforts is the effectiveness of HIV risk-reduction counseling, which has historically been an integral part of the HIV testing process. OBJECTIVE: To assess the effect of brief patient-centered risk-reduction counseling at the time of a rapid HIV test on the subsequent acquisition of sexually transmitted infections (STIs). DESIGN, SETTING, AND PARTICIPANTS: From April to December 2010, Project AWARE randomized 5012 patients from 9 sexually transmitted disease (STD) clinics in the United States to receive either brief patient-centered HIV risk-reduction counseling with a rapid HIV test or the rapid HIV test with information only. Participants were assessed for multiple STIs at both baseline and 6-month follow-up. INTERVENTIONS: Participants randomized to counseling received individual patient-centered risk-reduction counseling based on an evidence-based model. The core elements included a focus on the patient's specific HIV/STI risk behavior and negotiation of realistic and achievable risk-reduction steps. All participants received a rapid HIV test. MAIN OUTCOMES AND MEASURES: The prespecified outcome was a composite end point of cumulative incidence of any of the measured STIs over 6 months. All participants were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum (syphilis), herpes simplex virus 2, and HIV. Women were also tested for Trichomonas vaginalis. RESULTS: There was no significant difference in 6-month composite STI incidence by study group (adjusted risk ratio, 1.12; 95% CI, 0.94-1.33). There were 250 of 2039 incident cases (12.3%) in the counseling group and 226 of 2032 (11.1%) in the information-only group. CONCLUSION AND RELEVANCE: Risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition among STD clinic patients, suggesting no added benefit from brief patient-centered risk-reduction counseling. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01154296.

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs.

Background People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of substance use disorder (SUD) treatment programs offering on-site HIV testing. Fewer than half of SUDs in the United States offer on-site HIV testing. In addition, nearly a quarter of newly diagnosed cases have AIDS at the time of diagnosis. Lack of testing is one of the main reasons that annual HIV incidences have remained constant over time. Integration of HIV testing with testing for HCV, an infection prevalent among persons vulnerable to HIV infection, and in settings where they receive health services, including opioid treatment programs (OTPs), is of great public health importance. Methods/Design In this 3-arm cluster-RCT of opioid use disorders treatment programs, we test the effect of two evidence-based "practice coaching" (PC) interventions on: the provision and sustained implementation of on-site HIV testing, on-site HIV/HCV testing, and linkage to care. Using the National Survey of Substance Abuse Treatment Services data available from SAMHSA, 51 sites are randomly assigned to one of the three conditions: practice coach facilitated structured conversations around implementing change, with provision of resources and documents to support the implementation of (1) HIV testing only, or (2) HIV/HCV testing, and (3) a control condition that provides a package with information only. We collect quantitative (e,g., HIV and HCV testing at six-month-long intervals) and qualitative site data near the time of randomization, and again approximately 7-12 months after randomization. Discussion Innovative and comprehensive approaches that facilitate and promote the adoption and sustainability of HIV and HCV testing in opioid treatment programs are important for addressing and reducing HIV and HCV infection rates. This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals receiving treatment for opioid use disorder. The study may provide valuable insight and knowledge on the multiple levels of intervention that, if integrated, may better position OTPs to improve and sustain testing practices and improve population health. Trial registration ClinicalTrials.gov: NCT03135886. (02 05 2017).

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs.

BACKGROUND: People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of substance use disorder (SUD) treatment programs offering on-site HIV testing. Fewer than half of SUDs in the USA offer on-site HIV testing. In addition, nearly a quarter of newly diagnosed cases have AIDS at the time of diagnosis. Lack of testing is one of the main reasons that annual HIV incidences have remained constant over time. Integration of HIV testing with testing for HCV, an infection prevalent among persons vulnerable to HIV infection, and in settings where they receive health services, including opioid treatment programs (OTPs), is of great public health importance. METHODS/DESIGN: In this 3-arm cluster-RCT of opioid use disorders treatment programs, we test the effect of two evidence-based "practice coaching" (PC) interventions on the provision and sustained implementation of on-site HIV testing, on-site HIV/HCV testing, and linkage to care. Using the National Survey of Substance Abuse Treatment Services data available from SAMHSA, 51 sites are randomly assigned to one of the three conditions: practice coach facilitated structured conversations around implementing change, with provision of resources and documents to support the implementation of (1) HIV testing only, or (2) HIV/HCV testing, and (3) a control condition that provides a package with information only. We collect quantitative (e.g., HIV and HCV testing at 6-month-long intervals) and qualitative site data near the time of randomization, and again approximately 7-12 months after randomization. DISCUSSION: Innovative and comprehensive approaches that facilitate and promote the adoption and sustainability of HIV and HCV testing in opioid treatment programs are important for addressing and reducing HIV and HCV infection rates. This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals receiving treatment for opioid use disorder. The study may provide valuable insight and knowledge on the multiple levels of intervention that, if integrated, may better position OTPs to improve and sustain testing practices and improve population health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03135886. Registered on 2 May 2017.

Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial.

OBJECTIVES: We examined the effectiveness of risk reduction counseling and the role of on-site HIV testing in drug treatment. METHODS: Between January and May 2009, we randomized 1281 HIV-negative (or status unknown) adults who reported no past-year HIV testing to (1) referral for off-site HIV testing, (2) HIV risk-reduction counseling with on-site rapid HIV testing, or (3) verbal information about testing only with on-site rapid HIV testing. RESULTS: We defined 2 primary self-reported outcomes a priori: receipt of HIV test results and unprotected anal or vaginal intercourse episodes at 6-month follow-up. The combined on-site rapid testing participants received more HIV test results than off-site testing referral participants (P<.001; Mantel-Haenszel risk ratio=4.52; 97.5% confidence interval [CI]=3.57, 5.72). At 6 months, there were no significant differences in unprotected intercourse episodes between the combined on-site testing arms and the referral arm (P=.39; incidence rate ratio [IRR]=1.04; 97.5% CI=0.95, 1.14) or the 2 on-site testing arms (P=.81; IRR=1.03; 97.5% CI=0.84, 1.26). CONCLUSIONS: This study demonstrated on-site rapid HIV testing's value in drug treatment centers and found no additional benefit from HIV sexual risk-reduction counseling.

Disparities in years of potential life lost to Drug-involved overdose deaths in South Carolina.

INTRODUCTION: South Carolina has experienced a surge in fatal overdoses, primarily fueled by opioid-involved overdose deaths. This work aims to quantify the burden of premature mortality due to fatal opioid-involved overdoses in South Carolina while documenting the contribution of synthetic opioids to excess mortality, examining substance specific geographic and demographic patterns of mortality burden, and measuring the effect of fatal opioid and synthetic opioid-involved overdoses on average lifespan. METHODS: We obtained death certificates for fatalities involving opioids, cocaine, benzodiazepines, and psychostimulants (N = 3,726) in South Carolina from 2014 to 2018. Years of Potential Life Lost (YPLL) was used to examine gender, racial, and geographic disparities in mortality burden. We assessed the contribution of synthetic opioid poisoning to the overall opioid mortality burden over time and calculated the effect of fatal opioid and synthetic opioid-involved overdoses on average lifespan. RESULTS: From 2014 to 2018, opioid-involved overdose deaths resulted in 124,451 YPLL. The average age of fatal male and female opioid-involved overdoses decreased 2.8 and 3.9 years, respectively. Synthetic opioids increasingly contributed to opioid YPLL, accounting for 22% in 2014 to 64% in 2018. Mortality burden was not shared equally between races, sexes, or rural/urban counties. The largest change occurred in black male synthetic opioid-involved deaths (2234%). Rural counties comprised 44-48% of the population adjusted YPLL despite containing 34% of the population. CONCLUSION: Opioid-involved overdoses account for a critical cause of mortality in South Carolina, demonstrate significant impact on YPLL and highlight mortality burden disparities in gender, race, and rural/urban settings.

Differential Effects of Patient Navigation across Latent Profiles of Barriers to Care among People Living with HIV and Comorbid Conditions.

Engaging people living with HIV who report substance use (PLWH-SU) in care is essential to HIV medical management and prevention of new HIV infections. Factors associated with poor engagement in HIV care include a combination of syndemic psychosocial factors, mental and physical comorbidities, and structural barriers to healthcare utilization. Patient navigation (PN) is designed to reduce barriers to care, but its effectiveness among PLWH-SU remains unclear. We analyzed data from NIDA Clinical Trials Network's CTN-0049, a three-arm randomized controlled trial testing the effect of a 6-month PN with and without contingency management (CM), on engagement in HIV care and viral suppression among PLWH-SU (n = 801). Latent profile analysis was used to identify subgroups of individuals' experiences to 23 barriers to care. The effects of PN on engagement in care and viral suppression were compared across latent profiles. Three latent profiles of barriers to care were identified. The results revealed that PN interventions are likely to be most effective for PLWH-SU with fewer, less severe healthcare barriers. Special attention should be given to individuals with a history of abuse, intimate partner violence, and discrimination, as they may be less likely to benefit from PN alone and require additional interventions.

Comparative profiles of men and women with opioid dependence: results from a national multisite effectiveness trial.

BACKGROUND: Accumulating evidence indicates important gender differences in substance use disorders. Little is known, however, about gender differences and opioid use disorders. OBJECTIVES: To compare demographic characteristics, substance use severity, and other associated areas of functioning (as measured by the Addiction Severity Index-Lite (ASI-Lite)) among opioid-dependent men and women participating in a multisite effectiveness trial. METHODS: Participants were 892 adults screened for the National Institute on Drug Abuse Clinical Trials Network investigation of the effectiveness of two buprenorphine tapering schedules. RESULTS: The majority of men and women tested positive for oxycodone (68% and 65%, respectively) and morphine (89% each). More women than men tested positive for amphetamines (4% vs. 1%, p < .01), methamphetamine (11% vs. 4%, p < .01), and phencyclidine (8% vs. 4%, p = .02). More men than women tested positive for methadone (11% vs. 6%, p = .05) and marijuana (22% vs. 15%, p = .03). Craving for opioids was significantly higher among women (p < .01). Men evidenced higher alcohol (p < .01) and legal (p = .04) ASI composite scores, whereas women had higher drug (p < .01), employment (p < .01), family (p < .01), medical (p < .01), and psychiatric (p < .01) ASI composite scores. Women endorsed significantly more current and past medical problems. CONCLUSIONS: Important gender differences in the clinical profiles of opioid-dependent individuals were observed with regard to substance use severity, craving, medical conditions, and impairment in associated areas of functioning. The findings enhance understanding of the characteristics of treatment-seeking men and women with opioid dependence, and may be useful in improving identification, prevention, and treatment efforts for this challenging and growing population.

Gender research in the National Institute on Drug Abuse National Treatment Clinical Trials Network: a summary of findings.

BACKGROUND: The National Institute of Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (CTN) was established to foster translation of research into practice in substance abuse treatment settings. The CTN provides a unique opportunity to examine in multi-site, translational clinical trials, the outcomes of treatment interventions targeting vulnerable subgroups of women; the comparative effectiveness of gender-specific protocols to reduce risk behaviors; and gender differences in clinical outcomes. OBJECTIVES: To review gender-related findings from published CTN clinical trials and related studies from January 2000 to March 2010. METHODS: CTN studies were selected for review if they focused on treatment outcomes or services for special populations of women with substance use disorders (SUDs) including those with trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors; or implemented gender-specific protocols. The CTN has randomized 11,500 participants (41% women) across 200 clinics in 24 randomized controlled trials in community settings, of which 4 have been gender-specific. RESULTS: This article summarizes gender-related findings from CTN clinical trials and related studies, focusing on trauma histories, pregnancy, co-occurring eating and other psychiatric disorders, and HIV risk behaviors. CONCLUSIONS: These published studies have expanded the evidence base regarding interventions for vulnerable groups of women with SUDs as well as gender-specific interventions to reduce HIV risk behaviors in substance-using men and women. The results also underscore the complexity of accounting for gender in the design of clinical trials and analysis of results. SCIENTIFIC SIGNIFICANCE: To fully understand the relevance of gender-specific moderators and mediators of outcome, it is essential that future translational studies adopt more sophisticated approaches to understanding and measuring gender-relevant factors and plan sample sizes that are adequate to support more nuanced analytic methods.

NIDA's Clinical Trials Network: an opportunity for HIV research in community substance abuse treatment programs.

BACKGROUND/OBJECTIVES: HIV continues to be a significant problem among substance users and their sexual partners in the United States. The National Drug Abuse Treatment Clinical Trials Network (CTN) offers a national platform for effectiveness trials of HIV interventions in community substance abuse treatment programs. This article presents the HIV activities of the CTN during its first 10 years. RESULTS: While emphasizing CTN HIV protocols, this article reviews the (1) HIV context for this work; (2) the collaborative process among providers, researchers, and National Institute on Drug Abuse CTN staff, on which CTN HIV work was based; (3) results of CTN HIV protocols and HIV secondary analyses in CTN non-HIV protocols; and (4) implications for future HIV intervention effectiveness research in community substance abuse treatment programs. CONCLUSION/SIGNIFICANCE: While the feasibility of engaging frontline providers in this research is highlighted, the limitations of small to medium effect sizes and weak adoption and sustainability in everyday practice are also discussed.

Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064).

BACKGROUND: Direct-acting antivirals can cure hepatitis C virus (HCV). Persons with HCV/HIV and living with substance use are disadvantaged in benefiting from advances in HCV treatment. METHODS: In this randomized controlled trial, participants with HCV/HIV were randomized between February 2016 and January 2017 to either care facilitation or control. Twelve-month follow-up assessments were completed in January 2018.Care facilitation group participants received motivation and strengths-based case management addressing retrieval of HCV viral load results, engagement in HCV/HIV care, and medication adherence. Control group participants received referral to HCV evaluation and an offer of assistance in making care appointments. Primary outcome was number of steps achieved along a series of 8 clinical steps (eg, receiving HCV results, initiating treatment, sustained virologic response [SVR]) of the HCV/HIV care continuum over 12 months postrandomization. RESULTS: Three hundred eighty-one individuals were screened and 113 randomized. Median age was 51 years; 58.4% of participants were male and 72.6% were Black/African American. Median HIV-1 viral load was 27 209 copies/mL, with 69% having a detectable viral load. Mean number of steps completed was statistically significantly higher in the intervention group vs controls (2.44 vs 1.68 steps; χ 2 [1] = 7.36, P = .0067). Men in the intervention group completed a statistically significantly higher number of steps than controls. Eleven participants achieved SVR with no difference by treatment group. CONCLUSIONS: The care facilitation intervention increased progress along the HCV/HIV care continuum, as observed for men and not women. Study findings also highlight continued challenges to achieve individual-patient SVR and population-level HCV elimination. CLINICAL TRIALS REGISTRATION: NCT02641158.

Implementation of emergency department-initiated buprenorphine for opioid use disorder in a rural southern state.

AIM: The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN), an entity aimed at bridging researchers and community-based substance abuse treatment providers to develop new treatment approaches, has taken an interest in the dissemination of findings from a randomized clinical trial by D'Onofrio demonstrating that initiating buprenorphine in the emergency department (ED) enhances linkage to treatment [JAMA 2015; 313 (16): 1636-1644]. In the Southern Consortium Node of the CTN, the authors have taken an implementation science approach to expand on the D'Onofrio study by implementing an ED-based buprenorphine initiation program in three diverse South Carolina EDs utilizing a predominantly peer recovery coach model. The aim of this pilot program was to foundationally integrate universal screening, brief interventions and referral to treatment (SBIRT) in hospital EDs to identify patients with at-risk substance use. Through brief interventions, patient navigators assessed readiness to change and motivation for treatment of patients. Patients willing to engage in treatment were referred to appropriate community resources. Patients identified to have opioid use disorder (OUD) and willing to engage in treatment were eligible for ED-initiated buprenorphine and peer recovery coaches assisted in arranging next day follow up with a community treatment program or other local provider for ongoing treatment. METHOD: Hospital partner sites included a large academic medical center, a large private hospital, and a small community hospital. Prior to implementing this quality improvement initiative, the authors completed an ED workflow analysis at each site, developed internal planning committees including identification of a "hospital champion," facilitated electronic health record modifications, educated more than 200 ED nurses and providers, and identified a network of local community "fast-track" providers able to accept patients for next-day appointments. RESULTS: Within 14 months, all three sites were fully operationalized and project staff in 3 ED sites screened 6523 patients for substance misuse with 33.0% screened positive for at-risk substance use. Positive screening results were as follows by substance: 907 alcohol, 100 cocaine, 40 methamphetamine, 7 amphetamines, 96 marijuana, 12 benzodiazepines, 3 Ecstasy/MDMA/Molly, 10 other/unknown substance, 274 heroin, 90 prescription opioids, 32 other/unknown opioid, 254 undetermined polysubstance use without opioids, and 331 polysubstance use with opioids. Of the 727 positive screened patients for non-medical opioid use, 70.0% were determined potentially eligible to receive buprenorphine initiation. Two-hundred thirty-one patients were initiated with one dose of 8 mg sublingual buprenorphine or 8-2 mg sublingual buprenorphine/naloxone; 76.6% of those initiated arrived to next-day appointments for continued medications for opioid use disorder (MOUD); and 59.9% of those patients were retained in treatment at 30 days. Of referred patients, payor at time of ED visit were as follows: 71.1% uninsured, 21.4% state Medicaid, 1.6% Medicare, and 5.9% private health insurance. CONCLUSION: With adequate resources and institutional support, implementation of evidence-based quality improvement initiatives focused on OUDs are feasible and enhance linkage to evidence-based treatment in a rural Southern state. Lessons learned from this implementation study can be used to guide future CTN studies focused on ED settings. PROJECT SUPPORT: Financially supported by South Carolina Department of Health and Human Services with consultation and guidance from Mosaic Group and South Carolina Department of Alcohol and Other Drug Services.

Assessing the needs of front-line providers in addressing the opioid crisis in South Carolina.

Opioid use disorder (OUD) has been declared a national crisis, as prevalence of OUD has increased remarkably over the past decade (Jones, 2017). While Medication Assisted Treatment (MAT) is the standard of care for OUDs, several key barriers to implementation have been noted throughout the clinical and research literature (DeFlavio et al., 2015). As a first step toward enhancing implementation and dissemination of MAT across the state of South Carolina, a needs assessment was conducted with key persons from 33 agencies to inform our efforts. Results provided descriptive information regarding medical providers and patients seen within agencies. Of the 33 agencies, 6 agencies (18%) reported having buprenorphine-waivered providers on staff (total of 11 medical providers across the 6 agencies). Agencies reported that they referred a mean of 4.63 patients to other facilities for MAT in the past month. Barriers to providing MAT were identified, with the most significant barrier including the lack of medical staff to prescribe buprenorphine (47%). Overall, the current study reiterates the gap between treatment need and capacity for OUD patients, and highlights factors associated with barriers to MAT adoption in state-funded county drug and alcohol agencies across a southern, predominantly rural state.