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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. [ABSTRACT FROM AUTHOR]

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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Substance use relapse rates are often high in the first months after discharge from inpatient substance abuse treatment, and patient adherence to aftercare plans is often low. Four residential addiction treatment centers participated in a feasibility study designed to estimate the efficacy of a post-discharge telephone intervention intended to encourage compliance with aftercare. A total of 282 participants (100 women, 182 men) with substance use disorders were included in this secondary analysis. The findings revealed that women were more likely than men to attend aftercare. This "gender effect" persisted after adjustment for a number of potential mediators. [ABSTRACT FROM AUTHOR]

The TELE study examined the feasibility and potential efficacy of phone calls to patients after discharge from short- term inpatient and residential substance abuse treatment programs to encourage compliance with continuing care plans. After review of their continuing care plans, 339 patients from four programs were randomized either to receive calls or to have no planned contact. Ninety-two percent of patients randomized to receive calls received at least one call. No difference was found between groups in self-reported attendance at one or more outpatient counseling sessions after discharge (p = .89). When program records of all participants were examined, those receiving calls had a greater likelihood of documented attendance (48%) than those not called (37%). Results were not statistically significant (p < .003) because of the Hochberg correction for multiple tests. While the phone calls were feasible, the lack of clear evidence of efficacy of the calls suggests the need for further investigation of the role of telephone intervention to encourage compliance and improve outcomes. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. 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. • With adequate resources and institutional support, integration of evidence-based quality improvement initiatives focused on OUD are feasible. • Evidence-based quality improvement initiatives improve patient care in a rural Southern state. • Lessons learned from this implementation study can be used to guide future CTN studies focused on ED settings. [ABSTRACT FROM AUTHOR]

Objectives: Sexually transmitted infections (STIs) are significant public health and financial burdens in the United States. This manuscript examines the relationship between substance use and prevalent and incident STIs in HIV-negative adult patients at STI clinics.Methods: A secondary analysis of Project AWARE was performed based on 5012 patients from 9 STI clinics. STIs were assessed by laboratory assay and substance use by self-report. Patterns of substance use were assessed using latent class analysis. The relationship of latent class to STI rates was investigated using Poisson regression by population groups at high risk for STIs defined by participant's and partner's gender.Results: Drug use patterns differed by risk group and substance use was related to STI rates with the relationships varying by risk behavior group. Substance use treatment participation was associated with increased STI rates.Conclusions: Substance use focused interventions may be useful in STI clinics to reduce morbidity associated with substance use. Conversely, gender-specific sexual health interventions may be useful in substance use treatment. [ABSTRACT FROM AUTHOR]

Abstract: Background: The President''s National HIV/AIDS Strategy calls for coupling HIV screening and prevention services with substance abuse treatment programs. Fewer than half of US community-based substance abuse treatment programs make HIV testing available on-site or through referral. Methods: We measured the cost-effectiveness of three HIV testing strategies evaluated in a randomized trial conducted in 12 community-based substance abuse treatment programs in 2009: off-site testing referral, on-site rapid testing with information only, on-site rapid testing with risk-reduction counseling. Data from the trial included patient demographics, prior testing history, test acceptance and receipt of results, undiagnosed HIV prevalence (0.4%) and program costs. The Cost-Effectiveness of Preventing AIDS Complications (CEPAC) computer simulation model was used to project life expectancy, lifetime costs, and quality-adjusted life years (QALYs) for HIV-infected individuals. Incremental cost-effectiveness ratios (2009 US $/QALY) were calculated after adding costs of testing HIV-uninfected individuals; costs and QALYs were discounted at 3% annually. Results: Referral for off-site testing is less efficient (dominated) compared to offering on-site testing with information only. The cost-effectiveness ratio for on-site testing with information is $60,300/QALY in the base case, or $76,300/QALY with 0.1% undiagnosed HIV prevalence. HIV risk-reduction counseling costs $36 per person more without additional benefit. Conclusions: A strategy of on-site rapid HIV testing offer with information only in substance abuse treatment programs increases life expectancy at a cost-effectiveness ratio <$100,000/QALY. Policymakers and substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested. [Copyright &y& Elsevier]