Great expectations: A multisite, randomized controlled open-label trial of a novel patient expectations communication tool.

Objectives: In emergency medicine (EM), discerning patient expectations to inform patient-centered care poses unique challenges. We devised a novel questionnaire to facilitate clinicians' understanding of patients' expectations for their visit. Methods: We conducted a multisite, randomized controlled trial. A brief questionnaire soliciting patient expectations was developed through feedback from clinicians and patients. At the beginning of their visit, the intervention group patients completed the questionnaire and provided it to their treating clinician. The control group patients received standard care. Participants in both groups completed a survey at time of disposition assessing five satisfaction domains. The primary ordinal logistic regression analysis modeled the extent to which the intervention led to patient-reported improvement in clinician understanding of expectations with adjustment for demographic factors and site. Results: Among the 308 participants, 141 intervention and 123 control exit surveys were collected. In the primary analysis, the intervention group had 2.1 times greater odds of strongly agreeing that their clinician understood their expectations (odds ratio: 2.1, 95% confidence interval: 1.2, 3.7, p-value: 0.01), roughly equivalent to a net number needed to treat of 11 for one more improved satisfaction rating. Although the secondary outcome results were not significantly different between groups, all results tended toward the intervention group having more favorable answers. Conclusions: While more patients reported that their expectations were addressed when the novel tool was used, no significant difference was found for conventional satisfaction measures. Future studies may examine whether a tool to elicit patient expectations can lead to other improved outcomes.

Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia.

INTRODUCTION: Mortality is elevated after prison release and may be higher in people with HIV and opioid use disorder (OUD). Maintenance with opioid agonist therapy (OAT) like methadone or buprenorphine reduces mortality in people with OUD and may confer benefits to people with OUD and HIV leaving prison. Survival benefits of OAT, however, have not been evaluated prospectively in people with OUD and HIV leaving prison. METHODS: This study prospectively evaluated mortality after prison release and whether methadone initiated before release increased survival after release in a sample of men with HIV and OUD (n = 291). We linked national death records to data from a controlled trial of prerelease methadone initiation conducted from 2010 to 2014 with men with HIV and OUD imprisoned in Malaysia. Vital statistics were collected through 2015. Allocation to prerelease methadone was by randomization (n = 64) and participant choice (n = 246). Cox proportional hazards models were used to estimate treatment effects of prerelease methadone on postrelease survival. RESULTS: Overall, 62 deaths occurred over 872.5 person-years (PY) of postrelease follow-up, a crude mortality rate of 71.1 deaths per 1000 PY (95% confidence interval [CI] 54.5-89.4). Most deaths were of infectious etiology, mostly related to HIV. In a modified intention-to-treat analysis, the impact of prerelease methadone on postrelease mortality was consistent with a null effect in unadjusted (hazard ratio [HR] 1.3, 95% CI 0.6-3.1) and covariate-adjusted (HR 1.2, 95% CI 0.5-2.8) models. Predictors of mortality were educational level (HR 1.4, 95% CI 1.0-1.8), pre-incarceration alcohol use (HR 2.0, 95% CI 1.1-3.9), and lower CD4+ T-lymphocyte count (HR 0.8 per 100-cell/mL increase, 95% CI 0.7-1.0). CONCLUSIONS: Postrelease mortality in this sample of men with HIV and OUD was extraordinarily high, and most deaths were likely of infectious etiology. No effect of prerelease methadone on postrelease mortality was observed, which may be due to study limitations or an epidemiological context in which inadequately treated HIV, and not inadequately treated OUD, is the main cause of death after prison release. TRIAL REGISTRATION: NCT02396979. Retrospectively registered 24/03/2015.

Drug injection within prison in Kyrgyzstan: elevated HIV risk and implications for scaling up opioid agonist treatments.

Purpose Within-prison drug injection (WPDI) is a particularly high HIV risk behavior, yet has not been examined in Central Asia. A unique opportunity in Kyrgyzstan where both methadone maintenance treatment (MMT) and needle-syringe programs (NSP) exist allowed further inquiry into this high risk environment. The paper aims to discuss these issues. Design/methodology/approach A randomly selected, nationally representative sample of prisoners within six months of release in Kyrgyzstan completed biobehavioral surveys. Inquiry about drug injection focused on three time periods (lifetime, 30 days before incarceration and during incarceration). The authors performed bivariate and multivariable generalized linear modeling with quasi-binomial distribution and logit link to determine the independent correlates of current WPDI. Findings Of 368 prisoners (13 percent women), 109 (35 percent) had ever injected drugs, with most (86 percent) reporting WPDI. Among those reporting WPDI, 34.8 percent had initiated drug injection within prison. Despite nearly all (95 percent) drug injectors having initiated MMT previously, current MMT use was low with coverage only reaching 11 percent of drug injectors. Two factors were independently correlated with WPDI: drug injection in the 30 days before the current incarceration (AOR=12.6; 95%CI=3.3-48.9) and having hepatitis C infection (AOR: 10.1; 95%CI=2.5-41.0). Originality/value This study is the only examination of WPDI from a nationally representative survey of prisoners where both MMT and NSP are available in prisons and in a region where HIV incidence and mortality are increasing. WPDI levels were extraordinarily high in the presence of low uptake of prison-based MMT. Interventions that effectively scale-up MMT are urgently required as well as an investigation of the environmental factors that contribute to the interplay between MMT and WPDI.

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed.

Relapse to opioid use in opioid-dependent individuals released from compulsory drug detention centres compared with those from voluntary methadone treatment centres in Malaysia: a two-arm, prospective observational study.

BACKGROUND: Detention of people who use drugs into compulsory drug detention centres (CDDCs) is common throughout East and Southeast Asia. Evidence-based pharmacological therapies for treating substance use disorders, such as opioid agonist treatments with methadone, are generally unavailable in these settings. We used a unique opportunity where CDDCs coexisted with voluntary drug treatment centres (VTCs) providing methadone in Malaysia to compare the timing and occurrence of opioid relapse (measured using urine drug testing) in individuals transitioning from CDDCs versus methadone maintenance in VTCs. METHODS: We did a parallel, two-arm, prospective observational study of opioid-dependent individuals aged 18 years and older who were treated in Malaysia in the Klang Valley in two settings: CDDCs and VTCs. We used sequential sampling to recruit individuals. Assessed individuals in CDDCs were required to participate in services such as counselling sessions and manual labour. Assessed individuals in VTCs could voluntarily access many of the components available in CDDCs, in addition to methadone therapy. We undertook urinary drug tests and behavioural interviews to assess individuals at baseline and at 1, 3, 6, 9, and 12 months post-release. The primary outcome was time to opioid relapse post-release in the community confirmed by urinary drug testing in individuals who had undergone baseline interviewing and at least one urine drug test (our analytic sample). Relapse rates between the groups were compared using time-to-event methods. This study is registered at ClinicalTrials.gov (NCT02698098). FINDINGS: Between July 17, 2012, and August 21, 2014, we screened 168 CDDC attendees and 113 VTC inpatients; of these, 89 from CDDCs and 95 from VTCs were included in our analytic sample. The baseline characteristics of the two groups were similar. In unadjusted analyses, CDDC participants had significantly more rapid relapse to opioid use post-release compared with VTC participants (median time to relapse 31 days [IQR 26-32] vs 352 days [256-unestimable], log rank test, p<0·0001). VTC participants had an 84% (95% CI 75-90) decreased risk of opioid relapse after adjustment for control variables and inverse propensity of treatment weights. Time-varying effect modelling revealed the largest hazard ratio reduction, at 91% (95% CI 83-96), occurs during the first 50 days in the community. INTERPRETATION: Opioid-dependent individuals in CDDCs are significantly more likely to relapse to opioid use after release, and sooner, than those treated with evidence-based treatments such as methadone, suggesting that CDDCs have no role in the treatment of opioid-use disorders. FUNDING: The World Bank Group, Doris Duke Charitable Foundation, National Institute on Drug Abuse, Australian National Health & Medical Research Council, National Institute of Mental Health, and the University of Malaya-Malaysian Ministry of Higher Education High Impact Research Grant.

Pre-incarceration police harassment, drug addiction and HIV risk behaviours among prisoners in Kyrgyzstan and Azerbaijan: results from a nationally representative cross-sectional study.

INTRODUCTION: The expanding HIV epidemic in Azerbaijan and Kyrgyzstan is concentrated among people who inject drugs (PWID), who comprise a third of prisoners there. Detention of PWID is common but its impact on health has not been previously studied in the region. We aimed to understand the relationship between official and unofficial (police harassment) detention of PWID and HIV risk behaviours. METHODS: In a nationally representative cross-sectional study, soon-to-be released prisoners in Kyrgyzstan (N=368) and Azerbaijan (N=510) completed standardized health assessment surveys. After identifying correlated variables through bivariate testing, we built multi-group path models with pre-incarceration official and unofficial detention as exogenous variables and pre-incarceration composite HIV risk as an endogenous variable, controlling for potential confounders and estimating indirect effects. RESULTS: Overall, 463 (51%) prisoners reported at least one detention in the year before incarceration with an average of 1.3 detentions in that period. Unofficial detentions (13%) were less common than official detentions (41%). Optimal model fit was achieved (X (2)=5.83, p=0.44; Goodness of Fit Index (GFI) GFI=0.99; Comparative Fit Index (CFI) CFI=1.00; Root Mean Square Error of Approximation (RMSEA) RMSEA=0.00; PCLOSE=0.98) when unofficial detention had an indirect effect on HIV risk, mediated by drug addiction severity, with more detentions associated with higher addiction severity, which in turn correlated with increased HIV risk. The final model explained 35% of the variance in the outcome. The effect was maintained for both countries, but stronger for Kyrgyzstan. The model also holds for Kyrgyzstan using unique data on within-prison drug injection as the outcome, which was frequent in prisoners there. CONCLUSIONS: Detention by police is a strong correlate of addiction severity, which mediates its effect on HIV risk behaviour. This pattern suggests that police may target drug users and that such harassment may result in an increase in HIV risk-taking behaviours, primarily because of the continued drug use within prisons. These findings highlight the important negative role that police play in the HIV epidemic response and point to the urgent need for interventions to reduce police harassment, in parallel with interventions to reduce HIV transmission within and outside of prison.

Confronting the HIV, Tuberculosis, Addiction, and Incarceration Syndemic in Southeast Asia: Lessons Learned from Malaysia.

Throughout Southeast Asia, repressive drug laws have resulted in high rates of imprisonment in people who inject drugs (PWID) and people living with HIV (PLH), greatly magnifying the harm associated with HIV, tuberculosis, and addiction. We review findings from Malaysia's largest prison to describe the negative synergistic effects of HIV, tuberculosis, addiction, and incarceration that contribute to a 'perfect storm' of events challenging public and personal health and offer insights into innovative strategies to control these converging epidemics. The majority of PLH who are imprisoned in Malaysia are opioid dependent PWID. Although promoted by official policy, evidence-based addiction treatment is largely unavailable, contributing to rapid relapse and/or overdose after release. Similarly, HIV treatment in prisons and compulsory drug treatment centers is sometimes inadequate or absent. The prevalence of active tuberculosis is high, particularly in PLH, and over 80 % of prisoners and prison personnel are latently infected. Mandatory HIV testing and subsequent segregation of HIV-infected prisoners increases the likelihood of tuberculosis acquisition and progression to active disease, amplifying the reservoir of infection for other prisoners. We discuss strategies to control these intersecting epidemics including screening linked to standardized treatment protocols for all three conditions, and effective transitional programs for released prisoners. For example, recently introduced evidence-based interventions in prisons like antiretroviral therapy (ART) to treat HIV, isoniazid preventive therapy to treat latent tuberculosis infection, and methadone maintenance to treat opioid dependence, have markedly improved clinical care and reduced morbidity and mortality. Since introduction of these interventions in September 2012, all-cause and HIV-related mortality have decreased by 50.0 % and 75.7 %, respectively. We discuss the further deployment of these interventions in Malaysian prisons.

Novel Application of a Reverse Triage Protocol Providing Increased Access to Care in an Outpatient, Primary Care Clinic Setting.

BACKGROUND AND OBJECTIVES: As the number of patients with access to care increases, outpatient clinics will need to implement innovative strategies to maintain or enhance clinic efficiency. One viable alternative involves reverse triage. METHODS: A reverse triage protocol was implemented during a student-run free clinic. Each patient's chief complaint(s) were obtained at the beginning of the clinic session and ranked by increasing complexity. "Complexity" was defined as the subjective amount of time required to provide a full, thorough evaluation of a patient. Less complex cases were prioritized first since they could be expedited through clinic processing and allow for more time and resources to be dedicated to complex cases. Descriptive statistics were used to characterize and summarize the data obtained. Categorical variables were analyzed using chi-square. A time series analysis of the outcome versus centered time in weeks was also conducted. RESULTS: The average number of patients seen per clinic session increased by 35% (9.5 versus 12.8) from pre-implementation of the reverse triage protocol to 6 months after the implementation of the protocol. CONCLUSIONS: The implementation of a reverse triage in an outpatient setting significantly increased clinic efficiency as noted by a significant increase in the number of patients seen during a clinic session.

Correlates and Experiences of HIV Stigma in Prisoners Living With HIV in Indonesia: A Mixed-Method Analysis.

In Indonesia, the syndemic nature of HIV, drug use, and incarceration may influence experiences of stigma for HIV-infected prisoners. This mixed-method study explores HIV stigma in prisoners living with HIV in Indonesia. Randomly selected male HIV-infected prisoners (n = 102) from two large prisons in Jakarta completed in-depth interviews and a structured HIV stigma survey. Quantitative results found four groups of HIV-infected prisoners with significantly higher HIV stigma levels, including those: (a) with drug-related offenses, (b) seeking help to decrease drug use, (c) diagnosed with HIV before the current incarceration, and (d) who had not disclosed their HIV status to family members or friends. Qualitative results highlighted the prominent role of HIV stigma in decisions to disclose HIV status to family members, partners, and other prisoners. Interventions should address HIV stigma in HIV-infected prisoners in Indonesia to achieve HIV treatment as prevention goals.

Quality of Care for Chronic Conditions Among Disabled Medicaid Enrollees: An Evaluation of a 1915 (b) and (c) Waiver Program.

IMPORTANCE: Examining the impact of Medicaid-managed care home-based and community-based service (HCBS) alternatives to institutional care is critical given the recent rapid expansion of these models nationally. OBJECTIVE: We analyzed the effects of STAR+PLUS, a Texas Medicaid-managed care HCBS waiver program for adults with disabilities on the quality of chronic disease care. DESIGN, SETTING, AND PARTICIPANTS: We compared quality before and after a mandatory transition of disabled Medicaid enrollees older than 21 years from fee-for-service (FFS) or primary care case management (PCCM) to STAR+PLUS in 28 counties, relative to enrollees in counties remaining in the FFS or PCCM models. MEASURES AND ANALYSIS: Person-level claims and encounter data for 2006-2010 were used to compute adherence to 6 quality measures. With county as the independent sampling unit, we employed a longitudinal linear mixed-model analysis accounting for administrative clustering and geographic and individual factors. RESULTS: Although quality was similar among programs at baseline, STAR+PLUS enrollees experienced large and sustained improvements in use of ß-blockers after discharge for heart attack (49% vs. 81% adherence posttransition; P<0.01) and appropriate use of systemic corticosteroids and bronchodilators after a chronic obstructive pulmonary disease event (39% vs. 68% adherence posttransition; P<0.0001) compared with FFS/PCCM enrollees. No statistically significant effects were identified for quality measures for asthma, diabetes, or cardiovascular disease. CONCLUSION: In 1 large Medicaid-managed care HCBS program, the quality of chronic disease care linked to acute events improved while that provided during routine encounters appeared unaffected.

Burden of substance use disorders, mental illness, and correlates of infectious diseases among soon-to-be released prisoners in Azerbaijan.

BACKGROUND: Despite low HIV prevalence in the South Caucasus region, transmission is volatile. Little data are available from this region about addiction and infectious diseases among prisoners who transition back to communities. METHODS: A nation-wide randomly sampled biobehavioral health survey was conducted in 13 non-specialty Azerbaijani prisons among soon-to-be-released prisoners. After informed consent, participants underwent standardized health assessment surveys and testing for HIV, hepatitis B and C, and syphilis. RESULTS: Of the 510 participants (mean age = 38.2 years), 11.4% were female, and 31.9% reported pre-incarceration drug injection, primarily of heroin. Prevalence of HCV (38.2%), HIV (3.7%), syphilis (3.7%), and HBV (2.7%) was high. Among the 19 HIV-infected inmates, 14 (73.7%) were aware of their HIV status, 12 (63.2%) were receiving antiretroviral therapy (ART), and 5 (26.3%) had CD4 < 350 cells/mL (4 of these were on ART). While drug injection was the most significant independent correlate of HCV (AOR = 12.9; p = 0.001) and a significant correlate of HIV (AOR = 8.2; p = 0.001), both unprotected sex (AOR = 3.31; p = 0.049) and working in Russia/Ukraine (AOR = 4.58; p = 0.008) were also correlated with HIV. CONCLUSION: HIV and HCV epidemics are concentrated among people who inject drugs (PWIDs) in Azerbaijan, and magnified among prisoners. A transitioning HIV epidemic is emerging from migration from high endemic countries and heterosexual risk. The high diagnostic rate and ART coverage among Azerbaijani prisoners provides new evidence that HIV treatment as prevention in former Soviet Union (FSU) countries is attainable, and provides new insights for HCV diagnosis and treatment as new medications become available. Within prison evidence-based addiction treatments with linkage to community care are urgently needed.

Practicality of intermittent fasting in humans and its effect on oxidative stress and genes related to aging and metabolism.

Caloric restriction has consistently been shown to extend life span and ameliorate aging-related diseases. These effects may be due to diet-induced reactive oxygen species acting to up-regulate sirtuins and related protective pathways, which research suggests may be partially inhibited by dietary anti-oxidant supplementation. Because caloric restriction is not sustainable long term for most humans, we investigated an alternative dietary approach, intermittent fasting (IF), which is proposed to act on similar biological pathways. We hypothesized that a modified IF diet, where participants maintain overall energy balance by alternating between days of fasting (25% of normal caloric intake) and feasting (175% of normal), would increase expression of genes associated with aging and reduce oxidative stress and that these effects would be suppressed by anti-oxidant supplementation. To assess the tolerability of the diet and to explore effects on biological mechanisms related to aging and metabolism, we recruited a cohort of 24 healthy individuals in a double-crossover, double-blinded, randomized clinical trial. Study participants underwent two 3-week treatment periods-IF and IF with anti-oxidant (vitamins C and E) supplementation. We found strict adherence to study-provided diets and that participants found the diet tolerable, with no adverse clinical findings or weight change. We detected a marginal increase (2.7%) in SIRT3 expression due to the IF diet, but no change in expression of other genes or oxidative stress markers analyzed. We also found that IF decreased plasma insulin levels (1.01 µU/mL). Although our study suggests that the IF dieting paradigm is acceptable in healthy individuals, additional research is needed to further assess the potential benefits and risks.