Estimating the impact of stimulant use on initiation of buprenorphine and extended-release naltrexone in two clinical trials and real-world populations.

BACKGROUND: Co-use of stimulants and opioids is rapidly increasing. Randomized clinical trials (RCTs) have established the efficacy of medications for opioid use disorder (MOUD), but stimulant use may decrease the likelihood of initiating MOUD treatment. Furthermore, trial participants may not represent "real-world" populations who would benefit from treatment. METHODS: We conducted a two-stage analysis. First, associations between stimulant use (time-varying urine drug screens for cocaine, methamphetamine, or amphetamines) and initiation of buprenorphine or extended-release naltrexone (XR-NTX) were estimated across two RCTs (CTN-0051 X:BOT and CTN-0067 CHOICES) using adjusted Cox regression models. Second, results were generalized to three target populations who would benefit from MOUD: Housed adults identifying the need for OUD treatment, as characterized by the National Survey on Drug Use and Health (NSDUH); adults entering OUD treatment, as characterized by Treatment Episodes Dataset (TEDS); and adults living in rural regions of the U.S. with high rates of injection drug use, as characterized by the Rural Opioids Initiative (ROI). Generalizability analyses adjusted for differences in demographic characteristics, substance use, housing status, and depression between RCT and target populations using inverse probability of selection weighting. RESULTS: Analyses included 673 clinical trial participants, 139 NSDUH respondents (weighted to represent 661,650 people), 71,751 TEDS treatment episodes, and 1,933 ROI participants. The majority were aged 30-49 years, male, and non-Hispanic White. In RCTs, stimulant use reduced the likelihood of MOUD initiation by 32% (adjusted HR [aHR] = 0.68, 95% CI 0.49-0.94, p = 0.019). Stimulant use associations were slightly attenuated and non-significant among housed adults needing treatment (25% reduction, aHR = 0.75, 0.48-1.18, p = 0.215) and adults entering OUD treatment (28% reduction, aHR = 0.72, 0.51-1.01, p = 0.061). The association was more pronounced, but still non-significant among rural people injecting drugs (39% reduction, aHR = 0.61, 0.35-1.06, p = 0.081). Stimulant use had a larger negative impact on XR-NTX initiation compared to buprenorphine, especially in the rural population (76% reduction, aHR = 0.24, 0.08-0.69, p = 0.008). CONCLUSIONS: Stimulant use is a barrier to buprenorphine or XR-NTX initiation in clinical trials and real-world populations that would benefit from OUD treatment. Interventions to address stimulant use among patients with OUD are urgently needed, especially among rural people injecting drugs, who already suffer from limited access to MOUD.

A hepatitis C elimination model in healthcare for the homeless organization: A novel reflexive laboratory algorithm and equity assessment.

BACKGROUND: Reaching World Health Organization hepatitis C (HCV) elimination targets requires diagnosis and treatment of people who use drugs (PWUD) with direct acting antivirals (DAAs). PWUD experience challenges engaging in HCV treatment, including needing multiple provider and laboratory appointments. Women, minoritized racial communities, and homeless individuals are less likely to complete treatment. METHODS: We implemented a streamlined opt-out HCV screening and linkage-to-care program in two healthcare for the homeless clinics and a medically supported withdrawal center. Front-line staff initiated a single-order reflex laboratory bundle combining screening, confirmation, and pre-treatment laboratory evaluation from a single blood draw. Multinomial logistic regression models identified characteristics influencing movement through each stage of the HCV treatment cascade. Multiple logistic regression models identified patient characteristics associated with HCV care cascade progression and Cox proportional hazards models assessed time to initiation of DAAs. RESULTS: Of 11,035 clients engaged in services between May 2017 and March 2020, 3,607 (32.7%) were screened. Of those screened, 1,020 (28.3%) were HCV PCR positive. Of those with detectable RNA, 712 (69.8%) initiated treatment and 670 (94.1%) completed treatment. Of those initiating treatment, 407 (57.2%) achieved SVR12. There were eight treatment failures and six reinfections. In the unadjusted model, the bundle intervention was associated with increased care cascade progression, and in the survival analysis, decreased time to initiation; these differences were attenuated in the adjusted model. Women were less likely to complete treatment and SVR12 labs than men. Homelessness increased likelihood of screening and diagnosis but was negatively associated with completing SVR12 labs. Presence of opioid and stimulant use disorder diagnoses predicted increased care cascade progression. CONCLUSIONS: The laboratory bundle and referral pathways improved treatment initiation, time to initiation, and movement across the cascade. Despite overall population improvements, women and homeless individuals experienced important gaps across the HCV care cascade.

Uptake and virological outcomes of single- versus multi-tablet antiretroviral regimens among treatment-naïve youth in the HIV Research Network.

OBJECTIVES: Several single-tablet regimens (STRs) are now available and are recommended for first-line antiretroviral therapy (ART); however, STR use for youth with HIV (YHIV) has not been systematically studied. We examined the characteristics associated with initiation of STRs versus multi-tablet regimens (MTRs) and the virological outcomes for youth with nonperinatally acquired HIV (nPHIV). METHODS: A retrospective cohort study of nPHIV youth aged 13-24 years initiating ART between 2006 and 2014 at 18 US HIV clinical sites in the HIV Research Network was performed. The outcomes measured were initiation of STRs versus MTRs, virological suppression (VS) at 12 months, and time to VS. Demographic and clinical factors associated with initiation of STR versus MTR ART and VS (< 400 HIV-1 RNA copies/mL) at 12 months after initiation were assessed using multivariable logistic regression. Cox proportional hazards regression was used to assess VS within the first year. RESULTS: Of 987 youth, 67% initiated STRs. Of the 589 who had viral load data at 1 year, 84% of those on STRs versus 67% of those on MTRs achieved VS (P < 0.01). VS was associated with STR use [adjusted odds ratio (AOR) 1.61; 95% confidence interval (CI) 1.01-2.58], white (AOR 2.41; 95% CI 1.13-5.13) or Hispanic (AOR 2.38; 95% CI 1.32-4.27) race/ethnicity, and baseline CD4 count 351-500 cells/µL (AOR 1.94; 95% CI 1.18-3.19) and > 500 cells/µL (AOR 1.76; 95% CI 1.0-3.10). STR use was not associated with a shorter time to VS compared with MTR use [hazard ratio (HR) 1.07; 95% CI 0.90-1.28]. CONCLUSIONS: Use of STR was associated with a greater likelihood of sustained VS 12 months after ART initiation in YHIV.

Emergency department utilization among HIV-infected patients in a multisite multistate study.

OBJECTIVE: The aim of this study was to examine Emergency Department (ED) utilization and clinical and sociodemographic correlates of ED use among HIV-infected patients. METHODS: During 2003, 951 patients participated in face-to-face interviews at 14 HIV clinics in the HIV Research Network. Respondents reported the number of ED visits in the preceding 6 months. Using logistic regression, we identified factors associated with visiting the ED in the last 6 months and admission to the hospital from the ED. RESULTS: Thirty-two per cent of respondents reported at least one ED visit in the last 6 months. In multivariate analysis, any ED use was associated with Medicaid insurance, high levels of pain (the third or fourth quartile), more than seven primary care visits in the last 6 months, current or former illicit drug use, social alcohol use and female gender. Of those who used ED services, 39% reported at least one admission to the hospital. Patients with pain in the highest quartile reported increased admission rates from the ED as did those who made six or seven primary care visits, or more than seven primary care visits vs. three or fewer. CONCLUSIONS: The likelihood of visiting the ED has not diminished since the advent of highly active antiretroviral therapy (HAART). More ED visits are to treat illnesses not related to HIV or injuries than to treat direct sequelae of HIV infection. With the growing prevalence of people living with HIV infection, the numbers of HIV-infected patients visiting the ED may increase, and ED providers need to understand potential complications produced by HIV disease.

Alcohol use among HIV-infected persons in care: results of a multi-site survey.

OBJECTIVE: We sought to determine the prevalence of any alcohol use and hazardous alcohol consumption among HIV-infected individuals engaged in care and to identify factors associated with hazardous alcohol use. METHODS: During 2003, 951 patients were interviewed at 14 HIV primary care sites in the USA. Hazardous drinking was defined as >14 drinks/week or >or=5 drinks/occasion for men and >7 drinks/week or >or=4 drinks/occasion for women. Moderate alcohol use was consumption at less than hazardous levels. We used logistic regression to identify factors associated with any alcohol use and hazardous alcohol use. RESULTS: Forty per cent of the sample reported any alcohol use in the 4 weeks prior to the interview; 11% reported hazardous use. In multivariate regression, male sex [adjusted odds ratio (AOR) 1.52 (95% confidence interval, CI, 1.07-2.16)], a college education (compared toor=500 cells/microL [AOR 2.65 (1.23-5.69)] and illicit drug use [AOR 2.67 (1.48-4.82)] were associated with increased odds of hazardous alcohol use (compared to moderate and none). CONCLUSIONS: Alcohol use is prevalent among HIV-infected individuals and is associated with a variety of socioeconomic and demographic characteristics. Screening for alcohol use should be routine practice in HIV primary care settings.

The impact of illicit drug use and substance abuse treatment on adherence to HAART.

High levels of adherence to highly active antiretroviral therapy (HAART) are essential for virologic suppression and longer survival in patients with HIV. We examined the effects of substance abuse treatment, current versus former substance use, and hazardous/binge drinking on adherence to HAART. During 2003, 659 HIV patients on HAART in primary care were interviewed. Adherence was defined as > or =95% adherence to all antiretroviral medications. Current substance users used illicit drugs and/or hazardous/binge drinking within the past six months, while former users had not used substances for at least six months. Logistic regression analyses of adherence to HAART included demographic, clinical and substance abuse variables. Sixty-seven percent of the sample reported 95% adherence or greater. However, current users (60%) were significantly less likely to be adherent than former (68%) or never users (77%). In multivariate analysis, former users in substance abuse treatment were as adherent to HAART as never users (Adjusted Odds Ratio (AOR)=0.82; p>0.5). In contrast, former users who had not received recent substance abuse treatment were significantly less adherent than never users (AOR=0.61; p=0.05). Current substance users were significantly less adherent than never users, regardless of substance abuse treatment (p<0.01). Substance abuse treatment interacts with current versus former drug use status to affect adherence to HAART. Substance abuse treatment may improve HAART adherence for former substance users.

An outbreak of El Tor cholera associated with a tribal funeral in Irian Jaya, Indonesia.

An outbreak of El Tor biotype cholera occurring in a rural village in Irian Jaya, Indonesia was evaluated for risk factors associated with death from cholera. Among those dying in the village during the epidemic, a significant association between membership in one of the five tribal groups in the village complex was associated with an elevated risk of suffering a cholera death (odds ratio = 5.9). Interviews with members of the decedents' families revealed a very strong association (odds ratio = 11.6) between risk of cholera death and having attended the two day funeral of a woman who died of a cholera-like illness a few days prior to an outbreak of cholera-like diarrheal disease in the village complex. Recent flooding may have contributed to the creation of an environment conducive to cholera transmission.