Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study.

BACKGROUND: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection. METHODS: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. CONCLUSIONS: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.

Changes in Specific Substance Involvement Scores among SBIRT recipients in an HIV primary care setting.

BACKGROUND: Substance use is common among people living with HIV (PLHIV) and is associated with worse outcomes along the HIV care continuum. One potentially effective clinic-based approach to addressing unhealthy substance use is screening, brief intervention, and referral to treatment (SBIRT). METHODS: We conducted a two-arm randomized trial to examine the effects of a self-administered, computerized SBIRT intervention compared to a clinician-administered SBIRT intervention in an HIV primary clinic. Patients were surveyed before receiving the intervention and again at 1, 3, and 6 months. We administered the WHO Alcohol, Smoking and Substance Involvement Screening Test to determine Specific Substance Involvement Scores (SSIS) and to assign participants to categories of lower, moderate, or high risk to health and other problems for each substance. We collapsed moderate or severe risk responses into a single moderate-high risk category. Based on low rates of participation in the computerized arm, we conducted an "as treated" analysis to examine 6-month changes in mean SSIS among SBIRT intervention participants. RESULTS: For the overall sample (n = 208), baseline mean SSIS were in the moderate risk category for alcohol, tobacco, cannabis, cocaine, amphetamine, sedatives and opioids. Of those enrolled, 134 (64.4%) received the intervention, and 109 (52.4%) completed the 6-month follow up. There was a statistically significant decline in mean SSIS for all substances except tobacco and cannabis among participants who were at moderate-high risk at baseline. We also observed a statistically significant increase in mean SSIS for all substances except amphetamines and sedatives among participants who were at lower risk at baseline. CONCLUSIONS: Substance use among patients in this urban, safety-net, HIV primary care clinic was near universal, and moderate risk substance use was common. Among participants who received the SBIRT intervention, mean SSISs decreased among those at moderate-high risk at baseline, but increased among those at lower risk at baseline over the 6-month study period. Additional research should examine the clinical significance of SSIS changes for PLHIV, which SBIRT components drive changes in substance use scores, and what other interventions might support those patients at lower risk to maintain health and engagement along the HIV care continuum. Trial registration ClinicalTrials.gov study NCT01300806.

Integrated HIV care is associated with improved engagement in treatment in an urban methadone clinic.

BACKGROUND: Persons living with HIV and unhealthy substance use are often less engaged in HIV care, have higher morbidity and mortality and are at increased risk of transmitting HIV to uninfected partners. We developed a quality-improvement tracking system at an urban methadone clinic to monitor patients along the HIV care continuum and identify patients needing intervention. OBJECTIVE: To evaluate patient outcomes along the HIV Care Continuum at an urban methadone clinic and explore the relationship of HIV primary care site and patient demographic characteristics with retention in HIV treatment and viral suppression. METHODS: We reviewed electronic medical record data from 2015 for all methadone clinic patients with known HIV disease, including age, gender, race, HIV care sites, HIV care visit dates and HIV viral load. Patients received either HIV primary care at the methadone clinic, an HIV specialty clinic located in the adjacent building, or a community clinic. Retention was defined as an HIV primary care visit in both halves of the year. Viral suppression was defined as an HIV viral load <40 copies/ml at the last lab draw. RESULTS: The population (n = 65) was 63% male, 82% age 45 or older and 60% non-Caucasian. Of these 65 patients 77% (n = 50) were retained in care and 80% (n = 52) were virologically suppressed. Viral suppression was significantly higher for women (p = .022) and patients 45 years or older (p = .034). There was a trend towards greater retention in care and viral suppression among patients receiving HIV care at the methadone clinic (93, 93%) compared to the HIV clinic (74, 79%) or community clinics (62, 62%). CONCLUSIONS: Retention in HIV care and viral suppression are high in an urban methadone clinic providing integrated HIV services. This quality improvement analysis supports integrating HIV primary care with methadone treatment services for this at-risk population.

Ethnically diverse patients' perceptions of clinician computer use in a safety-net clinic.

Electronic health record (EHR) implementation may affect patient-clinician communication for diverse safety-net populations. We conducted a cross-sectional survey of English-, Spanish-, and Cantonese-speaking patients in a public hospital clinic with a basic EHR. We examined multivariate associations of patient race/ethnicity, language, and education with perceptions of primary-care provider (PCP) computer use. Among 399 respondents, 25% had less than a high school education, 22% preferred Spanish, and 17% Cantonese. Asian (AOR 3.1), non-English-speakers (AOR 3.6) were more likely to report that PCPs used the computer half or more of the visit. Asians were more likely to report that computers helped PCPs remember patient concerns (AOR 5.6). Non-English-speakers had lower odds of reporting that PCPs listened less carefully to them because of computers (AOR 0.3). Patients at risk for communication barriers may perceive advantages of PCP computer use. Safety-net clinics should consider EHR impact on communication disparities.