Ruth Finkelstein

Hiv Treatment Outcomes Among Hiv-infected, Opioid-dependent Patients Receiving Buprenorphine/naloxone Treatment within Hiv Clinical Care Settings: Results From a Multisite Study

Background:Having opioid dependence and HIV infection are associated with poor HIV-related treatment outcomes. Methods:HIV-infected, opioid-dependent subjects (N = 295) recruited from 10 clinical sites initiated buprenorphine/naloxone (BUP/NX) and were assessed at baseline and quarterly for 12 months. Primary outcomes included receiving antiretroviral therapy (ART), HIV-1 RNA suppression, and mean changes in CD4 lymphocyte count. Analyses were stratified for the 119 subjects not on ART at baseline. Generalized estimating equations were deployed to examine time-dependent correlates for each outcome. Results:At baseline, subjects on ART (N = 176) were more likely than those not on ART (N = 119) to be older, heterosexual, have lower alcohol addiction severity scores, and lower HIV-1 RNA levels; they were less likely to be homeless and report sexual risk behaviors. Subjects initiating BUP/NX (N = 295) were significantly more likely to initiate or remain on ART and improve CD4 counts over time compared with baseline; however, these improvements were not significantly improved by longer retention on BUP/NX. Retention on BUP/NX for three or more quarters was, however, significantly associated with increased likelihood of initiating ART (β = 1.34 [1.18, 1.53]) and achieve viral suppression (β = 1.25 [1.10, 1.42]) for the 64 of 119 (54%) subjects not on ART at baseline compared with the 55 subjects not retained on BUP/NX. In longitudinal analyses, being on ART was positively associated with increasing time of observation from baseline and higher mental health quality of life scores (β = 1.25 [1.06, 1.46]) and negatively associated with being homo- or bisexual (β = 0.55 [0.35, 0.97]), homeless (β = 0.58 [0.34, 0.98]), and increasing levels of alcohol addiction severity (β = 0.17 [0.03, 0.88]). The strongest correlate of achieving viral suppression was being on ART (β = 10.27 [5.79, 18.23]). Female gender (β = 1.91 [1.07, 3.41]), Hispanic ethnicity (β = 2.82 [1.44, 5.49]), and increased general health quality of life (β = 1.02 [1.00,1.04]) were also independently correlated with viral suppression. Improvements in CD4 lymphocyte count were significantly associated with being on ART and increased over time. Conclusions:Initiating BUP/NX in HIV clinical care settings is feasible and correlated with initiation of ART and improved CD4 lymphocyte counts. Longer retention on BPN/NX was not associated with improved prescription of ART, viral suppression, or CD4 lymphocyte counts for the overall sample in which the majority was already prescribed ART at baseline. Among those retained on BUP/NX, HIV treatment outcomes did not worsen and were sustained. Increasing time on BUP/NX, however, was especially important for improving HIV treatment outcomes for those not on ART at baseline, the group at highest risk for clinical deterioration. Retaining subjects on BUP/NX is an important goal for sustaining HIV treatment outcomes for those on ART and improving them for those who are not. Comorbid substance use disorders (especially alcohol), mental health problems, and quality-of-life indicators independently contributed to HIV treatment outcomes among HIV-infected persons with opioid dependence, suggesting the need for multidisciplinary treatment strategies for this population.

Factors affecting willingness to provide buprenorphine treatment

Buprenorphine is an effective long-term opioid agonist treatment. As the only pharmacological treatment for opioid dependence readily available in office-based settings, buprenorphine may facilitate a historic shift in addiction treatment from treatment facilities to general medical practices. Although many patients have benefited from the availability of buprenorphine in the United States, almost half of current prescribers are addiction specialists suggesting that buprenorphine treatment has not yet fully penetrated general practice settings. We examined factors affecting willingness to offer buprenorphine treatment among physicians with different levels of prescribing experience. Based on their prescribing practices, physicians were classified as experienced, novice, or as a nonprescriber and asked to assess the extent to which a list of factors impacted their prescription of buprenorphine. Several factors affected willingness to prescribe buprenorphine for all physicians: staff training; access to counseling and alternate treatment; visit time; buprenorphine availability; and pain medications concerns. Compared with other physicians, experienced prescribers were less concerned about induction logistics and access to expert consultation, clinical guidelines, and mental health services. They were more concerned with reimbursement. These data provide important insight into physician concerns about buprenorphine and have implications for practice, education, and policy change that may effectively support widespread adoption of buprenorphine.

The CASE adherence index: A novel method for measuring adherence to antiretroviral therapy

Abstract The Center for Adherence Support Evaluation (CASE) Adherence Index, a simple composite measure of self-reported antiretroviral therapy (ART) adherence, was compared to a standard three-day self-reported adherence measure among participants in a longitudinal, prospective cross-site evaluation of 12 adherence programs throughout the United States. The CASE Adherence Index, consisting of three unique adherence questions developed for the cross-site study, along with a three-day adherence self-report were administered by interviews every three months over a one-year period. Data from the three cross-site adherence questions (individually and in combination) were compared to three -day self-report data and HIV RNA and CD4 outcomes in cross-sectional analyses. The CASE Adherence Index correlated strongly with the three-day self-reported adherence data (p<0.001) and was more strongly associated with HIV outcomes, including a 1-log decline in HIV RNA level (maximum OR = 2.34; p<0.05), HIV RNA < 400 copies/ml (maximum OR = 2.33; p<0.05) and performed as well as the three-day self-report when predicting CD4 count status. Participants with a CASE Index score >10 achieved a 98 cell mean increase in CD4 count over 12 months, compared to a 41 cell increase for those with scores ≤10 (p<0.05). The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings.

Clinic-based treatment of opioid-dependent HIV-infected patients versus referral to an opioid treatment program: A randomized trial.

BACKGROUND Opioid dependence is common in HIV clinics. Buprenorphine-naloxone (BUP) is an effective treatment of opioid dependence that may be used in routine medical settings. OBJECTIVE To compare clinic-based treatment with BUP (clinic-based BUP) with case management and referral to an opioid treatment program (referred treatment). DESIGN Single-center, 12-month randomized trial. Participants and investigators were aware of treatment assignments. (ClinicalTrials.gov registration number: NCT00130819) SETTING HIV clinic in Baltimore, Maryland. PATIENTS 93 HIV-infected, opioid-dependent participants who were not receiving opioid agonist therapy and were not dependent on alcohol or benzodiazepines. INTERVENTION Clinic-based BUP included BUP induction and dose titration, urine drug testing, and individual counseling. Referred treatment included case management and referral to an opioid-treatment program. MEASUREMENTS Initiation and long-term receipt of opioid agonist therapy, urine drug test results, visit attendance with primary HIV care providers, use of antiretroviral therapy, and changes in HIV RNA levels and CD4 cell counts. RESULTS The average estimated participation in opioid agonist therapy was 74% (95% CI, 61% to 84%) for clinic-based BUP and 41% (CI, 29% to 53%) for referred treatment (P < 0.001). Positive test results for opioids and cocaine were significantly less frequent in clinic-based BUP than in referred treatment, and study participants receiving clinic-based BUP attended significantly more HIV primary care visits than those receiving referred treatment. Use of antiretroviral therapy and changes in HIV RNA levels and CD4 cell counts did not differ between the 2 groups. LIMITATION This was a small single-center study, follow-up was only moderate, and the study groups were unbalanced in terms of recent drug injections at baseline. CONCLUSION Management of HIV-infected, opioid-dependent patients with a clinic-based BUP strategy facilitates access to opioid agonist therapy and improves outcomes of substance abuse treatment. PRIMARY FUNDING SOURCE Health Resources and Services Administration Special Projects of National Significance program.

Stability of adherence to highly active antiretroviral therapy over time among clients enrolled in the treatment adherence demonstration project.

Adherence to antiretroviral medications is essential to therapeutic success. Many published studies have investigated the degree of adherence or nonadherence, but sample sizes have generally been small, and adherence has seldom been viewed as a longitudinal process. This paper investigates the stability of adherence over time among HIV-infected individuals attending adherence support programs in New York State. The study cohort consists of 435 clients who were on HAART at baseline and who completed at least 2 follow-up interviews. Although cross-sectional nonadherence did not exceed 35%, nonadherence reached 54% when considered across all 3 interviews. Analysis of transition matricies revealed moderate stability in adherence over time (e.g., first follow-up adherence was 81.0% for clients adherent at baseline, compared with 58.3% for clients nonadherent at baseline). Second-order transition matricies offered additional predictive utility. Multivariate results indicated that, for some, it was the transition from a desirable to an undesirable state (e.g., from no illicit drug use to illicit drug use) that increased the likelihood of nonadherence, rather than the presence of these characteristics over time. Findings illustrate the importance of multiple, periodic assessments of adherence and the need to consider strategies to increase stability in the factors affecting adherence to HAART.

HIV-related knowledge and adherence to HAART

Near perfect adherence is considered essential for patients on HAART, yet adherence to medical recommendations is rarely so high. Supportive services and reminder tools may help individuals to become adherent, yet it is difficult to determine who may need such interventions. In this study, based on data from the NYSDOH/AIDS Institute Treatment Adherence Demonstration Program, we look at the association between HIV-related knowledge and adherence, hypothesizing that a better understanding of HIVand its treatment is associated with better adherence. In analyses based on 997 participants, knowledge, as measured by five true/false questions, was significantly associated with self-reported adherence. In multivariate analysis, compared to persons with four or five items answered correctly, persons with fewer correct answers were more likely to report missed doses (OR = 1.72 for 2-3 correct, pB/0.01; OR = 2.92 for 0-1 correct, pB/0.05). Our data suggest that providers should include questions focused on knowledge of HIV in their assessments of medication readiness and need for adherence support. Similarly, providers should be diligent with respect to patient education, ensuring that each patient has the information needed to support reasoned decision making and adequate adherence.

Integration of buprenorphine/naloxone treatment into HIV clinical care: lessons from the BHIVES collaborative.

Background:Replication of effective practices requires detailed descriptions of implementation processes, barriers and facilitators, and lessons learned. The experiences of physicians leading the Buprenorphine HIV Evaluation and Support initiative provides valuable information for other HIV providers seeking to integrate medication-assisted treatment services into HIV clinical care. Methods:Evaluation staff conduced site visits to the 10 funded Buprenorphine HIV Evaluation and Support programs to better understand buprenorphine/naloxone (bup/nx) integration practices; services offered; staffing; provider experiences with and perceptions of bup/nx; perceived barriers, facilitators, and sustainability; and recommendations regarding replication of integrated care program components. Interviews with site principal investigators conducted during the last year of program implementation were transcribed, coded, and analyzed according to both pre-identified and emerging themes. Results:Integrated bup/nx and HIV treatment was successfully introduced to community and hospital-based clinics under the direction of infectious disease, psychiatry, and general internal medicine physicians. All but 1 of the principal investigators interviewed were highly satisfied with integrated HIV and bup/nx treatment, and all anticipated continued provision of the service. Multiple prescribers were necessary to ensure sufficient coverage and a bup/nx coordinator (eg, nurse, counselor) was seen as essential to the provision of quality care. Ongoing challenges included multisubstance use and mental health issues among patients; limited adoption of bup/nx treatment among colleagues; and the necessity of incorporating new procedures, including urine toxicology testing into established practice. Conclusions:Findings suggest that integrated bup/nx treatment and HIV care is acceptable to providers and feasible in a variety of practice settings.

Opioid use disorder in the United States: Insurance status and treatment access

BACKGROUND In the United States, insurance status and rates of treatment for individuals with opioid use disorder are unknown. METHODS Cross-sectional survey: 2002-2004 National Survey on Drug Use and Health (NSDUH). Bivariate and multivariate associations between demographics, treatment and insurance status and presence or absence of opioid use disorder were investigated. RESULTS On unadjusted analysis, young respondents, respondents of Hispanic ethnicity (OR 1.5; 95% CI 1.1-2.2), unemployed respondents (OR 2.6; 95% CI 1.8-3.8) and respondents with Medicaid (OR 4.5; 95% CI 2.5-8.3) or lack of insurance (OR 3.2; 95% CI 1.8-5.9) were more likely to have opioid use disorder. On unadjusted analysis among those with any substance use disorder, 12-16 year olds were more likely to have opioid use disorder (OR 3.4; 95% CI 2.0-5.8) than a non-opioid substance use disorder, as were women (OR for men 0.6; 95% CI 0.5-0.7) and unemployed respondents (OR 1.5; 95% CI 1.02-2.1). Only 15.2% of those with past-year opioid use disorder received treatment in the past year. Respondents treated for opioid use had higher rates of Medicaid (p<0.01), Medicare (p<0.01) and other public assistance (p=0.01) compared with those treated for other substances. Treatments for opioid use were more likely to be hospital (p=0.04) and inpatient rehabilitation (p=0.02) settings compared to treatment for other substance use. Among those with opioid use disorder, not being employed was independently associated with receiving treatment (AOR 3.5; 95% CI 1.4-8.5). CONCLUSIONS In the U.S., high rates of unemployment, Medicaid and uninsurance among those with opioid use disorder and low rates of treatment suggest that efforts to expand treatment must include policy strategies to help reach a population with significant barriers to treatment access.

The BHIVES collaborative: organization and evaluation of a multisite demonstration of integrated buprenorphine/naloxone and HIV treatment.

Substance abuse is associated with poor medical and quality-of-life outcomes among HIV-infected individuals. Although drug treatment may reduce these negative consequences, for many patients, options are limited. Buprenorphine/naloxone, an opioid agonist treatment that can be prescribed in the United States in office-based settings, can be used to expand treatment capacity and integrate substance abuse services into HIV care. Recognizing this potential, the US Health Resources and Services Administration funded the development and implementation of demonstration projects that integrated HIV care and buprenorphine/naloxone treatment at 10 sites across the country. An Evaluation and Technical Assistance Center provided programmatic and clinical support as well as oversight for an evaluation that examined the processes for and outcomes of integrated care. The evaluation included patient-level self-report and chart abstractions as well as provider and site level data collected through surveys and in-depth interviews. Although multisite demonstrations pose implementation and evaluation challenges, our experience demonstrates that these can, in part, be addressed through ongoing communication and technical assistance as well as a comprehensive evaluation design that incorporates multiple research methods and data sources. Although limitations to evaluation findings persist, they may be balanced by the scope and “real-world” context of the initiative.

Correlation of a brief perceived stress measure with nonadherence to antiretroviral therapy over time.

Adherence to antiretroviral medications has proven to be a challenge for individuals diagnosed with HIV infection. Nonadherence can lead to treatment failure, HIV resistance, and poor health outcomes. Many published studies have described factors associated with poor adherence, yet few have presented validated scales that could practically be applied in treatment settings to identify individuals at higher risk of nonadherence. This article explores the relationship between a revised version of the Perceived Stress Scale and nonadherence to antiretroviral therapy. The scale consists of the following items: How often in the past month have you felt that you were unable to control the important things in your life; confident in your ability to handle your personal problems; that things were going your way; and difficulties were piling up so high you could not handle them? Response options were “never or rarely,” “sometimes,” “often,” and “mostly or always.” In multivariate analysis, clients who scored in the highest quartile of perceived stress were more than twice as likely to be nonadherent at baseline and follow-up 1 and more than 5 times as likely to be nonadherent at follow-up 2 than clients in the lowest quartile of perceived stress scores.