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Evaluation Results
Throughout the course of the BHIVES evaluation, we will post findings from
the multi-site evaluation in this space. While we do not expect to
have client-level data ready for analysis for several months, we do hope
to have descriptions of the integrated program models, case studies, and
other products available soon.
JAIDS SUPPLEMENT
The findings from this project are presented in a special issue of JAIDS: Journal of Acquired Immune Deficiency Syndromes (Volume 56, Supplement 1, March, 2011, Edited by Gerald Friedland
and David Vlahov). The 104 page supplement is a collection of 15
articles.
To view ToC and download articles:
JAIDS, V56(S1),March, 2011
(ToC and abstracts below).
JAIDS: Journal of Acquired Immune Deficiency Syndromes
Volume 56, Supplement 1, March, 2011
Editor Introduction
Gerald Friedland and David Vlahov
A Model Federal Collaborative to Increase Patient Access to Buprenorphine Treatment in HIV Primary Care.
Cheever LW, Kresina TF, Cajina A, Lubran R.
Abstract: A Health Resources Services Administration–Substance Abuse and Mental Health Services Administration collaboration was established to improve health outcomes for opiate-dependent HIV-infected patients through promotion of integrated models of HIV primary care and substance abuse treatment. The collaboration comprised 10 demonstration sites coordinated by a technical assistance/evaluation center that worked to refine planned interventions, address state-of-the-art treatment and policy issues relating to the use of buprenorphine opioid abuse treatment in HIV primary care settings, conduct local and multisite evaluations, and disseminate program findings. This article describes the goals and objectives of the collaborative as well as the interagency interactions and steps taken to establish the collaborative.
The BHIVES collaborative: Organization and Evaluation of a Multi-Site Demonstration of Integrated Buprenorphine/Naloxone and HIV Treatment.
Weiss L, Egan JE, Botsko M, Netherland J, Fiellin DA, Finkelstein R.
Abstract: 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 officebased 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.
Participant Characteristics and HIV Risk Behaviors among Individuals Entering Integrated Buprenorphine/Naloxone and HIV Care.
Chaudhry AA, Botsko M, Weiss L, Egan JE, Mitty J, Estrada B, Lucas GM, Woodson T, Flanigan T, Fiellin DA.
Objective: This study was part of a national, multisite demonstration project evaluating the impact of integrated buprenorphine/naloxone treatment and HIV care. The goals of this study were to describe the baseline demographic, clinical, and substance use characteristics of the participants and to explore HIV transmission risk behaviors in this group. Methods: Nine sites across the United States participated. Data obtained by interview and chart review included demographic information, medical history, substance use, and risk behaviors. Weperformed a descriptive analysis of patient characteristics at entry and used logistic regression to evaluate factors associated with 1) unprotected anal or vaginal sex; and 2) needle-sharing within the previous 90 days. Results: Three hundred eighty-six individuals were included in the study: 303 (78.5%) received buprenorphine/naloxone; 41 (10.6%) received methadone; and 42 (10.9%) received another form of treatment. The analysis of risk behaviors was limited to those in the buprenorphine group (n = 303). Among those reporting vaginal or anal sex in the previous 90 days, 24% had sex without a condom. Factors significantly associated with unprotected sex were: having a partner; female gender; and alcohol use in previous 30 days. A total of 8.9% of participants shared needles in the previous 90 days. Factors significantly associated with needle-sharing were: amphetamine use; marijuana use; homelessness; and anxiety. Conclusions: Addressing transmission risk behaviors is an important secondary HIV prevention strategy. In addition to treatment for opioid dependence, addressing other substance use, social issues, particularly housing, and mental health may have important implications for reducing HIV transmission in HIV-infected opioid-dependent patients.
HIV Treatment Outcomes among HIV-infected, Opioid-Dependent Patients Receiving Buprenorphine/Naloxone Treatment and HIV Care: Results from a Multi-site Study.
Altice FL, Bruce RD, Lucas GM, Lum P, Korthuis PT, Flanigan T, Cunningham C, Sullivan LE, Vergara-Rodriguez P, Fiellin DA, Cajina A, Botsko M, Nandi V, Gourevitch M, Finkelstein R.
Background: 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 significantly associated with increased likelihood of initiating ART (b = 1.34 [1.18, 1.53]) and achieve viral suppression (b = 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 (b = 1.25 [1.06, 1.46]) and negatively associated with being homo- or bisexual (b = 0.55 [0.35, 0.97]), homeless (b = 0.58 [0.34, 0.98]), and increasing levels of alcohol addiction severity (b = 0.17 [0.03, 0.88]). The strongest correlate of achieving viral suppression was being on ART (10.27 [5.79, 18.23]). Female gender (b = 1.91 [1.07, 3.41]), Hispanic ethnicity (b = 2.82 [1.44, 5.49]), and increased general health quality of life (b = 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 (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.
Drug Treatment Outcomes among HIV-Infected Opioid-Dependent Patients Receiving Buprenorphine/Naloxone.
Fiellin DA, Weiss L, Botsko M, Egan JE, Altice FL, Bazerman LB, Chaudhry AA, Cunningham C, Gourevitch MN, Lum PJ, Sullivan LE, Schottenfeld RS, O'Connor PG.
Background: Buprenorphine/naloxone allows the integration of opioid dependence and HIV treatment. Methods: We conducted a prospective study in HIV-infected opioid-dependent patients to investigate the impact of buprenorphine/ naloxone treatment on drug use. Self-report and chart review assessments were conducted every 3 months (quarters 1–4) for 1 year. Outcomes were buprenorphine/naloxone treatment retention, drug use, and addiction treatment processes. Results: Among 303 patients enrolled between July 2005 and December 2007, retention in buprenorphine/naloxone treatment was 74%, 67%, 59%, and 49% during Quarters 1, 2, 3, and 4, respectively. Past 30-day illicit opioid use decreased from 84% of patients at baseline to 42% in retained patients over the year. Patients were 52% less likely to use illicit opioids for each quarter in treatment (Odds ratio = 0.66; 95% CI: 0.61 to 0.72). Buprenorphine/naloxone doses and office visits approximated guidelines published by the United States Department of Health and Human Services. Urine toxicology monitoring was less frequent than recommended. Conclusions: Buprenorphine/naloxone provided in HIV treatment settings can decrease opioid use. Strategies are needed to improve retention and address ongoing drug use in this treatment population.
Improved Quality of Life for Opioid Dependent patients receiving Buprenorphine Treatment in HIV Clinics.
Korthuis PT, Tozzi MJ, Nandi V, Fiellin DA, Weiss L, Egan JE, Botsko M, Acosta A, Gourevitch MN, Hersh D, Hsu J, Boverman J, Altice FL, Egan JE, Netherland J, Gass J, Finkelstein R, Weiss L.
Background: Opioid dependence and HIV infection are associated with poor health-related quality of life (HRQOL). Buprenorphine/naloxone (bup/nx) provided in HIV care settings may improve HRQOL. Methods: We surveyed 289 HIV-infected opioid-dependent persons treated with clinic-based bup/nx about HRQOL using the Short Form Health Survey (SF-12) administered at baseline, 3, 6, 9, and 12 months. We used normalized SF-12 scores, which correspond to a mean HRQOL of 50 for the general US population (SD 10, possible range 0–100). We compared mean normalized mental and physical composite and component scores in quarters 1, 2, 3, and 4 with baseline scores using generalized estimating equation models. We assessed the effect of clinic-based bup/nx prescription on HRQOL composite scores using mixed effects regression with site as random effect and time as repeated effect. Results: Baseline normalized SF-12 scores were lower than the general US population for all HRQOL domains. Average composite mental HRQOL improved from 38.3 (SE 12.5) to 43.4 (SE 13.2) [b 1.13 (95% CI: 0.72 to 1.54)] and composite physical HRQOL remained unchanged [b 0.21 (95% CI: 20.16 to 0.57)] over 12 months follow-up. Continued bup/nx treatment across all 4 quarters was associated with improvements in both physical [b 2.38 (95% CI: 0.63 to 4.12)] and mental [b 2.51 (95% CI: 0.42 to 4.60)] HRQOL after adjusting for other contributors to HRQOL. Conclusions: Clinic-based bup/nx maintenance therapy is potentially effective in ameliorating some of the adverse effects of opioid dependence on HRQOL for HIV-infected populations.
Patient Perspectives on Buprenorphine/Naloxone Treatment in the Context of HIV Care.
Egan JE, Netherland J, Gass J, Finkelstein R, Weiss L.
Background: Research has shown that buprenorphine/naloxone (bup/nx) is a safe and effective treatment for opioid dependence. Few reports, however, describe the patient perspective on bup/nx treatment and its integration into HIV care settings. Methods: We conducted qualitative interviews with 33 patients to further investigate patient satisfaction and experience with bup/nx treatment and integrated care. Interviews focused on drug use/cessation history; attitudes toward and satisfaction with bup/nx treatment; and perspectives on integrated bup/nx treatment and HIV care. Results: Patients were overwhelmingly satisfied with the pharmacologic effects and treatment outcomes of bup/nx, including effectiveness in blocking cravings and controlling opioid use; decreased fear of withdrawal and/or missing doses; and an overall improvement in quality of life. Patients also described being more engaged with both their substance abuse treatment and HIV care, including greater ability to manage their own treatment, keep, appointments, and adhere to antiretroviral medication regimes. Counseling was seen by some patients as an important component of bup/nx treatment. Nearly all were positive about their experience with integrated care, appreciating an improved drug treatment environment, convenience, and quality of care. Conclusions: Findings suggest that patients report bup/nx to be a viable treatment and many prefer it to other opioid replacements therapies.
The Impact of Cocaine Use on Outcomes in HIV-Infected Patients Receiving Buprenorphine/Naloxone.
Sullivan LE, Botsko M, Cunningham C, O'Connor PG, Hersh D, Mitty J, Lum PJ, Schottenfeld RS, Fiellin DA.
Background: Cocaine use is common in opioid-dependent HIV-infected patients, but its impact on treatment outcomes in these patients receiving buprenorphine/naloxone is not known. Methods: We conducted a prospective study in 299 patients receiving buprenorphine/naloxone who provided baseline cocaine data and a subset of 266 patients who remained in treatment for greater than or equal to one quarter. Assessments were conducted at baseline and quarterly for 1 year. We evaluated the association between baseline and in-treatment cocaine use on buprenorphine/ naloxone retention, illicit opioid use, antiretroviral adherence, CD4 counts, HIV RNA, and risk behaviors. Results: Sixty-six percent (197 of 299) of patients reported baseline cocaine use and 65% (173 of 266) of patients with follow-up data reported in-treatment cocaine use. Baseline and in-treatment cocaine use did not impact buprenorphine/naloxone retention, antiretroviral adherence, CD4 lymphocytes, or HIV risk behaviors. However, baseline cocaine use was associated with a 14.8 (95% confidence interval [CI], 9.0–24.2) times greater likelihood of subsequent cocaine use (95% CI, 9.0–24.2), a 1.4 (95% CI, 1.02–2.00) times greater likelihood of subsequent opioid use, and higher log10 HIV RNA (P , 0.016) over time. In-treatment cocaine use was associated with a 1.4 (95% CI, 1.01–2.00) times greater likelihood of concurrent opioid use. Conclusions: Given cocaine use negatively impacts opioid and HIV treatment outcomes, interventions to address cocaine use in HIV infected patients receiving buprenorphine/naloxone treatment are warranted.
Hepatic Safety and Lack of Antiretroviral Interactions with Buprenorphine/Naloxone in HIV-Infected Opioid Dependent Patients.
Vergara-Rodriguez P, Tozzi MJ, Botsko M, Nandi V, Altice FL, Egan JE, O'Connor PG, Sullivan LE, Fiellin DA.
Background: The safety of buprenorphine/naloxone (bup/nx) in HIV-infected patients has not been established. Prior reports raise concern about hepatotoxicity and interactions with atazanavir. Methods: We conducted a prospective cohort study of 303 opioiddependent HIV-infected patients initiating bup/nx treatment. We assessed changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) over time. We compared bup/nx doses in patients receiving the antiretroviral atazanavir to those not receiving atazanavir. We conducted surveillance for pharmacodynamic interactions. Results: Median AST [37.0 vs. 37.0 Units/L (U/L respective interquartile ranges (IQRs) 26–53 and 26–59] and ALT (33.0 vs. 33.0 U/L, respective IQRs 19–50 and 18–50) values did not change over time among 141 patients comparing pre-bup/nx exposure with post-bup/nx exposure measures. During bup/nx exposure, 207 subjects demonstrated no significant change in median AST (36.0 vs. 35.0 U/L, respective IQRs 25–57 and 25–61) and ALT (29.0 vs. 31.0 U/L, respective IQRs 19–50 and 18–50) values collected a median of 6 months apart. Analyses restricted to patients with hepatitis C and HIV co-infection yielded similar results, except a small but significant decrease in first and last AST, during treatment with bup/nx (P = 0.048). Mean bup/nx dose, ranging 16.0–17.8 mg, did not differ over time or with co-administration of atazanavir. No pharmacodynamic interactions were noted. Conclusions: Buprenorphine/naloxone did not produce measurable hepatic toxicity or pharmacodynamic interaction with atazanavir in HIV-infected opioid-dependent patients.
Integration of Buprenorphine/Naloxone Treatment into HIV Clinical Care: Lessons from the BHIVES Collaborative.
Weiss L, Netherland J, Egan JE, Flanigan T, Fiellin DA, Finkelstein R, Altice FL.
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.
The Cost of Integrated HIV Care and Buprenorphine/Naloxone Treatment: Results of a Cross-Site Evaluation.
Schackman BS, Leff J, Botsko M, Fiellin DA, Altice FL, Korthuis PT, Sohler N, Weiss L, Egan JE, Netherland J, Gass J, Finkelstein R.
Background: Implementing integrated HIV and buprenorphine/ naloxone treatment requires cost estimates to plan and obtain funding. Methods: We identified costs incurred at HIV clinical sites participating in a cross-site evaluation of integrated care that followed patients for 1 year. Costs include labor, overhead, and urine toxicology analyses (clinic perspective), buprenorphine/naloxone (payer perspective) and patient time and transportation (patient perspective). Sites provided resource utilization quarterly, and providers estimated time required for each activity. With site as the unit of analysis, results are reported as median (range) of average site costs in 2008 US dollars. Results: The median number of monthly provider encounters for integrated care patients was 3.2 (1.5–13.3) compared with 1.7 (1.1–4.2) for similar patients not in integrated care, but integrated care patients had fewer physician encounters. Median monthly clinic costs per integrated care patient were $136 ($67–$677) for labor and overhead and $8 ($2–$23) for toxicology analyses, $22 higher than clinic costs for patients not in integrated care. Median monthly costs for buprenorphine/naloxone were $209 ($165–$272), and monthly patient costs in integrated care were $11 ($1–$54) higher. Conclusions: Integrated HIV and buprenorphine/naloxone treatment requires different resources, including costs that are not third-party reimbursed. Implementing integrated care will require funding for training and for new staff such as buprenorphine coordinators, in addition to reimbursement for buprenorphine/naloxone. Further research is needed to identify potential cost offsets outside of the clinic setting.
Improving Adherence to HIV Quality of Care Indicators in Persons with Opioid Dependence: The Role of Buprenorphine.
Korthuis PT, Fiellin DA, Rongwei F, Lum PJ, Altice FL, Sohler N, Tozzi MJ, Asch SM, Botsko M, Fishl M, Flannigan T, Boverman J, McCarty D.
Background: Opioid-dependent HIV-infected patients are less likely to receive HIV quality of care indicators (QIs) compared with nondependent patients. Buprenorphine/naloxone maintenance therapy (bup/nx) could affect the quality of HIV care for opioid dependent patients. Methods: We abstracted 16 QIs from medical records at nine HIV clinics 12 months before and after initiation of bup/nx versus other treatment for opioid dependence. Summary quality scores (number of QIs received/number eligible 3 100) were calculated. We compared change in QIs and summary quality scores in patients receiving bup/nx versus other participants. Results: One hundred ninety-four of 268 participants (72%) received bup/nx and 74 (28%) received other treatment. Mean summary quality scores increased over 12 months for participants receiving bup/nx (45.6% to 51.6%, P , 0.001) but not other treatment (48.6% to 47.8%, P = 0.788). Bup/nx participants experienced improvements in six of 16 HIV QIs versus three of 16 QIs in other participants. Improvements were mostly in preventive and monitoring care domains. In multivariate analysis, bup/nx was associated with improved summary quality score (b 8.55; 95% confidence interval, 2.06–15.0). Conclusions: In this observational cohort study, HIV-infected patients with opioid dependence received approximately half of HIV QIs at baseline. Buprenorphine treatment was associated with improvement in HIV QIs at 12 months. Integration of bup/nx into HIV clinics may increase receipt of high-quality HIV care. Further research is required to assess the effect of improved quality of HIV care on clinical outcomes.
Opioid Prescribing and Provider Confidence Recognizing Opioid Abuse in HIV Primary Care Settings.
Lum PJ, Little S, Botsko M, Hersh D, Thawley RE, Egan JE, Mitty J, Boverman J, Fiellin DA.
Background: Pain syndromes are common in HIV-infected patients, who also are commonly affected by opioid-use disorders. Although opioids can treat pain, prescribers must consider the consequences of iatrogenic or missed addiction diagnoses. Methods: In an anonymous online survey, we asked a national sample of HIV providers about their demographics, experience, and patients, and their practices and attitudes about chronic opioid therapy, addiction, and confidence recognizing opioid analgesic abuse. Results: One hundred six providers reported 28% of their patients had chronic pain; 21% received opioid analgesics; 37% were HIV infected by injecting drug use; and 12% were addicted to prescription opioids. Few providers followed recommended guidelines for chronic opioid therapy in nonmalignant pain. Mean provider confidence was 6.3 on a scale of 10. Higher confidence was associated with provider sex (P , 0.05), patient volume (P , 0.03), discussing substance use, (P , 0.05), urine toxicology (P , 0.01), prescribing longer acting opioids (P = 0.005), and prescribing buprenorphine (P = 0.009). Conclusions: HIV providers seldom follow recommended guidelines for opioid prescribing and have limited confidence in their ability to recognize opioid analgesic abuse. Clinical practices developed to reduce misuse and increase early detection and treatment of opioid dependence are associated with higher confidence. The implementation of guidelines to improve the quality of opioid prescribing in HIV clinics may aid in the diagnosis of addictive disorders and prevent their adverse outcomes.
Policy Implications of Integrating Buprenorphine/Naloxone Treatment and HIV Care.
Finkelstein R, Netherland J, Sylla L, Gourevitch MN, Cajina A, Cheever LW.
Abstract: Researchers, practitioners, and policymakers have long recognized the potential benefits of providing integrated substance abuse and medical care services, particularly for special populations such as people living with HIV/AIDS. Buprenorphine, an office based pharmacological treatment for opioid dependence, offers new opportunities for integrating drug treatment into HIV care settings. However, the historical separation between the drug treatment and medical care systems has resulted in a host of policy barriers. The Buprenorphine and HIV Care Evaluation and Support initiative, a multisite demonstration project to assess the feasibility and effectiveness of integrating buprenorphine/naloxone into HIV care settings, provided an opportunity to evaluate if and how policy barriers affect efforts to integrate HIV care and addiction treatment. We found that financing issues, workforce and training issues, and the operational consequences of some conceptual differences between HIV care and addiction treatment are barriers to the full integration of buprenorphine into HIV care. We recommend changes to financing and reimbursement policies, programs to strengthen the addiction treatment skills of physicians, and cross training between the fields of addiction, medicine, drug treatment, and HIV medicine. By addressing some of the policy barriers to integration, this promising new treatment can help the thousands of people living with HIV/AIDS who are also opioid dependent.
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