HIV And HCV adherence and treatment outcomes among people who inject drugs receiving opioid agonist therapy.

Among people who inject drugs (PWID), 60% have HCV and 50-90% of HIV-infected PWID are co-infected with HCV. Data comparing adherence to direct-acting antiviral (DAA) therapy among HCV mono-infected and HIV/HCV co-infected PWID is limited. The impact of HCV treatment initiation on HIV antiretroviral therapy (ART) adherence is also poorly understood. We assessed DAA adherence in HCV mono-infected and HIV/HCV co-infected PWID and examined changes in ART adherence and HIV outcomes following HCV treatment. Study was conducted in three Medication for Opioid use Disorder (MOUD) programs in Bronx, New York. HCV treatment adherence was measured using electronic blister packs. 2-week DAA adherence rates were compared and controlled for study arm, psychiatric illness and alcohol intoxication within the past 30 days. ART adherence was measured using participant self-report and dichotomized to "excellent" or "other". ART adherence, CD4 count, and HIV viral load were identified six months prior to, during, and six months after HCV treatment. Statistical significance was assessed with mixed-effects regression linear or logistic models. Overall DAA adherence rates among HCV mono-infected and HIV/HCV co-infected PWID were 74% (95% CI=71-78%) and 76% (95%CI=70-83%), respectively (p=.55). There were no significant changes in ART adherence, CD4 counts, or HIV viral loads prior to, during, or after HCV treatment. This is the first study assessing the impact of DAA therapy on ART adherence and HIV treatment outcomes among PWID. It is one of the first to compare DAA adherence among HCV and HIV/HCV co-infected PWID. Our data demonstrate no significant difference in DAA adherence and no significant impact of HCV treatment on ART adherence or HIV outcomes.

Hepatitis C Virus Direct-Acting Antiviral Treatment Adherence Patterns and Sustained Viral Response Among People Who Inject Drugs Treated in Opioid Agonist Therapy Programs.

BACKGROUND: Adequate medication adherence is critical for achieving sustained viral response (SVR) of hepatitis C virus (HCV) among people who inject drugs (PWID). However, it is less known which patterns of direct-acting antiviral (DAA) treatment adherence are associated with SVR in this population or what factors are associated with each pattern. METHODS: The randomized 3-arm PREVAIL study used electronic blister packs to obtain daily time frame adherence data in opiate agonist therapy program settings. Exact logistic regressions were applied to test the associations between SVR and 6 types of treatment adherence patterns. RESULTS: Of the 113 participants treated with combination DAAs, 109 (96.5%) achieved SVR. SVR was significantly associated with all pattern parameters except for number of switches between adherent and missed days: total adherent daily doses (exact adjusted odds ratio [AOR] = 1.12; 95% confidence interval [CI] = 1.04-1.22), percent total doses (1.09; 1.03-1.16), days on treatment (1.16; 1.05-1.32), maximum consecutive adherent days (1.34; 1.06-2.04), and maximum consecutive nonadherent days (0.85; .74-.95 = 0.003). SVR was significantly associated with total adherent doses in the first 2 months of treatment, it was not in the last month. While alcohol intoxication was significantly associated with frequent switches, drug use was not associated with any adherence pattern. CONCLUSIONS: Consistent maintenance of adequate total dose adherence over the entire course of HCV treatment is important in achieving SVR among PWID. Additional integrative addiction and medical care may be warranted for treating PWID who experience alcohol intoxication.

New normal: caring for hospitalised patients in the Bronx, New York, during COVID-19.

The Bronx, New York, is the poorest congressional district in the United States and has the highest COVID-19 infection rate in New York City. COVID-19 has led to major changes in our healthcare system, including heightened infection-control practices, novel staffing patterns and widespread social distancing. In this article, we describe how our experience with inpatient care has changed in the wake of COVID-19.

When human immunodeficiency virus (HIV) treatment goals conflict with guideline-based opioid prescribing: A qualitative study of HIV treatment providers.

BACKGROUND: Human immunodeficiency virus (HIV)-infected patients have a high prevalence of chronic pain and opioid use, making HIV care a critical setting for improving the safety of opioid prescribing. Little is known about HIV treatment providers' perspectives about opioid prescribing to patients with chronic pain. METHODS: The authors administered a questionnaire and conducted semistructured telephone interviews with 18 HIV treatment providers (infectious disease specialists, general internists, family medicine physicians, nurse practitioners, and physician assistants) in Bronx, NY. Open-ended interview questions focused on providers' experiences, beliefs, and attitudes about opioid prescribing and about the use of guideline-based opioid prescribing practices (conservative prescribing, and monitoring for and responding to misuse). Transcripts were thematically analyzed using a modified grounded theory approach. RESULTS: Eighteen HIV treatment providers included 13 physicians, four nurse practitioners, and one physician assistant. They were 62% female, 56% white, and practiced as HIV treatment providers for a mean of 14.6 years. Most reported always or almost always using opioid treatment agreements (56%) and urine drug testing (61%) with their patients on long-term opioid therapy. HIV treatment providers tended to view opioid prescribing for chronic pain within the "HIV paradigm," a set of priorities and principles defined by three key themes: (1) primacy of HIV goals, (2) familiarity with substance use, and (3) the clinician as ally. The HIV paradigm sometimes supported, and sometimes conflicted with, guideline-based opioid prescribing practices. For HIV treatment providers, perceived alignment with the HIV paradigm determined whether and how guideline-based opioid prescribing practices were adopted. For example, the primacy of HIV goals superseded conservative opioid prescribing when providers prescribed opioids with the goal of retaining patients in HIV care. CONCLUSION: These findings highlight unique factors in HIV care that influence adoption of guideline-based opioid prescribing practices. These factors should be considered in future research and initiatives to address opioid prescribing in HIV care.

Loss, liberation, and agency: Patient experiences of methadone treatment at opioid treatment programs during the COVID-19 pandemic.

BACKGROUND: Despite its safety and effectiveness, methadone treatment for opioid use disorder (OUD) remains highly stigmatized, and stringent opioid treatment program (OTP) attendance requirements create barriers to retention for many patients. The COVID-19 pandemic prompted a shift in federal regulations governing methadone, including a blanket exemption permitting increased take-home doses of methadone. We studied the impact of these changes upon established patients' experiences of OTP care. METHOD: We conducted semi-structured qualitative interviews with 18 OTP patients who met our criteria of having established OTP care (i.e., enrolled at the OTP for at least 12 weeks) and were administered methadone three to six days weekly prior to the March 2020 blanket exemption. Interviews centered on how COVID-19 had affected their experiences of receiving treatment at an OTP. RESULTS: We identified three interconnected themes relevant to transformation of OTP care by the COVID-19 pandemic. Participants described mourning therapeutic OTP relationships and structure (1. loss), yet feeling more satisfaction with fewer in-person OTP visits (2. liberation), and appreciating more opportunities to self-direct their OUD care (3. agency). DISCUSSION: Structural changes made to OTP care early in the COVID-19 pandemic resulted in loss of community and structure. Increasing the availability of take-home methadone also improved patient experience and sense of agency. Our findings join a diverse body of converging evidence in support of policy changes allowing for more flexible dosing and individualized OTP care.

Offering nurse care management for opioid use disorder in primary care: Impact on emergency and hospital utilization in a cluster-randomized implementation trial.

BACKGROUND: Patients with opioid use disorder (OUD) have increased emergency and hospital utilization. The PROUD trial showed that implementation of office-based addiction treatment (OBAT) increased OUD medication treatment compared to usual care, but did not decrease acute care utilization in patients with OUD documented pre-randomization (clinicaltrials.gov/study/NCT03407638). This paper reports secondary emergency and hospital utilization outcomes in patients with documented OUD in the PROUD trial. METHODS: This cluster-randomized implementation trial was conducted in 12 clinics from 6 diverse health systems (March 2015-February 2020). Patients who visited trial clinics and had an OUD diagnosis within 3 years pre-randomization were included in primary analyses; secondary analyses added patients with OUD who were new to the clinic or with newly-documented OUD post-randomization. Outcomes included days of emergency care and hospital utilization over 2 years post-randomization. Explanatory outcomes included measures of OUD treatment. Patient-level analyses used mixed-effect regression with clinic-specific random intercepts. RESULTS: Among 1988 patients with documented OUD seen pre-randomization (mean age 49, 53 % female), days of emergency care or hospitalization did not differ between intervention and usual care; OUD treatment also did not differ. In secondary analyses among 1347 patients with OUD post-randomization, there remained no difference in emergency or hospital utilization despite intervention patients receiving 32.2 (95 % CI 4.7, 59.7) more days of OUD treatment relative to usual care. CONCLUSIONS: Implementation of OBAT did not reduce emergency or hospital utilization among patients with OUD, even in the sample with OUD first documented post-randomization in whom the intervention increased treatment.

Teaching and assessing residents' skills in managing heroin addiction with objective structured clinical examinations (OSCEs).

BACKGROUND: Heroin-abusing patients present a significant challenge. Objective Structured Clinical Examinations (OSCEs) allow evaluation of residents' clinical skills. The objective of this study was to examine residents' OSCE performance assessing and managing heroin abuse. METHODS: Evaluation and comparison of heroin-specific communication, assessment, and management skills in a 5-station postgraduate year 3 (PGY3) substance abuse OSCE. Faculty used a 4-point Likert scale to assess residents' skills; standardized patients provided written comments. RESULTS: Two hundred sixty-five internal and family medicine residents in an urban university hospital participated over 5 years. In the heroin station, residents' skills were better (P < .001 for both comparisons) in communication (mean overall score: 316 ± 0.51) than in either assessment (mean overall score: 2.66 ± 0.60) or management (mean overall score: 2.50 ± 0.73). The mean score for assessing specific high-risk behaviors was lower than the mean overall assessment score (222 ± 1.01 vs. 2.74 ± .59; P < .0001), and the mean score for recommending appropriate harm reduction management strategies was lower than the mean overall management score (2.39 ± .89 vs. 2.54 ± .74; P < .005). Standardized patients' comments reflected similar weaknessess in residents' skills. CONCLUSIONS: Assessment and management of heroin abuse were more challenging for residents than general communication. Additional training is required for residents to assess and counsel patients about high-risk behaviors.

Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial.

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. Objective: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization. Design, Setting, and Participants: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system's randomization date through 2 years after. Intervention: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine. Main Outcomes and Measures: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up. Results: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70). Conclusions and Relevance: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT03407638.

Strategies to improve access to and utilization of health care services and adherence to antiretroviral therapy among HIV-infected drug users.

We review five innovative strategies to improve access, utilization, and adherence for HIV-infected drug users and suggest areas that need further attention. In addition, we highlight two innovative programs. The first increases access and utilization through integrated HIV and opioid addiction treatment with buprenorphine in a community health center, and the second incorporates adherence counseling for antiretroviral therapy in methadone programs. Preliminary evaluations demonstrated that these strategies may improve both HIV and opioid addiction outcomes and may be appropriate for wider dissemination. Further refinement and expansion of strategies to improve outcomes of HIV-infected drug users is warranted.

Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial.

BACKGROUND AND AIMS: Level of adherence to tobacco cessation medication regimens is believed to be causally related to medication effectiveness. This study aimed to evaluate the efficacy of varenicline directly observed therapy (DOT) on varenicline adherence and smoking cessation rates among smokers with opioid use disorder (OUD) receiving methadone treatment. DESIGN: Multicenter, parallel-group two-arm randomized controlled trial. SETTING: Urban opioid treatment program (OTP) in the Bronx, New York, USA. PARTICIPANTS: Daily smokers of ≥ 5 cigarettes/day, interested in quitting (ladder of change score 6-8), in methadone treatment for ≥ 3 months, attending OTP ≥ 3 days/week. Participants' mean age was 49 years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes/day. INTERVENTIONS: Individual, block, random assignment to 12 weeks of varenicline, either directly observed with methadone (DOT, n = 50) or via unsupervised self-administered treatment (SAT, n = 50). MEASUREMENTS: The primary outcome was adherence measured by pill count. The secondary outcome was 7-day point prevalence tobacco abstinence verified by expired carbon monoxide (CO) < 8 parts per million. FINDINGS: Retention at 24 weeks was 92%. Mean adherence was 78.5% [95% confidence interval (CI) = 71.8-85.2%] in the DOT group versus 61.8% in the SAT group (95% CI = 55.0-68.6%); differences were driven by DOT effects in the first 6 weeks. CO-verified abstinence did not differ between groups during the intervention (P = 0.26), but was higher in the DOT than the SAT group at intervention end (DOT = 18% versus SAT = 10%, difference = 8%, 95% CI = -13, 28); this difference was not significant (P = 0.39) and was not sustained at 24-week follow-up. CONCLUSIONS: Among daily smokers attending opioid treatment programs, opioid treatment program-based varenicline directly observed therapy was associated with early increases in varenicline adherence compared with self-administered treatment, but findings were inconclusive as to whether directly observed therapy was associated with a difference in tobacco abstinence.

Use of Cannabis to Relieve Pain and Promote Sleep by Customers at an Adult Use Dispensary.

Medical cannabis patients consistently report using cannabis as a substitute for prescription medications; however, little is known about individuals accessing cannabis through adult-use markets. A survey at two retail stores was conducted in Colorado, United States. Between August 2016 and October 2016, store staff asked customers if they wanted to participate and, if so, provided an electronic survey link. All customers reporting medical certification were excluded. Of 1,000 adult-use only customer respondents, 65% reported taking cannabis to relieve pain and 74% reported taking cannabis to promote sleep. Among respondents taking cannabis for pain, 80% reported that it was very or extremely helpful, and most of those taking over-the-counter pain medications (82%) or opioid analgesics (88%) reported reducing or stopping use of those medications. Among respondents taking cannabis for sleep, 84% found it very or extremely helpful, and most of those taking over-the-counter (87%) or prescription sleep aids (83%) reported reducing or stopping use of those medications. De facto medical use of cannabis for symptom relief was common among adult-use dispensary customers and the majority reported that cannabis decreased their medication use. Adult use cannabis laws may broaden access to cannabis for the purpose of symptom relief.

An intervention to improve advance emergency contraceptive prescribing practices among academic primary care physicians.

BACKGROUND: Primary care physicians care for reproductive-aged women, yet do not routinely counsel women about or prescribe contraceptives, including emergency contraception (EC). STUDY DESIGN: We used a pre-/post-study to design to assess whether the proportion of primary care physicians who counseled women about and prescribed EC increased 6 months after a peer-led intervention with educational and reminder components. Participants included 36 residents and attending physicians at an academically affiliated internal medicine practice from July 2004 to June 2005 (when prescription was required for EC in New York). Data were collected by self-administered questionnaire. RESULTS: At baseline, 37% of participants had counseled women about EC and 34% had prescribed EC in the prior month. After the intervention, 80% of participants had counseled women about EC (p<.001) and 66% had prescribed EC (p=.03) in the prior month. CONCLUSION: Six months after a peer-led intervention including educational and reminder components, the proportion of primary care physicians who had counseled women about and prescribed EC in the past month increased significantly.

Empowering With PrEP (E-PrEP), a Peer-Led Social Media-Based Intervention to Facilitate HIV Preexposure Prophylaxis Adoption Among Young Black and Latinx Gay and Bisexual Men: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Young black and Latinx, gay, bisexual, and other men who have sex with men (YBLGBM, aged 18-29 years) have among the highest rates of new HIV infections in the United States and are not consistently reached by existing prevention interventions. Preexposure prophylaxis (PrEP), an oral antiretroviral regimen taken daily by HIV-uninfected individuals to prevent HIV acquisition, is highly efficacious in reducing HIV acquisition and could help stop the HIV epidemic in YBLGBM. Use of social media (eg, Facebook, Twitter, online dating sites) is ubiquitous among young people, providing an efficient avenue to engage YBLGBM to facilitate PrEP adoption. OBJECTIVE: Our overall goal was to develop and pilot test a theoretically grounded, social media-based, peer-led intervention to increase PrEP uptake in YBLGBM. We used diffusion of innovation and information-motivation-behavioral skills frameworks to (1) identify potential factors associated with interest in and adoption of PrEP among YBLGBM; (2) develop Empowering with PrEP (E-PrEP), a social media-based, peer-led intervention to increase PrEP uptake in YBLGBM; and (3) pilot test the feasibility and acceptability of E-PrEP, and determine its preliminary efficacy for increasing adoption of PrEP by YBLGBM. We describe the development and protocol for E-PrEP. METHODS: Using a participatory research approach, we partnered with YBLGBM intervention development partners to develop a social media-based behavioral intervention to facilitate PrEP uptake, which involved an online messaging campaign disseminated by YBLGBM peer leaders to their existing online networks. We designed the 6-week campaign to provide education about PrEP, increase motivation to use PrEP, and facilitate access to PrEP. We then conducted a cluster-randomized trial of E-PrEP compared with an attention-matched general health control condition (E-Health) among YBLGBM aged 18 to 29 years to assess E-PrEP's feasibility, acceptability, preliminary efficacy for increasing self-reported intention to use PrEP, PrEP uptake, and impact on knowledge and attitudes about PrEP at 12-week follow-up (6 weeks after the end of the online campaign). RESULTS: From October 2016 to March 2017, we developed, pretested, and refined E-PrEP with 6 YBLGBM intervention development partners. From May to June 2017, we recruited, enrolled, and randomly assigned 10 peer leaders (n=5 for each condition). The 10 peer leaders then recruited and enrolled 152 participants from their existing online networks (range 3-33 per peer leader), during June and July 2017. Intervention follow-up was completed after 12 weeks, in November 2017, with analyses underway. CONCLUSIONS: We hypothesize that, compared with E-Health, participants randomly assigned to E-PrEP will be more likely to express intention to use PrEP and greater PrEP uptake, and will also show changes in potential mediators of PrEP uptake (knowledge, attitudes, stigma, and access). A Web-based biobehavioral intervention model such as E-PrEP could be rapidly scaled even with limited resources and have significant population-level impact. TRIAL REGISTRATION: ClinicalTrials.gov NCT03213366; https://clinicaltrials.gov/ct2/show/NCT03213366 (Archived by WebCite at http://www.webcitation.org/71onSdcXY). REGISTERED REPORT IDENTIFIER: RR1-10.2196/11375.

Teaching about Substance Abuse with Objective Structured Clinical Exams.

BACKGROUND: Although residents commonly manage substance abuse disorders, optimal approaches to teaching these specialized interviewing and intervention skills are unknown. OBJECTIVE: We developed a Substance Abuse Objective Structured Clinical Exam (OSCE) to teach addiction medicine competencies using immediate feedback. In this study we evaluated OSCE performance, examined associations between performance and self-assessed interest and competence in substance abuse, and assessed learning during the OSCE. DESIGN: Five-station OSCE, including different substance abuse disorders and readiness to change stages, administered during postgraduate year-3 ambulatory rotations for 2 years. PARTICIPANTS: One hundred and thirty-one internal and family medicine residents. MEASUREMENTS: Faculty and standardized patients (SPs) assessed residents' general communication, assessment, management, and global skills using 4-point scales. Residents completed a pre-OSCE survey of experience, interest and competence in substance abuse, and a post-OSCE survey evaluating its educational value. Learning during the OSCE was also assessed by measuring performance improvement from the first to the final OSCE station. RESULTS: Residents performed better (P<.001) in general communication (mean+/-SD across stations=3.12+/-0.35) than assessment (2.65+/-0.32) or management (2.58+/-0.44), and overall ratings were lowest in the contemplative alcohol abuse station (2.50+/-0.83). Performance was not associated with residents' self-assessed interest or competence. Perceived educational value of the OSCE was high, and feedback improved subsequent performance. CONCLUSIONS: Although internal and family medicine residents require additional training in specialized substance abuse skills, immediate feedback provided during an OSCE helped teach needed skills for assessing and managing substance abuse disorders.

Improving access to sterile syringes and safe syringe disposal for injection drug users in methadone maintenance treatment.

We evaluated a novel intervention designed to improve access to sterile syringes and safe syringe disposal for injection drug users (IDUs) newly enrolled in methadone maintenance, through interviews with two sequential cohorts of 100 recent entrants into a methadone program in the Bronx, NY. A substantial number of participants had injected in the previous 6 months, and most continued injecting during the early weeks of treatment. The intervention was associated with significant behavior changes among IDUs, including increased use of pharmacies as a primary source of syringes (11% vs. 37%, p < .05) and decreases in both purchasing of syringes on the street (51% vs. 27%, p < .05) and needle sharing (40% vs. 7%, p < .01). The intervention had no impact on the prevalence of injection or on syringe disposal practices. Our findings suggest that drug treatment programs can serve an important role in reducing injection-related risk behavior by facilitating access to sterile syringes.

It made my life a little easier: primary care providers' beliefs and attitudes about using opioid treatment agreements.

OBJECTIVE: To understand primary care providers (PCPs)' experiences, beliefs, and attitudes about using opioid treatment agreements (OTAs) for patients with chronic pain. DESIGN: Qualitative research study. PARTICIPANTS: Twenty-eight internists and family medicine physicians at two health centers. APPROACH: Semistructured telephone interviews, informed by the Integrative Model of Behavioral Prediction. Themes were analyzed using a Grounded Theory approach, and similarities and differences in themes were examined among OTA adopters, nonadopters, and selective adopters. RESULTS: Participants were 64 percent female and 68 percent white, and practiced for a mean of 9.5 years. Adoption of OTAs varied: seven were adopters, five were nonadopters, and 16 were selective adopters. OTA adoption reflected PCPs' beliefs and attitudes in the following three thematic categories: 1) perceived effect of OTA use on the therapeutic alliance, 2) beliefs about the utility of OTAs for patients or providers, and 3) perception of patients' risk for opioid misuse. PCPs commonly believed that OTAs were useful for physician self-protection, but few believed that they prevent opioid misuse. Selective adopters expressed ambivalent beliefs and made decisions about OTA use for individual patients based on both observed data and a subjective sense of each patient's risk for misuse. CONCLUSIONS: Substantial variability in PCP use of OTAs reflects differences in PCP beliefs and attitudes. Research to understand the impact of OTA use on providers, patients, and the therapeutic alliance is urgently needed to guide best practices.

A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers.

BACKGROUND: More than half of the persons living with human immunodeficiency virus (HIV; PLWH) in the US smoke cigarettes, and tobacco use is responsible for considerable morbidity and mortality in this group. Little is known about the efficacy of tobacco treatment strategies in PLWH. DESIGN: Randomized controlled trial comparing Positively Smoke Free (PSF), an intensive group-therapy intervention targeting HIV-infected smokers, to standard care. METHODS: A cohort of 145 PLWH smokers, recruited from an HIV-care center in the Bronx, New York, were randomized 1:1 into the PSF program or standard care. All were offered a 3-month supply of nicotine replacement therapy. PSF is an 8-session program tailored to address the needs and concerns of HIV-infected smokers. The sessions were cofacilitated by a graduate student and an HIV-infected peer. The primary outcome was biochemically confirmed, 7-day point-prevalence abstinence at 3 months. RESULTS: In the intention-to-treat analysis, PSF condition subjects had nearly double the quit rate of controls (19.2% vs. 9.7%, P = 0.11). In the complete case, as-treated analysis, assignment to PSF was associated with increased odds of quitting (odds ratio(adj) 3.55, 95% confidence interval 1.04 to 12.0). Latino ethnicity and lower loneliness score were predictive of abstinence. The subjects in the PSF condition exhibited significant decreases in daily cigarette consumption and significant increases in self-efficacy and in motivation to quit. Attendance of ≥7 sessions was associated with higher quit rates. CONCLUSIONS: These findings suggest a positive effect of PSF on cessation rates in PLWH smokers. Loneliness and self-efficacy are influential factors in the smoking behaviors of PLWH.

Association between alcohol consumption and both osteoporotic fracture and bone density.

OBJECTIVE: Alcoholism is a risk factor for osteoporotic fractures and low bone density, but the effects of moderate alcohol consumption on bone are unknown. We performed a systematic review and meta-analysis to assess the associations between alcohol consumption and osteoporotic fractures, bone density and bone density loss over time, bone response to estrogen replacement, and bone remodeling. METHODS: MEDLINE, Current Contents, PsychINFO, and Cochrane Libraries were searched for studies published before May 14, 2007. We assessed quality using the internal validity criteria of the US Preventive Services Task Force. RESULTS: We pooled effect sizes for 2 specific outcomes (hip fracture and bone density) and synthesized data qualitatively for 4 outcomes (non-hip fracture, bone density loss over time, bone response to estrogen replacement, and bone remodeling). Compared with abstainers, persons consuming from more than 0.5 to 1.0 drinks per day had lower hip fracture risk (relative risk=0.80 [95% confidence interval, 0.71-0.91]), and persons consuming more than 2 drinks per day had higher risk (relative risk=1.39 [95% confidence interval, 1.08-1.79]). A linear relationship existed between femoral neck bone density and alcohol consumption. Because studies often combined moderate and heavier drinkers in a single category, we could not assess relative associations between alcohol consumption and bone density in moderate compared with heavy drinkers. CONCLUSION: Compared with abstainers and heavier drinkers, persons who consume 0.5 to 1.0 drink per day have a lower risk of hip fracture. Although available evidence suggests a favorable effect of alcohol consumption on bone density, a precise range of beneficial alcohol consumption cannot be determined.