"I'm Not a Good Drug Dealer": Styles of Buprenorphine Diversion in a Multisite Qualitative Study.

BACKGROUND: Against the backdrop of the U.S. opioid epidemic, there has been a concerted movement to improve access to buprenorphine maintenance therapy (BMT). In Pennsylvania, where overdose mortality increased 65% between 2015 and 2017, over $75 million has been appropriated toward BMT since 2016. Concurrently, efforts to increase BMT availability while lowering barriers to entry have given way to fears of increased diversion and illegitimate patients. Little is known about the circumstances and motivations that surround buprenorphine diversion, particularly within the context of treatment expansion. METHOD: Drawing on 27 in-depth interviews with individuals who reported sharing or selling buprenorphine in the past year, in this study we consider the relationship between treatment access, treatment experiences, and individuals' decision to divert buprenorphine, while further comparing motivations for buprenorphine diversion across two Pennsylvania counties with disparate levels of BMT availability. RESULTS: We identify four styles of buprenorphine diversion ("ad hoc sellers," "concerned suppliers," "social sharers," "professional dealers"), with different levels of representation by county. Overall, our analysis found the explicit economic exploitation of BMT was rare, while a plurality of participants reported selling unwanted or unneeded buprenorphine only when presented with an opportunity. CONCLUSIONS: Across our typology, market demand in the form of unmet need for buprenorphine was the major driver of diversion, suggesting that "supply-side interventions" intended to again limit access to BMT may be counterproductive.

First Responders' Views of Naloxone: Does Stigma Matter?

BACKGROUND: Prior work has suggested that first responders have mixed feelings about harm reduction strategies used to fight the opioid epidemic, such as the use of naloxone to reverse opioid overdose. Researchers have also noted that provider-based stigma of people who use opioids (PWUO) may influence perceptions of appropriate interventions for opioid use disorder (OUD). This study examined first responders' perceptions of naloxone and the relationship between stigma of OUD and perceptions of naloxone. METHODS: A web-based survey assessing perceptions of PWUO and naloxone was administered to 282 police officers and students enrolled in EMT and paramedic training courses located in the Northeastern United States. Bivariate and multivariable analyses assessed the relationship between variants of stigma (e.g., perceived dangerousness, blame, social distance, and fatalism) and self-reported perceptions of naloxone. RESULTS: Participants, in the aggregate, held slightly negative attitudes toward the use of naloxone. Findings from multivariable modeling suggest that stigma of OUD, living in a rural area, and prior experience administering naloxone, were significantly and inversely related to support for the use of naloxone. Support for the disease model of addiction and associating drug use with low socioeconomic status were positively related to support for the use of naloxone. CONCLUSION: Efforts to alleviate perceptions of PWUO as dangerous, blameworthy, or incapable of recovery may increase first responders' support for naloxone. To this end, first responder training programs should include instruction on the disease model of addiction, and more broadly, attempt to foster familiarity between PWUO and the professionals who serve them.

The effect of maternal antidepressants on third trimester uteroplacental hemodynamics and the neonatal abstinence syndrome: a retrospective cohort study.

The objective of this study is to determine whether maternal antidepressant use during pregnancy influences uteroplacental hemodynamics, thereby affecting fetal growth and gestational age at delivery. The secondary aim was to determine the incidence of neonatal abstinence syndrome (NAS) among infants exposed to antidepressant medications. The charts of women who received obstetrical care and had a history of depression from January 2014 to December 2016 at Mount Sinai Hospital in Toronto, Canada, were reviewed. Exclusion criteria were substance abuse; narcotic or lithium use at the time of delivery.In total, 205 women met the inclusion criteria (92 took antidepressants; 113 women did not). There were no significant differences in umbilical artery pulsatility index (PI), gestational age at delivery, or birth weight when comparing women based on antidepressant use. A small proportion (18%) of neonates had mild withdrawal symptoms; one baby had a score (≥ 8) consistent with severe NAS. In women with a history of depression, there was no difference in uteroplacental hemodynamics as measured by third trimester Doppler ultrasonography when comparing women who took antidepressant medication versus those who did not. The large majority of babies who were exposed to antidepressants in utero did not show withdrawal symptoms. These results lend support for the relative safety of antidepressants during pregnancy.

"You Never Know What You're Getting": Opioid Users' Perceptions of Fentanyl in Southwest Pennsylvania.

BACKGROUND: Urban areas in the United States have experienced a dramatic surge in fentanyl overdose deaths since 2014, a trend affecting both larger and smaller metropolitan areas. Encompassing only 1.2 million residents, Allegheny County, Pennsylvania, nevertheless saw 412 fentanyl-involved deaths in 2016, a number surpassed only by New York City and Cook County (Chicago), Illinois. OBJECTIVES: This article seeks to describe opioid users' perceptions of fentanyl in Allegheny and three adjacent counties; it further considers how the drug's emergence shapes some users' market behaviors and consumption practices. METHODS: This article reports on qualitative interview data (N = 30) collected as part of a larger, multi-phase, mixed methods study (N = 125) among individuals reporting past-year prescription opioid misuse or heroin use in four southwest Pennsylvania Counties. RESULTS: Most interviewees reported past-year suspected exposure to fentanyl, and many reported suffering or seeing suspected fentanyl overdoses. Where roughly one-third reported strategies for avoiding fentanyl, a small group of interviewees identified advantages to fentanyl, while still acknowledging its associated risks. Conclusions/Importance: Given users' diverse opinions around fentanyl, the distribution of fentanyl test strips may represent an effective response to the current crisis.

Identifying Factors that Facilitate Treatment Adherence in Cystic Fibrosis: Qualitative Analyses of Interviews with Parents and Adolescents.

Cystic fibrosis (CF) is a progressive, genetic disease affecting multiple organ systems. Treatments are complex and take 2-4 h per day. Adherence is 50% or less for pulmonary medications, airway clearance, and enzymes. Prior research has identified demographic and psychological variables associated with better adherence; however, no study has extensively identified facilitators of treatment adherence (e.g., adaptive behaviors and cognitions) in a sample of parents and adolescents. Forty-three participants were recruited from four CF centers as part of a larger measurement study. Participants included 29 parents (72% mothers; 72% Caucasian) and 14 adolescents (ages 11-20, 64% female, 71% Caucasian). Participants completed semi-structured interviews to elicit barriers to adherence. However, facilitators of adherence naturally emerged, therefore indicating need for further exploration. Interviews were audiotaped, transcribed and content-analyzed in NVivo to identify those behaviors and beliefs that facilitated adherence, using a phenomenological analysis. Frequencies of these themes were tabulated. Nine themes emerged, with individual codes subsumed under each. Themes included social support, community support, organizational strategies, "intrinsic characteristics," combining treatments with pleasurable activity, flexibility, easier or faster treatment, prioritizing treatments, and negative effects of non-adherence. Results demonstrated the importance of identifying strategies that positively affect adherence. Interventions that are strength-focused, build on prior success, and utilize positive models generated by those who have successfully integrated CF treatments into their lives are more likely to be efficacious.

Routine proteinuria monitoring for bevacizumab in patients with gynecologic malignancies.

BACKGROUND: Proteinuria leading to nephrotic syndrome is a rare adverse event arising from treatment with bevacizumab. There is limited evidence to guide the frequency and appropriate test for monitoring for proteinuria. The purpose of this study was to determine the prevalence and severity of proteinuria during bevacizumab administration to patients with gynecologic malignancies, and to evaluate risk factors associated with this toxicity; a secondary objective was to evaluate the cost of routine proteinuria monitoring to assess for opportunities of cost containment that could change clinical practice. METHODS: A retrospective chart review was performed at an academic gynecologic oncology clinic. Women over 18 years of age with a diagnosed gynecologic malignancy were evaluated for the development of proteinuria while receiving bevacizumab treatment as measured by a urine protein-to-creatinine ratio. Patient and disease-specific risk factors were evaluated using logistic regression to determine correlations of risk factors to development of proteinuria. Cost assessment was performed using institution-specific data for urine laboratory tests. RESULTS: Eighty-nine patients were identified, and the overall prevalence of proteinuria of any grade was 35%. The mean number of bevacizumab cycles was 13 (2-64 cycles). The majority of patients experienced grade 1 proteinuria (70%, 62 patients). Grade 3 proteinuria was observed in two patients (2%). There was a trend toward increased bevacizumab cycles associated with increased grade proteinuria (p = 0.053), however there were no factors significantly associated with the development of proteinuria as measured by urine protein-to-creatinine ratio. CONCLUSION: Monitoring of urine protein-to-creatinine ratios with each cycle may be unnecessary due to the low prevalence of grade 3 proteinuria observed. Additionally, urine protein-to-creatinine ratios may not provide adequate assessment of proteinuria toxicity associated with bevacizumab therapy. Potential cost savings opportunities for the institution can be realized with a cost-reductive monitoring algorithm that will utilize less costly laboratory techniques for patients at high risk of developing proteinuria.

Thrombus-in-Transit: A Case for a Multidisciplinary Hospital-Based Pulmonary Embolism System of Care.

BACKGROUND: Venous thromboembolism, including pulmonary embolism (PE), is a common disease identified in the emergency department that carries significant morbidity and mortality. In its most severe form, PE is fulminant and characterized by cardiac arrest and death. CASE REPORT: In the midst of risk-stratifying PE by using echocardiography to assess right ventricular function, thrombus-in-transit (free-floating clot in the right atrium or ventricle) may be seen. We present a case of a 49-year-old man diagnosed with an acute saddle PE who was incidentally found to have a thrombus-in-transit and patent foramen ovale and required open thrombectomy. Identification of these additional potentially life-threatening features was possible only due to our availability of risk-stratification resources, specifically bedside echocardiography. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Albeit rare, with a reported incidence estimated at 4%, the presence of thrombus-in-transit may change emergent clinical management. A multidisciplinary team of resources should be considered emergently as part of a hospital-based PE system of care.

"I think we're getting better but we're still not there": Provider-based stigma and perceived barriers to care for people who use opioids (PWUO).

BACKGROUND: Despite significant efforts to improve access to medications for opioid use disorder (MOUD), uptake remains low relative to the scope of the problem in the United States. A growing body of quantitative and qualitative research has documented consistent barriers to MOUD treatment access and retention, at the level of individuals, institutions, and society at large. Stigma - surrounding both people who use opioids (PWUO) and treatment using MOUD - is among the most-cited barriers by patients and providers alike, yet few studies have examined provider-based stigma specifically, or considered its interaction with other impediments to OUD care. METHODS: This paper employs a qualitative approach to the analysis of provider-based stigma among professionals involved in the treatment or supervision of individuals with OUD. We conducted and analyzed interviews with 19 professionals as part of a larger mixed methods study on stigma among substance use treatment providers and court personnel in Pennsylvania. Beyond capturing providers' perceptions of PWUO and MOUD, the authors asked participants to describe barriers to recovery, and the effective delivery of care within this population. RESULTS: Interviewees enumerated multiple entrenched barriers that sometimes operated at different levels, such as criminal-legal involvement, which weakened PWUO's social networks and employment prospects, while undermining providers' attempts at continuity of care; moreover, participants cited the "War on Drugs" as an overarching impediment to effective substance use treatment, not least for its role in perpetuating stigma against PWUO. CONCLUSIONS: Interestingly, while an overwhelming majority of participants named stigma as a barrier to treatment at every level, most also articulated stigmatizing beliefs around PWUO. Namely, providers evoked one element of stigma - blameworthiness - in their contention that many PWUO are inadequately motivated to recover. In addition to adding further complexity to MOUD barriers research, this study troubles the notion that professional training and education on the disease model of addiction serve to eradicate stigma.

Correlates of Staff Acceptability of a Novel Telemedicine-Delivered Medications for Opioid Use Disorder Program in a Rural Detention Center.

Opioid overdose death is significantly increased immediately following incarceration. Evidence-based medications are underutilized in rural jails and detention centers. We have reported our efforts to address this gap through telemedicine-based medications for opioid use disorder treatment (tele-MOUD) for incarcerated patients. Staff acceptance and perceptions are critically important factors in the assurance of program validation. We assessed tele-MOUD acceptability and perceptions of effectiveness and stigma in one detention center. Overall, we found that jail staff's general acceptability of the program was rather low, as was perceived effectiveness of MOUD, while stigmatizing beliefs were present. Furthermore, tele-MOUD acceptability was positively correlated with perceptions of MOUD effectiveness and negatively correlated with stigmatizing notions of MOUD (p's < 0.001). Findings suggest the need for educational interventions. Future research investigating the potential moderating effects of training on staff acceptability of jail-based tele-MOUD will support the implementation and sustainability of these life-saving programs.

A reexamination of connectivity trends via exponential random graph modeling in two IDU risk networks.

Patterns of risk in injecting drug user (IDU) networks have been a key focus of network approaches to HIV transmission histories. New network modeling techniques allow for a reexamination of these patterns with greater statistical accuracy and the comparative weighting of model elements. This paper describes the results of a reexamination of network data from the SFHR and P90 data sets using Exponential Random Graph Modeling. The results show that "transitive closure" is an important feature of IDU network topologies, and provides relative importance measures for race/ethnicity, age, gender, and number of risk partners in predicting risk relationships.

A novel amniote model of epimorphic regeneration: the leopard gecko, Eublepharis macularius.

BACKGROUND: Epimorphic regeneration results in the restoration of lost tissues and structures from an aggregation of proliferating cells known as a blastema. Among amniotes the most striking example of epimorphic regeneration comes from tail regenerating lizards. Although tail regeneration is often studied in the context of ecological costs and benefits, details of the sequence of tissue-level events are lacking. Here we investigate the anatomical and histological events that characterize tail regeneration in the leopard gecko, Eublepharis macularius. RESULTS: Tail structure and tissue composition were examined at multiple days following tail loss, revealing a conserved pattern of regeneration. Removal of the tail results in a consistent series of morphological and histological events. Tail loss is followed by a latent period of wound healing with no visible signs of regenerative outgrowth. During this latent period basal cells of the epidermis proliferate and gradually cover the wound. An additional aggregation of proliferating cells accumulates adjacent to the distal tip of the severed spinal cord marking the first appearance of the blastema. Continued growth of the blastema is matched by the initiation of angiogenesis, followed by the re-development of peripheral axons and the ependymal tube of the spinal cord. Skeletal tissue differentiation, corresponding with the expression of Sox9, and muscle re-development are delayed until tail outgrowth is well underway. CONCLUSIONS: We demonstrate that tail regeneration in lizards involves a highly conserved sequence of events permitting the establishment of a staging table. We show that tail loss is followed by a latent period of scar-free healing of the wound site, and that regeneration is blastema-mediated. We conclude that the major events of epimorphic regeneration are highly conserved across vertebrates and that a comparative approach is an invaluable biomedical tool for ongoing regenerative research.

Risk and enabling environments in sport: Systematic doping as harm reduction.

Doping and the use of performance enhancing drugs (PEDs) are often considered and discussed as a separate issue from other types of substance use, by sporting bodies, politicians, the media, and athletes who use drugs themselves. However, perceptions and understandings of substance use in the sport and fitness world are directly related to those of substance use in the non-sport world. One way the gap between sport and non-sport substance use research can be bridged is to consider sport risk and enabling environments. Similar to non-sport contexts and drug use, it is important to analyse the environments in which doping occurs. This approach allows us to examine the dynamic interplay between risk and enabling factors, as the enabling environment shifts in response to changes produced in the risk environment, and vice versa. There are models of sport environments that have proven effective at both enabling doping by athletes and reducing harms to athletes: systematic doping. This article will use secondary literature in order to review and analyse known cases of systematic doping through the risk and enabling environment frameworks. We argue that these systems responded to anti-doping in ways that protected athletes from the risk factors established by anti-doping policy and that athletes suffered most when these systems were revealed, exposing athletes to the full range of doping harms. Further, we argue that risks within these systems (i.e. extortion, bullying) resulted from the broader prohibitive sport environment that forces doping underground and allows such abuses to occur.

Policing pain: A qualitative study of non-criminal justice approaches to managing opioid overdose during the COVID-19 pandemic.

Opioid related drug overdose deaths are a leading cause of death and injury in the United States. While research demonstrates that where people live has a major impact on drug use and abuse, most work looks at social dynamics at the county level or under the rubric of the urban/rural divide. Only recently, scholarship has become attuned to the post-industrialized areas located on the fringes of urban cores. Data presented in here are from field research conducted in McKeesport, Pennsylvania, a small river town located east of Pittsburgh. Once a thriving industrial city, it is now deteriorated and has documented high levels of overdose experience. Preliminary results suggest that McKeesport residents, even before the emergence of SARS-CoV-2 (COVID-19), practice social and physical distancing as a way of life; data indicate how the pandemic potentially exacerbates the risk of accidental opioid overdose among a population defined by both geographic and social isolation.

Treatment trajectories and barriers in opioid agonist therapy for people who inject drugs in rural Puerto Rico.

BACKGROUND: Research has shown medication for opioid use disorder (MOUD) to have positive effects, including reducing HIV and HCV transmission, but important barriers to access remain among people who inject drugs (PWID). Barriers include lack of social and familial support, bureaucracy, distance to treatment, poverty, and homelessness. However, we know little about how these barriers interact with each other to shape PWID's drug treatment access and retention. METHODS: We used qualitative methods with a dataset from a study conducted during 2019 with 31 active PWID residing in rural Puerto Rico. The study gathered ethnographic data and narratives about treatment trajectories to document the lived experiences of PWID as they moved in and out of treatment. RESULTS: Participants were at least 18 years old; 87.7% were male, the mean age was 44.1 years, and the mean age at first injection was 22 years. Participants identified homelessness, lack of proper ID or other identifying documents, and previous negative experiences with MOUD as the main barriers to treatment entry and retention. In addition, PWID's belief that MOUD simply substitutes an illegal drug for a legal one, while furthering drug dependence by chronically subjecting patients to treatment, constitutes an additional barrier to entry. Findings from this study demonstrate that MOUD barriers to access and retention compound and are severely affected by poverty and other forms of vulnerability among PWID in rural Puerto Rico. CONCLUSION: Policies to increase access and retention should consider barriers not in isolation but as an assemblage of many factors.

Exploring first responders' perceptions of medication for addiction treatment: Does stigma influence attitudes?

Researchers have suggested that provider-based stigma of persons who suffer from opioid use disorder (OUD) in the criminal justice system serves as a barrier to fully implementing harm reduction strategies, such as the use of naloxone and medication for addiction treatment (MAT). While scholars have begun to explore the relationships between stigma and first responders' attitudes toward naloxone, little work has been done to assess first responders' attitudes toward other forms of harm reduction, including MAT. The goal of the current exploratory study was to help fill this gap in the literature by assessing first responders' (N = 282) attitudes toward MAT, as well as the correlates of these attitudes. The study specifically focused on examining the relationship between provider-based stigma and attitudes toward MAT. Results show that, in the aggregate, first responders held slightly negative attitudes toward the use of MAT. Moreover, the study found that certain dimensions of stigma (i.e., dangerousness and fatalism) to exhibit a negative relationship with attitudes toward MAT, while support for the disease model of addiction was associated with positive perceptions. Policy implications based on these findings are discussed within.

Visualizing Age, Period, and Cohort Patterns of Substance Use in the U.S. Opioid Crisis.

Descriptions of the contemporary U.S. opioid crisis emphasize several "waves" of overdose deaths. However, a focus on trends in overdose deaths may obscure important sociological dynamics. The authors provide heatmap visualizations of estimated annual rates of past-year substance use, rather than overdose deaths, for prescription pain relievers and heroin. These visualizations are based on weighted analyses of self-reports, cross-classified by age and period, collected as part of the National Survey on Drug Use and Health from 2002 to 2017. Whereas descriptions of the U.S. opioid crisis tend to focus on period dynamics, these visualizations indicate that cohort patterns of drug use are also evident in addition to well-known age variation. A substantive focus on cohort patterns highlights the possibility that cohorts of people who use drugs may remain at risk for overdose in the years to come. These findings suggest that policies aimed only at restricting opioid availability may have limited effects.

Misunderstandings, misperceptions, and missed opportunities: Perspectives on adherence barriers from people with CF, caregivers, and CF team members.

OBJECTIVE: To identify differences in perspectives of people with cystic fibrosis (PwCF) and caregivers versus healthcare providers on adherence barriers. Mismatched perspectives may lead to miscommunication and missed opportunities to reduce barriers and improve CF outcomes. METHODS: PwCF, caregivers, and CF providers completed audio-taped, semi-structured interviews about adherence barriers. Interviews were transcribed and coded for themes. Themes were reviewed to identify when PwCF-caregiver perspectives differed from providers'. RESULTS: Participants included 14 adolescents with CF (mean age = 15.89 years, 64 % female, 71 % Caucasian), 14 adults with CF (mean age = 30.03 years, 64 % female, 57 % Caucasian), 29 caregivers (76 % female; 72 % Caucasian), and 42 providers. Four barriers were identified that could generate miscommunication between PwCF-caregivers and providers: Tired = Fatigued/Sleepy versus Tired = Burnout, Vacation and Travel, Knowledge and Skills About CF Regimen, and Daily Habits or Routines. PwCF and caregivers used similar words as providers, but conceptualized barriers differently. PwCF and caregivers discussed barriers pragmatically, however, providers viewed certain barriers more abstractly or unidimensionally, or did not discuss them. CONCLUSIONS: PwCF-caregivers and providers may not align in how they discuss barriers, which may contribute to miscommunication about adherence challenges. PRACTICE IMPLICATIONS: Patient-centered communication strategies may enhance providers' understandings of PwCF-caregiver perspectives on barriers and facilitate adherence interventions.

"They're making it so hard for people to get help:" Motivations for non-prescribed buprenorphine use in a time of treatment expansion.

BACKGROUND: Buprenorphine maintenance therapy (BMT) has been widely recognized as one of the most effective treatments for opioid use disorders (OUD). In the midst of the U.S. opioid overdose crisis, local, state, and federal authorities have attempted to increase the availability of BMT, yet few individuals meeting the criteria for OUD utilize BMT. Moreover, recent research suggests that a significant proportion of individuals who use opioids seek out buprenorphine on the illicit market to self-govern and manage withdrawal sickness. METHODS: This paper presents data from a geographic sub-sample within a multi-site study of buprenorphine diversion in Pennsylvania. We endeavor to bolster a slim qualitative literature on the use of non-prescribed buprenorphine through in-depth interviews with 20 individuals who reported buying or receiving buprenorphine outside of medically-sanctioned contexts. Interviews characterized participants' reasons for both using non-prescribed buprenorphine and eschewing formal treatment, in a state (Pennsylvania) afflicted with high rates of heroin use and overdose deaths. Transcripts were initially coded for broad interview topics, while latent themes relating to buprenorphine diversion and extra-medical use also emerged. RESULTS: Analyses revealed complex motivations underlying participants' extra-medical use of buprenorphine. Where some expressed a desire for treatment autonomy and treatment medications that could not be achieved or obtained within BMT, individuals also indicated a persistent lack of treatment availability and access due to diverse barriers. CONCLUSION: This study shows how issues related to availability, accessibility, and acceptability many explain low rates of BMT utilization, even within a place and time defined by medication-assisted treatment expansion. Beyond offering broad rhetorical and financial support for MAT, our findings suggest that governmental actors should continue to pursue policies that expand the spatial distribution of BMT. It also underscores the need to look beyond current models of buprenorphine maintenance and to consider modes of buprenorphine delivery beyond long-term maintenance.

Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis.

BACKGROUND: In Cystic Fibrosis (CF), adherence to pulmonary medications is about 50% and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence. METHODS: iCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11-20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months. RESULTS: Effectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18% addressed pulmonary medications. Average intervention fidelity score was 67% (SD = 14%; Range = 25-100%). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC. CONCLUSIONS: The IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.