Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

BACKGROUND: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. METHODS: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. RESULTS: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis. CONCLUSIONS: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

Individual and Health System Factors for Uptake of Pre-exposure Prophylaxis Among Young Black and Latino Gay Men.

BACKGROUND: Young Black and Latino men who have sex with men (YBLMSM) have the highest rates of new HIV infections in the USA and use PrEP at lower rates than White MSM. OBJECTIVE: To explore YBLMSM's perspectives and experiences of PrEP use to identify factors enabling or impeding uptake. DESIGN: Qualitative study using semi-structured interviews conducted between August 2015 and April 2016. PARTICIPANTS: Black and Latino MSM, 18-20 years of age, who live, socialize, or work in the Bronx, and were fluent in English or Spanish. APPROACH: We used a thematic analysis to identify themes related to not taking PrEP and PrEP uptake. KEY RESULTS: Half the participants (n = 9) were currently using PrEP, a majority had Medicaid (n = 13), all reported having a PCP, all identified English as their primary language (n = 15), and all identified as gay. Salient themes included concerns over-side effects, stigma related to HIV and sexuality, mistrust of medical providers, provider's refusal to prescribe PrEP, and insurance and cost. CONCLUSIONS: Modifiable barriers for PrEP uptake and persistence were reported by most participants, with an emphasis on PrEP misinformation and the pervasiveness of intersectional stigma, providers' low awareness, and hesitant attitudes towards PrEP and barriers created by insurance companies. Supportive infrastructures for PrEP providers and patients are needed.

Moral injury and the hidden curriculum in medical school: comparing the experiences of students underrepresented in medicine (URMs) and non-URMs.

Underrepresented students in medicine (URM) have more negative perceptions of the medical school learning environment (LE), a phenomenon that can contribute to higher rates of burnout and attrition in these populations. The hidden curriculum (HC)-defined as a set of values informally conveyed to learners through clinical role-modeling-is a LE socialization construct that has been critically examined for its role in shaping students' professional identities. Yet differences in how URMs and non-URMs experience the HC remain underexplored. The study used a pragmatic approach that drew on elements of grounded theory and employed both deductive and inductive reasoning. Investigators conducted qualitative, semi-structured interviews with a purposive sample of 13 URM and 21 non-URM participants at a Bronx, NY medical school. Interviews examined student experiences and reactions to the HC. Both cohorts witnessed patient disparagement and mistreatment. However, from these encounters, URM participants expressed more moral injury-the adverse emotional consequence of feeling pressured to accept ideologically incongruent values. URMs were also more likely to describe resisting the HC. Differences in group reactions appeared to arise from URMs' identity resonance with patients' lived experiences. Participants across cohorts emphasized increasing URM recruitment as one step toward mitigating these circumstances. URM participants experienced more distress and offered more resistance to the HC relative to non-URMs. The etiology of these differential reactions may stem from relative barriers in negotiating personal and professional identities. As such, URMs' perceptions of the LE may be adversely impacted given their more negative interactions with the HC.

A Video-Observed Treatment Strategy to Improve Adherence to Treatment Among Persons Who Inject Drugs Infected With Hepatitis C Virus: Qualitative Study of Stakeholder Perceptions and Experiences.

BACKGROUND: Direct-acting antiviral medications have the potential to eliminate the hepatitis C virus (HCV) epidemic among people who inject drugs; yet, suboptimal adherence remains a barrier. Directly observed treatment (DOT), an effective strategy for optimizing adherence, has been frequently implemented in opioid treatment programs but less commonly in community health settings due to the heavy burden of daily visits. An alternative is video-observed therapy (VOT), which uses mobile health technology to monitor adherence. VOT has not been widely studied among people who inject drugs with HCV. OBJECTIVE: This qualitative study, part of a larger implementation evaluation, investigates stakeholder perceptions and experiences with VOT in Project HERO (Hepatitis C Real Outcomes), a multisite pragmatic trial testing treatment delivery models for people who inject drugs with HCV. Our goal was to understand the potential barriers and facilitators to the implementation of the VOT technology. METHODS: Qualitative interviews were conducted with 27 Project HERO study staff and 7 patients. Interviews focused on perceptions and experiences with the VOT app and barriers and facilitators to implementation. Team meeting minutes over the first 2 years of the project were transcribed. A coding system was developed and applied to the data. We summarized thematic data and compared participant perceptions to generate a close understanding of the data. RESULTS: Frequent barriers to VOT included mechanical failure, stolen or lost phones, and a steep learning curve for participants and study staff. In sites with older and less technically skilled participants, staff found it difficult to implement the VOT app. Research staff found that the routine monitoring of app use led to closer engagement with participants. This was both a benefit and a potential threat to the validity of this pragmatic trial. Patient participants reported mixed experiences. CONCLUSIONS: VOT may be a useful alternative to DOT for some patients, but it may not be feasible for all. Significant staff involvement may be required.

A Sense of Belonging: Perceptions of the Medical School Learning Environment among URM and Non-URM Students.

Phenomenon: Improving the learning environment (LE), particularly for students underrepresented in medicine (URM), has become an important goal for institutions that provide undergraduate and graduate medical education. Until recently, research and intervention development have been limited by the lack of comprehensive theoretical frameworks. A multi-dimensional conceptual model of the medical school environment, developed by Gruppen and colleagues in 2019, provides a useful framework for guiding research and interventions in this area.Approach: Using Gruppen et al's model, this study investigated experiences of the LE from the perspectives of both URM and non-URM students at a medical school in New York City. In examining experiences of the organizational, social, and physical domains of the LE, we sought to explore the symbolic and experiential links across domains and identify concrete needs for improvement.Findings: Institutional structures and policies, features of the built environment, and social relationships that put learning first and generated a sense of community were highly valued. Although both URM and non-URM students shared many perceptions and experiences, URM students expressed heightened vulnerability to the experiences of devaluation and exclusion.Insights: All participants in the study greatly appreciated aspects of the LE that made them feel like valued members of the community. Medical schools should approach the task of improving the LE for URM students using a comprehensive, multi-dimensional approach.

Environmental Scan of Sleep Health in Early Childhood Programs.

OBJECTIVE: To ascertain how sleep health knowledge is translated to early care and education (ECE) programs, using a multi-component environmental scan. METHODS: A website scan identified organizations' sleep content re: recommended practices, developmental effects, and "actionable" ratings (0-2). ECE staff surveys assessed preparedness, practices, and beliefs about addressing sleep health and sleep problems in ECE programs. Semi-structured interviews with stakeholders from the ECE, pediatric and sleep communities assessed awareness, priorities, and practices at their organizations. RESULTS: Of 15 websites scanned, half lacked sleep content on links to development, optimal duration, or scientific background. ECE staff (n = 31) were comfortable speaking to parents about healthy sleep, and with incorporating sleep education and guidance into ECE. Stakeholders (n = 15) rated healthy sleep as a high relevance, but lower priority issue. Within ECE settings stakeholders reported that knowledge about specific links to health and development was poor and that sleep health was often obscured by "safe sleep" issues. Their recommendations included: linking sleep health to "hot topics" such as obesity or preschool suspensions and expulsions, integrating it with the teaching of routines, and raising public awareness. CONCLUSION: Despite understanding that healthy sleep promotes school readiness, there is insufficiently specific, actionable information in ECE training, programs, or policies. Findings suggest a need for an awareness campaign with clear, actionable messaging, dissemination of turnkey materials, and integration with policy and professional training systems. TRIAL REGISTRATION: - ClinicalTrials.Gov: NCT03556462.

Network models can help focus research on the role of culture and context in psychopathology, but don't discount latent variable models.

Borsboom et al. correctly note that the use of latent variable models in cross-cultural research has resulted in a futile search for universal, biological causes of psychopathology; however, this is not an inevitable outcome of such models. While network analytic approaches require further development, network models have the potential to better elucidate the role of cultural and contextual variables related to psychopathology.

Reducing pediatric caries and obesity risk in South Asian immigrants: randomized controlled trial of common health/risk factor approach.

BACKGROUND: This paper describes the design and methods of a multi-phase study to reduce early childhood caries and obesity in vulnerable South Asian (SA) immigrants in the United States. Early childhood caries and obesity are the most common diseases of early childhood. Risk factors for both diseases are rooted in early childhood feeding practices such as bottle feeding and intake of sweets and sweetened beverages. The Common Health/Risk Factor Approach to addressing oral health is widely promoted by the WHO and other policy makers. This approach recognizes links between oral health and other diseases of modernity. Our CHALO! ("Child Health Action to Lower Obesity and Oral health risk"--from a Hindi word meaning "Let's go!") study targets SA families at high risk for early childhood caries and obesity. CHALO! addresses common risk factors associated with these two common diseases of childhood. METHODS: This two part project includes a randomized controlled trial, and a Knowledge Translation campaign. A randomized controlled trial will enroll n =  360 families from pediatric practices serving South Asians in the New York metro area. The intervention group will receive home visits by SA community health workers at 6, 8, 10, 12, 14, and 16 months of age. Controls will receive culturally tailored educational material. Primary outcomes-- cariogenic and obesogenic feeding practices at 6, 12, and 18 months-- will be assessed with the MySmileBuddy iPad based tool. Secondary outcomes include: oral hygiene practices, anthropometrics, and caries incidence at 18 months. A public education campaign will focus on both families and health care providers. DISCUSSION: There are few Common Health/Risk Factor Approach published studies on obesity and oral health risk in children, despite health morbidity and costs associated with both conditions. CHALO! comprises a multi-level interventions designed to promote culturally competent, sustainable change. TRIAL REGISTRATION: ClinicalTrials.gov NCT03077425 .

The elephant in the room: Dialogues about race within cross-cultural supervisory relationships.

OBJECTIVES: For centuries, the concept of race, a uniquely pervasive social construct, has often complicated dialogue and interactions between groups of people. This study assessed perceptions and attitudes of faculty and trainees with varied racial backgrounds within graduate medical and psychology programs. Self-reported responses addressed potential barriers and facilitating factors required for meaningful conversations about race. METHODS: A brief 18-question survey was developed and administered electronically to three professional and academic Listservs within a large metropolitan city in northeast United States. Quantitative and qualitative analysis were conducted using SPSS Statistical Software and Text analyzer. RESULTS: Results revealed that among participants (N = 57) a majority experienced cross-racial supervision, and more than half indicated engaging in conversations about race within supervision. Respondents endorsed lack of comfort and lack of opportunity/time as significant barriers to discussing race within supervision. When race-related dialogues occurred, a majority of supervisees and supervisors found it beneficial. Most Supervisors of Color(a) actively initiated these conversations in supervision, while White supervisees endorsed the least benefit from these conversations. Contrary to our expectations, few respondents endorsed limited training as a barrier. DISCUSSION: The current study revealed cross-racial dialogues about race may be occurring frequently in supervisory relationships. Supervisees of Color reported benefiting from these dialogues, in contrast to their White counterparts, who endorsed the least benefit. Lack of comfort in supervisory relationships appears to be a significant barrier to having these conversations. Therefore, it is important for supervisors to create supervisory relationships emphasizing safety and comfort. Directions for future research are discussed.

What Women Want: A Qualitative Study of Contraception in Jail.

OBJECTIVES: We undertook this study to understand women's perceptions of receiving contraception at Rikers Island Jail. METHODS: We conducted semi-structured in-depth interviews in 2011 to 2012 with 32 women incarcerated at Rikers Island Jail. We analyzed the data using standard qualitative techniques. RESULTS: Almost all participants believed that contraception should be provided at the jail. However, many said they would hesitate to use these services themselves. Reservations were caused in part by women's negative views of health care services at the jail. Fears about the safety of birth control, difficulties associated with follow-up in the community, and desire for pregnancy were other factors that influenced interest in accepting contraception. CONCLUSIONS: Contraception at the jail must be provided by trusted medical providers delivering high quality care with the goal of allowing women to control their own fertility; this would ensure that women could access birth control and cease using birth control when desired.

Barriers and facilitators to the implementation of SPNS interventions designed to engage and retain HIV positive women of color in medical care.

The use of evidence-based strategies to increase access to medical care and improve health outcomes for people living with HIV is a major public health priority in the United States. As part of a multi-site evaluation funded under the Health Resources and Services Administration (HRSA), a process evaluation was conducted with the goal of understanding barriers and facilitators to the implementation of eleven heterogeneous interventions designed to engage and retain HIV positive women of color (WoC) in medical care. Findings identified barriers and facilitators to program implementation at five levels: (1) program; (2) team; (3) agency; (4) partner network; and (5) the larger socio-ecological context. We conclude with a series of recommendations that may be useful for the implementation of similar interventions focused on recruitment and retention of WoC in HIV medical care.

Effect of self-efficacy among persons who inject drugs treated with direct-acting antivirals on Hepatitis C treatment initiation, duration, completion, adherence, and cure.

BACKGROUND: Self-efficacy, a patient-level factor, has been shown to facilitate patient engagement in treatment and optimize treatment-related outcomes in various health contexts. Research on interventions supporting hepatitis C virus (HCV) direct-acting antiviral (DAA) treatment uptake and adherence among persons who inject drugs (PWID) is needed, but whether self-efficacy factors influence DAA treatment cascade outcomes in this population has been less studied. METHODS: Using the HERO study data, we analyzed a subset of participants with any general health self-efficacy data (n=708) measured at baseline and end-of-treatment time points using a 5-items instrument (facets: 'goal setting', 'goal attainment', 'having a positive effect', 'being in control', and 'working to improve'). The cascade outcomes included DAA treatment initiation, duration, adherence, completion, and sustained virologic response (SVR). The effect of baseline and change (Δ) scores for composite and item-level self-efficacy on the cascade outcomes was assessed using logistic regression and generalized linear models. RESULTS: Higher baseline composite self-efficacy [adjusted odds ratio (95 % confidence interval) =1.57 (1.07, 2.29)], 'goal attainment' [1.31 (1.03, 1.67)] and 'having a positive effect' [1.33 (1.03, 1.74)] were associated with greater likelihood of treatment initiation. 'Δ Goal attainment' was significantly associated with SVR [1.63 (1.04, 2.53)]. 'Δ Being in control' and 'Δ working to improve' were associated with treatment adherence and duration, respectively. CONCLUSIONS: General health self-efficacy positively influences DAA treatment initiation among PWID. 'Goal attainment' facilitates the achievement of DAA treatment-related outcomes. Further studies should assess the effect of self-efficacy related to performing healthcare tasks specific to DAAs on the treatment-related outcomes.

Challenges and Barriers to Providing Primary Care to Children of South Asian Origin: Pediatricians' Perspectives.

South Asian (SA) Americans have a high risk of metabolic and cardiovascular disease. Prevention efforts should start in childhood and should be culturally appropriate. We sought to understand the challenges and barriers that pediatricians face in providing care for SA children to inform professional education on culturally effective care. Qualitative interviews were conducted with a diverse sample (N = 17) of pediatricians. Challenges reported included feeding problems, inadequate physical activity, and mental health concerns. Communication barriers included parents' anxiety around feeding, influence of grandparents, stigma around mental health, and cultural communication gaps. Effective strategies included clear communication, a gradual approach, ensuring buy-in from grandparents, greater attention to family history, and improved cultural knowledge in pediatrician. Addressing feeding problems was the most mentioned challenge, which is especially concerning given the high chronic disease risk in SAs. Education on culturally appropriate strategies can equip pediatricians to effectively counsel SA families to address these risks.

A qualitative analysis of patients' experiences with an emergency department diagnosis of gastrointestinal cancer.

OBJECTIVES: Optimally, cancer is diagnosed through periodic screening or detection of early symptoms in primary care settings. However, an estimated 23%-52% of gastrointestinal (GI) cancers are diagnosed in the emergency department (ED). Cancer diagnosed in the ED has been associated with worse clinical and patient-reported outcomes even after adjustment for cancer stage. We sought to explore patients' accounts of patient and health care system factors related to their diagnosis in the ED and their lived experience of receiving a diagnosis in this setting. METHODS: Patients with an ED visit during or within 30 days of their GI cancer diagnosis at an urban academic hospital serving a largely disadvantaged population were recruited. Interviews were coded in NVivo 12 and analyzed using a thematic analysis approach. RESULTS: Patient-reported factors associated with their experiences included denial and avoidance of symptoms, mistrust of the health system, and lack of cancer screening knowledge. Health care system factors included misdiagnosis and delayed access to specialty care or tests. Experiences receiving a cancer diagnosis in the ED were overwhelmingly negative. CONCLUSIONS: This study highlights the unmet needs in identifying and diagnosing patients who ultimately present to the ED for evaluation and eventual diagnosis of cancer. Our results shed light on several modifiable factors, including the need for increased public awareness of the asymptomatic nature of cancer and the importance of cancer screening. Additionally, health care systems modifications beyond the ED are needed to improve access to timely care when symptoms arise.

The experience of re-infection among people who inject drugs successfully treated for hepatitis C.

INTRODUCTION: Highly effective direct-acting antiviral (DAA) agents have changed the landscape of hepatitis C virus infection (HCV) treatment and have become more available to people who inject drugs (PWID) over the past several years. Although many achieve a sustained virologic response (SVR), a small proportion will become re-infected. This study examined experiences of re-infection among participants in Project HERO, a large multi-site treatment trial designed to test alternative treatment delivery models for DAAs. METHODS: Study staff conducted qualitative interviews with twenty-three HERO participants who experienced reinfection following successful treatment for HCV. Interviews focused on life circumstances and experiences with treatment/re-infection. We conducted a thematic analysis, followed by a narrative analysis. RESULTS: Participants described challenging life circumstances. The initial experience of cure was joyful, leading participants to feel that they had escaped a defiled, stigmatized identity. Re-infection was very painful. Feelings of shame were common. Participants with fully developed narratives of re-infection described both a strong emotional response as well as a plan for avoiding re-infection during retreatment. Participants who lack such stories showed signs of hopelessness and apathy. CONCLUSION: Though the promise of personal transformation through SVR may be motivating for patients, clinicians should be cautious about how they describe the "cure" when educating patients about HCV treatment. Patients should be encouraged to avoid stigmatizing, dichotomizing language of the self, including terms such as "dirty" and "clean." In acknowledging the benefits of HCV cure, clinicians should emphasize that re-infection does not mean failed treatment; and that current treatment guidelines support retreatment of re-infected PWID.

Reduction in Depressive Symptoms in People who Inject Drugs who Are Cured of Hepatitis C Virus Infection: The HERO Study.

Background: Depressive symptoms are prevalent among people who inject drugs (PWID) and people with hepatitis C virus (HCV). We examined changes in depressive symptoms among HCV-infected PWID following direct-acting antiviral treatments to evaluate whether these changes differed by history of depressive symptoms, substance use, or HCV treatment outcome. Methods: We conducted a secondary analysis of the HERO Study (NCT02824640), a pragmatic randomized clinical trial among PWID, to test the effectiveness of HCV care models. Depressive symptoms (primary outcome) were measured using the Patient Health Questionnaire (PHQ-9) at baseline, end of treatment (EOT), and at follow-up 12 and 24 weeks after EOT. Sustained virologic response (SVR) was defined as undetectable HCV RNA at ≥12 weeks following EOT. Baseline drug use was defined as having a positive urine screening test for amphetamine, methamphetamine, benzodiazepine, cocaine, cannabis, opiate, or oxycodone. Results: The sample (n = 498) was 72.3% male, 64.2% White, and on average 43.9 years old. In patients who achieved SVR (F(3432) = 4.58; P = .004) and those with drug use at baseline (F(3478) = 5.11; P < .01), PHQ-9 scores significantly declined over time, with scores lower at EOT and both follow-ups as compared with baseline. Mean PHQ-9 scores at EOT and follow-ups were significantly lower than at baseline, except for those with no depression or mild depression at baseline. Conclusions: This study showed that HCV treatment in PWID is associated with sustained declines in depression up to 24 weeks post-treatment among those who achieve SVR and that drug use does not interfere with improvement in depressive symptoms.

Concepts of healthy diet among urban, low-income, African Americans.

We sought to explore concepts of healthy diet and to elicit recommendations to support healthier eating among urban, low-income, African Americans. We conducted semi-structured interviews with 33 self-identified African American adults (18-81 years of age, 15 male participants) from a low-income neighborhood in west Philadelphia, PA, during summer and fall 2008. Our qualitative approach was continuous, iterative and thematic considering gender, age category, and participants' "mentions" of fast-food and fruit-and-vegetable intake from the preceding day. We found that participants shared concepts about broad nutritional principles consistent with national dietary recommendations, but disagreed about the healthfulness of specific foods-e.g. meat. On average-with little variation-participants reported eating >2 "mentions" more of fast foods the preceding day than fruits and vegetables (P < 0.001). Suggested strategies to help promote eating more produce included increasing exposure, advertising, affordability, and local availability (vice versa to limit fast-food consumption), and more education on the health effects of diet and how to find and prepare healthy foods. Women's ideas reflected their roles in food shopping and food preparation; otherwise, participants' ideas did not differ appreciably by gender or age. Overall, participants generally expressed sufficient understanding of nutritional principles to eat healthfully, but disagreed about the healthfulness of specific foods and described largely unhealthy dietary consumption from the preceding day. If poor dietary intake results from barriers to recognizing, purchasing, and preparing healthy foods, then participants' suggestions to increase education and modify the environment may lead to improved diets and better health in the community.

Treatment for hepatitis C virus with direct acting antiviral agents: Perspectives and treatment experiences of people who inject drugs.

INTRODUCTION: Increasingly, people who inject drugs (PWID) infected with hepatitis C virus (HCV) are gaining access to highly effective direct-acting antiviral agents (DAAs). Although past studies examined patient experiences with interferon-based treatments, few have explored patient experiences with these new generation therapeutics. Research and real world experience indicate that many PWID can be successfully treated with the new DAAs. Yet a substantial minority fail to complete treatment or achieve only suboptimal adherence. This qualitative study examines experiences with treatment among participants in Project HERO, a large multisite trial designed to compare treatment delivery methods for DAAs. We explored treatment experiences among HERO participants, with the goal of understanding potential barriers to treatment engagement and completion. METHODS: We conducted qualitative interviews with a sample of 21 participants, including 14 who completed HCV treatment and 7 participants who discontinued treatment before the end of the 12-week medication course. The first phase of the analysis was descriptive, examining participants' life experiences, histories of disease and treatment seeking, experiences with the program, and barriers to treatment completion. The second phase of the analysis examined differences between completers and noncompleters. RESULTS: Participants offered a variety of reasons for seeking treatment. Both groups of participants reported highly positive experiences of the HERO trial. Participants described research staff as caring, respectful, and nonjudgmental. Substance use was reported by both groups, yet completers described "manageable" substance use, while noncompleters described substance use that sapped their energy and motivation. Shame over drug use was a barrier to treatment completion. Homelessness and a reported lack of social support were much more common in the noncompleter group. CONCLUSIONS: Reasons for noncompletion were not related to features of the clinical trial or treatment program. Our results indicate the importance of: 1) recognizing and addressing severe social and economic challenges such as homelessness; and 2) building a program culture of respect and compassion in treatment programs for PWID infected with HCV.

Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study.

PURPOSE: Pain accounts for up to 78% of emergency department (ED) patient visits and opioids remain a primary method of treatment despite risks of addiction and adverse effects. While prior acupuncture studies are promising as an alternative opioid-sparing approach to pain reduction, successful conduct of a multi-center pilot study is needed to prepare for a future definitive randomized control trial (RCT). METHODS: Acupuncture in the Emergency Department for Pain Management (ACUITY) is funded by the National Center for Complementary and Integrative Health. The objectives are to: conduct a multi-center feasibility RCT, examine feasibility of data collection, develop/deploy a manualized acupuncture intervention and assess feasibility/implementation (barrier/facilitators) in 3 EDs affiliated with the BraveNet Practice Based Research Network.Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible. ED participants (n = 165) will be equally randomized to Acupuncture or Usual Care.At pre-, post-, and discharge time-points, patients will self-assess pain and anxiety using the Numeric Rating Scale. Pain, anxiety, post-ED opioid use and adverse events will be assessed at 1 and 4 weeks. Opioid utilization in the ED and discharge prescriptions will be extracted from patients' electronic medical records.Acupuncture recipients will asked to participate in a brief qualitative interview about 3 weeks after their discharge. ED providers and staff will also be interviewed about their general perspectives/experiences related to acupuncture in the ED and implementation of acupuncture in ACUITY. RESULTS: Recruitment began on 5/3/21. As of 12/7/21: 84 patients have enrolled, the responsive acupuncture intervention has been developed and deployed, and 26 qualitative interviews have been conducted. CONCLUSION: Successful conduct of ACUITY will provide the necessary framework for conducting a future, multi-center, definitive RCT of acupuncture in the ED. CLINICAL TRIALSGOV: NCT04880733 https://clinicaltrials.gov/ct2/show/NCT04880733.

Patient-centred models of hepatitis C treatment for people who inject drugs: a multicentre, pragmatic randomised trial.

BACKGROUND: To achieve WHO targets for the elimination of hepatitis C virus (HCV) as a public threat, an increased uptake of HCV treatment among people who inject drugs (PWID) is urgently needed. Optimal HCV co-located treatment models for PWID have not yet been identified. We aimed to compare two patient-centred models of HCV care in PWID with active drug use. METHODS: We did a pragmatic randomised controlled trial at eight US cities in eight opioid treatment programmes and 15 community health centres. PWID actively injecting within 90 days of study entry were randomly assigned (1:1) to either patient navigation or modified directly observed therapy (mDOT) using computer-generated variable block sizes of 2-6 stratified by city, clinical settings, and cirrhosis status. The randomisation code was concealed, in a centralised REDCap database platform, from all investigators and research staff except for an authorised data manager at the data coordinating centre. All participants received a fixed-dose combination tablet (sofosbuvir 400 mg plus velpatasvir 100 mg) orally once daily for 12 weeks. The primary outcome was sustained virological response (SVR; determined by chart review between 70 days and 365 days after end of treatment and if unavailable, by study blood draws), and secondary outcomes were treatment initiation, adherence (measured by electronic blister packs), and treatment completion. Analyses were conducted within the modified intention-to-treat (mITT; all who initiated treatment), intention-to-treat (all who were randomised), and per-protocol populations. This trial is registered with ClinicalTrials.gov, NCT02824640. FINDINGS: Between Sept 15, 2016, and Aug 14, 2018, 1891 individuals were screened and 1136 were excluded (213 declined to participate and 923 did not meet the eligibility criteria). We randomly assigned 755 participants to patient navigation (n=379) or mDOT (n=376). In the mITT sample of participants who were randomised and initiated treatment (n=623), 226 (74% [95% CI 69-79]) of 306 participants in the mDOT group and 236 (76% [69-79]) of 317 in the patient navigation group had an SVR, with no significant difference between the groups (adjusted odds ratio [AOR] 0·97 [95% CI 0·66-1·42]; p=0·35). In the ITT sample (n=755), 226 (60% [95% CI 55-65]) of 376 participants in the mDOT group and 236 (62% [57-67]) of 379 in the patient navigation group had an SVR (AOR 0·92 [0·68-1·25]; p=0·61) and in the per-protocol sample (n=501), 226 (91% [87-94]) of 248 participants in the mDOT group and 235 (93% [89-96]) of 253 in the patient navigation group had an SVR (AOR 0·79 [0·41-1·55]; p=0·44). 306 (81%) of 376 participants in the mDOT group and 317 (84%) of 379 participants in the patient navigation group initiated treatment (AOR 0·86 [0·58-1·26]; p=0·44) and, among those, 251 (82%) participants in the mDOT group and 264 (83%) participants in the patient navigation group completed treatment (AOR 0·90 [0·58-1·39]; p=0·63). Mean daily adherence was higher in the mDOT group (78% [95% CI 75-81]) versus the patient navigation group (73% [70-77]), with a difference of 4·7% ([1·9-7·4]; p=0·0010). 421 serious adverse events were reported (217 in the mDOT group and 204 in the patient navigation group), with the most common being hospital admission (176 in the mDOT group vs 161 in the patient navigation group). INTERPRETATION: In this trial of active PWID, both models resulted in high SVR. Although adherence was significantly higher in the mDOT group versus the patient navigation group, there was no significant difference in SVR between the groups. Increases in adherence and treatment completion were associated with an increased likelihood of SVR. These results suggest that active PWID can reach high SVRs in diverse settings with either mDOT or patient navigation support. FUNDING: Patient-Centered Outcomes Research Institute, Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies.