Pain plays a significant role in emergency department (ED) visits, however safe and effective nonpharmacologic options are needed. Prior studies of acupuncture in the ED reported pain reduction with minimal side effects, but most were small and single site. We conducted ACUITY, a prospectively designed multi-center feasibility RCT. Our goal was to recruit 165 adults with acute non-emergent pain ≥4 on a 0–10-point scale at three EDs affiliated with BraveNet Practice Based Research Network. At baseline and 45–60 min later (post), participants self-assessed their pain and anxiety using a 0–10 rating scale. The primary feasibility outcome was recruitment of participants, whereas secondary outcomes were retention, and participant/provider acceptability. From May 3, 2021, to September 24, 2022, 632 eligible individuals were approached and 165 enrolled (165/632: 26.1 %), meeting our recruitment goal. Notably, 42.4 % of enrollees were Black/African American, 42.4 % were White/Caucasian, and 13.9 % were Hispanic/Latino. Participants were randomized to Acupuncture (n = 83) or Usual care (n = 82), of which 151 (91.5 %) and 128 (77.6 %) provided pain and anxiety scores at post-treatment and 1-week respectively. Acupuncture was rated acceptable to participants and providers. Mean pain ratings (pre-to-post) were 7.4 (2.2) to 4.8 (2.8) for acupuncture and 7.1 (2.3) to 6.4 (2.5) for usual care. Mean anxiety ratings (pre-to-post) were 4.5 (3.4) to 2.5 (2.6) for acupuncture and 4.1 (3.4) to 3.5 (3.2) for usual care. Successful completion of ACUITY indicates we have the expertise and preliminary data to conduct a future definitive, multi-center RCT. NCT04880733.

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. 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. 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. 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.

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.

Background: Personal protective measures help prevent infection and disease transmission during health crises such as Coronavirus disease 2019 (COVID-19). Populations facing barriers to adhering to these measures are more vulnerable to the health crisis. This study investigated the association of social drivers of health (SDoH), self-efficacy, and adverse substance use behavior changes with ability to practice COVID-19 personal protective behaviors among persons who inject drugs (PWID) with hepatitis C virus (HCV) infection history. Methods: This study used the Hepatitis C Real Options (HERO) study’s COVID-19 survey data (n = 157). The association of inability to practice COVID-19 personal protective behaviors (hand washing, social distancing, etc.) with (a) SDoH difficulties (employment, housing, etc.); (b) adverse substance use behavior change (overdose, injecting behavior, etc.); and (c) self-efficacy was tested using logistic regression. Results: Inability to practice any personal protective behaviors was more likely among those experiencing any vs. no SDoH difficulties [adjusted odds ratio (aOR) (95% confidence interval (CI))] = 4.57 (1.57, 16.40); p = 0.003] but less likely for those with higher overall self-efficacy [aOR (95% CI) = 0.55 (0.32, 0.93); p = 0.025] and self-efficacy for setting goals [aOR (95% CI) = 0.63 (0.40, 0.96); p = 0.031]. The association between adverse substance use behavior changes and the outcome was not significant. Conclusions: Greater SDoH difficulties and lower self-efficacy were associated with greater inability to practice COVID-19 personal protective behaviors. Interventions to meet SDoH-related challenges and increase self-efficacy could help encourage practice of personal protective behaviors and economically reduce disease burden during health crises.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). 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. Trial Registration: