Julia H. Arnsten

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.

Background: Hepatitis C virus (HCV) is a leading cause of infectious disease death in the United States. Although highly effective direct-acting antiviral (DAA) regimens are well established, retreatment among people who inject drugs (PWID) has not been sufficiently studied. This study assessed DAA retreatment outcomes and associated factors. Methods: We performed analyses of longitudinal data from the HERO Study, a US-based multi-site pragmatic randomized trial conducted in 8 states to evaluate effectiveness of 2 HCV care models among DAA treatment-naïve PWID in opioid treatment programs and community clinics. After initial HERO Study sofosbuvir/velpatasvir (SOF/VEL) treatment, participants eligible for retreatment were identified, from 15 September 2016 to 13 September 2021. This analysis characterizes participants who either did not achieve sustained virologic response (SVR) or were reinfected with HCV post-SVR. We compared categorical variables using Fisher exact test and continuous variables using the Welch 2 sample t test for means and an asymptotic 2-sample Mood median test. Results: One hundred four participants were identified as eligible for retreatment. Less than half, 43 (41.3%), initiated retreatment. Among the 25 who initiated retreatment and for whom SVR results were available, 24 achieved SVR (96%). Participants who did not achieve SVR initiated retreatment more promptly than participants reinfected post-SVR (respectively, 471 vs 784 days on average, P < .001). Conclusions: After reinfection or not achieving SVR with the first DAA regimen, retreated PWID achieved higher SVR rates than with initial DAA treatment. To attain HCV elimination and benefit individual and public health, assisting PWID with accessing prompt retreatment is crucial.

Background: Current programs to engage marginalized populations such as gay and bisexual individuals and other men who have sex with men (MSM) in HIV prevention interventions do not often reach all MSM who may benefit from them. To reduce the global burden of HIV, far-reaching strategies are needed to engage MSM in HIV prevention and treatment. Globally, including low- and middle-income countries, MSM are now widely using internet-based social and mobile technologies (SMTs; eg, dating apps, social media, and WhatsApp [Meta]), which provides an unprecedented opportunity to engage unreached and underserved groups, such as MSM for HIV prevention and care. Objective: This study aimed to assess the effectiveness of a multilevel mobile health (mHealth)–based intervention to improve HIV testing uptake and status neutral linkage-to-care among sexually active MSM reached through internet-based platforms in Mumbai, India. Methods: In this randomized controlled trial, we will determine whether CHALO! 2.0 (a theory-based multilevel intervention delivered in part through WhatsApp) results in increased HIV testing and linkage-to-care (prevention or treatment). This study is being conducted among 1000 sexually active MSM who are unaware of their HIV status (never tested or tested >6 months ago) and are recruited through SMTs in Mumbai, India. We will conduct a 12-week, 3-arm randomized trial comparing CHALO! 2.0 to 2 control conditions—an attention-matched SMT-based control (also including a digital coupon for free HIV testing) and a digital coupon–only control. The primary outcomes will be HIV testing and status neutral linkage-to-care by 6 months post enrollment. Participants will be followed up for a total of 18 months to evaluate the long-term impact. Results: The study was funded in 2020, with recruitment having started in April 2022 due to delays from the COVID-19 pandemic. Baseline survey data collection began in April 2022, with follow-up surveys starting in July 2022. As of April 2022, we enrolled 1004 participants in the study. The completion of follow-up data collection is expected in January 2025, with results to be published thereafter. Conclusions: While global health agencies have called for internet-based interventions to engage populations vulnerable to HIV who are not being reached, few proven effective and scalable models exist and none is in India, which has one of the world’s largest HIV epidemics. This study will address this gap by testing a multicomponent mHealth intervention to reach and engage MSM at high priority for HIV interventions and link them to HIV testing and prevention or treatment. Trial Registration: ClinicalTrials.gov NCT04814654; https://clinicaltrials.gov/study/NCT04814654. Clinical Trial Registry of India CTRI/2021/03/032280 International Registered Report Identifier (IRRID): DERR1-10.2196/59873

This study is a secondary analysis of a randomized clinical trial (October 2013–April 2017) involving 150 People Who Inject Drugs (PWIDs) with hepatitis C virus (HCV) seen in opioid agonist treatment programs in the Bronx, New York, and investigates the impact of distrust in the healthcare system on adherence to Direct-Acting Antivirals (DAAs) HCV treatment therapy among PWIDs. The distrust was scaled on a 9-item instrument and the adherence to DAA medications was measured using electronic blister packs. This study demonstrated a significant inverse relationship between levels of distrust and medication adherence: 71.8 ± 2.2% (se) vs. 77.9 ± 1.8%, p = 0.024 between participants with higher and lower distrust levels. Despite the absence of significant association of distrust with sociodemographic or substance use characteristics, these findings suggest that building trust within the healthcare system is paramount for improving adherence to DAAs among PWIDs. The results call for a healthcare approach that emphasizes trust-building through patient-centered care, sensitivity training, peer support, and health system reform to effectively address the treatment needs of this marginalized population.

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: Current programs to engage marginalized populations such as gay and bisexual individuals and other men who have sex with men (MSM) in HIV prevention interventions do not often reach all MSM who may benefit from them. To reduce the global burden of HIV, far-reaching strategies are needed to engage MSM in HIV prevention and treatment. Globally, including low- and middle-income countries, MSM are now widely using internet-based social and mobile technologies (SMTs; eg, dating apps, social media, and WhatsApp [Meta]), which provides an unprecedented opportunity to engage unreached and underserved groups, such as MSM for HIV prevention and care. Objective: This study aimed to assess the effectiveness of a multilevel mobile health (mHealth)–based intervention to improve HIV testing uptake and status neutral linkage-to-care among sexually active MSM reached through internet-based platforms in Mumbai, India. Methods: In this randomized controlled trial, we will determine whether CHALO! 2.0 (a theory-based multilevel intervention delivered in part through WhatsApp) results in increased HIV testing and linkage-to-care (prevention or treatment). This study is being conducted among 1000 sexually active MSM who are unaware of their HIV status (never tested or tested >6 months ago) and are recruited through SMTs in Mumbai, India. We will conduct a 12-week, 3-arm randomized trial comparing CHALO! 2.0 to 2 control conditions—an attention-matched SMT-based control (also including a digital coupon for free HIV testing) and a digital coupon–only control. The primary outcomes will be HIV testing and status neutral linkage-to-care by 6 months post enrollment. Participants will be followed up for a total of 18 months to evaluate the long-term impact. Results: The study was funded in 2020, with recruitment having started in April 2022 due to delays from the COVID-19 pandemic. Baseline survey data collection began in April 2022, with follow-up surveys starting in July 2022. As of April 2022, we enrolled 1004 participants in the study. The completion of follow-up data collection is expected in January 2025, with results to be published thereafter. Conclusions: While global health agencies have called for internet-based interventions to engage populations vulnerable to HIV who are not being reached, few proven effective and scalable models exist and none is in India, which has one of the world’s largest HIV epidemics. This study will address this gap by testing a multicomponent mHealth intervention to reach and engage MSM at high priority for HIV interventions and link them to HIV testing and prevention or treatment. Trial Registration: ClinicalTrials.gov NCT04814654; https://clinicaltrials.gov/study/NCT04814654. Clinical Trial Registry of India CTRI/2021/03/032280

People on buprenorphine maintenance treatment (BMT) commonly present cognitive deficits that have been associated with illicit drug use and dropout from buprenorphine treatment. This study has compared cognitive responses to the Stroop Task and the Continuous Performance Task (CPT) among individuals on BMT, with recent drug use, and healthy controls and explored the associations between cognitive responses and drug use, craving, and buprenorphine use among participants on BMT. The participants were 16 individuals on BMT and 23 healthy controls. All participants completed a 60 min laboratory session in which they completed the Stroop Task and the CPT, a saliva drug test, a brief clinical history that collected substance-use- and treatment-related information, and the Opioid Craving Scale. The results showed that the BMT participants presented more commission errors (MBMT participants = 2.49; Mhealthy controls = 1.38; p = 0.048) and longer reaction times (MBMT participants = 798.09; Mhealthy controls = 699.09; p = 0.047) in the Stroop Task than did the healthy controls. More days on buprenorphine were negatively associated with reaction time in the CPT (−0.52) and the number of commission errors (−0.53), simple reaction time (−0.54), and reaction time correct (−0.57) in the Stroop Task. Neither drug use nor craving was significantly associated with the results for the cognitive tasks. Relative to the control participants, the BMT individuals performed worse in terms of longer reaction times and more commission errors in the Stroop Task. Within the BMT participants, longer times on buprenorphine were associated with better cognitive results in terms of faster reaction times for both tasks and lower commission errors for the Stroop Task.

Young Black and Latinx Gay and Bisexual Men and Transgender Women (YBLGBMTW) face high levels of mental health related concerns. While online interventions show promise for addressing mental health conditions, few models focus on this population. We used a pre-post design to assess the feasibility and acceptability of a peer delivered mental health awareness intervention for YBLGBMTW. This study was nested as the control arm from a larger study investigating if Peer Influencers (PIs) can improve HIV prevention. PIs helped develop an online outreach campaign to raise awareness of pertinent mental health topics as chosen by the PIs. PIs recruited YBLGBMTW participants from online social networks, posted contents over a six-week period, and participants completed baseline and post-intervention surveys. PIs successfully recruited 71 participants of whom 92% completed the six-week post-intervention survey. Participants had on average 6.7 engagements with posted contents and 82% of participants indicated being very satisfied with the intervention. Using an intervention informed and delivered by PIs, participants were presented with information to address relevant mental health concerns. We found that such novel means of engaging this sample for mental health is feasible, acceptable, and merits further development.

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.

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: