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Objective: To identify primary care structures and processes that have the highest and lowest impact on chronic disease management and screening and prevention outcomes as well as to assess the feasibility of implementing these structures and processes into practice., Design: A two-round Delphi study was conducted to establish consensus on the impact and feasibility of 258 primary care structures and processes., Participants: 29 primary care providers, health system leaders and health services researchers in the USA., Outcomes: Primary outcomes were (1) consensus on the impact of each structure and process on chronic disease management and screening and prevention outcomes, separately and (2) consensus on feasibility of implementation by primary care practices., Results: Consensus on high impact and feasibility of implementation was reached on four items for chronic disease management: 'Providers use motivational interviewing to help patients set goals', 'Practice has designated staff to manage patient panel', 'Practice has onsite providers or staff that speak the most dominant, non-English language spoken by patients' and 'Practice includes mental health providers and/or behavioural health specialists in care team' and seven items for screening and prevention: 'Practice utilizes standing protocols and orders', 'Practice generates reports to alert clinicians to missed targets and to identify gaps in care, such as overdue visits, needed vaccinations, screenings or other preventive services', 'Practice has designated staff to manage patient panel', 'Practice sets performance goals and uses benchmarking to track quality of care', 'Practice uses performance feedback to identify practice-specific areas of improvement', 'Practice builds quality improvement activities into practice operations' and 'Pre-visit planning data are reviewed during daily huddles'. Only 'Practice has designated staff to manage patient panel' appeared on both lists., Conclusion: Findings suggest that practices need to focus on implementing mostly distinct, rather than common, structures and processes to optimise chronic disease and preventive care., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Few implementation science (IS) measures have been evaluated for validity, reliability and utility - the latter referring to whether a measure captures meaningful aspects of implementation contexts. We present a real-world case study of rigorous measure development in IS that assesses Barriers and Facilitators in Implementation of Task-Sharing in Mental Health services (BeFITS-MH), with the objective of offering lessons-learned and a framework to enhance measurement utility., Methods: We summarize conceptual and empirical work that informed the development of the BeFITS-MH measure, including a description of the Delphi process, detailed translation and local adaptation procedures, and concurrent pilot testing. As validity and reliability are key aspects of measure development, we also report on our process of assessing the measure's construct validity and utility for the implementation outcomes of acceptability, appropriateness, and feasibility., Results: Continuous stakeholder involvement and concurrent pilot testing resulted in several adaptations of the BeFITS-MH measure's structure, scaling, and format to enhance contextual relevance and utility. Adaptations of broad terms such as "program," "provider type," and "type of service" were necessary due to the heterogeneous nature of interventions, type of task-sharing providers employed, and clients served across the three global sites. Item selection benefited from the iterative process, enabling identification of relevance of key aspects of identified barriers and facilitators, and what aspects were common across sites. Program implementers' conceptions of utility regarding the measure's acceptability, appropriateness, and feasibility clustered across several common categories., Conclusions: This case study provides a rigorous, multi-step process for developing a pragmatic IS measure. The process and lessons learned will aid in the teaching, practice and research of IS measurement development. The importance of including experiences and knowledge from different types of stakeholders in different global settings was reinforced and resulted in a more globally useful measure while allowing for locally-relevant adaptation. To increase the relevance of the measure it is important to target actionable domains that predict markers of utility (e.g., successful uptake) per program implementers' preferences. With this case study, we provide a detailed roadmap for others seeking to develop and validate IS measures that maximize local utility and impact., (© 2024. The Author(s).)

Improving engagement along the HIV care continuum and reducing racial/ethnic disparities are necessary to end the HIV epidemic. Research on African American/Black and Latine (AABL) younger people living with HIV (LWH) is essential to this goal. However, a number of key subgroups are challenging to locate and engage, and are therefore under-represented in research. Primary among these are persons with non-suppressed HIV viral load, severe socioeconomic disadvantage, transgender/gender expansive identities, and refugee/migrant/immigrant populations. Research in community settings is needed to complement studies conducted in medical institutions. The present study describes the efficiency of recruitment strategies used in the community to enroll AABL young and emerging adults LWH ages 19-28 years. Strategies were designed to be culturally responsive and structurally salient. They were: peer-to-peer, social media, classified advertisements (newspaper, craigslist), subway ads, dating apps (Jack'd, Positive Singles), and direct recruitment in community-based organizations. Data were analyzed using mainly descriptive statistics and interpreted using a consensus building approach. We screened 575 individuals in a first step, 409 were eligible (71%), of these 297 presented to the second screening step (73%), but 112 were lost. Almost all presenting at the second step were eligible (98%, 291/297) and 94% enrolled (274/291). Peer-to-peer, dating app (Jack'd), direct recruitment, and craigslist were the most efficient strategies. Recruitment on dating apps was superior to the peer-to-peer approach in yielding eligible participants (OR = 1.5; 95% CI: 0.98-2.3; p = 0.06). The sample enrolled was diverse with respect to HIV viral suppression, gender identify, sexual orientation, immigration status, and barriers to HIV care engagement. We discuss the advantages and disadvantages of each strategy. Recruitment is a vital aspect of research and warrants attention in the empirical literature., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: The overdose crisis in the U.S. disproportionately impacts people experiencing homelessness. Permanent supportive housing (PSH) - permanent, affordable housing with voluntary support services - is an effective, evidence-based intervention to address homelessness. However, overdose risk remains high even after entering PSH for individual and structural reasons. In this study, we aimed to refine a set of evidence-based overdose prevention practices (EBPs) and an associated implementation support package for PSH settings using focus groups with PSH tenants, frontline staff, and leaders., Methods: Our community-academic team identified an initial set of overdose EBPs applicable for PSH through research, public health guidance, and a needs assessment. We adapted these practices based on feedback from focus groups with PSH leaders, staff, and tenants. Focus groups followed semi-structured interview guides developed using the EPIS (Exploration, Preparation, Implementation, Sustainment) framework constructs of inner context, outer context, and bridging factors related to overdose prevention and response., Results: We conducted 16 focus groups with 40 unique participants (14 PSH tenants, 15 PSH staff, 11 PSH leaders); focus groups were held in two iterative rounds and individuals could participate in one or both rounds. Participants were diverse in gender, race, and ethnicity. Focus group participants were enthusiastic about the proposed EBPs and implementation strategies, while contributing unique insights and concrete suggestions to improve upon them. The implementation support package contains an iteratively refined PSH Overdose Prevention (POP) Toolkit with 20 EBPs surrounding overdose prevention and response, harm reduction, and support for substance use treatment and additional core implementation strategies including practice facilitation, tenant-staff champion teams, and learning collaboratives., Conclusions: This manuscript describes how robust community-academic partnerships and input from people with lived experience as tenants and staff in PSH informed adaptation of evidence-based overdose prevention approaches and implementation strategies to improve their fit for PSH settings. This effort can inform similar efforts nationally in other settings serving highly marginalized populations. We are currently conducting a randomized trial of the refined overdose prevention implementation support package in PSH., Competing Interests: Declaration of competing interest The authors do not report any competing interests., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Primary diabetes care and diabetic retinopathy (DR) screening persist as major public health challenges due to a shortage of trained primary care physicians (PCPs), particularly in low-resource settings. Here, to bridge the gaps, we developed an integrated image-language system (DeepDR-LLM), combining a large language model (LLM module) and image-based deep learning (DeepDR-Transformer), to provide individualized diabetes management recommendations to PCPs. In a retrospective evaluation, the LLM module demonstrated comparable performance to PCPs and endocrinology residents when tested in English and outperformed PCPs and had comparable performance to endocrinology residents in Chinese. For identifying referable DR, the average PCP's accuracy was 81.0% unassisted and 92.3% assisted by DeepDR-Transformer. Furthermore, we performed a single-center real-world prospective study, deploying DeepDR-LLM. We compared diabetes management adherence of patients under the unassisted PCP arm (n = 397) with those under the PCP+DeepDR-LLM arm (n = 372). Patients with newly diagnosed diabetes in the PCP+DeepDR-LLM arm showed better self-management behaviors throughout follow-up (P < 0.05). For patients with referral DR, those in the PCP+DeepDR-LLM arm were more likely to adhere to DR referrals (P < 0.01). Additionally, DeepDR-LLM deployment improved the quality and empathy level of management recommendations. Given its multifaceted performance, DeepDR-LLM holds promise as a digital solution for enhancing primary diabetes care and DR screening., (© 2024. The Author(s).)

Research suggests that hair color, hair dyeing, and perspiration can bias hair test results regarding drug exposure, but research is needed to examine such associations in a multivariable manner. In this epidemiology study, adults were surveyed entering nightclubs and dance festivals in New York City, and 328 provided hair samples, which were analyzed using ultra-high-performance liquid chromatography-tandem mass spectrometry to determine the level of detection of cocaine and 3,4-methylenedioxymethamphetamine (MDMA). Reporting use was not an inclusion criterion for analysis. We used two-part multivariable models to delineate associations of hair color, past-year hair dyeing, and frequency of past-month hat wearing (which may increase perspiration) in relation to any vs. no detection of cocaine and MDMA as well as level of detection, controlling for hair length, self-reported past-year cocaine/ecstasy/MDMA use, and age, sex, and race/ethnicity. Those reporting having dyed their hair were at increased odds of having any level of cocaine detected (adjusted odds ratio [aOR] = 3.75, 95% CI confidence interval [CI]: 1.85-6.70), and compared to those with brown hair, those with blond(e) hair on average had lower levels of cocaine (ng/mg) detected (beta = -7.97, p = 0.025). Those reporting having dyed their hair were at increased odds of having any level of MDMA detected (aOR = 3.05, 95% CI: 1.44-6.48), and compared to those who reported never wearing a hat, those who reported wearing a hat daily or almost daily on average had lower levels of MDMA (ng/mg) detected (beta = -6.61, p = 0.025). This study demonstrates the importance of using multivariable models to delineate predictors of drug detection., (© 2023 John Wiley & Sons, Ltd.)

Background: Engaging researchers as research subjects is key to informing the development of effective and relevant research practices. It is important to understand how best to engage researchers as research subjects., Methods: A 2 4 factorial experiment, as part of a Multiphase Optimization Strategy, was performed to evaluate effects of four recruitment strategy components on participant opening of an emailed survey link and survey completion. Participants were members of three US-based national health research consortia. A stratified simple random sample was used to assign potential survey participants to one of 16 recruitment scenarios. Recruitment strategy components were intended to address both intrinsic and extrinsic sources of motivation, including: $50 gift, $1,000 raffle, altruistic messaging, and egoistic messaging. Multivariable generalized linear regression analyses adjusting for consortium estimated component effects on outcomes. Potential interactions among components were tested. Results are reported as adjusted odds ratios (aOR) with 95% confidence intervals (95% CI)., Results: Surveys were collected from June to December 2023. A total of 418 participants were included from the consortia, with final analytical sample of 400 eligible participants. Out of the final sample, 82% (341) opened the survey link and 35% (147) completed the survey. Altruistic messaging increased the odds of opening the survey (aOR 2.02, 95% CI: 1.35-2.69, p = 0.033), while egoistic messaging significantly reduced the odds of opening the survey (aOR 0.56, 95%CI 0.38-0.75, p = 0.08). The receipt of egoistic messaging increased the odds of completing the survey once opened (aOR 1.81, 95%CI: 1.39-2.23, p < 0.05). There was a significant negative interaction effect between the altruistic appeal and egoistic messaging strategies for survey completion outcome. Monetary incentives did not a have a significant impact on survey completion., Conclusion: Intrinsic motivation is likely to be a greater driver of health researcher participation in survey research than extrinsic motivation. Altruistic and egoistic messaging may differentially impact initial interest and survey completion and when combined may lead to improved rates of recruitment, but not survey completion. Further research is needed to determine how to best optimize message content and whether the effects observed are modified by survey burden., (© 2024. The Author(s).)

We used results from an optimization randomized controlled trial which tested five behavioral intervention components to support HIV antiretroviral adherence/HIV viral suppression, grounded in the multiphase optimization strategy and using a fractional factorial design to identify intervention components with cost-effectiveness sufficiently favorable for scalability. Results were incorporated into a validated HIV computer simulation to simulate longer-term effects of combinations of components on health and costs. We simulated the 32 corresponding long-term trajectories for viral load suppression, health related quality of life (HRQoL), and costs. The components were designed to be culturally and structurally salient. They were: motivational interviewing counseling sessions (MI), pre-adherence skill building (SB), peer mentorship (PM), focused support groups (SG), and patient navigation (short version [NS], long version [NL]. All participants also received health education on HIV treatment. We examined four scenarios: one-time intervention with and without discounting and continuous interventions with and without discounting. In all four scenarios, interventions that comprise or include SB and NL (and including health education) were cost effective (< $100,000/quality-adjusted life year). Further, with consideration of HRQoL impact, maximal intervention became cost-effective enough to be scalable. Thus, a fractional factorial experiment coupled with cost-effectiveness analysis is a promising approach to optimize multi-component interventions for scalability. The present study can guide service planning efforts for HIV care settings and health departments., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: Medicare Home Health Care (HHC) services are integral to the care of homebound seriously ill older adults requiring ongoing specialized medical care. Although disparities in health outcomes are well documented in inpatient and primary care, disparities experienced by historically marginalized racial and ethnic groups underrepresented in HHC are understudied. This study aimed to examine the relationship between individual characteristics and differences in HHC health outcomes for seriously ill older adults., Design: Secondary data analysis, repeated measure., Setting and Participants: Seriously ill older adults who received HHC in 2016 in the HHC Outcome and Assessment Information Set (OASIS)., Methods: Start of care and discharge data from the 2016 HCC OASIS were used to examine the relationship between individual characteristics and differences in HHC health outcomes identified by the Centers for Medicare and Medicaid Services as key indicators of quality in HHC, including dyspnea, pain frequency, cognitive functioning, and presence of unhealed pressure ulcer stage II or higher. A generalized ordered logit model with partial proportional odds was used for the ordinal categorical outcomes and a logistic regression was used for the binary dependent variable., Results: Findings indicated that of 227,402 seriously ill individuals with an HHC episode in 2016, those from underrepresented racial and ethnic groups had between 14% and 57% higher odds of worse health outcomes compared with non-Hispanic white patients with the exception of pain frequency., Conclusions and Implications: For people living with serious illness, there are significant differences in Medicare HHC health outcomes when comparing underrepresented racial or ethnic beneficiaries with white counterparts. More research is needed to understand how health care processes such as referral patterns or time to care initiation, and structural factors such as HHC agency quality and neighborhood social deprivation are related to health differences observed in the population., Competing Interests: Disclosure The authors declare no conflicts of interest., (Copyright © 2024 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Black sexual minority men and Black transgender women (BSMM/BTW) experience disproportionate levels of HIV/STI-related risk factors as well as police harassment (PH). PH is linked to psychiatric risk and could play a role in substance use, sexual risk behavior, and HIV/STI risk., Methods: We used data from the HIV Prevention Trials Network 061(HPTN 061) study to examine associations between PH and HIV/STI-related outcomes. Using PH exposure measured at baseline and 6-month study visits, we examined an ordinal exposure (PH reported at both visits, PH reported at either visit, versus PH reported at neither baseline nor 6 months) and a binary exposure of persistent PH reported at both visits (yes versus no). We estimate risk ratios (RR) for associations between PH and depression, use of alcohol and methamphetamine, multiple partnerships, condomless sex, and syphilis., Results: Persistent PH (binary) was associated with a 20% or greater increase in the risk of depression (RR, 1.26 (1.07, 1.47)) and multiple partnerships (RR, 1.20 (1.05, 1.39)). There was evidence that ordinal PH was associated with elevated risk of alcohol use (RR, 1.17 (1.00, 1.36)); the point estimate for the association between persistent PH and alcohol use was similar but the imprecision was greater (RR, 1.16 (0.95, 1.42))., Conclusion: PH may influence not only mental health but also behavioral risks that contribute to HIV/STI among BSMM/BTW, highlighting the potential wide-ranging and downstream effects of PH on health. Further research is required to confirm associations and elucidate pathways through which PH may influence HIV/STI among BSMM/BTW., (© 2024. W. Montague Cobb-NMA Health Institute.)

ABSTRACT In resource-limited settings, alternatives to HIV viral load testing may be necessary to monitor the health of people living with HIV. We assessed the utility of self-report antiretroviral therapy (ART) to screen for HIV viral load among persons who inject drugs in Hai Phong Vietnam, and consider differences by recent methamphetamine use. From 2016 to 2018 we recruited PWID through cross sectional surveys and collected self-report ART adherence and HIV viral load to estimate sensitivity, specificity, positive and negative predictive values (PPV, NPV) and likelihood ratios (LR+, LR-) for self-reported ART adherence as a screening test for HIV viral load. We used three HIV viral load thresholds: < 1000, 500 and 250 copies/mL; laboratory-confirmed HIV viral load was the gold standard. Among 792 PWID recruited, PPV remained above 90% regardless of recent methamphetamine use with slightly higher PPV among those not reporting recent methamphetamine use. The results remained consistent across all three HIV viral load thresholds. Our findings suggest that when HIV viral load testing is not possible, self-reported ART adherence may inform decisions about how to prioritize HIV viral load testing among PWID. The high PPV values suggest self-reported high ART adherence indicates likely HIV viral suppression, irrespective of methamphetamine use.

Background: Given the disproportionate rates of incarceration and lower life expectancy (LE) among Black sexual minority men (BSMM) and Black transgender women (BTW) with HIV, we modeled the impact of decarceration and screening for psychiatric conditions and substance use on LE of US BSMM/BTW with HIV., Methods: We augmented a microsimulation model previously validated to predict LE and leading causes of death in the US with estimates from the HPTN 061 cohort and the Veteran's Aging Cohort Studies. We estimated independent associations among psychiatric and substance use disorders, to simulate the influence of treatment of one condition on improvement on others. We used this augmented simulation to estimate LE for BSMM/BTW with HIV with a history of incarceration under alternative policies of decarceration (ie, reducing the fraction exposed to incarceration), screening for psychiatric conditions and substance use, or both., Results: Baseline LE was 61.3 years. Reducing incarceration by 25%, 33%, 50%, and 100% increased LE by 0.29, 0.31, 0.53, and 1.08 years, respectively, versus no reductions in incarceration. When reducing incarceration by 33% and implementing screening for alcohol, tobacco, substance use, and depression, in which a positive screen triggers diagnostic assessment for all psychiatric and substance use conditions and linkage to treatment, LE increased by 1.52 years compared with no screening or decarceration., Discussion: LE among BSMM/BTW with HIV is short compared with other people with HIV. Reducing incarceration and improving screening and treatment of psychiatric conditions and substance use could substantially increase LE in this population., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: We assessed longitudinal effects of e-cigarette use on respiratory symptoms in a nationally representative sample of US adults by combustible tobacco smoking status., Methods: We analyzed Waves 4-5 public-use data from the Population Assessment of Tobacco and Health Study. Study sample included adult respondents who reported no diagnosis of respiratory diseases at Wave 4, and completed Waves 4-5 surveys with no missing data on analytic variables (N = 15,291). Outcome was a validated index of functionally important respiratory symptoms based on 7 wheezing/cough questions (range 0-9). An index score of ≥2 was defined as having important respiratory symptoms. Weighted lagged logistic regression models were performed to examine the association between e-cigarette use status at Wave 4 (former/current vs. never use) and important respiratory symptoms at Wave 5 by combustible tobacco smoking status (i.e., never/former/current smokers), adjusting for Wave 4 respiratory symptom index, sociodemographic characteristics, secondhand smoke exposure, body mass index, and chronic disease., Results: Among current combustible tobacco smokers, e-cigarette use was associated with increased odds of reporting important respiratory symptoms (former e-cigarette use: adjusted odds ratio [AOR] = 1.39, 95% confidence interval [CI]: 1.07-1.81; current e-cigarette use: AOR = 1.55, 95% CI: 1.17-2.06). Among former combustible tobacco smokers, former e-cigarette use (AOR = 1.51, 95% CI: 1.06-2.15)-but not current e-cigarette use (AOR = 1.59, 95% CI: 0.91-2.78)-was associated with increased odds of important respiratory symptoms. Among never combustible tobacco smokers, no significant association was detected between e-cigarette use and important respiratory symptoms (former e-cigarette use: AOR = 1.62, 95% CI: 0.76-3.46; current e-cigarette use: AOR = 0.82, 95% CI: 0.27-2.56)., Conclusions: The association between e-cigarette use and respiratory symptoms varied by combustible tobacco smoking status. Current combustible tobacco smokers who use e-cigarettes have an elevated risk of respiratory impairments., Competing Interests: Dr. Emma Karey is an employee and owns stock in AstraZeneca. No pharmaceutical financial support was provided for this work and all contributions occurred outside of working hours. All remaining authors declared no competing interests.This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Karey et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: Optimizing multicomponent behavioral and biobehavioral interventions presents a complex decision problem. To arrive at an intervention that is both effective and readily implementable, it may be necessary to weigh effectiveness against implementability when deciding which components to select for inclusion. Different components may have differential effectiveness on an array of outcome variables. Moreover, different decision-makers will approach this problem with different objectives and preferences. Recent advances in decision-making methodology in the multiphase optimization strategy (MOST) have opened new possibilities for intervention scientists to optimize interventions based on a wide variety of decision-maker preferences, including those that involve multiple outcome variables. In this study, we introduce decision analysis for intervention value efficiency (DAIVE), a decision-making framework for use in MOST that incorporates these new decision-making methods. We apply DAIVE to select optimized interventions based on empirical data from a factorial optimization trial., Method: We define various sets of hypothetical decision-maker preferences, and we apply DAIVE to identify optimized interventions appropriate to each case., Results: We demonstrate how DAIVE can be used to make decisions about the composition of optimized interventions and how the choice of optimized intervention can differ according to decision-maker preferences and objectives., Conclusions: We offer recommendations for intervention scientists who want to apply DAIVE to select optimized interventions based on data from their own factorial optimization trials. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Introduction: Globally, diabetic retinopathy (DR) is a major cause of blindness. Sub-Saharan Africa is projected to see the largest proportionate increase in the number of people living with diabetes over the next two decades. Screening for DR is recommended to prevent sight loss; however, in many low and middle-income countries, because of a lack of specialist eye care staff, current screening services for DR are not optimal. The use of artificial intelligence (AI) for DR screening, which automates the grading of retinal photographs and provides a point-of-screening result, offers an innovative potential solution to improve DR screening in Tanzania., Methods and Analysis: We will test the hypothesis that AI-supported DR screening increases the proportion of persons with true referable DR who attend the central ophthalmology clinic following referral after screening in a single-masked, parallel group, individually randomised controlled trial. Participants (2364) will be randomised (1:1 ratio) to either AI-supported or the standard of care DR screening pathway. Participants allocated to the AI-supported screening pathway will receive their result followed by point-of-screening counselling immediately after retinal image capture. Participants in the standard of care arm will receive their result and counselling by phone once the retinal images have been graded in the usual way (typically after 2-4 weeks). The primary outcome is the proportion of persons with true referable DR attending the central ophthalmology clinic within 8 weeks of screening. Secondary outcomes, by trial arm, include the proportion of persons attending the central ophthalmology clinic out of all those referred, sensitivity and specificity, number of false positive referrals, acceptability and fidelity of AI-supported screening., Ethics and Dissemination: The London School of Hygiene & Tropical Medicine, Kilimanjaro Christian Medical Centre and Tanzanian National Institute of Medical Research ethics committees have approved the trial. The results will be submitted to peer-reviewed journals for publication., Trial Registration Number: ISRCTN18317152., Competing Interests: Competing interests: CE has received fees from Heidelberg Engineering and Inozyme Pharma. AT has received fees from Annexon, Apellis, Bayer, Genentech, Iveric Bio, Novartis, Oxurion and Roche. PAK has acted as a consultant for Roche, Novartis, Boehringer Ingelheim, Adecco and Bitfount and is an equity owner in Big Picture Medical; has received speaker fees from Novartis, Gyroscope, Bayer, Thea, Boehringer Ingelheim, Apellis, AbbVie, Alimera, Roche, Genentech, Specsavers, Heidelberg Engineering, Topcon and Santen; has received travel support from Bayer, Topcon and Roche; and has attended advisory boards for Boehringer Ingelheim, RetinAI, Novartis, Apellis, AbbVie and Roche., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Black men and people belonging to sexual minority groups are disproportionately impacted by criminal legal involvement and sexually transmitted infections (STIs). Traumatic experiences are often associated with later criminal legal involvement, depression symptoms, sexual risk behavior, and STIs. Research on the joint influence of trauma and incarceration on STI risk among racial and/or sexual minority people is limited. This study tested the association between post-traumatic stress disorder (PTSD) symptoms and incarceration on sexual risk behavior and STI among Black sexual minority men, a population that may be at higher risk for contracting STIs. Using data from the HIV Prevention Trials Network 061 Study, a longitudinal study of adult Black sexual minority men in six U.S. cities ( N = 855), we tested associations between past six-month incarceration and subsequent sexual risk behavior, STI, and depression symptoms, for those with and without pre-incarceration PTSD symptoms. PTSD symptoms were elevated among participants who reported Hispanic ethnicity, having sex with both men and women, and previous incarceration. Although there were not significant differences between recent incarceration and sexual risk for those with and without PTSD, incarceration was linked to some sexual risk behaviors regardless of PTSD symptoms. Among people with PTSD symptoms, there was a higher prevalence of sexual risk and depression symptoms, regardless of incarceration. These findings suggest a potentially compounding influence of PTSD symptoms and incarceration on sexual risk and infection among Black sexual minority men.

Background: Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD., Methods: The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population., Discussion: Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population., Trial Registration: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020., (© 2023. The Author(s).)

Background: Nightclub/festival attendees are a population with high rates of party drug use, but research is needed to determine whether there have been shifts in unintended drug exposure in this population (e.g., via adulterants) to inform prevention and harm reduction efforts., Methods: Adults entering nightclubs and festivals in New York City were asked about past-year drug use in 2016 through 2022, with a subset providing a hair sample for testing. We focused on the 1943 who reported ecstasy use (of which 247 had a hair sample analyzed) and compared trends in self-reported drug use, drug positivity, and adjusted prevalence (adjusting for unreported use)., Results: MDMA positivity decreased from 74.4 % to 42.3 %, and decreases occurred regarding detection of synthetic cathinones ("bath salts"; a 100.0 % decrease), MDA (a 76.9 % decrease), amphetamine (an 81.3 % decrease), methamphetamine (a 64.2 % decrease), and ketamine (a 33.4 % decrease) (ps < .05). Although prevalence of MDA and synthetic cathinone use was comparable between self-report and adjusted report in 2022, gaps in prevalence were wider in 2016 (ps < .01). Adjusted prevalence of synthetic cathinone use decreased more across time than prevalence based on self-report (a 79.4 % vs. 69.1 % decrease) and adjusted report for MDA use decreased more than prevalence based on self-report (a 50.6 % vs. 38.9 % decrease)., Conclusions: Combining self-report and toxicology tests helped us determine that decreases in drug use/exposure were steeper regarding adjusted prevalence. Underreported drug exposure-possibly due to exposure to adulterants-appears to have had less of an effect on prevalence in 2022 than it did in 2016., Competing Interests: The authors declare no conflicts of interest., (© 2023 Published by Elsevier B.V.)

Incarceration can lead to different risk behaviors often due to increased distress and disruption of social networks. It is not well known, however, how these associations may differ by age. In this study, we measure age differences in longitudinal associations between incarceration and substance use, sex risk, and sexually transmitted infection (STI) among Black sexual minority men and Black transgender women (BSMM/BTW). We recruited BSMM/BTW from 2009 to 2011 that were part of the HIV Prevention Trials Network 061 study. We compared those less than 30 years old ( n = 375) to those 30 years old or greater ( n = 794) examining substance use, sex risk, and STI infection stratified by age. Logistic regression with inverse probability weighting was used for the statistical analysis. Approximately 59% of the sample reported incarceration history. In adjusted analysis, incarceration was more strongly associated with alcohol use and stimulant use among older individuals as was sexual risk behaviors including buying and selling sex. Concurrent partnerships were associated with the younger age groups. STI incidence was associated with younger individuals while associations with HIV infection were similar for the two age groups. Understanding differences in substance use and STI risk among age cohorts is imperative to the design and implementation of re-entry programs. Younger BSMM/BTW participating in re-entry support programs may benefit in particular from HIV/STI prevention and care efforts, while post-release substance abuse treatment and harm reduction programs should target older individuals with continued substance abuse., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

There is an urgent need for efficient behavioral interventions to increase rates of HIV viral suppression for populations with serious barriers to engagement along the HIV care continuum. We carried out an optimization trial to test the effects of five behavioral intervention components designed to address barriers to HIV care continuum engagement for African American/Black and Latino persons living with HIV (PLWH) with non-suppressed HIV viral load levels: motivational interviewing sessions (MI), focused support groups (SG), peer mentorship (PM), pre-adherence skill building (SB), and navigation with two levels, short (NS) and long (NL). The primary outcome was HIV viral suppression (VS) and absolute viral load (VL) and health-related quality of life were secondary outcomes. Participants were 512 African American/Black and Latino PLWH poorly engaged in HIV care and with detectable HIV viral load levels in New York City, recruited mainly through peer referral. Overall, VS increased to 37%, or 45% in a sensitivity analysis. MI and SG seemed to have antagonistic effects on VS (z = - 1.90; p = 0.057); the probability of VS was highest when either MI or SG was assigned, but not both. MI (Mean Difference = 0.030; 95% CI 0.007-0.053; t(440) = 2.60; p = 0.010) and SB (Mean Difference = 0.030; 95% CI 0.007-0.053; t(439) = 2.54; p = 0.012) improved health-related quality of life. This is the first optimization trial in the field of HIV treatment. The study yields a number of insights into approaches to improve HIV viral suppression in PLWH with serious barriers to engagement along the HIV care continuum, including chronic poverty, and underscores challenges inherent in doing so., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Opioid withdrawal is a regular occurrence among many people who use illicit opioids (PWUIO) that has also been shown to increase their willingness to engage in risk-involved behavior. The proliferation of fentanyl in the illicit opioid market may have amplified this relationship, potentially putting PWUIO at greater risk of negative health outcomes. Understanding the relationship between withdrawal and risk-involved behavior may also have important implications for the ways that problematic drug use is conceptualized, particularly in disease models of addiction, which position risk behavior as evidence of pathology that helps to justify ontological distinctions between addicts and non-addicts. Examining withdrawal, and its role in PWUIO's willingness to engage in risk, may aid in the development of alternative theories of risk involvement and create discursive spaces for de-medicalizing and de-othering people who use illegal drugs., Methods: This article is based on 32 semi-structured interviews with PWUIO in the New York City area who also reported recent withdrawal experience. Interviews were conducted remotely between April and August 2022 and recorded for later transcription. Data were then coded and analyzed based on a combination of inductive and deductive coding strategies and informed by the literature., Results: Participants described a strong relationship between withdrawal and their willingness to engage in risk-involved behavior that was exacerbated by the proliferation of fentanyl. Yet, their descriptions did not align with narratives of risk as a product of bad decisions made by individuals. Rather, data demonstrated the substantial role of social and structural context, particularly drug policies like prohibition and criminalization, in the kinds of risks that PWUIO faced and their ability to respond to them., Conclusions: Withdrawal should be taken more seriously both from an ethical perspective and as an important catalyst of risk behavior. However, theories that position activities taken to avoid withdrawal as irrational and as evidence of pathology are poorly aligned with the complexity of PWUIO's actual lives. We recommend the use of less deterministic and less medicalized theories of risk that better account for differences between how people view the world, and for the role of socio-structural forces in the production of risk., (© 2023. The Author(s).)

Background: Racial/ethnic inequities along the HIV care continuum persist in the United States despite substantial federal investment. Numerous studies highlight individual and social-level impediments in HIV, but fewer foreground systemic barriers. The present qualitative study sought to uncover and describe systemic barriers to the HIV care continuum from the perspectives of African American/Black and Latino persons living with HIV (PLWH) with unsuppressed HIV viral load, including how barriers operated and their effects., Methods: Participants were African American/Black and Latino PLWH with unsuppressed HIV viral load (N = 41). They were purposively sampled for maximum variability on key indices from a larger study. They engaged in semi-structured in-depth interviews that were audio-recorded and professionally transcribed. Data were analyzed using directed content analysis., Results: Participants were 49 years old, on average (SD = 9), 76% were assigned male sex at birth, 83% were African American/Black and 17% Latino, 34% were sexual minorities (i.e., non-heterosexual), and 22% were transgender/gender-nonbinary. All had indications of chronic poverty. Participants had been diagnosed with HIV 19 years prior to the study, on average (SD = 9). The majority (76%) had taken HIV medication in the six weeks before enrollment, but at levels insufficient to reach HIV viral suppression. Findings underscored a primary theme describing chronic poverty as a fundamental cause of poor engagement. Related subthemes were: negative aspects of congregate versus private housing settings (e.g., triggering substance use and social isolation); generally positive experiences with health care providers, although structural and cultural competency appeared insufficient and managing health care systems was difficult; pharmacies illegally purchased HIV medication from PLWH; and COVID-19 exacerbated barriers. Participants described mitigation strategies and evidenced resilience., Conclusions: To reduce racial/ethnic inequities and end the HIV epidemic, it is necessary to understand African American/Black and Latino PLWH's perspectives on the systemic impediments they experience throughout the HIV care continuum. This study uncovers and describes a number of salient barriers and how they operate, including unexpected findings regarding drug diversion and negative aspects of congregate housing. There is growing awareness that systemic racism is a core determinant of systemic barriers to HIV care continuum engagement. Findings are interpreted in this context., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objective: Evaluate associations between racialized and homophobia-based police harassment (RHBPH) and healthcare distrust and utilization among Black Sexual Minority Men (BSMM)., Methods: We utilized data from a longitudinal cohort study from HIV Prevention Trials Network (HPTN) 061 with baseline, six and 12 month follow-up assessments. Using multivariable analysis, we evaluated associations between RHBPH and healthcare distrust and utilization reported at the 6 and 12 month visits., Results: Of 1553 BSMM present at baseline, 1160 were available at six-month follow-up. In multivariable analysis, increasing frequency of RHBPH was associated with increasing levels of distrust in healthcare providers (aOR 1.31, 95% CI: 1.00, 1.74) and missing 50% or more of healthcare visits at six-month follow-up (aOR 1.93, 95% CI: 1.09, 3.43)., Conclusions: Recent experiences of RHBPH are associated with reduced trust in and access to healthcare among BSMM, with more frequent RHBPH associated with greater vulnerability., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Feelemyer et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Diabetic retinopathy (DR) is a leading cause of blindness globally. There is growing evidence to support the use of artificial intelligence (AI) in diabetic eye care, particularly for screening populations at risk of sight loss from DR in low-income and middle-income countries (LMICs) where resources are most stretched. However, implementation into clinical practice remains limited. We conducted a scoping review to identify what AI tools have been used for DR in LMICs and to report their performance and relevant characteristics. 81 articles were included. The reported sensitivities and specificities were generally high providing evidence to support use in clinical practice. However, the majority of studies focused on sensitivity and specificity only and there was limited information on cost, regulatory approvals and whether the use of AI improved health outcomes. Further research that goes beyond reporting sensitivities and specificities is needed prior to wider implementation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Incarceration among Black sexual minority men and Black transgender women (BSMM/BTW) is disproportionately high in the United States. Limited research has documented the disruptive effect of incarceration on sexual networks and sexual partnership exchange among BSMM/BTW. We estimate the influence of incarceration on selling sex and mediating pathways among 1169 BSMM/BTW enrolled in the HIV Prevention Trials Network (HPTN) 061 cohort to assess this relationship. Mediators investigated were social support, violence, illicit drug use, and distress due to experienced racism and homophobia. During the 6 months following baseline, 14% of the cohort was incarcerated, including 24% of BTW. After adjustment, recent incarceration was associated with 1.57 (95% CI 1.02, 2.42) times the risk of subsequently selling sex. The hypothesized mediators together explained 25% of the relationship, with an indirect effect risk ratio of 1.09 (95% CI 0.97, 1.24). Our results document an association and call for more research investigating mechanisms., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take-home dosing (THD) of methadone offer an opportunity to improve quality of care with a lifesaving treatment. There is a pressing need for research to study the long-term effects of the new PHE THD rules and to test data-driven interventions to promote more effective adoption by opioid treatment programs (OTPs). We propose a two-phase project to develop and test a multidimensional intervention for OTPs that leverages information from large State administrative data., Methods and Analysis: We propose a two-phased project to develop then test a multidimensional OTP intervention to address clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to THD. The intervention will include OTP THD specific dashboards drawn from multiple State databases. The approach will be informed by the Health Equity Implementation Framework (HEIF). In phase 1, we will employ an explanatory sequential mixed methods design to combine analysis of large state administrative databases-Medicaid, treatment registry, THD reporting-with qualitative interviews to develop and refine the intervention. In phase 2, we will conduct a stepped-wedge trial over three years with 36 OTPs randomized to 6 cohorts of a six-month clinic-level intervention. The trial will test intervention effects on OTP-level implementation outcomes and patient outcomes (1) THD use; 2) retention in care; and 3) adverse healthcare events). We will specifically examine intervention effects for Black and Latinx clients. A concurrent triangulation mixed methods design will be used: quantitative and qualitative data collection will occur concurrently and results will be integrated after analysis of each. We will employ generalized linear mixed models (GLMMs) in the analysis of stepped-wedge trials. The primary outcome will be weekly or greater THD. The semi-structured interviews will be transcribed and analyzed with Dedoose to identify key facilitators, barriers, and experiences according to HEIF constructs using directed content analysis., Discussion: This multi-phase, embedded mixed methods project addresses a critical need to support long-term practice changes in methadone treatment for opioid use disorder following systemic changes emerging from the PHE-particularly for Black and Latinx individuals with opioid use disorder. By combining findings from analyses of large administrative data with lessons gleaned from qualitative interviews of OTPs that were flexible with THD and those that were not, we will build and test the intervention to coach clinics to increase flexibility with THD. The findings will inform policy at the local and national level., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: Permanent supportive housing (PSH)-subsidized housing paired with support services such as case management-is a key part of national strategic plans to end homelessness. PSH tenants face high overdose risk due to a confluence of individual and environmental risk factors, yet little research has examined overdose prevention in PSH., Methods: We describe the protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial (RCT) of overdose prevention practice implementation in PSH. We adapted evidence-based overdose prevention practices and implementation strategies for PSH using input from stakeholder focus groups. The trial will include 20 PSH buildings (with building size ranging from 20 to over 150 tenants) across New York City and New York's Capital Region. Buildings will be randomized to one of four 6-month intervention waves during which they will receive a package of implementation support including training in using a PSH Overdose Prevention (POP) Toolkit, time-limited practice facilitation, and learning collaboratives delivered to staff and tenant implementation champions appointed by each building. The primary outcome is building-level fidelity to a defined list of overdose prevention practices. Secondary and exploratory implementation and effectiveness outcomes will be examined using PSH staff and tenant survey questionnaires, and analysis of tenant Medicaid data. We will explore factors related to implementation success, including barriers and facilitators, using qualitative interviews with key stakeholders. The project is being conducted through an academic-community partnership, and an Advisory Board including PSH tenants and other key stakeholders will be engaged in all stages of the project., Discussion: We describe the protocol for a hybrid type 3 stepped-wedge cluster RCT of overdose prevention practice implementation in PSH. This study will be the first controlled trial of overdose prevention implementation in PSH settings. The research will make a significant impact by testing and informing future implementation strategies to prevent overdose for a population at particularly high risk for overdose mortality. Findings from this PSH-focused research are expected to be broadly applicable to other housing settings and settings serving people experiencing homelessness., Trial Registration: ClinicalTrials.gov, NCT05786222 , registered 27 March 2023., (© 2023. The Author(s).)

Effective antiretroviral therapy (ART) adherence strategies for HIV+ adolescents and young adults (AYA) are needed to prevent HIV-related morbidity, mortality, and onward transmission. In the Adherence Connection for Counseling, Education, and Support (ACCESS) pilot, an exploratory sequential mixed-methods design was used to develop and test a peer-led, mobile health (mHealth) cognitive behavioral ART adherence intervention. HIV+ AYA (ages 16-29 years) with unsuppressed plasma HIV RNA (HIV viral load) were eligible for this five-session intervention directed to improving ART adherence and HIV viral load. A total of 78 peer-led remote videoconferencing sessions (via WebEx) were delivered to 16 participants. High completion rates (97.5%) and client satisfaction scores (mean = 29.13 of 32; SD = 2.45) were observed. Self-reported ART adherence improved (32% increase in doses taken; 95th CI 11.2-53.3) with an annualized average rate of 47.5% (0.28 log 10 ) reduction in HIV viral load. We established proof of concept for the ACCESS peer-led, mHealth cognitive behavioral ART adherence intervention, with promising adherence and virologic outcome data., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: There are well-established guidelines for treating hypertension (HTN), yet only half of patients with HTN meet the defined target of < 140/90. Team-based care (TBC) is an evidence-based strategy for improving blood pressure (BP) management and control. TBC is defined as the provision of health services by at least two health professionals "who work collaboratively with patients and their caregivers to accomplish shared goals to achieve coordinated, high-quality care". However, primary care practices experience challenges to implementing TBC principles and care processes; these are more pronounced in small independent practice settings (SIPs). Practice facilitation (PF) is an implementation strategy that may overcome barriers to adopting evidence-based TBC to improve HTN management in SIPs., Methods: Using a stepped wedge randomized controlled trial design, we will test the effect of PF on the adoption of TBC to improve HTN management in small practices (< 5 FTE clinicians) in New York City, and the impact on BP control compared with usual care. We will enroll 90 SIPs and randomize them into one of three 12-month intervention waves. Practice facilitators will support SIPs to adopt TBC principles to improve implementation of five HTN management strategies (i.e., panel management, population health, measuring BP, supporting medication adherence, self-management). The primary outcome is the adoption of TBC for HTN management measured at baseline and 12 months. Secondary outcomes include the rate of BP control and sustainability of TBC and BP outcomes at 18 months. Aggregated data on BP measures are collected every 6 months in all clusters so that each cluster provides data points in both the control and intervention conditions. Using a mixed methods approach, we will also explore factors that influence the effectiveness of PF at the organization and team level., Discussion: This study will provide much-needed guidance on how to optimize adoption and sustainability of TBC in independent primary care settings to reduce the burden of disease related to suboptimal BP control and advance understanding of how facilitation works to improve implementation of evidence-based interventions., Trial Registration: ClinicalTrials.gov; NCT05413252 ., (© 2023. The Author(s).)

Introduction: Virtual and low-touch behavioral interventions are needed for African American/Black and Latino persons living with HIV (PLWH) with barriers to HIV viral suppression, particularly during COVID-19. Guided by the multiphase optimization strategy, we explored three components for PLWH without viral suppression, grounded in motivational interviewing and behavioral economics: (1) motivational interviewing counseling, (2) 21-weeks of automated text messages and quiz questions about HIV management, and (3) financial rewards for viral suppression (lottery prize vs. fixed compensation)., Methods: This pilot optimization trial used sequential explanatory mixed methods to explore the components' feasibility, acceptability, and preliminary evidence of effects using an efficient factorial design. The primary outcome was viral suppression. Participants engaged in baseline and two structured follow-up assessments over an 8-month period, and provided laboratory reports to document HIV viral load. A subset engaged in qualitative interviews. We carried out descriptive quantitative analyses. Then, qualitative data were analyzed using directed content analysis. Data integration used the joint display method., Results: Participants ( N = 80) were 49 years old, on average (SD = 9), and 75% were assigned male sex at birth. Most (79%) were African American/Black, and the remainder were Latino. Participants were diagnosed with HIV 20 years previously on average (SD = 9). Overall, components were feasible (>80% attended) and acceptability was satisfactory. A total of 39% (26/66) who provided laboratory reports at follow-up evidenced viral suppression. Findings suggested no components were entirely unsuccessful. The lottery prize compared to fixed compensation was the most promising component level. In qualitative analyses, all components were seen as beneficial to individual wellbeing. The lottery prize appeared more interesting and engaging than fixed compensation. However, structural barriers including financial hardship interfered with abilities to reach viral suppression. The integrated analyses yielded areas of convergence and discrepancy and qualitative findings added depth and context to the quantitative results., Conclusions: The virtual and/or low-touch behavioral intervention components tested are acceptable and feasible and show enough potential to warrant refinement and testing in future research, particularly the lottery prize. Results must be interpreted in the context of the COVID-19 pandemic., Trial Registration: NCT04518241 (https://clinicaltrials.gov/ct2/show/NCT04518241)., Competing Interests: RF and SC was employed by Independent Consultant. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Filippone, Serrano, Gwadz, Cleland, Freeman, Linnemayr, Cluesman, Campos, Rosmarin-DeStefano, Amos and Israel.)

Background: Drug use is prevalent among people who attend electronic dance music (EDM) parties at nightclubs or festivals. This population can serve as a sentinel population to monitor trends in use of party drugs and new psychoactive substances (NPS) that may diffuse through larger segments of the population., Methods: We surveyed adults entering randomly selected EDM parties at nightclubs and dance festivals in New York City about their drug use in 2017 (n=954), 2018 (n=1,029), 2019 (n=606), 2021 (n=229), and 2022 (n=419). We estimated trends in past-year and past-month use of 22 drugs or drug classes based on self-report from 2017-2022 and examined whether there were shifts pre- vs. post-COVID (2017-2019 vs. 2021-2022)., Results: Between 2017 and 2022, there were increases in past-year and past-month use of shrooms (psilocybin), ketamine, poppers (amyl/butyl nitrites), synthetic cathinones ("bath salts"), and novel psychedelics (lysergamides and DOx series), increases in past-year cannabis use, and increases in past-month use of 2C series drugs. Between 2017 and 2022, there were decreases in past-year heroin use and decreases in past-month cocaine use, novel stimulant use, and nonmedical benzodiazepine use. The odds of use of shrooms, poppers, and 2C series drugs significantly increased after COVID, and the odds of use of cocaine, ecstasy, heroin, methamphetamine, novel stimulants, and prescription opioids (nonmedical use) decreased post-COVID., Conclusions: We estimate shifts in prevalence of various drugs among this sentinel population, which can inform ongoing surveillance efforts and public health response in this and the general populations., Competing Interests: Declarations of Interest Dr. Palamar has consulted for Alkermes. The authors have no other potential conflicts to declare., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Introduction: Electronic nicotine delivery system (ENDS) devices evolve rapidly and impact nicotine dependence. This study described the type of ENDS devices used most frequently by U.S. youth and adults from 2013/14 to 2018/19., Methods: We analyzed Waves 1-5 data of the Population Assessment of Tobacco and Health Study. Among current ENDS users, descriptive statistics summarized the most frequently used ENDS devices (i.e., disposable cigalike, refillable cartridge, nonrefillable cartridge, tank, mod, prefilled pod, disposable pod) among youth (12-17 years), young adults (18-34 years), and older adults (≥35 years) for each wave., Results: The proportion of current ENDS users who reported they most frequently used disposable cigalikes and cartridge-based devices declined over time across all age groups. At Waves 1-4, tank was generally the most popular type for all ages and an increasing proportion of ENDS users reported they most frequently used tanks. The primary use of mods decreased among youth, and fluctuated among young and older adults. At Wave 5, prefilled pods became the dominant type (youth: 55.0%; young adults: 44.7%; older adults: 42.7%), and 4.2-10.0% of ENDS users reported using disposable pods most often. The popularity of tanks, mods, and prefilled pods was more evident in youth and young adults, and primary use of disposable pods was more common in older adults., Conclusions: The primary use of ENDS devices changed over the years and varied by age. More research is warranted to continuously monitor the characteristics of ENDS devices in youth and adults to inform product regulations and intervention efforts., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: There has been a significant increase in methamphetamine use among persons who use drugs in Vietnam in the last 5-10 years. We examined the degree to which adherence to antiretroviral therapy (ART) mediates the relationship between recent methamphetamine use and unsuppressed HIV viral load among people who inject drugs (PWID) in Hai Phong, Vietnam., Methods: We recruited PWID from October 2016-October 2018 and enrolled HIV positive PWID into a cohort, with up to three years of total follow-up. We assessed relationships among recent methamphetamine use frequency, ART adherence and unsuppressed HIV viral load. Mediation analysis was used to estimate the total and natural direct effects of recent methamphetamine use on unsuppressed HIV viral load and the indirect effect proportion., Results: We enrolled 792 HIV seropositive PWID into the cohort; approximately 75.9% reported high/perfect ART adherence at baseline and 81.3% were virally suppressed. In mediation analysis, the total effect for the association between methamphetamine use and unsuppressed HIV viral load (1000 copies/mL) was 3.94 (95% CI: 1.95, 7.96); the natural direct effect was 2.14 (95% CI: 1.29, 3.55); the proportion mediated by self-reported ART adherence was 0.444. Similar results were found when examining lower unsuppressed HIV viral load cutpoints of 250 copies/mL and 500 copies/mL., Conclusions: Methamphetamine use is associated with unsuppressed HIV viral load among PWID despite high levels of ART adherence. Further research is needed to better understand these relationships, with emphasis on potential biological pathways that may interact with ART.

Background: Patients presenting to emergency departments (EDs) after a nonfatal opioid-involved overdose are at high risk for future overdose and death. Responding to this risk, the New York City (NYC) Department of Health and Mental Hygiene operates the Relay initiative, which dispatches trained peer "Wellness Advocates" to meet patients in the ED after a suspected opioid-involved overdose and follow them for up to 90 days to provide support, education, referrals to treatment, and other resources using a harm reduction framework., Methods: In this article, we describe the protocol for a multisite randomized controlled trial of Relay. Study participants are recruited from four NYC EDs and are randomized to receive the Relay intervention or site-directed care (the control arm). Outcomes are assessed through survey questionnaires conducted at 1-, 3-, and 6-months after the baseline visit, as well as through administrative health data. The primary outcome is the number of opioid-related adverse events, including any opioid-involved overdose or any other substance use-related ED visit, in the 12 months post-baseline. Secondary and exploratory outcomes will also be analyzed, as well as hypothesized mediators and moderators of Relay program effectiveness., Conclusion: We present the protocol for a multisite randomized controlled trial of a peer-delivered OD prevention intervention in EDs. We describe how the study was designed to minimize disruption to routine ED operations, and how the study was implemented and adapted during the COVID-19 pandemic. This trial is registered with ClinicalTrials.gov [NCT04317053]., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The persistence of racial/ethnic inequities in rates of engagement along the HIV care continuum signals the need for novel approaches. We developed six behavioral intervention components for use in an optimization trial, grounded in a model that integrates critical race theory, harm reduction, and self-determination theory, designed to address various barriers that African American/Black and Latino persons living with HIV (PLWH) experience to the HIV care continuum. The components were: health education, motivational interviewing sessions, pre-adherence skill building, peer mentorship, focused support groups, and navigation. The present qualitative exploratory study describes participants' perspectives on the components' acceptability, feasibility, and impact., Methods: Participants were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City. From a larger trial, we randomly selected 46 participants for in-depth semi-structured interviews. Interviews were audio-recorded and transcribed verbatim, and data were analyzed using directed content analysis. Quantitative data on sociodemographic and background characteristics and components' acceptability and feasibility were also collected., Results: On average, participants were 49 years old and had lived with HIV for 19 years. Most were cisgender-male and African American/Black. Participants reported a constellation of serious social and structural challenges to HIV management including chronic poverty, unstable housing, and stigma. Across components, a non-judgmental and pressure-free approach and attention to structural and cultural factors were seen as vital to high levels of engagement, but lacking in most medical/social service settings. Prominent aspects of individual components included establishing trust (health education); developing intrinsic motivation, goals, and self-reflection (motivational interviewing sessions); learning/practicing adherence strategies and habits (pre-adherence skill building); reducing social isolation via peer role models (peer mentorship); reflecting on salient goals and common challenges with peers without stigma (focused support groups); and circumventing structural barriers to HIV management with support (navigation). Components were found acceptable and feasible. Findings suggested ways components could be improved., Conclusions: The present study advances research on interventions for African American/Black and Latino PLWH, who experience complex barriers to engagement along the HIV care continuum. Future study of the components is warranted to address racial/ethnic health inequities in HIV., (© 2023. The Author(s).)

Objectives: People who inject drugs (PWID) in Kenya have high HIV (range across settings: 14-26%) and hepatitis C virus (HCV; 11-36%) prevalence. We evaluated the impact of existing and scaled-up interventions on HIV and HCV incidence among PWID in Kenya., Design: HIV and HCV transmission model among PWID, calibrated to Nairobi and Kenya's Coastal region., Methods: For each setting, we projected the impact (percent of HIV/HCV infections averted in 2020) of existing coverages of antiretroviral therapy (ART; 63-79%), opioid agonist therapy (OAT; 8-13%) and needle and syringe programmes (NSP; 45-61%). We then projected the impact (reduction in HIV/HCV incidence over 2021-2030), of scaling-up harm reduction [Full harm reduction ('Full HR'): 50% OAT, 75% NSP] and/or HIV (UNAIDS 90-90-90) and HCV treatment (1000 PWID over 2021-2025) and reducing sexual risk (by 25/50/75%). We estimated HCV treatment levels needed to reduce HCV incidence by 90% by 2030., Results: In 2020, OAT and NSP averted 46.0-50.8% (range of medians) of HIV infections and 50.0-66.1% of HCV infections, mostly because of NSP. ART only averted 12.9-39.8% of HIV infections because of suboptimal viral suppression (28-48%). Full HR and ART could reduce HIV incidence by 51.5-64% and HCV incidence by 84.6-86.6% by 2030. Also halving sexual risk could reduce HIV incidence by 68.0-74.1%. Alongside full HR, treating 2244 PWID over 2021-2025 could reduce HCV incidence by 90% by 2030., Conclusion: Existing interventions are having substantial impact on HIV and HCV transmission in Kenya. However, to eliminate HIV and HCV, further scale-up is needed with reductions in sexual risk and HCV treatment., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Respiratory effects of e-cigarette use among youth are not fully understood. This study investigated the longitudinal association between e-cigarette use and a validated index of functionally important respiratory symptoms among US youth. Data from Waves 3-4 of the Population Assessment of Tobacco and Health Study were analyzed. The sample included youth (aged 12-17) without asthma at baseline (Wave 3), who completed a follow-up survey (Wave 4), and were not missing data for analytic variables (n = 3899). Exposure was e-cigarette use status (never, former, or current) at baseline. The outcome was a respiratory symptom index based on responses for seven wheezing items at Wave 4. An index of ≥2 was defined as having functionally important respiratory symptoms. Lagged logistic regression models examined the association between baseline e-cigarette use and functionally important respiratory symptoms at follow-up by combustible tobacco use status (never or ever), and controlling for baseline covariates. At baseline, 13.7% of participants reported former e-cigarette use, and 4.3% reported current use. Baseline e-cigarette use did not increase the odds of having functionally important respiratory symptoms at follow-up regardless of combustible tobacco use status. Future research on larger populations of e-cigarette users with longer follow-up periods will improve our understanding of the respiratory risks associated with e-cigarette use among youth.

Background: Smoking rates remain high in Vietnam, particularly among people living with HIV/AIDS (PLWH), but tobacco cessation services are not available in outpatient HIV clinics (OPCs). The research team is conducting a type II hybrid randomized controlled trial (RCT) comparing the cost-effectiveness of three tobacco cessation interventions among PLWH receiving care in HIV clinics in Vietnam. The study is simultaneously evaluating the implementation processes and outcomes of strategies aimed at increasing the implementation of tobacco dependence treatment (TDT) in the context of HIV care. This paper describes the systematic, theory-driven process of adapting intervention components and implementation strategies with demonstrated effectiveness in high-income countries, and more recently in Vietnam, to a new population (i.e., PLWH) and new clinical setting, prior to launching the trial., Methods: Data collection and analyses were guided by two implementation science frameworks and the socio-ecological model. Qualitative interviews were conducted with 13 health care providers and 24 patients in three OPCs. Workflow analyses were conducted in each OPC. Qualitative data were analyzed using rapid qualitative analysis procedures. Based on findings, components of the intervention and implementation strategies were adapted, followed by a 3-month pilot study in one OPC with 16 patients randomized to one of two intervention arms., Results: The primary adaptations included modifying the TDT intervention counseling content to address barriers to quitting among PLWH and Vietnamese sociocultural norms that support smoking cessation. Implementation strategies (i.e., training and system changes) were adapted to respond to provider- and clinic-level determinants of implementation effectiveness (e.g., knowledge gaps, OPC resource constraints, staffing structure, compatibility)., Conclusions: Adaptations were facilitated through a mixed method, stakeholder (patient and health care provider, district health leader)-engaged evaluation of context-specific influences on intervention and implementation effectiveness. This data-driven approach to refining and adapting components aimed to optimize intervention effectiveness and implementation in the context of HIV care. Balancing pragmatism with rigor through the use of rapid analysis procedures and multiple methods increased the feasibility of the adaptation process., Trial Registration: ClinicalTrials.gov NCT05162911 . Registered on December 16, 2021., (© 2022. The Author(s).)

Support from social networks buffers against negative effects of stress but is disrupted by incarceration. Few studies examine incarceration, social support networks, and health among Black sexual minority men (BSMM) and Black transgender women (BTW). We conducted a secondary analysis using HIV Prevention Trials Network 061 (HPTN 061), a sample of BSMM/BTW recruited from six US cities. We measured associations between recent incarceration reported at six months follow-up and social support networks at twelve months follow-up, and cross-sectional associations between support networks and twelve-month health outcomes (e.g., sexual partnerships, substance use, healthcare access and depressive symptoms). Among the analytic sample (N = 1169), recent incarceration was associated with small medical support networks (adjusted risk ratio [aRR] 1.16, 95% CI 1.01, 1.34) and small financial support networks (aRR 1.18, 95% CI 1.04, 1.35). Support networks were associated with multiple partnerships (adjusted prevalence ratio [aPR] 0.77, 95% CI 0.65, 0.90), unhealthy alcohol use (aPR 1.20, 95% CI 0.96, 1.51), and depressive symptoms (aPR 1.16, 95% CI 0.99, 1.36). Incarceration adversely impacts social support networks of BSMM/BTW, and support networks were associated with a range of important health outcomes., Competing Interests: The authors declare no conflict of interest.

Introduction: Sustained HIV viral suppression is the ultimate goal of HIV treatment. African American/Black and Latino persons with HIV (PWH) in the United States are less likely than their White peers to achieve and sustain viral suppression. To address these disparities, we developed a "low-touch" behavioral intervention drawing on motivational interviewing and behavioral economics. The intervention had three main components: (1) a motivational interviewing counseling session, (2) 16 weeks of automated text messages and quiz questions about HIV management, where participants earned points by answering quiz questions, and 3) a lottery prize, based on viral suppression status, number of points earned, and chance (max. $275)., Materials and Methods: The intervention was tested in a pre-test/post-test design. The present pilot study used mixed methods to explore the intervention's feasibility, acceptability, impact, and ways it could be improved. Participants engaged in a baseline assessment, qualitative interview, and two structured follow-up assessments over an 8-month period, and provided laboratory reports to document HIV viral load. We carried out descriptive quantitative analyses. Qualitative data were analyzed using a directed content analysis approach. Data integration was carried out using the joint display method., Findings: Participants ( N = 40) were 50 years old, on average (SD = 11), and approximately half (58%) were male. Close to two-thirds (68%) were African American/Black and 32% were Latino. Participants were diagnosed with HIV 22 years ago on average (SD = 8). The intervention was feasible (e.g., mean number of quiz questions answered = 13/16) and highly acceptable. While not powered to assess efficacy, the proportion with suppressed HIV viral load increased from baseline to follow-up (46% participants at the first, 52% participants at the second follow-up evidenced HIV viral suppression). In qualitative analyses, perspectives included that overall, the intervention was acceptable and useful, it was distinct from other programs, lottery prizes were interesting and appreciated but not sufficient to motivate behavior change, and the structure of lottery prizes was not sufficiently clear. Regarding data integration, qualitative data shed light on and extended quantitative results, and added richness and context., Conclusion: This low-touch intervention approach is sufficiently promising to warrant refinement and study in future research., Competing Interests: Author RF was employed by Independent Consultant. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Gwadz, Serrano, Linnemayr, Cleland, Cluesman, Freeman, Kellam, De Stefano, Israel and Pan.)

Associations of incarceration with healthcare access and utilization among Black sexual minority men (BSMM) and differences in association among those with and without pre-incarceration symptoms of depression were measured. Secondary analysis using survey data from the longitudinal cohort HIV Prevention Trials Network 061 study was conducted among 1553 BSMM from six major U.S. cities from 2009 to 2011. We used modified log-binomial regression with robust standard errors to estimate associations of incarceration (reported at 6 month follow-up) on next six-month healthcare utilization and access (reported at the 12 month follow-up). We tested the significance of baseline depressive symptoms by incarceration interaction and reported differences in associations when observed. Participants with a history of incarceration were more likely to have depressive symptoms at baseline compared to those without. Recent incarceration was associated with almost twice the risk of mistrust in healthcare providers and emergency room utilization. Among men reporting depressive symptoms, a history of incarceration was associated with almost tripled risk of reporting providers do not communicate understandably. Among those with depression, one in five reported a missed visit regardless of incarceration status.

Black men who have sex with men (BMSM) are disproportionately incarcerated in the United States. Incarceration is a barrier to health equity and may be a risk factor for experiences of interpersonal violence. However, the effect of incarceration on experienced violence among BMSM is understudied. We examined associations between recent incarceration on subsequent experiences of race- or sexuality-based violence, intimate partner violence, or community violence. We analyzed data from the HPTN 061 study. Analysis includes data on 1,169 BMSM recruited from 6 U.S. cities who were present at baseline as well as 6- and 12-month follow-up interview. We tested if self-reported incarceration between baseline and 6 months was associated with self-reported outcomes between 6 and 12 months using logistic regression with inverse probability of treatment weighting and multiple imputation methods. Experienced outcomes included violence due to race or sexuality, intimate partner violence and aggression, and community violence (i.e., gang violence, robbery, shooting). Approximately 14% reported incarceration between baseline and 6 months and 90% reported experiencing violence between 6 and 12 months. In adjusted analyses, incarceration was associated with subsequent race- or sexuality-based violence [a OR (adjusted odds ratio) range: 1.25-1.41, 95% CI (confidence interval) range: 1.00-1.74], experiences of physical abuse and aggression from intimate partners (a OR : 2.35; 95% CI: 1.50, 3.70) and community violence ( OR 1.82; 95% CI: 1.23, 2.72). Recent incarceration experience increased risk of exposure to future violence in this population. Mixed methods research examining mediating paths between and downstream effects of incarceration and violence on the wellbeing and health of BMSM is needed. We implore researchers to study violence and incarceration among BMSM. Practitione should implement strategies such as trauma-informed interventions, and policies strengthening the social and economic support needs of Black populations.

Background: Rates of participation in HIV care, medication uptake, and viral suppression are improving among persons living with HIV (PLWH) in the United States. Yet, disparities among African American/Black and Latino PLWH are persistent, signaling the need for new conceptual approaches. To address gaps in services and research (e.g., insufficient attention to structural/systemic factors, inadequate harm reduction services and autonomy support) and improve behavioral interventions, we integrated critical race theory, harm reduction, and self-determination theory into a new conceptual model, then used the model to develop a set of six intervention components which were tested in a larger study. The present qualitative study explores participants' perspectives on the study's acceptability, feasibility, and impact, and the conceptual model's contribution to these experiences., Methods: Participants in the larger study were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City (N = 512). We randomly selected N = 46 for in-depth semi-structured interviews on their experiences with and perspectives on the study. Interviews were audio-recorded and professionally transcribed verbatim, and data were analyzed using directed qualitative content analysis., Results: On average, participants were 49 years old (SD = 9) and had lived with HIV for 19 years (SD = 7). Most were male (78%) and African American/Black (76%). All had taken HIV medication previously. Challenging life contexts were the norm, including poverty, poor quality/unstable housing, trauma histories exacerbated by current trauma, health comorbidities, and substance use. Participants found the study highly acceptable. We organized results into four themes focused on participants' experiences of: 1) being understood as a whole person and in their structural/systemic context; 2) trustworthiness and trust; 3) opportunities for self-reflection; and 4) support of personal autonomy. The salience of nonjudgment was prominent in each theme. Themes reflected grounding in the conceptual model. Participants reported these characteristics were lacking in HIV care settings., Conclusions: The new conceptual model emphasizes the salience of systemic/structural and social factors that drive health behavior and the resultant interventions foster trust, self-reflection, engagement, and behavior change. The model has potential to enhance intervention acceptability, feasibility, and effectiveness with African American/Black and Latino PLWH., (© 2022. The Author(s).)

Background: Among those at highest risk for COVID-19 exposure is the large population of frontline essential workers in occupations such food service, retail, personal care, and in-home health services, among whom Black and Latino/Hispanic persons are over-represented. For those not vaccinated and at risk for exposure to COVID-19, including frontline essential workers, regular (approximately weekly) COVID-19 testing is recommended. However, Black and Latino/Hispanic frontline essential workers in these occupations experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines), social- (e.g., social norms), and structural-levels of influence (e.g., poor access), and rates of testing for COVID-19 are insufficient., Methods/design: The proposed community-engaged study uses the multiphase optimization strategy (MOST) framework and an efficient factorial design to test four candidate behavioral intervention components informed by an integrated conceptual model that combines critical race theory, harm reduction, and self-determination theory. They are A) motivational interview counseling, B) text messaging grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to an appointment vs. a self-test kit). All participants receive health education on COVID-19. The specific aims are to: identify which components contribute meaningfully to improvement in the primary outcome, COVID-19 testing confirmed with documentary evidence, with the most effective combination of components comprising an "optimized" intervention that strategically balances effectiveness against affordability, scalability, and efficiency (Aim 1); identify mediators and moderators of the effects of components (Aim 2); and use a mixed-methods approach to explore relationships among COVID-19 testing and vaccination (Aim 3). Participants will be N = 448 Black and Latino/Hispanic frontline essential workers not tested for COVID-19 in the past six months and not fully vaccinated for COVID-19, randomly assigned to one of 16 intervention conditions, and assessed at 6- and 12-weeks post-baseline. Last, N = 50 participants will engage in qualitative in-depth interviews., Discussion: This optimization trial is designed to yield an effective, affordable, and efficient behavioral intervention that can be rapidly scaled in community settings. Further, it will advance the literature on intervention approaches for social inequities such as those evident in the COVID-19 pandemic., Trial Registration: ClinicalTrials.gov: NCT05139927 ; Registered on 11/29/2021. Protocol version 1.0. May 2, 2022, Version 1.0., (© 2022. The Author(s).)

Purpose: Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings., Methods: The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design., Results: All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends., Conclusions: The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection. VISUAL ABSTRACT ., (© 2022 Annals of Family Medicine, Inc.)