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Abstract Background In the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration. Objective To determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD. Methods This study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD (N = 250; n = 83 trans women; n = 167 SMM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n = 187) or SOC (n = 63). Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP, while non-responders will receive added attention to their SUD via Contingency Management (CM). Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP + CM, or (b) shift the primary focus to their SUD (CM alone). Results Recruitment and enrollment began in May 2023. Recruitment will span approximately 36 months. Data collection, including all follow-up assessments, is expected to be completed in April 2027. Discussion Trans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances. Trial registration This trial has been registered at ClinicalTrials.gov under the number NCT05934877.

Abstract Background There are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic antidepressant, to be effective in reducing methamphetamine use. The proposed Tina Trial is the first phase 3 placebo-controlled randomised trial to examine the effectiveness and safety of mirtazapine as an outpatient pharmacotherapy for methamphetamine use disorder. Methods This is a multi-site phase 3 randomised, double-blind, placebo-controlled parallel trial. Participants are randomly allocated (1:1) to receive either mirtazapine (30 mg/day for 12 weeks) or matched placebo, delivered as a take-home medication. The target population is 340 people aged 18–65 years who have moderate to severe methamphetamine use disorder. The trial is being conducted through outpatient alcohol and other drug treatment clinics in Australia. The primary outcome is measured as self-reported days of methamphetamine use in the past 4 weeks at week 12. Secondary outcomes are methamphetamine-negative oral fluid samples, depressive symptoms, sleep quality, HIV risk behaviour and quality of life. Other outcomes include safety (adverse events), tolerability, and health service use. Medication adherence is being monitored using MEMS® Smart Caps fitted to medication bottles. Discussion This trial will provide information on the safety and effectiveness of mirtazapine as a pharmacotherapy for methamphetamine use disorder when delivered as an outpatient medication in routine clinical practice. If found to be safe and effective, this trial will support an application for methamphetamine use disorder to be included as a therapeutic indication for the prescription of mirtazapine. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12622000235707. Registered on February 9, 2022.

Background: The syndemic of HIV, substance use (SU), and mental illness has serious implications for HIV disease progression among women. We described co-utilization of HIV care, SU treatment, and mental health treatment among women with or at risk for HIV. Methods: We included data from women with or at risk for HIV (n = 2559) enrolled in all 10 sites of the Women’s Interagency HIV Study (WIHS) from 2013 to 2020. Current SU was defined as self-reported, non-medical use of drugs in the past year, excluding use of only marijuana. Tobacco and alcohol were assessed separately. We described co-utilization of SU treatment, tobacco and alcohol use treatment, HIV care, and mental health care in the past year among women who were eligible for each service. We compared service utilization by those who did/did not utilize SU treatment using Wald Chi-square tests. Results: Among women with current SU (n = 358), 42% reported utilizing SU treatment. Among those with current SU+HIV (n = 224), 84% saw their HIV provider, and 34% saw a mental health provider. Among women with current SU+heavy alcohol use (n = 95), 18% utilized alcohol use treatment; among current SU+tobacco use (n = 276), 8% utilized tobacco use treatment. Women who utilized SU treatment had higher utilization of alcohol use treatment (59% vs. 5%; P

Abstract Background Delivering methadone treatment in community health facilities by primary care providers is a task-shifting strategy to expand access to drug use treatment, especially in rural mountainous areas. This study aims to investigate factors related to confidence in providing methadone treatment among primary care providers in Vietnam to inform good practice development. Methods We conducted a cross-sectional survey with 276 primary care providers who were physicians, physician assistants, nurses, pharmacists or dispensing staff from 67 communes in a mountainous province in Northern Vietnam. Using self-report scales, we measured providers’ confidence in providing methadone treatment, beliefs in harm reduction, perceived work-related support, perceived stigma and risk in working with drug-using patients, and empathy towards this population. We used multiple linear regression analyses to explore factors associated with providers’ confidence in providing methadone treatment in the whole sample and to compare two groups of providers who did and did not have experience providing methadone. Potential associated factors were measured at facility and provider levels. Result 114 (41.3%) participants had previously experience in providing methadone treatment. Providers with methadone treatment experiences had higher confidence in and more accurate knowledge of methadone treatment, perceived less stigma of working with drug-using patients, and reported more work-related support than those without experiences. Higher medical education is associated with lower confidence in providing methadone treatment among providers without methadone experiences, but higher confidence among providers with methadone experiences. Better methadone knowledge was associated with greater confidence in providing methadone treatment among inexperienced providers but not among those with experiences. Receiving work-related support was associated with greater confidence in providing treatment in both groups, regardless of their past methadone experiences. Conclusion In rural provinces where methadone treatment has been expanded to primary care clinics, interventions to improve primary care providers’ confidence should benefit professionals with diverse experiences in providing methadone treatment. Continued training and support at work for providers is essential to ensuring quality in decentralized methadone treatment.

In South Africa, alcohol use during pregnancy is prevalent and associated with increased HIV risk. Developing locally sensitive and contextually appropriate evidence-based interventions to address alcohol use among pregnant and breastfeeding women in South Africa requires comprehensive understanding of the context of perinatal alcohol use and how relationships and lived environments may serve as barriers or supports for alcohol reduction. We conducted twenty in-depth qualitative interviews with isiXhosa speaking women who reported alcohol use during their recent pregnancy and/or recent intimate partner violence in Cape Town, South Africa between September and November 2022. We describe patterns and drivers of ongoing alcohol use during pregnancy and map them onto levels of the socioecological model. Data were analyzed utilizing the interpretivist paradigm and interpretive thematic analysis. Eight women reported alcohol use during pregnancy, sixteen reported experiencing recent IPV, and four women reported both alcohol use during pregnancy and recent IPV. In interviews, commonly cited reasons for continued alcohol use in pregnancy included stress (e.g., due to financial concerns), peer pressure, the central role of alcohol use in socialization and the persistence of misconceptions regarding the safety of alcohol use in pregnancy. Still, despite women reporting social norms that supported continued alcohol use in pregnancy, many altered who they drank with due to fear of judgement from close friends and family, leaving them isolated from their social support system. Interventions aimed at increasing interpersonal support, such as the use of peer mentors, could prove beneficial. Although the clinic provides messaging around the harms of alcohol use in pregnancy, these messages conflict with messaging received from their peers, limiting their impact on behavior. Locally sensitive tailored, relevant programming that intervenes on barriers to reducing alcohol use in pregnancy at multiple levels of the socioeconomic model are vital to effectively addressing this public health issue.

Abstract Background Persons with opioid use disorders who inject drugs (PWID) in the United States (US) face multiple and intertwining health risks. These include interference with consistent access, linkage, and retention to health care including medication for opioid use disorder (MOUD), HIV prevention using pre-exposure prophylaxis (PrEP), and testing and treatment for sexually transmitted infections (STIs). Most services, when available, including those that address substance misuse, HIV prevention, and STIs, are often provided in multiple locations that may be difficult to access, which further challenges sustained health for PWID. HPTN 094 (INTEGRA) is a study designed to test the efficacy of an integrated, “whole-person” strategy that provides integrated HIV prevention including antiretroviral therapy (ART), PrEP, MOUD, and STI testing and treatment from a mobile health delivery unit (“mobile unit”) with peer navigation compared to peer navigation alone to access these services at brick and mortar locations. Methods HPTN 094 (INTEGRA) is a two-arm, randomized controlled trial in 5 US cities where approximately 400 PWID without HIV are assigned either to an experimental condition that delivers 26 weeks of “one-stop” integrated health services combined with peer navigation and delivered in a mobile unit or to an active control condition using peer navigation only for 26 weeks to the same set of services delivered in community settings. The primary outcomes include being alive and retained in MOUD and PrEP at 26 weeks post-randomization. Secondary outcomes measure the durability of intervention effects at 52 weeks following randomization. Discussion This trial responds to a need for evidence on using a “whole-person” strategy for delivering integrated HIV prevention and substance use treatment, while testing the use of a mobile unit that meets out-of-treatment PWID wherever they might be and links them to care systems and/or harm reduction services. Findings will be important in guiding policy for engaging PWID in HIV prevention or care, substance use treatment, and STI testing and treatment by addressing the intertwined epidemics of addiction and HIV among those who have many physical and geographic barriers to access care. Trial registration ClinicalTrials.gov NCT04804072 . Registered on 18 March 2021.

Abstract Intimate partner violence (IPV) occurs at alarmingly high rates towards pregnant women in South Africa. Experiences of emotional, physical, and sexual IPV in pregnancy can adversely impact the health and safety of mother and fetus. Furthermore, IPV is associated with increased risk of HIV, exacerbating the public health impact of violence among pregnant women in this HIV endemic setting. In-depth understanding of cultural and contextual drivers of experiences of IPV is a critical precursor to development of interventions effectively addressing this issue among pregnant women in South Africa. The present study examines factors contributing to IPV among pregnant women to identify potential points of intervention. We conducted twenty in-depth interviews with postpartum women who used oral pre-exposure prophylaxis (PrEP) in pregnancy and reported recent experiences of IPV and/or ongoing alcohol use in a township near Cape Town, South Africa that experiences a heavy burden of both HIV and IPV. Interpretive thematic analysis was used. Several patterns of IPV during pregnancy were identified and violence was frequently described as co-occurring with male partner alcohol use. A majority of women referenced oral PrEP as their preferred method for HIV prevention, highlighting the agency and discretion it provided as beneficial attributes for women experiencing IPV. Fear of judgement from peers for remaining with an abusive partner and a lack of clear community messaging around IPV were identified as barriers to disclosure and support-seeking. Addressing the lack of social support received by women experiencing IPV during pregnancy in South Africa is essential to comprehensive IPV programming.

Summary: Background: While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. Methods: In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7–15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. Findings: Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05–0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01–0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. Interpretation: Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. Funding: National Institutes of Health.

Abstract Background The SARS-CoV-2 pandemic has resulted in an increase in telemedicine utilization for routine HIV care. However, there is limited information on perceptions of and experiences with telemedicine from United States (U.S.) federally qualified health centers (FQHCs) offering HIV care. We sought to understand telemedicine experiences of stakeholders with various roles: people living with HIV (PLHIV), clinical (clinicians and case managers), programmatic (clinic administrators), and policy (policymakers). Methods Qualitative interviews about benefits and challenges of telemedicine (telephone and video) for HIV care were conducted with 31 PLHIV and 23 other stakeholders (clinicians, case managers, clinic administrators, and policymakers). Interviews were transcribed, translated to English if conducted in Spanish, coded, and analyzed for major themes. Results Almost all PLHIV felt capable of engaging in telephone visits, with some expressing interest in learning how to use video visits as well. Nearly all PLHIV wanted to continue telemedicine as part of their routine HIV care, and this was also endorsed by clinical, programmatic and policy stakeholders. Interviewees agreed that telemedicine for HIV care has benefits for PLHIV, especially savings of time and transportation costs, which also reduced stress. Clinical, programmatic, and policy stakeholders expressed concerns around patients’ technological literacy and resources, as well as their access to privacy, and some felt that PLHIV strongly preferred in-person visits. These stakeholders also commonly reported clinic-level implementation challenges, including integrating telephone and video telemedicine into workflows and difficulty with video visit platforms. Conclusions Telemedicine for HIV care, largely delivered via telephone (audio-only), was highly acceptable and feasible for both PLHIV, clinicians, and other stakeholders. Addressing barriers for stakeholders in incorporating video visits will be important for the successful implementation of telemedicine with video as part of routine HIV care at FQHCs.

BackgroundThe Ending the HIV Epidemic initiative in the United States relies on HIV hotspots to identify where to geographically target new resources, expertise, and technology. However, interventions targeted at places with high HIV transmission and infection risk, not just places with high HIV incidence, may be more effective at reducing HIV incidence and achieving health equity. ObjectiveWe described the implementation and validation of a web-based activity space survey on HIV risk behaviors. The survey was intended to collect geographic information that will be used to map risk behavior hotspots as well as the geography of sexual networks in Los Angeles County. MethodsThe survey design team developed a series of geospatial questions that follow a 3-level structure that becomes more geographically precise as participants move through the levels. The survey was validated through 9 cognitive interviews and iteratively updated based on participant feedback until the saturation of topics and technical issues was reached. ResultsIn total, 4 themes were identified through the cognitive interviews: functionality of geospatial questions, representation and accessibility, privacy, and length and understanding of the survey. The ease of use for the geospatial questions was critical as many participants were not familiar with mapping software. The inclusion of well-known places, landmarks, and road networks was critical for ease of use. The addition of a Google Maps interface, which was familiar to many participants, aided in collecting accurate and precise location information. The geospatial questions increased the length of the survey and warranted the inclusion of features to simplify it and speed it up. Using nicknames to refer to previously entered geographic locations limited the number of geospatial questions that appeared in the survey and reduced the time taken to complete it. The long-standing relationship between participants and the research team improved comfort to disclose sensitive geographic information related to drug use and sex. Participants in the cognitive interviews highlighted how trust and inclusive and validating language in the survey alleviated concerns related to privacy and representation. ConclusionsThis study provides promising results regarding the feasibility of using a web-based mapping survey to collect sensitive location information relevant to ending the HIV epidemic. Data collection at several geographic levels will allow for insights into spatial recall of behaviors as well as future sensitivity analysis of the spatial scale of hotspots and network characteristics. This design also promotes the privacy and comfort of participants who provide location information for sensitive topics. Key considerations for implementing this type of survey include trust from participants, community partners, or research teams to overcome concerns related to privacy and comfort. The implementation of similar surveys should consider local characteristics and knowledge when crafting the geospatial components.

Summary: Background: Alterations in the gut microbiome have been associated with HIV infection, but the relative impact of HIV versus other factors on the gut microbiome has been difficult to determine in cross-sectional studies. Methods: To address this, we examined the gut microbiome, serum metabolome, and cytokines longitudinally within 27 individuals before and during acute HIV using samples collected from several ongoing cohort studies. Matched control participants (n=28) from the same cohort studies without HIV but at similar behavioral risk were used for comparison. Findings: We identified few changes in the microbiome during acute HIV infection, but did find alterations in serum metabolites involving secondary bile acid (lithocholate sulfate, glycocholenate sulfate) and amino acid metabolism (3-methyl-2-oxovalerate, serine, cysteine, N-acetylputrescine). Greater microbiome differences, including decreased Bacteroides spp and increased Megasphaera elsdenii, were seen when comparing pre-HIV infection visits to matched at-risk controls. Those who acquired HIV also had elevated inflammatory cytokines (TNF-α, B cell activating factor, IL-8) and bioactive lipids (palmitoyl-sphingosine-phosphoethanolamide and glycerophosphoinositol) prior to HIV acquisition compared to matched controls. Interpretation: Longitudinal sampling identified pre-existing microbiome differences in participants with acute HIV compared to matched control participants observed over the same period. These data highlight the importance of increasing understanding of the role of the microbiome in HIV susceptibility. Funding: This work was supported by NIH/NIAID (K08AI124979; P30AI117943), NIH/NIDA (U01DA036267; U01DA036939; U01DA036926; U24DA044554), and NIH/NIMH (P30MH058107; R34MH105272).

Abstract Background Synthesis of psychometric properties of substance use measures to identify patterns of use and substance use disorders remains limited. To address this gap, we sought to systematically evaluate the psychometric properties of measures to detect substance use and misuse. Methods We conducted a systematic review and meta-analysis of literature on measures of substance classes associated with HIV risk (heroin, methamphetamine, cocaine, ecstasy, alcohol) that were published in English before June 2016 that reported at least one of the following psychometric outcomes of interest: internal consistency (alpha), test-retest/inter-rater reliability (kappa), sensitivity, specificity, positive predictive value, and negative predictive value. We used meta-analytic techniques to generate pooled summary estimates for these outcomes using random effects and hierarchical logistic regression models. Results Findings across 387 paper revealed that overall, 65% of pooled estimates for alpha were in the range of fair-to-excellent; 44% of estimates for kappa were in the range of fair-to-excellent. In addition, 69, 97, 37 and 96% of pooled estimates for sensitivity, specificity, positive predictive value, and negative predictive value, respectively, were in the range of moderate-to-excellent. Conclusion We conclude that many substance use measures had pooled summary estimates that were at the fair/moderate-to-excellent range across different psychometric outcomes. Most scales were conducted in English, within the United States, highlighting the need to test and validate these measures in more diverse settings. Additionally, the majority of studies had high risk of bias, indicating a need for more studies with higher methodological quality.

Abstract Background In recent years, the number of infective endocarditis (IE) cases associated with injection drug use has increased. Clinical guidelines suggest deferring surgery for IE in people who inject drugs (PWID) due to a concern for worse outcomes in comparison to non-injectors (non-PWID). We performed a systematic review and meta-analysis of long-term outcomes in PWID who underwent cardiac surgery and compared these outcomes to non-PWID. Methods We systematically searched for studies reported between 1965 and 2018. We used an algorithm to estimate individual patient data (eIPD) from Kaplan-Meier (KM) curves and combined it with published individual patient data (IPD) to analyze long-term outcomes after cardiac surgery for IE in PWID. Our primary outcome was survival. Secondary outcomes were reoperation and mortality at 30-days, one-, five-, and 10-years. Random effects Cox regression was used for estimating survival. Results We included 27 studies in the systematic review and 19 provided data (KM or IPD) for the meta-analysis. PWID were younger and more likely to have S. aureus than non-PWID. Survival at 30-days, one-, five-, and 10-years was 94.3, 81.0, 62.1, and 56.6% in PWID, respectively; and 96.4, 85.0, 70.3, and 63.4% in non-PWID. PWID had 47% greater hazard of death (HR 1.47, 95% CI, 1.05–2.05) and more than twice the hazard of reoperation (HR 2.37, 95% CI, 1.25–4.50) than non-PWID. Conclusion PWID had shorter survival that non-PWID. Implementing evidence-based interventions and testing new modalities are urgently needed to improve outcomes in PWID after cardiac surgery.

Healthcare workers (HCWs) from minoritized communities are a critical partner in moving vaccine-hesitant populations toward vaccination, yet a significant number of these HCWs are delaying or deciding against their own COVID-19 vaccinations. Our study aims to provide a more nuanced understanding of vaccine hesitancy among racially and ethnically minoritized HCWs and to describe factors associated with vaccine non-acceptance. Analysis of a sub-sample of racially and ethnically minoritized HCWs (N = 1131), who participated in a cross-sectional study at two large Southern California medical centers, was conducted. Participants completed an online survey consisting of demographics, work setting and clinical role, influenza vaccination history, COVID-19 knowledge, beliefs, personal COVID-19 exposure, diagnosis, and impact on those closest to them. While overall most HCWs were vaccinated (84%), 28% of Black, 19% of Hispanic, and 8% of Asian American HCWs were vaccine-hesitant. Age, education level, occupation, history of COVID-19, and COVID-19 related knowledge were predictive of vaccine hesitancy. We found significant variations in COVID-19 related knowledge and reasons for vaccine hesitancy among Black (governmental mistrust), Hispanic (preference for physiological immunity), and Asian-American HCWs (concern about side effects) who were vaccine-hesitant or not. Our findings highlight racial and ethnic differences in vaccine-hesitancy and barriers to vaccination among HCWs of color. This study indicates the necessity of targeted interventions to reduce vaccine hesitancy that are mindful of the disparities in knowledge and access and differences between and among racial and ethnic groups.

Functional support-the availability of material aid, emotional support, or companionship-promotes general well-being. For men who have sex with men (MSM) living with HIV, having a person who supports you associates with viral suppression. This study examines the association between supportive partnerships and HIV viral suppression among middle-aged and aging MSM living with HIV. A total of 423 middle-aged and aging MSM (mean age, 58.2 years) from the Multicenter AIDS Cohort Study provided self-reported data about their partnerships. Separate Poisson regression models assessed how partnership type, support, strain, and duration from April 2017 were associated with repeated viral load measurements up to April 2019. Of the follow-up visits (N = 1289), 90.0% of participants were virally suppressed. Most participants reported being non-Hispanic White (61.0%) and college-educated (83.4%). Participants were asked about their primary partnerships (i.e., "someone they are committed to above anyone else") and secondary partnerships (i.e., those who can also be intimate or supportive but not necessarily romantic or sexual). The participants reported: no partnerships (45.2%), only primary partnerships (31.0%), only secondary partnerships (11.1%), or both primary and secondary partnerships (12.8%). Primary and secondary partnerships had mean (SD) durations of 15.9 (11.3) and 25.2 (16.5) years, respectively. Participants reporting both primary and secondary partnerships (compared with no partnership) showed significantly higher odds of being virally suppressed (adjusted prevalence ratio [aPR], 1.04; 95% CI, 1.00-1.08; p = 0.043). Albeit not statistically significant, primary-only (aPR, 1.01; 95% CI, 0.97-1.06; p = 0.547) or secondary-only (aPR, 1.03; 95% CI, 0.98-1.08; p = 0.224) partnership types were positively associated with viral suppression. Partner support and strain were not associated with viral suppression in any partnership group. Being older and non-Hispanic Black were positively and negatively associated with viral suppression, respectively. Encouraging partnerships should be considered one of clinicians' many tools to help middle-aged and aging MSM achieve long-term viral suppression.

Background: While there is significant research exploring adults’ use of opioids, there has been minimal focus on the opioid impact within emergency departments for the pediatric population. Methods: We examined data from the Agency for Healthcare Research, the National Emergency Department Sample (NEDS), and death data from the Centers for Disease Control and Prevention. Sociodemographic and financial variables were analyzed for encounters during 2014–2017 for patients under age 18, matching diagnoses codes for opioid-related overdose or opioid use disorder. Results: During this period, 59,658 children presented to an ED for any diagnoses involving opioids. The majority (68.5%) of visits were related to overdoses (poisoning), with a mean age of 11.3 years and a majority female (53%). There was a curvilinear relationship between age and encounters, with teens representing the majority of visits, followed by infants. The highest volume was seen in the Southern U.S., with over 58% more opioid visits than the next highest region (Midwest). Charges exceeded USD 157 million, representing 2% of total ED costs, with Medicaid responsible for 54% of the total. Conclusions: With increases in substance use among children, there is a growing need for pediatric emergency physicians to recognize, refer, and initiate treatments.

BackgroundIndividuals with substance use disorders exhibit maladaptive decision-making on the Iowa Gambling Task (IGT), which involves selecting from card decks differing in the magnitudes of rewards, and the frequency and magnitude of losses. We investigated whether baseline IGT performance could predict responses to contingency management (CM) by treatment-seeking individuals with methamphetamine use disorder (MA Use Disorder) in Cape Town, South Africa.MethodsTwenty-nine individuals with MA Use Disorder underwent an 8-week, escalating reinforcement, voucher-based CM treatment in a study on the suitability of CM therapy for the South African context. Along with 20 healthy control participants, they performed a computerized version of the IGT before starting CM treatment. Seventeen participants maintained abstinence from methamphetamine throughout the trial (full responders), and 12 had an incomplete response (partial responders). Performance on the IGT was scored for magnitude effect (selection of large immediate rewards with high long-term loss) and for frequency effect (preference for frequent rewards and avoidance of frequent losses). Group differences were investigated using linear mixed-effect modeling.ResultsPartial responders made more selections from decks providing large, immediate rewards and long-term losses than healthy controls [p = 0.038, g = -0.77 (-1.09: -0.44)]. Full responders showed a greater, nonsignificant preference for frequent rewards and aversion to frequent losses than partial responders [p = 0.054, g = -0.63 (-0.95: -0.29)].ConclusionsA predilection for choices based on the size and immediacy of reward may reflect a cognitive strategy that works against CM. Pretesting with a decision-making task, such as the IGT, may help in matching cognitive therapies to clients with MA Use Disorder.

In this study, we evaluated the status of and attitudes toward COVID-19 vaccination of healthcare workers in two major hospital systems (academic and private) in Southern California. Responses were collected via an anonymous and voluntary survey from a total of 2491 participants, including nurses, physicians, other allied health professionals, and administrators. Among the 2491 participants that had been offered the vaccine at the time of the study, 2103 (84%) were vaccinated. The bulk of the participants were middle-aged college-educated White (73%), non-Hispanic women (77%), and nursing was the most represented medical occupation (35%). Political affiliation, education level, and income were shown to be significant factors associated with vaccination status. Our data suggest that the current allocation of healthcare workers into dichotomous groups such as “anti-vaccine vs. pro-vaccine” may be inadequate in accurately tailoring vaccine uptake interventions. We found that healthcare workers that have yet to receive the COVID-19 vaccine likely belong to one of four categories: the misinformed, the undecided, the uninformed, or the unconcerned. This diversity in vaccine hesitancy among healthcare workers highlights the importance of targeted intervention to increase vaccine confidence. Regardless of governmental vaccine mandates, addressing the root causes contributing to vaccine hesitancy continues to be of utmost importance.

Abstract Background Contingency management (CM) is an evidence-based intervention providing tangible rewards as positive reinforcement for abstinence from stimulants such as methamphetamine. Integrative approaches targeting affect regulation could boost the effectiveness of CM in community-based settings and optimize HIV/AIDS prevention efforts. Methods/Design This randomized controlled trial with HIV-positive, methamphetamine-using men who have sex with men (MSM) is examining the efficacy of a 5-session, individually delivered positive affect regulation intervention – Affect Regulation Treatment to Enhance Methamphetamine Intervention Success (ARTEMIS). ARTEMIS is designed to sensitize individuals to non-drug-related sources of reward as well as assist with managing depression and other symptoms of stimulant withdrawal during CM. HIV-positive, methamphetamine-using MSM who are enrolled in a community-based, 12-week CM program are randomized to receive ARTEMIS or an attention-matched control condition. Follow-up assessments are conducted at 3, 6, 12, and 15 months after enrollment in CM. Four peripheral venous blood samples are collected over the 15-month follow-up with specimen banking for planned biomarker sub-studies. The primary outcome is mean HIV viral load. Secondary outcomes include: sustained HIV viral suppression, T-helper cell count, psychological adjustment, stimulant use, and potentially amplified transmission risk behavior. Discussion Implementation of this randomized controlled trial highlights the importance of delineating boundaries between research activities and community-based service provision. It also provides insights into best practices for integrating the distinct agendas of academic and community partners in clinical research. This trial is currently enrolling and data collection is anticipated to be completed in September of 2018. Trial registration This trial was registered on clinicaltrials.gov ( NCT01926184 ) on August 16, 2013.

HIV acquisition during pregnancy and breastfeeding significantly contributes toward paediatric HIV infection; however, little is known about risk behaviours in HIV-uninfected pregnant and postpartum women. We conducted twenty-six in-depth-interviews between July and December 2016 using a semi-structured interview guide among HIV-uninfected pregnant and recently postpartum women at-risk of HIV acquisition (defined as reporting ≥1 of the following: partner's serostatus unknown or HIV-infected, recent condomless sex in pregnancy, and/or alcohol use during pregnancy) who attended primary healthcare services. Our study contextualizes factors related to risky sexual behaviours during pregnancy and postpartum periods and assesses knowledge and hypothetical acceptability of pre-exposure prophylaxis (PrEP) in pregnancy. Translated and transcribed data were coded and analysed by three researchers using a thematic analysis approach. In interviews with HIV-uninfected pregnant/postpartum women at-risk of HIV acquisition, we identified common themes associated with sexual risk behaviours during pregnancy, including: lack of control over decisions in sex and condom use in pregnancy, low perceived risk (e.g. beliefs that their partner has the same HIV-negative serostatus), and socio-cultural beliefs around condom use during pregnancy (e.g. contact with sperm is essential for baby's development). PrEP knowledge was low among HIV-uninfected pregnant and breastfeeding women, and potential acceptability was good, though primary concerns were around the potential impact on the infant. While mothers presented a clear desire to protect themselves from HIV acquisition once pregnant, they also reported lack of control, and socio-cultural beliefs, like sex is good for the baby, that increased their risk of seroconversion. Mothers had limited PrEP awareness but reported hypothetical willingness to use PrEP because of concerns over HIV acquisition and onward mother to child transmission.

BackgroundCardiovascular disease is emerging as a major cause of morbidity and mortality among patients with HIV. We compared use of national guideline‐recommended cardiovascular care during office visits among HIV‐infected versus HIV‐uninfected adults. Methods and ResultsWe analyzed data from a nationally representative sample of HIV‐infected and HIV‐uninfected patients aged 40 to 79 years in the National Ambulatory Medical Care Survey/National Hospital Ambulatory Medical Care Survey, 2006 to 2013. The outcome was provision of guideline‐recommended cardiovascular care. Logistic regressions with propensity score weighting adjusted for clinical and demographic factors. We identified 1631 visits by HIV‐infected patients and 226 862 visits by HIV‐uninfected patients with cardiovascular risk factors, representing ≈2.2 million and 602 million visits per year in the United States, respectively. The proportion of visits by HIV‐infected versus HIV‐uninfected adults with aspirin/antiplatelet therapy when patients met guideline‐recommended criteria for primary prevention or had cardiovascular disease was 5.1% versus 13.8% (P=0.03); the proportion of visits with statin therapy when patients had diabetes mellitus, cardiovascular disease, or dyslipidemia was 23.6% versus 35.8% (P

A randomized controlled trial was conducted with homeless gay and bisexual men to assess the impact of two culturally sensitive intervention programs on reduction of drug use and risky sexual behavior. In this study, gay and bisexual men between 18 and 46 years of age were randomly assigned to one of two culturally sensitive behavioral intervention programs: a Nurse Case Management Plus Contingency Management (NCM + CM; n = 204) or a Standard Education Plus Contingency Management (SE + CM; n = 210) program. Regardless of group assignment, significant and clinically relevant reductions were observed in stimulant use over time. Multivariable predictors of stimulant use at 4- and 8-month follow-up evaluations were recent injection drug use, tested positive for HIV, or for use of amphetamine. Data revealed a significant linear decline over time for those who had sex with multiple partners. Furthermore, being HIV positive was associated with reporting multiple partners, while higher homophobia scores and having children were inversely related to reports of having sex with multiple partners at follow-up. Culturally sensitive approaches are needed to successfully reduce drug use and risky sexual activities among gay and bisexual populations.

BACKGROUND:HIV populations often diversify in response to selective pressures, such as the immune response and antiretroviral drug use. We analyzed HIV diversity in Black men who have sex with men who were enrolled in the HIV Prevention Trials Network 061 study. METHODS:A high resolution melting (HRM) diversity assay was used to measure diversity in six regions of the HIV genome: two in gag, one in pol, and three in env. HIV diversity was analyzed for 146 men who were HIV infected at study enrollment, including three with acute infection and 13 with recent infection (identified using a multi-assay algorithm), and for 21 men who seroconverted during the study. HIV diversification was analyzed in a paired analysis for 62 HIV-infected men using plasma samples from the enrollment and 12-month (end of study) visits. RESULTS:Men with acute or recent infection at enrollment and seroconverters had lower median HRM scores (lower HIV diversity) than men with non-recent infection in all six regions analyzed. In univariate analyses, younger age, higher CD4 cell count, and HIV drug resistance were associated with lower median HRM scores in multiple regions; ARV drug detection was marginally associated with lower diversity in the pol region. In multivariate analysis, acute or recent infection (all six regions) and HIV drug resistance (both gag regions) were associated with lower median HRM scores. Diversification in the pol region over 12 months was greater for men with acute or recent infection, higher CD4 cell count, and lower HIV viral load at study enrollment. CONCLUSIONS:HIV diversity was significantly associated with duration of HIV infection, and lower gag diversity was observed in men who had HIV drug resistance. HIV pol diversification was more pronounced in men with acute or recent infection, higher CD4 cell count, and lower HIV viral load.

Black men who have sex with men (MSM) in the United States (US) are affected by HIV at disproportionate rates compared to MSM of other race/ethnicities. Current HIV incidence estimates in this group are needed to appropriately target prevention efforts.From July 2009 to October 2010, Black MSM reporting unprotected anal intercourse with a man in the past six months were enrolled and followed for one year in six US cities for a feasibility study of a multi-component intervention to reduce HIV infection. HIV incidence based on HIV seroconversion was calculated as number of events/100 person-years. Multivariate proportional hazards modeling with time-dependent covariates was used to identify correlates of HIV acquisition.Of 1,553 Black MSM enrolled, 1,164 were HIV-uninfected at baseline and included in follow-up. Overall annual HIV incidence was 3.0% (95% confidence interval (CI): 2.0, 4.4%) and 5.9% among men ≤30 years old (95% CI: 3.6, 9.1%). Men ≤30 years old reported significantly higher levels of sexual risk and were more likely to have a sexually transmitted infection diagnosed during follow-up. Younger men also were more likely to not have a usual place for health care, not have visited a health care provider recently, and to have unmet health care needs. In multivariate analysis, age ≤30 years (hazard ratio (HR): 3.4; 95% CI: 1.4, 8.3) and unprotected receptive anal intercourse with HIV-positive or unknown status partners (HR: 4.1; 95% CI: 1.9, 9.1) were significantly associated with HIV acquisition.In the largest cohort of prospectively-followed Black MSM in the US, HIV incidence was high, particularly among young men. Targeted, tailored and culturally appropriate HIV prevention strategies incorporating behavioral, social and biomedical based interventions are urgently needed to lower these rates.

Homeless gay and bisexual (G/B) young men have multiple risk factors that increase their risk of contracting hepatitis B virus (HBV) and human immunodeficiency virus (HIV). This study used baseline information from structured instruments to assess correlates of knowledge to HIV and HBV infection from 267 young (18-39 year old) G/B active methamphetamine, cocaine, and crack-using homeless men enrolled in a longitudinal trial. The study is designed to reduce drug use and improve knowledge of hepatitis and HIV/AIDS in a community center in Hollywood, California. Regression modeling revealed that previous hepatitis education delivered to G/B men was associated with higher levels of HIV/AIDS and hepatitis knowledge. Moreover, higher HIV/AIDS knowledge was associated with combining sex and drinking alcohol. Associations with hepatitis B knowledge was found among G/B men who were engaging in sex while under the influence of marijuana, who were receiving support from non–drug users, and who had been homeless in the last 4 months. Although being informed about HIV/AIDS and hepatitis did not preclude risky sexual and drug use behavior, knowledge about the dangers of concurrent sex with substance use is important. As higher levels of knowledge of hepatitis was associated with more moderate drug use, early access to testing and teaching harm reduction strategies remain critical to reduce exposure and infection of HBV and HIV in this population.

In biomedical research with longitudinal designs, missing values due to intermittent nonresponse or premature withdrawal are usually 'nonignorable' in the sense that unobserved values are related to the patterns of missingness. When missing values are simply ignored, analyses based on observed-data likelihood may yield biased estimates or invalid inferences. By drawing the framework of a shared-parameter mechanism, the process yielding the repeated count measures and the process yielding missing values can be modelled separately, conditionally on a group of shared parameters. For chronic diseases, Markov transition models can be used to study the transitional features of the pathologic processes. In this paper, Markov chain Monte Carlo (MCMC) algorithms are developed to fit a random-effects Markov transition model (REMTM) for incomplete count repeated measures, within which random effects are shared by the counting process and the missing-data mechanism. Assuming a Poisson distribution for the count measures, the transition probabilities are estimated using a Poisson linear regression model. The missingness mechanism is modeled with a multinomial-logit regression to calculate the transition probabilities of the missingness indicators. The method is demonstrated using both simulated data sets and a practical data set from a smoking cessation clinical trial.

Longitudinal data sets from certain fields of biomedical research often consist of several variables repeatedly measured on each subject yielding large number of observations. This characteristic complicates the use of standard longitudinal modeling strategies, such as random effects models and marginal models, where rigorous assumptions on intra-subject correlation structure are required. An innovative way to model the data is to apply functional regression analysis, an emerging statistical approach in which observations of the same subject are viewed as a sample from a functional space. No assumptions are needed for the intra-subject correlation structure. Shen and Faraway (Satistica Sinica 2004; 1239-1257) introduced an F test for linear models with functional responses. This paper illustrates how to apply this F test and functional regression analysis to the setting of longitudinal data where intra-subject repeated measures are viewed as discrete samples from an underlying curve with continuous function forms. A smoking cessation study for methadone-maintained tobacco smokers is analyzed for demonstration. In estimating the treatment effects, the functional regression analysis provides meaningful clinical interpretations, and the functional F test provides consistent results supported by a random-effects linear regression model.

Biomedical research is plagued with problems of missing data, especially in clinical trials of medical and behavioral therapies adopting longitudinal design. After a comprehensive literature review on modeling incomplete longitudinal data based on the full-likelihood functions, this paper proposes a set of imputation-based strategies for implementing three advanced models for handling intermittent missing values and dropouts that are potentially nonignorable according to various criteria. In multiple partial imputation (MPI), intermittent missing values are first imputed several times. Then, each partially imputed data set is analyzed using selection, pattern-mixture, or shared-parameter models to deal with dropouts. If imputations are additionally created for dropouts, it is a 2-stage version of MPI. Depending on models used for making imputations, various strategies can offer a framework for analyzing the sensitivity of parameter estimation to the assumptions of the missingness mechanism. For illustration, both continuous and dichotomized binary data from a smoking cessation clinical trial are analyzed. Both likelihood-based and Markov Chain Monte Carlo (MCMC) based inferences are also described.