Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services.

BACKGROUND: People who inject drugs (PWID) remain a high priority population under the federal Ending the HIV Epidemic initiative with 11% of new HIV infections attributable to injection drug use. There is a critical need for innovative, efficacious, scalable, and community-driven models of healthcare in non-stigmatizing settings for PWID. We seek to test a Comprehensive-TeleHarm Reduction (C-THR) intervention for HIV prevention services delivered via a syringe services program (SSP). METHODS: The CHARIOT trial is a hybrid type I effectiveness-implementation study using a parallel two-arm randomized controlled trial design. Participants (i.e., PWID; n = 350) will be recruited from a syringe services program (SSP) in Miami, Florida. Participants will be randomized to receive either C-THR or non-SSP clinic referral and patient navigation. The objectives are: (1) to determine if the C-THR intervention increases engagement in HIV prevention (i.e., HIV pre-exposure prophylaxis; PrEP or medications for opioid use disorder; MOUD) compared to non-SSP clinic referral and patient navigation, (2) to examine the long-term effectiveness and cost-effectiveness of the C-THR intervention, and (3) to assess the barriers and facilitators to implementation and sustainment of the C-THR intervention. The co-primary outcomes are PrEP or MOUD engagement across follow-up at 3, 6, 9 and 12 months. For PrEP, engagement is confirmed by tenofovir on dried blood spot or cabotegravir injection within the previous 8 weeks. For MOUD, engagement is defined as screening positive for norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine injection within the previous 4 weeks. Secondary outcomes include PrEP adherence, engagement in HCV treatment and sustained virologic response, and treatment of sexually transmitted infections. The short and long term cost-effectiveness analyses and mixed-methods implementation evaluation will provide compelling data on the sustainability and possible impact of C-THR on comprehensive HIV prevention delivered via SSPs. DISCUSSION: The CHARIOT trial will be the first to our knowledge to test the efficacy of an innovative, peer-led telehealth intervention with PWID at risk for HIV delivered via an SSP. This innovative healthcare model seeks to transform the way PWID access care by bypassing the traditional healthcare system, reducing multi-level barriers to care, and meeting PWID where they are. TRIAL REGISTRATION: ClinicalTrials.gov NCT05897099. Trial registry name: Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT). Registration date: 06/12/2023.

Linkage Case Management and Posthospitalization Outcomes in People With HIV: The Daraja Randomized Clinical Trial.

Importance: Despite the widespread availability of antiretroviral therapy (ART), people with HIV still experience high mortality after hospital admission. Objective: To determine whether a linkage case management intervention (named "Daraja" ["bridge" in Kiswahili]) that was designed to address barriers to HIV care engagement could improve posthospital outcomes. Design, Setting, and Participants: Single-blind, individually randomized clinical trial to evaluate the effectiveness of the Daraja intervention. The study was conducted in 20 hospitals in Northwestern Tanzania. Five hundred people with HIV who were either not treated (ART-naive) or had discontinued ART and were hospitalized for any reason were enrolled between March 2019 and February 2022. Participants were randomly assigned 1:1 to receive either the Daraja intervention or enhanced standard care and were followed up for 12 months through March 2023. Intervention: The Daraja intervention group (n = 250) received up to 5 sessions conducted by a social worker at the hospital, in the home, and in the HIV clinic over a 3-month period. The enhanced standard care group (n = 250) received predischarge HIV counseling and assistance in scheduling an HIV clinic appointment. Main Outcomes and Measures: The primary outcome was all-cause mortality at 12 months after enrollment. Secondary outcomes related to HIV clinic attendance, ART use, and viral load suppression were extracted from HIV medical records. Antiretroviral therapy adherence was self-reported and pharmacy records confirmed perfect adherence. Results: The mean age was 37 (SD, 12) years, 76.8% were female, 35.0% had CD4 cell counts of less than 100/µL, and 80.4% were ART-naive. Intervention fidelity and uptake were high. A total of 85 participants (17.0%) died (43 in the intervention group; 42 in the enhanced standard care group); mortality did not differ by trial group (17.2% with intervention vs 16.8% with standard care; hazard ratio [HR], 1.01; 95% CI, 0.66-1.55; P = .96). The intervention, compared with enhanced standard care, reduced time to HIV clinic linkage (HR, 1.50; 95% CI, 1.24-1.82; P < .001) and ART initiation (HR, 1.56; 95% CI, 1.28-1.89; P < .001). Intervention participants also achieved higher rates of HIV clinic retention (87.4% vs 76.3%; P = .005), ART adherence (81.1% vs 67.6%; P = .002), and HIV viral load suppression (78.6% vs 67.1%; P = .01) at 12 months. The mean cost of the Daraja intervention was about US $22 per participant including startup costs. Conclusions and Relevance: Among hospitalized people with HIV, a linkage case management intervention did not reduce 12-month mortality outcomes. These findings may help inform decisions about the potential role of linkage case management among hospitalized people with HIV. Trial Registration: ClinicalTrials.gov Identifier: NCT03858998.

Estimating the epidemiological impact of reaching the objectives of the Florida integrated HIV prevention and care plan in Miami-Dade County.

Background: The US Ending the HIV Epidemic (EHE) initiative aims to reduce national HIV incidence 90% by 2030 and to address the disproportionate burden of HIV among different racial/ethnic populations. Florida's state-wide 2022-2026 Integrated HIV Prevention and Care Plan outlines objectives for reaching EHE goals. In Miami-Dade County, we determined the epidemiological impact of achieving the integrated plan's objectives individually and jointly. Methods: We adapted an HIV transmission model calibrated to Miami-Dade County adjusting access to HIV testing, pre-exposure prophylaxis (PrEP) and antiretroviral treatment to model the effects of each objective between 2022 and 2030. We compared two service scale-up approaches: (a) scale-up proportionally to existing racial/ethnic group access levels, and (b) scale-up according to new diagnoses across racial/ethnic groups (equity-oriented). We estimated reductions in new HIV infections by each objective and approach, compared to the EHE's incidence reduction target. Findings: The single most influential strategy was reducing new HIV diagnoses in Hispanic/Latinx men who have sex with men through increased PrEP uptake, resulting in 907/2444 (37.1%) fewer annual new HIV infections in 2030. Achieving all objectives jointly would result in 1537/2444 (62.9%) and 1553/2444 (63.5%) fewer annual new HIV infections with the proportional and equity-oriented approaches, respectively. Interpretation: Achieving the goals of Florida's integrated care plan would significantly reduce HIV incidence in Miami-Dade County; however, further efforts are required to achieve EHE targets. Structural changes in service delivery and a focus on effective implementation of available interventions to address racial/ethnic disparities will be crucial to ending the HIV epidemic. Funding: This work was supported by the National Institutes of Health/National Institute on Drug Abuse grant no. R01-DA041747.

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs.

BACKGROUND: People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of substance use disorder (SUD) treatment programs offering on-site HIV testing. Fewer than half of SUDs in the USA offer on-site HIV testing. In addition, nearly a quarter of newly diagnosed cases have AIDS at the time of diagnosis. Lack of testing is one of the main reasons that annual HIV incidences have remained constant over time. Integration of HIV testing with testing for HCV, an infection prevalent among persons vulnerable to HIV infection, and in settings where they receive health services, including opioid treatment programs (OTPs), is of great public health importance. METHODS/DESIGN: In this 3-arm cluster-RCT of opioid use disorders treatment programs, we test the effect of two evidence-based "practice coaching" (PC) interventions on the provision and sustained implementation of on-site HIV testing, on-site HIV/HCV testing, and linkage to care. Using the National Survey of Substance Abuse Treatment Services data available from SAMHSA, 51 sites are randomly assigned to one of the three conditions: practice coach facilitated structured conversations around implementing change, with provision of resources and documents to support the implementation of (1) HIV testing only, or (2) HIV/HCV testing, and (3) a control condition that provides a package with information only. We collect quantitative (e.g., HIV and HCV testing at 6-month-long intervals) and qualitative site data near the time of randomization, and again approximately 7-12 months after randomization. DISCUSSION: Innovative and comprehensive approaches that facilitate and promote the adoption and sustainability of HIV and HCV testing in opioid treatment programs are important for addressing and reducing HIV and HCV infection rates. This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals receiving treatment for opioid use disorder. The study may provide valuable insight and knowledge on the multiple levels of intervention that, if integrated, may better position OTPs to improve and sustain testing practices and improve population health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03135886. Registered on 2 May 2017.

Health Care Provider Stigma Toward Patients With Substance Use Disorders: Protocol for a Nationally Representative Survey.

BACKGROUND: The US overdose epidemic is an escalating public health emergency, accounting for over 100,000 deaths annually. Despite the availability of medications for opioid use disorders, provider-level barriers, such as negative attitudes, exacerbate the treatment gap in clinical care settings. Assessing the prevalence and intensity of provider stigma, defined as the negative perceptions and behaviors that providers embody and enact toward patients with substance use disorders, across providers with different specialties, is critical to expanding the delivery of substance use treatment. OBJECTIVE: To thoroughly understand provider stigma toward patients with substance use disorders, we conducted a nationwide survey of emergency medicine and primary care physicians and dentists using a questionnaire designed to reveal how widely and intensely provider attitudes and stigma can impact these providers' clinical practices in caring for their patients. The survey also queried providers' stigma and clinical practices toward other chronic conditions, which can then be compared with their stigma and practices related to substance use disorders. METHODS: Our cross-sectional survey was mailed to a nationally representative sample of primary care physicians, emergency medicine physicians, and dentists (N=3011), obtained by American Medical Association and American Dental Association licensees based on specified selection criteria. We oversampled nonmetropolitan practice areas, given the potential differences in provider stigma and available resources in these regions compared with metropolitan areas. Data collection followed a recommended series of contacts with participants per the Dillman Total Design Method, with mixed-modality options offered (email, mail, fax, and phone). A gradually increasing compensation scale (maximum US$250) was implemented to recruit chronic nonresponders and assess the association between requiring higher incentives to participate and providers stigma. The primary outcome, provider stigma, was measured using the Medical Condition Regard Scale, which inquired about participants' views on substance use and other chronic conditions. Additional survey measures included familiarity and social engagement with people with substance use disorders; clinical practices (screening, treating, and referring for a range of chronic conditions); subjective norms and social desirability; knowledge and prior education; and descriptions of their patient populations. RESULTS: Data collection was facilitated through collaboration with the National Opinion Research Center between October 2020 and October 2022. The overall Council of American Survey Research Organizations completion rate was 53.62% (1240/2312.7; physicians overall: 855/1681.9, 50.83% [primary care physicians: 506/1081.3, 46.79%; emergency medicine physicians: 349/599.8, 58.2%]; dentists: 385/627.1, 61.4%). The ineligibility rate among those screened is applied to those not screened, causing denominators to include fractional numbers. CONCLUSIONS: Using systematically quantified data on the prevalence and intensity of provider stigma toward substance use disorders in health care, we can provide evidence-based improvement strategies and policies to inform the development and implementation of stigma-reduction interventions for providers to address their perceptions and treatment of substance use. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47548.

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs.

Background People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of substance use disorder (SUD) treatment programs offering on-site HIV testing. Fewer than half of SUDs in the United States offer on-site HIV testing. In addition, nearly a quarter of newly diagnosed cases have AIDS at the time of diagnosis. Lack of testing is one of the main reasons that annual HIV incidences have remained constant over time. Integration of HIV testing with testing for HCV, an infection prevalent among persons vulnerable to HIV infection, and in settings where they receive health services, including opioid treatment programs (OTPs), is of great public health importance. Methods/Design In this 3-arm cluster-RCT of opioid use disorders treatment programs, we test the effect of two evidence-based "practice coaching" (PC) interventions on: the provision and sustained implementation of on-site HIV testing, on-site HIV/HCV testing, and linkage to care. Using the National Survey of Substance Abuse Treatment Services data available from SAMHSA, 51 sites are randomly assigned to one of the three conditions: practice coach facilitated structured conversations around implementing change, with provision of resources and documents to support the implementation of (1) HIV testing only, or (2) HIV/HCV testing, and (3) a control condition that provides a package with information only. We collect quantitative (e,g., HIV and HCV testing at six-month-long intervals) and qualitative site data near the time of randomization, and again approximately 7-12 months after randomization. Discussion Innovative and comprehensive approaches that facilitate and promote the adoption and sustainability of HIV and HCV testing in opioid treatment programs are important for addressing and reducing HIV and HCV infection rates. This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals receiving treatment for opioid use disorder. The study may provide valuable insight and knowledge on the multiple levels of intervention that, if integrated, may better position OTPs to improve and sustain testing practices and improve population health. Trial registration ClinicalTrials.gov: NCT03135886. (02 05 2017).

Application of The Consolidated Framework for Implementation Research to inform understanding of barriers and facilitators to the implementation of opioid and naloxone training on college campuses.

BACKGROUND: The opioid epidemic in the US continues to worsen. Opioid-only and polysubstance-involved opioid overdose deaths are increasing among adolescents and young adults, who have limited knowledge of opioid overdose prevention, including recognition and response. College campuses have infrastructure to support national-level implementation of evidence-based public health strategies for providing opioid overdose prevention and naloxone training programs among this priority population. However, college campuses are an underutilized, understudied setting for this programming. To address this gap, we conducted research assessing barriers and facilitators to planning and implementing this programming on college campuses. METHODS: We held 9 focus groups among purposively selected campus stakeholders whose perceptions were important to understand in planning for the dissemination and implementation of opioid overdose prevention and naloxone training. Focus group scripts were informed by The Consolidated Framework for Implementation Research (CFIR) to query about perceptions of opioid and other substance use, opioid and other substance use-related resources, and naloxone administration training. We used a deductive-inductive, iterative approach to thematic analysis. RESULTS: Themes about implementation barriers included (1) the perception that problematic use of other (non-opioid) substances was more prevalent than opioid use on campus and focus on those substances would be a greater priority on college campuses; (2) student schedules were overwhelmed with academic commitments and extracurricular activities, making delivery of additional training challenging; (3) barriers related to the perceived complexity and decentralization of communication on campus, preventing students from knowing how to access substance use-related resources. Themes about implementation facilitators included (1) framing naloxone training as important in becoming a responsible leader on campus and in the broader community and (2) leveraging existing infrastructure, champions within existing campus groups, and tailored messaging to facilitate participation in naloxone training. CONCLUSIONS: This is the first study to provide in-depth insights into potential barriers and facilitators to widespread, routine implementation of naloxone/opioid education on undergraduate college campuses. The study captured diverse stakeholder perspectives and was theoretically grounded in CFIR, contributing to the growing literature on the application and refinement of CFIR across diverse community and school contexts.

Assessing HIV Care Outcomes Among Persons Who Use Drugs in Puerto Rico Before and After Hurricane Maria.

OBJECTIVES: To explore the health impacts of Hurricane Maria (HM) on HIV care outcomes among people living with HIV who use drugs. METHODS: Using data from an ongoing cohort study in San Juan, Puerto Rico (Proyecto PACTo), we measured differences in HIV care outcomes (viral load, viral suppression, and CD4 counts) before and after HM using assessments conducted at 6-month intervals. Generalized estimating equations were used to assess factors associated with HIV care outcomes. RESULTS: All HIV care outcomes showed a deterioration from pre-HM values to post-HM values (mean viral load increased, CD4 counts decreased, and rate of viral suppression decreased) after controlling for pre-HM sociodemographic and health characteristics. In addition to HM, age (aIRR = 1·01), being homeless (aIRR = 0·78) and having health insurance (aIRR = 1·6) were independently associated with viral suppression. PARTICIPANTS: 219 participants completed follow-up visits between April 2017 and January 2018, before and after HM. CONCLUSIONS: People living with HIV who use drugs in Puerto Rico experienced poorer HIV outcomes following HM. Socio-environmental factors contributing to these outcomes is discussed in the context of disaster response, recovery, and program planning.

Longitudinal Relationship Between Food Insecurity, Engagement in Care, and ART Adherence Among US Women Living with HIV.

Food insecurity disproportionately affects people with HIV and women in the United States (US). More evidence is needed to understand the interplay between levels of food insecurity and levels of antiretroviral therapy (ART) adherence over time, as well as how food insecurity relates to engagement in HIV care. We used random effects models with longitudinal data from the US Women's Interagency HIV Study to estimate the (1) adjusted associations of current and 6-month lagged food security with ART adherence categories (n = 1646), and (2) adjusted associations of food security with engagement-in-care (n = 1733). Very low food security was associated with a higher relative risk of ART non-adherence at prior and current visits compared with food security, and this association increased across non-adherence categories. Very low food security was associated with lower odds of receiving HIV care and higher odds of a missed visit. Food insecurity among US women with HIV is associated with poorer engagement in care and degree of ART non-adherence over time.

Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs.

BACKGROUND: The resurgence of HIV outbreaks and rising prevalence among people who inject drugs (PWID) remain exigent obstacles to Ending the HIV Epidemic in the USA. Adapting a low threshold, comprehensive treatment model for PWID with HIV can leverage syringe services programs (SSPs) to increase availability and accessibility of antiretrovirals (ART), medications for opioid use disorder (MOUD), and hepatitis C cure. We developed Tele-Harm Reduction, a telehealth-enhanced, harm reduction intervention delivered within an SSP venue. METHODS: The T-SHARP trial is an open-label, multi-site, randomized controlled superiority trial with two parallel treatment arms. Participants (n=240) recruited from SSPs in Miami, Ft. Lauderdale, and Tampa, Florida, who are PWID with uncontrolled HIV (i.e., HIV RNA>200) will be randomized to Tele-Harm Reduction or off-site linkage to HIV care. The primary objective is to compare the efficacy of Tele-Harm Reduction for initiation of ART at SSPs vs. off-site linkage to an HIV clinic with respect to viral suppression across follow-up (suppression at 3, 6, and 12 months post randomization). Participants with HIV RNA<200 copies/ml will be considered virally suppressed. The primary trial outcome is time-averaged HIV viral suppression (HIV RNA <200 copies/ml) over 3-, 6-, and 12-month follow-up. Secondary outcomes include initiation of MOUD measured by urine drug screen and HCV cure, defined as achieving 12-week sustained virologic response (negative HCV RNA at 12 weeks post treatment completion). A cost-effectiveness analysis will be performed. DISCUSSION: The T-SHARP Trial will be the first to our knowledge to test the efficacy of an innovative telehealth intervention with PWID with uncontrolled HIV delivered via an SSP to support HIV viral suppression. Tele-Harm Reduction is further facilitated by a peer to support adherence and bridge the digital divide. This innovative, flipped healthcare model sets aside the traditional healthcare system, reduces multi-level barriers to care, and meets PWID where they are. The T-SHARP trial is a pragmatic clinical trial that seeks to transform the way that PWID access HIV care and improve HIV clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05208697. Trial registry name: Tele-Harm Reduction. Registration date: January 26, 2022.

Strategies of Managing Repeated Measures: Using Synthetic Random Forest to Predict HIV Viral Suppression Status Among Hospitalized Persons with HIV.

The HIV/AIDS epidemic remains a major public health concern since the 1980s; untreated HIV infection has numerous consequences on quality of life. To optimize patients' health outcomes and to reduce HIV transmission, this study focused on vulnerable populations of people living with HIV (PLWH) and compared different predictive strategies for viral suppression using longitudinal or repeated measures. The four methods of predicting viral suppression are (1) including the repeated measures of each feature as predictors, (2) utilizing only the initial (baseline) value of the feature as predictor, (3) using the last observed value as the predictors and (4) using a growth curve estimated from the features to create individual-specific prediction of growth curves as features. This study suggested the individual-specific prediction of the growth curve performed the best in terms of lowest error rate on an independent set of test data.

Integrated Infectious Disease and Substance Use Disorder Care for the Treatment of Injection Drug Use-Associated Infections: A Prospective Cohort Study With Historical Control.

Background: To address the infectious disease (ID) and substance use disorder (SUD) syndemic, we developed an integrated ID/SUD clinical team rooted in harm reduction at a county hospital in Miami, Florida. The Severe Injection-Related Infection (SIRI) team treats people who inject drugs (PWID) and provides medical care, SUD treatment, and patient navigation during hospitalization and after hospital discharge. We assessed the impact of the SIRI team on ID and SUD treatment and healthcare utilization outcomes. Methods: We prospectively collected data on patients seen by the SIRI team. A diagnostic code algorithm confirmed by chart review was used to identify a historical control group of patients with SIRI hospitalizations in the year preceding implementation of the SIRI team. The primary outcome was death or readmission within 90 days post-hospital discharge. Secondary outcomes included initiation of medications for opioid use disorder (MOUD) and antibiotic course completion. Results: There were 129 patients included in the study: 59 in the SIRI team intervention and 70 in the pre-SIRI team control group. SIRI team patients had a 45% risk reduction (aRR, 0.55 [95% confidence interval CI, .32-.95]; 24% vs 44%) of being readmitted in 90 days or dying compared to pre-SIRI historical controls. SIRI team patients were more likely to initiate MOUD in the hospital (93% vs 33%, P < .01), complete antibiotic treatment (90% vs 60%, P < .01), and less likely to have patient-directed discharge (17% vs 37%, P = .02). Conclusions: An integrated ID/SUD team was associated with improvements in healthcare utilization, MOUD initiation, and antibiotic completion for PWID with infections.

Patient acceptance of HIV rapid testing in the dental care setting.

Dental settings are untapped venues to identify patients with undiagnosed HIV who may otherwise lack testing opportunities. Perceived lack of patient acceptance has been a significant barrier limiting dentists' willingness to offer HIV testing. This study implemented rapid HIV testing in dental settings located in an HIV prevalent region to evaluate patient acceptance. Two South Florida community health centers implemented routine oral rapid HIV testing as part of clinical practice, followed by exit interviews with patients immediately after to determine patient acceptance. The binary primary outcome was patient's acceptance of the rapid HIV test. Multivariable logistic regression assessed associations between patient characteristics and acceptance. Overall acceptance by dental patients (N = 600) was 84.5%. Patients who were more likely to participate in other medical screenings in dental settings were more than twice as likely to accept the test compared to those who were neutral/less likely (OR: 2.373; 95% CI: 1.406-4.004). Study findings highlight the high patient acceptance of HIV testing in dental settings. Widespread implementation of such testing will require an expanded societal view of the traditional role of the dentist that will embrace the potentially valuable role of dentistry in preventive health screenings and population health.

Collateral consequences of the school-to-prison pipeline: Adolescent substance use and developmental risk.

OBJECTIVE: The adolescent health consequences of the school-to-prison pipeline remain underexplored. We test whether initiating components of the school-to-prison pipeline-suspensions, expulsions, and school policing-are associated with higher school-average levels of student substance use, depressed feelings, and developmental risk in the following year. METHOD: We linked 2003-2014 data from the California Healthy Kids Survey and the Civil Rights Data Collection from over 4,800 schools and 4,950,000 students. With lagged multi-level models, we estimated relationships between the school prevalence of total discipline, out-of-school discipline, and police-involved discipline, and standardized school-average levels of 6 substance use measures and 8 measures of developmental risk, respectively. RESULTS: The prevalence of school discipline predicted subsequent school-mean substance use and developmental risk. A one-unit higher prevalence of total discipline predicted higher school levels (in standard deviations) of binge drinking alcohol (0.14, 95% CI: 0.11, 0.17), drinking alcohol (0.15, 95% CI: 0.12, 0.18), smoking tobacco (0.09, 95% CI: 0.06, 0.12), using cannabis (0.16, 95% CI: 0.14, 0.19), using other drugs (0.17, 95% CI: 0.14, 0.21), and violence/harassment (0.16, 95% CI: 0.12, 0.2). Total discipline predicted lower levels of reported community support (-0.07, 95% CI: -0.1, -0.05), feeling safe in school (-0.12, 95% CI: -0.16, -0.09), and school support (-0.16, 95% CI: -0.19, -0.12). Associations were greater in magnitude for more severe out-of-school discipline. Findings were inconsistent for police-involved discipline. CONCLUSION: Exclusionary school discipline and school policing-core elements of the school-to-prison pipeline-are previously unidentified population predictors of adolescent substance use and developmental risk.

Effectiveness of an Intervention to Improve HIV Service Delivery for People Who Inject Drugs in Kazakhstan: A Cluster Trial.

Importance: The increasing HIV incidence rates and suboptimal rates of testing, engagement, and retention in care for people who inject drugs (PWID) in Kazakhstan underscore the need for effective HIV care continuum interventions for PWID. Objective: To determine the effectiveness of the Bridge HIV care continuum intervention implemented in needle and syringe programs (NSPs) in Kazakhstan. Design, Setting, and Participants: This stepped-wedge cluster trial was conducted from February 2017 to May 2020, with implementation beginning sequentially across 3 cities (Almaty, Karaganda-Temirtau, and Shymkent) in August 2017, January 2018, and May 2019. Intervention effect sizes were estimated via population-averaged models, and hypothesis testing relied on a permutation testing approach. The primary unit of analysis was an NSP. Data analysis was performed from October 2020 to April 2022. Interventions: The intervention addresses the full HIV care continuum: identification, testing, referral to services, and linkage to HIV care. The 3 intervention components were (1) a social network strategy, a peer-driven recruitment approach for HIV testing; (2) HIV counseling, rapid testing, and referral following international and national guidelines and protocols; and (3) enhanced antiretroviral treatment and access to services. Main Outcomes and Measures: The primary outcomes were the effectiveness of implementing Bridge's enhanced service integration approach in increasing the number of PWID served at NSPs, increasing the number of PWID who are tested for HIV in NSPs, and improving linking HIV-positive PWID with HIV care. Secondary outcomes included numbers of clients registered for HIV care, initiation of antiretroviral therapy, and viral suppression. Results: Twenty-four NSPs (8 in each city) served a total of 1225 PWID (369 in Almaty, 618 in Karaganda-Temirtau, and 238 in Shymkent) at the preimplementation study step; 1015 clients (82.9%) were male, and the mean (SD) age was 36.7 (7.1) years. Compared with preimplementation study steps, during Bridge intervention implementation steps, NSPs experienced a significant increase in the number of PWID clients registered (incidence rate ratio, 2.37; 95% CI, 1.48-3.78) and the number of PWID who received rapid HIV tests (incidence rate ratio, 3.98; 95% CI, 2.30-6.90). No significant increase in referral to HIV care was observed. The study also found significant support for secondary outcomes of antiretroviral therapy initiation and the number of clients who achieved viral suppression. Conclusions and Relevance: In this stepped-wedge cluster trial, the findings suggest that implementation of the Bridge intervention was associated with significant improvement in several steps in the continuum of HIV care for PWID in Kazakhstan. Trial Registration: ClinicalTrials.gov Identifier: NCT02796027.

Resilience and Optimism as Moderators of the Negative Effects of Stigma on Women Living with HIV.

Resilience and optimism may not only have main effects on health outcomes, but may also moderate and buffer negative effects of stressors. We examined whether dispositional resilience and optimism moderate the associations between HIV-related stigma in health care settings and health-related outcomes (trust in HIV health care providers and depression symptoms) among women living with HIV (WLHIV). One thousand four hundred five WLHIV in nine US cities completed validated questionnaires for cross-sectional analyses. Higher self-reported experienced and anticipated stigma and lower resilience and optimism were associated with higher depression symptoms and with lower trust in HIV providers. Importantly, resilience moderated the effects of experienced stigma (but not of anticipated stigma): When resilience was high, the association of experienced stigma with higher depression symptoms and lower trust in HIV providers was weaker compared with when resilience was low. Further, significant moderation effects suggested that when optimism was high, experienced and anticipated stigma was both less strongly associated with depression symptoms and with lower trust in one's HIV care providers compared with when optimism was low. Thus, the effects of experienced stigma on depression symptoms and provider trust were moderated by both resilience and optimism, but the effects of anticipated stigma were moderated only by optimism. Our findings suggest that in addition to their main effects, resilience and optimism may function as buffers against the harmful effects of stigma in health care settings. Therefore, optimism and resilience may be valuable intervention targets to reduce depression symptoms or improve trust in providers among populations that experience or anticipate stigma, such as WLHIV.

M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID.

BACKGROUND: Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. METHODS: The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial (M2HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. DISCUSSION: The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. TRIAL REGISTRATION: Clinicaltrials.gov NCT03981445 . Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201.

Cost of Hepatitis C care facilitation for HIV/Hepatitis C Co-infected people who use drugs.

BACKGROUND: Using data from a randomized trial, we evaluated the cost of HCV care facilitation that supports moving along the continuum of care for HIV/HCV co-infected individuals with substance use disorder. METHODS: Participants were HIV patients residing in the community, initially recruited from eight US hospital sites. They received HCV care facilitation (n = 51) or treatment as usual (n = 62) for up to six months. We used micro-costing methods to evaluate costs from the healthcare sector and patient perspectives in 2017 USD. We conducted sensitivity analyses varying care facilitator caseloads and examined offsetting savings using participant self-reported healthcare utilization. RESULTS: The average site start-up cost was $6320 (site range: $4320-$7000), primarily consisting of training. The mean weekly cost per participant was $20 (site range: $4-$30) for care facilitation visits and contacts, $360 (site range: $130- $700) for supervision and client outreach, and $70 (site range: $20-$180) for overhead. In sensitivity analyses applying a weekly caseload of 10 participants per care facilitator (versus 1-6 observed in the trial), the total mean weekly care facilitation cost from the healthcare sector perspective decreased to $110. Weekly participant time and travel costs averaged $7. There were no significant differences in other healthcare service costs between participants in the intervention and control arms. CONCLUSION: Weekly HCV care facilitation costs were approximately $450 per participant, but approximately $110 at a real-world setting maximum caseload of 10 participants per week. No healthcare cost offsets were identified during the trial period, although future savings might result from successful HCV treatment.

Differential Effects of Patient Navigation across Latent Profiles of Barriers to Care among People Living with HIV and Comorbid Conditions.

Engaging people living with HIV who report substance use (PLWH-SU) in care is essential to HIV medical management and prevention of new HIV infections. Factors associated with poor engagement in HIV care include a combination of syndemic psychosocial factors, mental and physical comorbidities, and structural barriers to healthcare utilization. Patient navigation (PN) is designed to reduce barriers to care, but its effectiveness among PLWH-SU remains unclear. We analyzed data from NIDA Clinical Trials Network's CTN-0049, a three-arm randomized controlled trial testing the effect of a 6-month PN with and without contingency management (CM), on engagement in HIV care and viral suppression among PLWH-SU (n = 801). Latent profile analysis was used to identify subgroups of individuals' experiences to 23 barriers to care. The effects of PN on engagement in care and viral suppression were compared across latent profiles. Three latent profiles of barriers to care were identified. The results revealed that PN interventions are likely to be most effective for PLWH-SU with fewer, less severe healthcare barriers. Special attention should be given to individuals with a history of abuse, intimate partner violence, and discrimination, as they may be less likely to benefit from PN alone and require additional interventions.