Improving access to HIV care among people who inject drugs through tele-harm reduction: a qualitative analysis of perceived discrimination and stigma.

BACKGROUND: Tele-harm reduction (THR) is a telehealth-enhanced, peer-led, harm reduction intervention delivered within a trusted syringe services program (SSP) venue. The primary goal of THR is to facilitate linkage to care and rapid, enduring virologic suppression among people who inject drugs (PWID) with HIV. An SSP in Miami, Florida, developed THR to circumvent pervasive stigma within the traditional healthcare system. METHODS: During intervention development, we conducted in-depth interviews with PWID with HIV (n = 25) to identify barriers and facilitators to care via THR. We employed a general inductive approach to transcripts guided by iterative readings of the raw data to derive the concepts, themes, and interpretations of the THR intervention. RESULTS: Of the 25 PWID interviewed, 15 were in HIV care and adherent to medication; 4 were in HIV care but non-adherent; and 6 were not in care. Themes that emerged from the qualitative analysis included the trust and confidence PWID have with SSP clinicians as opposed to professionals within the traditional healthcare system. Several barriers to treatment were reported among PWID, including perceived and actual discrimination by friends and family, negative internalized behaviors, denial of HIV status, and fear of engaging in care. Facilitators to HIV care included empathy and respect by SSP staff, flexibility of telehealth location, and an overall destigmatizing approach. CONCLUSION: PWID identified barriers and facilitators to receipt of HIV care through the THR intervention. Interviews helped inform THR intervention development, centered on PWID in the destigmatizing environment of an SSP.

"We want everything in a one-stop shop": acceptability and feasibility of PrEP and buprenorphine implementation with mobile syringe services for Black people who inject drugs.

INTRODUCTION: A recent surge in HIV outbreaks, driven by the opioid and stimulant use crises, has destabilized our progress toward targets set forth by Ending the HIV Epidemic: A Plan for America for the high-priority community of people who inject drugs (PWID), particularly Black PWID. METHODS: In order to ascertain the acceptability and feasibility of using a mobile syringe services program (SSP) for comprehensive HIV prevention via PrEP and medications for opioid use disorder (MOUD), our mixed methods approach included a quantitative assessment and semi-structured qualitative interviews with Black PWID (n = 30) in Miami-Dade County who were actively engaged in mobile syringe services. RESULTS: Participants felt that delivery of MOUD and PrEP at a mobile SSP would be both feasible and acceptable, helping to address transportation, cost, and stigma barriers common within traditional healthcare settings. Participants preferred staff who are compassionate and nonjudgmental and have lived experience. CONCLUSIONS: A mobile harm reduction setting could be an effective venue for delivering comprehensive HIV prevention services to Black PWID, a community that experiences significant barriers to care via marginalization and racism in a fragmented healthcare system.

Sex and race differences of cerebrospinal fluid metabolites in healthy individuals.

INTRODUCTION: Analyses of cerebrospinal fluid (CSF) metabolites in large, healthy samples have been limited and potential demographic moderators of brain metabolism are largely unknown. OBJECTIVE: Our objective in this study was to examine sex and race differences in 33 CSF metabolites within a sample of 129 healthy individuals (37 African American women, 29 white women, 38 African American men, and 25 white men). METHODS: CSF metabolites were measured with a targeted electrochemistry-based metabolomics platform. Sex and race differences were quantified with both univariate and multivariate analyses. Type I error was controlled for by using a Bonferroni adjustment (0.05/33 = .0015). RESULTS: Multivariate Canonical Variate Analysis (CVA) of the 33 metabolites showed correct classification of sex at an average rate of 80.6% and correct classification of race at an average rate of 88.4%. Univariate analyses revealed that men had significantly higher concentrations of cysteine (p < 0.0001), uric acid (p < 0.0001), and N-acetylserotonin (p = 0.049), while women had significantly higher concentrations of 5-hydroxyindoleacetic acid (5-HIAA) (p = 0.001). African American participants had significantly higher concentrations of 3-hydroxykynurenine (p = 0.018), while white participants had significantly higher concentrations of kynurenine (p < 0.0001), indoleacetic acid (p < 0.0001), xanthine (p = 0.001), alpha-tocopherol (p = 0.007), cysteine (p = 0.029), melatonin (p = 0.036), and 7-methylxanthine (p = 0.037). After the Bonferroni adjustment, the effects for cysteine, uric acid, and 5-HIAA were still significant from the analysis of sex differences and kynurenine and indoleacetic acid were still significant from the analysis of race differences. CONCLUSION: Several of the metabolites assayed in this study have been associated with mental health disorders and neurological diseases. Our data provide some novel information regarding normal variations by sex and race in CSF metabolite levels within the tryptophan, tyrosine and purine pathways, which may help to enhance our understanding of mechanisms underlying sex and race differences and potentially prove useful in the future treatment of disease.

Rapid Identification and Investigation of an HIV Risk Network Among People Who Inject Drugs -Miami, FL, 2018.

Prevention of HIV outbreaks among people who inject drugs remains a challenge to ending the HIV epidemic in the United States. The first legal syringe services program (SSP) in Florida implemented routine screening in 2018 leading to the identification of ten anonymous HIV seroconversions. The SSP collaborated with the Department of Health to conduct an epidemiologic investigation. All seven acute HIV seroconversions were linked to care (86% within 30 days) and achieved viral suppression (mean 70 days). Six of the seven individuals are epidemiologically and/or socially linked to at least two other seroconversions. Analysis of the HIV genotypes revealed that two individuals are connected molecularly at 0.5% genetic distance. We identified a risk network with complex transmission dynamics that could not be explained by epidemiological methods or molecular analyses alone. Providing wrap-around services through the SSP, including routine screening, intensive linkage and patient navigation, could be an effective model for achieving viral suppression for people who inject drugs.

Correction to: Low Life Course Socioeconomic Status (SES) Is Associated with Negative NEO PI-R Personality Patterns.

After the publication of the original article, the Editor was notified by Duke University that they have determined the authorship to be incomplete. Consequently, Dr Edward Suarez has been added as a co-author to represent his contribution to the conception and design of the work and acquisition of the data.

The Relation of Light-to-Moderate Alcohol Consumption to Glucose Metabolism and Insulin Resistance in Nondiabetic Adults: the Moderating Effects of Depressive Symptom Severity, Adiposity, and Sex.

PURPOSE: We examined the relation of alcohol consumption to glucose metabolism and insulin resistance (IR) as a function of depressive symptoms, adiposity, and sex. METHOD: Healthy adults (aged 18-65 years) provided fasting blood samples and information on lifestyle factors. Alcohol intake was categorized as never, infrequent (1-3 drinks/month), occasional (1-7 drinks/week), and regular (≥2 drinks/day) drinkers. The Beck Depression Inventory (BDI) was used to assess symptom severity. Primary outcomes were fasting insulin, glucose, and IR assessed by the homeostasis model assessment (HOMA). RESULTS: In univariate analysis, alcohol consumption was negatively associated with HOMA-IR (p = 0.03), insulin (p = 0.007), and body mass index (BMI) (p = 0.04), but not with glucose or BDI. Adjusting for potential confounders including BMI, alcohol consumption was associated with HOMA-IR (p = 0.01) and insulin (p = 0.009) as a function of BDI and sex. For women with minimal depressive symptoms, light-to-moderate alcohol consumption was associated with lower HOMA-IR and insulin. Alcohol consumption was not associated with metabolic markers in women with higher depressive symptoms and in men. In analysis using BMI as a continuous moderator, alcohol consumption was only associated with insulin (p = 0.004). Post-hoc comparisons between BMI groups (<25 vs ≥25 kg/m2) revealed that light-to-moderate alcohol consumption was associated with lower insulin but only in subjects with BMI ≥ 25 kg/m2. CONCLUSIONS: The benefits of light-to-moderate alcohol consumption on fasting insulin and IR are sex dimorphic and appear to be independently moderated by adiposity and depressive symptom severity.

Depressogenic vulnerability and gender-specific patterns of neuro-immune dysregulation: What the ratio of cortisol to C-reactive protein can tell us about loss of normal regulatory control.

We examined whether the ratio of cortisol (CORT) to high-sensitivity C-reactive protein (hsCRP), an index that captures the integrity of homeostatic regulation between the hypothalamic-pituitary-adrenal (HPA) axis and inflammatory processes, is associated with vulnerability to depression in a gender specific manner and whether glucocorticoid receptor (GR) sensitivity plays a role in these associations. Fasting blood samples were collected between 08:45 and 09:15 and assayed for CORT, hsCRP, and leukocyte count in 213 healthy, medication-free men and women. The NEO-Personality Inventory was used to assess neuroticism, extraversion and anxiety. We used the Hamilton Depression Interview to assess depressive symptoms, the Buss-Perry anger subscale to measure anger, and the Pittsburgh Sleep Quality Index to evaluate subjective sleep quality and its components. Log-transformed CORT/CRP values were analyzed using multiple regression with Holms' adjusted p-values and age, body mass index (BMI), and race as covariates. GR sensitivity was estimated using the log-transformed ratio of neutrophils (N)-to-monocytes (M). The log-transformed ratio of CORT/CRP did not differ between men and women but was significantly and negatively associated with age and BMI. Severity of depressive symptoms, extraversion, anxiety, and sleep quality were associated with the CORT/CRP ratio in a gender-specific manner. For women, decreasing CORT/CRP ratios, suggestive of an insufficient release of CORT coupled with a heightened inflammatory state, were associated with increasing severity of depressive symptoms, decreasing quality of sleep, increasing frequency of sleep disturbance, and decreasing extraversion. For men, increasing frequency of daytime disturbance and levels of anxiety were associated with increasing CORT/CRP ratio, suggestive of an enhanced release of CORT relative to attenuated levels of hsCRP. For both genders, increasing anger was associated with decreasing CORT/CRP ratios. Although results suggested GR downregulation in women but not men, such differences did not mediate the observed associations. With the use of the CORT/CRP ratio, we showed that vulnerability factors for depression are associated with a loss of normal regulatory controls resulting in gender-specific patterns of neuro-immune dysregulation. That GR downregulation did not influence these associations suggests that the loss of regulatory controls in at risk individuals is primarily at the level of the hormone. Beyond the individual contribution of each component of the CORT/CRP ratio, disruption of normal neuroimmune regulatory feedback provides a plausible biological framework useful in understanding biobehavioral vulnerabilities to depression in a gender specific manner. The CORT/CRP ratio may be a viable biomarker not only for delineating risk for MDD but also progression and treatment responses among patients with MDD; possibilities that are testable in future studies.

Limited acceptance of buprenorphine in recovery residences in South Florida: A secret shopper survey.

BACKGROUND: Buprenorphine is a first-line treatment for opioid use disorder (OUD), essential for reducing opioid overdose mortality and improving treatment retention. Despite federal policies that mandate the acceptance of buprenorphine in recovery residences, individuals in South Florida taking this medication often face significant barriers to admission. This study uses a secret shopper survey to examine whether federal policies regarding prescribed buprenorphine use are being violated in South Florida recovery residences. METHODS: We selected recovery residences in South Florida due to the region's high opioid overdose death rate and its prominence as a recovery hub. From a list of 141 Florida Association of Recovery Residences (FARR)-certified residences in Palm Beach, Broward, and Miami-Dade, we randomly surveyed 100 programs across all treatment levels (I-IV) using a standardized script. The primary outcome was whether residences accepted individuals taking buprenorphine, classified into three categories: (1) unconditional acceptance, where any person taking buprenorphine was accepted; (2) denial, where admission was refused for all individuals taking buprenorphine; and (3) conditional acceptance, where admission was granted under specific conditions. Secondary outcomes included requirements for conditional acceptance, such as dose limits or tapering policies. RESULTS: The distribution of the 100 surveyed recovery residences was comparable to the 141 FARR-certified facilities: 67 % were in Palm Beach, 31 % in Broward, and 2 % in Miami-Dade. Most residences (55 %) were level II certified, followed by 26 % level IV, 14 % level I, and 5 % level III. Sixteen percent of residences permitted admission of individuals taking any buprenorphine dose, 31 % had conditional policies, and 53 % prohibited buprenorphine. The maximum acceptance across all counties and levels was 20 %. No significant differences were observed by county (p = 0.61) or facility level (p = 0.29). Of 31 residences with conditional policies, 25.8 % (n = 8) required a mandatory taper, 38.7 % (n = 12) allowed a maximum 8 mg daily dosage, 12.9 % (n = 4) had a maximum 12 mg daily dosage, 6.5 % (n = 2) had a maximum 16 mg daily dosage, 6.5 % (n = 2) required a provider letter, and 9.7 % (n = 3) did not provide further information. CONCLUSIONS: Access to FARR-certified recovery residences is severely limited for individuals in South Florida taking buprenorphine. Urgent action is needed to improve access to evidence-based OUD treatments, address complexities influencing recovery residence policy and practice, and ensure appropriate allocation of public funds like State Opioid Response dollars.

Accessibility of methadone treatment via public transit for syringe services program participants in Miami-Dade County, Florida.

Methadone is an opioid receptor agonist medication used in the treatment of opioid use disorder (OUD). Geographic distance to opioid treatment programs (OTPs) is a major barrier to treatment, given requirements for direct observation of dosing and periodic drug screens, and 'methadone treatment deserts' are defined as a public transit threshold of 30 minutes. The purpose of this study was to examine public transit access to methadone treatment for participants of a syringe services program (SSP) in Miami-Dade County, Florida. Public transit times were calculated using the R library r5r, which facilitates multi-modal transportation network routing. General Transit Feed Specification data was combined with street network data from OpenStreetMap for Miami-Dade County. Transit times were estimated from the population-weighted centroid of each zip code (n=79) with participants of Miami's only SSP (n=1597) to the nearest OTP (n=4) using 10 departure windows aligned with OTP service hours. The mean one-way transit time from zip codes with SSP participants in Miami-Dade County to the nearest OTP was 80 minutes. 75 of the 79 (95%) zip codes with SSP participants in Miami-Dade County have a mean transit time to the closest OTP greater than 30 minutes. Transit times differ substantially between zip codes with different numbers of SSP participants, but not between departure windows. Nearly all zip codes with SSP participants in Miami-Dade County can be classified as 'methadone treatment deserts'. Geographic isolation of methadone treatment from public transit routes represents a significant barrier to equitable OUD treatment.

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.

Depression inhibits the anti-inflammatory effects of leisure time physical activity and light to moderate alcohol consumption.

Light to moderate alcohol consumption and leisure time physical activity (LTPA) are independently associated with lower levels of high sensitivity C-reactive protein (CRP), a predictor of cardiometabolic risk. In contrast, depression, ranging from low mood disturbance to major depressive disorder, has been associated with elevated CRP. To test the hypothesis that depression attenuates the anti-inflammatory effects of LTPA and alcohol consumption, the current study tested the moderating effect of severity of depressive symptomatology on the relation of alcohol consumption and LTPA to CRP in 222 healthy adult men and women (18-65 years of age). Given the known effects of gender on inflammation, we also examined the effects of gender on the tested interactions. Depression was assessed using the Beck Depression Inventory. Frequency of alcohol consumption, hours of LTPA per week and other coronary risk/protective factors were assessed via self-report and structured interview. Fasting blood samples were used to measure CRP and lipids. As predicted, the interaction between LTPA and depressive symptomatology was significant (F=5.29, p<.03) such that lower CRP was associated with the combination of decreased depressive symptomatology and increased LTPA. Among those with increased depressive symptoms, increased LTPA was not associated with higher CRP. Similarly, depression interacted with alcohol consumption in predicting CRP in men but not women (F=5.03, p<.008) such that for men light to moderate alcohol consumption was associated with lower CRP but only among those with decreased depressive symptoms. Light to moderate alcohol consumption was not associated with lower CRP in those with increased depressive symptom severity. The pattern of the interactions between anti-inflammatory activities such as light to moderate alcohol consumption and LTPA and psychological distress as indexed by severity of depressive symptomatology suggests an important new avenue for future research.

Adaptation of the Tele-Harm Reduction intervention to promote initiation and retention in buprenorphine treatment among people who inject drugs: a retrospective cohort study.

Background: At the start of the pandemic, relaxation of buprenorphine prescribing regulations created an opportunity to create new models of medications for opioid use disorder (MOUD) delivery and care. To expand and improve access to MOUD, we adapted and implemented the Tele-Harm Reduction (THR) intervention; a multicomponent, telehealth-based and peer-driven intervention to promote HIV viral suppression among people who inject drugs (PWID) accessing a syringe services program (SSP). This study examined buprenorphine initiation and retention among PWID with opioid use disorder who received the adapted THR intervention at the IDEA Miami SSP.Methods: A retrospective chart review of participants who received the THR intervention for MOUD was performed to examine the impact of telehealth on buprenorphine retention. Our primary outcome was three-month retention, defined as three consecutive months of buprenorphine dispensed from the pharmacy.Results: A total of 109 participants received the adapted THR intervention. Three-month retention rate on buprenorphine was 58.7%. Seeing a provider via telehealth at baseline or any follow up visit (aOR = 7.53, 95% CI: [2.36, 23.98]) and participants who had received an escalating dose of buprenorphine after baseline visit (aOR = 8.09, 95% CI: [1.83, 35.87]) had a higher adjusted odds of retention at three months. Participants who self-reported or tested positive for a stimulant (methamphetamine, amphetamine, or cocaine) at baseline had a lower adjusted odds of retention on buprenorphine at three months (aOR = 0.29, 95% CI: [0.09, 0.93]).Conclusions: Harm reduction settings can adapt dynamically to the needs of PWID in provision of critical lifesaving buprenorphine in a truly destigmatising approach. Our pilot suggests that an SSP may be an acceptable and feasible venue for delivery of THR to increase uptake of buprenorphine by PWID and promote retention in care.KEY MESSAGESThe Tele-Harm Reduction intervention can be adapted for initiating and retaining people who inject drugs with opioid use disorder on buprenorphine within a syringe services program settingUsing telehealth was associated with increased three-month buprenorphine retentionBaseline stimulant use was negatively associated with three-month buprenorphine retention.

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.

Implementation of an integrated infectious disease and substance use disorder team for injection drug use-associated infections: a qualitative study.

BACKGROUND: Hospitalizations for severe injection drug use-related infections (SIRIs) are characterized by high costs, frequent patient-directed discharge, and high readmission rates. Beyond the health system impacts, these admissions can be traumatizing to people who inject drugs (PWID), who often receive inadequate treatment for their substance use disorders (SUD). The Jackson SIRI team was developed as an integrated infectious disease/SUD treatment intervention for patients hospitalized at a public safety-net hospital in Miami, Florida in 2020. We conducted a qualitative study to identify patient- and clinician-level perceived implementation barriers and facilitators to the SIRI team intervention. METHODS: Participants were patients with history of SIRIs (n = 7) and healthcare clinicians (n = 8) at one implementing hospital (Jackson Memorial Hospital). Semi-structured qualitative interviews were performed with a guide created using the Consolidated Framework for Implementation Research (CFIR). Interviews were transcribed, double coded, and categorized by study team members using CFIR constructs. RESULTS: Implementation barriers to the SIRI team intervention identified by participants included: (1) complexity of the SIRI team intervention; (2) lack of resources for PWID experiencing homelessness, financial insecurity, and uninsured status; (3) clinician-level stigma and lack of knowledge around addiction and medications for opioid use disorder (OUD); and (4) concerns about underinvestment in the intervention. Implementation facilitators of the intervention included: (1) a non-judgmental, harm reduction-oriented approach; (2) the team's advocacy for PWID as a means of institutional culture change; (3) provision of close post-hospital follow-up that is often inaccessible for PWID; (4) strong communication with patients and their hospital physicians; and (5) addressing diverse needs such as housing, insurance, and psychological wellbeing. CONCLUSION: Integration of infectious disease and SUD treatment is a promising approach to managing patients with SIRIs. Implementation success depends on institutional buy-in, holistic care beyond the medical domain, and an ethos rooted in harm reduction across multilevel (inner and outer) implementation contexts.

Prevalence of xylazine among people who inject drugs seeking medical care at a syringe services program clinic: Miami, Florida, 2023.

Background: We aimed to report the preliminary xylazine prevalence among people who inject drugs (PWID) treated at a student-run free clinic in Miami, FL, USA and to identify characteristics associated with screening positive for xylazine. Methods: A retrospective chart review of 59 patients presenting to a syringe services program (SSP) clinic in was conducted between April 27th and August 17th, 2023. We measured presence of xylazine with rapid visual immunoassay strips on patient urine samples. Results: Xylazine was present in 55.9 % (33/59) of urine samples including 2 without detected opioids. Xylazine presence was significantly associated with unsheltered homelessness (p = 0.018), presence of wound(s) (p = 0.008), and testing positive for hepatitis C antibody (p = 0.014), fentanyl (p = 0.005) and MDMA (p = 0.002). Conclusions: A high prevalence of xylazine in the Southeastern United States furthers evidence of the geographical spread of xylazine and rapidly evolving illicit drug supply. Widespread xylazine screening is urgently needed to inform people who inject drugs and to studyinterventions to minimize harms associated with xylazine.

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.

Recruitment into a Clinical Trial of People Living with Uncontrolled HIV Infection Who Inject Drugs: a Site Case Report from the CTN 67 CHOICES Study.

CHOICES was an open-label, randomized, comparative effectiveness trial of office-based extended-release naltrexone versus treatment as usual in people with untreated opioid use disorder and HIV. This study explored facilitators to recruitment in Miami, a successful recruiting site in the national trial. The mixed-methods study included quantitative surveys of randomized participants, medical record abstraction, and qualitative interviews with study staff. Miami recruited 47 (40.5%) of 116 randomized participants in the six-site national trial. In-depth interviews of study staff (n = 6) revealed that Miami had a recruitment approach consisting of street level outreach and a close relationship with the local syringe services program (SSP). Partnership with a local SSP provided access to people living with HIV who inject drugs in Miami. SSPs' fundamental trust within the community of people who inject drugs can be leveraged in studies aiming to improve health outcomes in this underserved and high-priority population.