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: Introduction: Transgender women in the United States experience high HIV incidence and suboptimal Pre‐exposure prophylaxis (PrEP) engagement. We sought to estimate PrEP initiation and discontinuation rates and characterize PrEP discontinuation experiences among a prospective cohort of transgender women. Methods: Using a sequential, explanatory, mixed‐methods design, 1312 transgender women at risk for HIV acquisition were enrolled from March 2018 to August 2020 and followed through July 2022 (median follow‐up 24 months; interquartile range 15–36). Cox regression models assessed predictors of initiation and discontinuation. In‐depth interviews were conducted among 18 participants, including life history calendars to explore key events and experiences surrounding discontinuations. Qualitative and quantitative data were integrated to generate typologies of discontinuation, inform meta‐inferences and facilitate the interpretation of findings. Results: 21.8% (n = 286) of participants reported taking PrEP at one or more study visits while under observation. We observed 139 PrEP initiations over 2127 person‐years (6.5 initiations/100 person‐years, 95% CI: 5.5–7.7). Predictors of initiation included identifying as Black and PrEP indication. The rate of initiation among those who were PrEP‐indicated was 9.6 initiations/100 person‐years (132/1372 person‐years; 95% CI: 8.1–11.4). We observed 138 PrEP discontinuations over 368 person‐years (37.5 discontinuations/100 person‐years, 95% CI: 31.7–44.3). Predictors of discontinuation included high school education or less and initiating PrEP for the first time while under observation. Four discontinuation typologies emerged: (1) seroconversion following discontinuation; (2) ongoing HIV acquisition risk following discontinuation; (3) reassessment of HIV/STI prevention strategy following discontinuation; and (4) dynamic PrEP use coinciding with changes in HIV acquisition risk. Conclusions: PrEP initiation rates were low and discontinuation rates were high. Complex motivations to stop using PrEP did not consistently correspond with HIV acquisition risk reduction. Evidence‐based interventions to increase PrEP persistence among transgender women with ongoing acquisition risk and provide HIV prevention support for those who discontinue PrEP are necessary to reduce HIV incidence in this population., INTRODUCTION Transgender women experience a high and disproportionate burden of HIV [1, 2]. Many socio‐structural drivers of high HIV incidence among transgender women are also barriers to engagement in the [...]

Individuals living with HIV report disproportionately high levels of trauma exposure and PTSD symptoms, both which have been associated with suboptimal ART adherence. Often conflated, the question arises as to which construct is driving subsequent HIV self-care behavior. Given the HIV disparities among Black and Hispanic/Latinx individuals, and that Miami is a geographic region with a high racial/ethnic minority make up and a unique socioeconomic environment, it is important to explore factors related to HIV outcomes in Miami to mitigate its uncontrolled epidemic. This study aimed to examine the association of trauma exposure, PTSD symptoms, and relevant additional key factors with adherence to ART among a sample of majority Black and Hispanic/Latinx individuals who are economically marginalized receiving public HIV care in Miami, FL (N = 1237) via a cross-sectional survey. Sequential linear regression was used to examine the study aim in four blocks: (1) trauma, (2) PTSD symptoms, and key covariates of ART adherence including (3) depression and substance use (potential psychological covariates), and (4) indicators of socioeconomic status (potential structural covariates). In the first block, trauma exposure was associated with worse adherence. However, in the second block, the association with trauma dropped and PTSD was significantly associated with worse adherence. Of note, for those experiencing high levels of trauma exposure, adherence was negatively impacted regardless of PTSD. When other key factors associated with adherence were entered in the third and fourth blocks, neither trauma exposure nor PTSD were uniquely significant. In this final model, depression, substance use, and unstable housing were uniquely associated with worse adherence. Trauma-informed models of HIV care that holistically address co-occurring factors are warranted to cater to communities with HIV health disparities and keep them from falling off the HIV care continuum., Author(s): Tiffany R. Glynn [sup.1] , Noelle A. Mendez [sup.1] , Deborah L. Jones [sup.3] , Sannisha K. Dale [sup.1] , Adam W. Carrico [sup.2] , Daniel J. Feaster [sup.2] [...]

Despite the prevalence of HIV among transgender women (TGW), gaps exist in understanding the impact of HIV-related stigma (HRS) on TGW with HIV. This is a small cross-sectional pilot study examining HRS in TGW (n=18) with HIV in Miami, FL, who completed a survey during an HIV clinical visit. In contrast with previous studies, results demonstrated low levels of HRS and suggest the potential of increasing acceptance of TGW with HIV as a contributing factor. Larger studies are needed to explore factors underlying HRS with the aim of further reducing stigma among TGW with HIV. [ABSTRACT FROM AUTHOR]

ImportanceSubstance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates.ObjectiveTo assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients.Design, setting, and participantsFrom July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months.InterventionsPatient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment.Main outcomes and measuresThe primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up.ResultsOf 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68).Conclusions and relevanceAmong hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting.Trial registrationclinicaltrials.gov Identifier: NCT01612169.

BackgroundThe HIV epidemic disproportionately impacts transgender women in the United States. Cohort studies identify unique risks for affected populations, but use of facility-based methods may bias findings towards individuals living in research catchment areas, more engaged in health services, or, in the case of transgender populations, those who are open about their transgender identity. Digital clinical trials and other online research methods are increasingly common, providing opportunity to reach those not commonly engaged in research. Simultaneously, there is a need to understand potential biases associated with digital research, how these methods perform, and whether they are accepted across populations. ObjectiveThis study aims to assess the feasibility of developing and implementing an online cohort of transgender women to assess risks for HIV acquisition and other health experiences. Further, this study aims to evaluate how an online cohort compares to a site-based, technology-enhanced cohort for epidemiologic research. The overarching goal is to estimate incidence of HIV and other health outcomes among transgender women in eastern and southern United States. MethodsThis substudy is part of a larger multisite prospective cohort (LITE) conducted among transgender women, which also includes a site-based, technology-enhanced cohort in 6 eastern and southern US cities. The online cohort was launched to enroll and follow participants across 72 cities in the same region and with similar demographic characteristics as the site-based cohort. Participants are followed for 24 months. Adult transgender women are recruited via convenience sampling (eg, peer referrals, social media, and dating apps). Participants reporting negative or unknown HIV status are enrolled in a baseline study visit, complete a sociobehavioral survey, and provide oral fluid specimens to test for HIV. Participants not living with HIV (lab-confirmed) at baseline are offered enrollment into the cohort; follow-up assessments occur every 6 months. ResultsEnrollment into the online cohort launched in January 2019. Active recruitment stopped in May 2019, and enrollment officially closed in August 2020. A total of 580 participants enrolled into and are followed in the cohort. A recruitment-enrollment cascade was observed across screening, consent, and completion of study activities. Implementation experiences with HIV test kits highlight the need for heavy staff engagement to support participant engagement, visit completion, and retention, even with automated digital procedures. ConclusionsThis study is responsive to increasing research interest in digital observational and intervention research, particularly for populations who are most affected by the HIV epidemic and for those who may otherwise not participate in person. The progression across stages of the recruitment-enrollment cascade provides useful insight for implementation of cohort studies in the online environment. International Registered Report Identifier (IRRID)DERR1-10.2196/29152

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The comparison of the HIV care needs and hospital admission patterns of HIV-positive Haitian-born African American and U.S.-born African American is presented. It is suggested that barriers to medical care might exist for Haitians at an early stage of the access continuum and that prevention effort among the Haitian HIV-positive population should be directed at promoting the need for timely use of health services.