Background: In the United States, transgender women (TW) are disproportionately burdened by HIV infection. Cohort studies are needed to evaluate factors driving HIV acquisition among TW over time. These will require implementation strategies that are acceptable to the TW community and feasible to implement. Objective: This study aims to investigate the rate and correlates of HIV acquisition and other health outcomes among TW in eastern and southern United States. Methods: LITE is a multisite prospective cohort in 6 eastern and southern US cities, which will be followed across 24 months of technology-enhanced biobehavioral follow-up. Adult TW, regardless of HIV status, are recruited via convenience sampling (eg, peer referrals, social media, and dating apps). Participants are enrolled in a baseline study visit, complete a sociobehavioral survey, and test for HIV and sexually transmitted infections. Participants who are not living with HIV at baseline are offered enrollment into the cohort (N=1100); follow-up assessments occur quarterly. Results: Cohort assembly was informed by synchronous Web-based focus group discussions with TW (n=41) and by continuing engagement with community advisory board members from each site. Enrollment launched in March 2018. The study is underway in the Atlanta; Baltimore; Boston; Miami; New York City; and Washington, DC, metro areas. As of March 2019, 795 TW completed a baseline visit (mean age 35 years). The majority of the participants are racial/ethnic minorities, with 45% of the TW identifying as black and 28% of the TW identifying as Hispanic/Latinx. More than one-quarter (28%) of the TW are living with HIV infection (laboratory-confirmed). Online recruitment methods support engagement with TW, although peer referral and referral through trusted health facilities and organizations remain most effective. Conclusions: This study is responsive to increasing research interest in technology-enhanced methods for cohort research, particularly for hard-to-reach populations. Importantly, the diversity of literacy, technology use, and overall socioeconomic situations in this sample of TW highlights the need to leverage technology to permit a flexible, adaptive methodology that enhances engagement of potential participants living in marginalized contexts while still ensuring rigorous and sound study design. International Registered Report Identifier (IRRID): DERR1-10.2196/14704

Barriers to retention in HIV care are detrimental to patients' progress along the HIV continuum of care. Previous literature has focused on individual, client-level barriers, and interventions to address them. In contrast, less work has examined the role of system-level barriers on HIV care outcomes. This study seeks to understand how individual and systemic barriers individually are associated with clinic appointment attendance and virologic suppression in HIV-infected patients attending the largest HIV clinic in Miami-Dade, FL. In addition, we examined the synergistic effects of these barriers as potential syndemic factors on these health outcomes. Barriers to clinic attendance were determined in a face-to-face study interview with 444 HIV-infected outpatients (187 regular attenders, 191 irregular attenders, and 66 nonattenders) identified from electronic medical records. Compared with the other attendance groups, nonattenders had higher viral loads, were less likely to be virologically suppressed, had lower CD4 counts, had higher depressive symptoms, life chaos, lower quality of life, and higher rates of food insecurity, and recent drug use. Additionally, nonattenders compared with regular attenders had lower physician relationship ratings, had lower medical information clarity and more often reported transportation as a barrier to clinic attendance. When viewed as a syndemic, compared with patients not reporting any barriers, patients with 3 or more individual-level barriers were more likely to have a detectable viral load (odds ratio = 3.60, 95% CI: 1.71 to 7.61). Our findings suggest that patients presenting to the clinic with multiple barriers should be prioritized for assistance and future interventions to improve retention in care. Interventions should address multiple individual and system-level barriers simultaneously with particular attention to addressing depressive symptoms, organizational skills, relationship with the physician, and HIV-related health education.

Background: The 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. Objective: This 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. Methods: This 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. Results: Enrollment 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. Conclusions: This 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

Cardiovascular (CV) responses to mental stress are prospectively associated with poor CV outcomes. The association between CV responses to mental stress and reaction times (RTs) in aging individuals may be important but warrants further investigation. The present study assessed RTs to examine associations with CV responses to mental stress in healthy, older individuals using robust regression techniques. Participants were 262 men and women (mean age = 63.3 ± 5.5 years) from the Whitehall II cohort who completed a RT task (Stroop) and underwent acute mental stress (mirror tracing) to elicit CV responses. Blood pressure, heart rate, and heart rate variability were measured at baseline, during acute stress, and through a 75‐min recovery. RT measures were generated from an ex‐Gaussian distribution that yielded three predictors: mu‐RT, sigma‐RT, and tau‐RT, the mean, standard deviation, and mean of the exponential component of the normal distribution, respectively. Decreased intraindividual RT variability was marginally associated with greater systolic (B = −.009, SE = .005, p = .09) and diastolic (B = −.004, SE = .002, p = .08) blood pressure reactivity. Decreased intraindividual RT variability was associated with impaired systolic blood pressure recovery (B = −.007, SE = .003, p = .03) and impaired vagal tone (B = −.0047, SE = .0024, p = .045). Study findings offer tentative support for an association between RTs and CV responses. Despite small effect sizes and associations not consistent across predictors, these data may point to a link between intrinsic neuronal plasticity and CV responses.

Pre-exposure prophylaxis (PrEP) use among transgender women in the U.S. has not reached levels optimal to change the trajectory of the HIV epidemic owing to multilevel barriers. Long-acting injectable PrEP received Food and Drug Administration approval in 2021 and may potentially address some of the barriers experienced in initiating and adhering to daily oral PrEP (e.g., pill fatigue, medication storage). However, preferences for long-acting injectable PrEP compared with daily oral PrEP have not been well studied among transgender women. The authors analyzed data collected from transgender women not living with HIV in eastern and southern U.S. in 2020–2022. Using multivariable Poisson regression with robust standard errors, the authors estimated prevalence ratios and 95% CIs for factors associated with preference for long-acting injectable PrEP. The study sample (N=789) was racially and ethnically diverse, with 42.6% identifying as Black, Latina, and/or multiracial and 12% using daily oral PrEP. Fifty-eight percent preferred long-acting injectable PrEP to daily oral PrEP. In multivariable regression analyses, preference for long-acting injectable PrEP was associated with residence in Midwest (reference group=Northeast, adjusted prevalence ratio=1.33; 95% CI=1.10, 1.60), current PrEP indications (adjusted prevalence ratio=1.14; 95% CI=1.01, 1.30), and history of gender-affirming hormone injection (adjusted prevalence ratio=1.36; 95% CI=1.18, 1.57). Transgender women may prefer long-acting injectable PrEP to daily oral PrEP, especially those with current PrEP indications and experience with gender-affirming hormone injections. Increasing availability and access to long-acting injectable PrEP may improve PrEP uptake in transgender women, particularly in combination with other interventions to reduce multilevel PrEP barriers.

This study characterized arrest, incarceration, and risk factors for incident incarceration among transgender women (TW) in the northeastern and southern United States. During semiannual study visits over 24 months in a multicenter cohort study, TW completed HIV testing and self-administered surveys. In total, 1571 TW completed baseline survey; 1,312 HIV-negative TW enrolled in the cohort and contributed 2134.3 person-years to the analysis. At baseline, 37% had been arrested and 21% had been incarcerated. Incident incarceration was 23.4 per 1,000 person-years (95% confidence interval [CI]: 16.9–29.9). Sex work was significantly associated with baseline and incident incarceration ( p < .01). A history of incarceration at enrollment was the strongest predictor of incident incarceration (adjusted odds ratio [aOR] 6.99; 95% CI: 3.43–14.24). Living in the South (aOR 2.69, 95% CI: 1.22–5.93), income below the federal poverty level (aOR 2.65 95% CI: 3.43–14.24), and having a recent partner who had been incarcerated (aOR 2.62, 95% CI: 1.20–5.69) also increased the odds of incident incarceration in multivariable modeling. Structural interventions to reduce poverty and decriminalize sex work have the potential to reduce incarceration rates among TW.