Site-based and Digital Cohort Participation Among Transgender Women in the Eastern and Southern USA: Findings from the LITE Study.

BACKGROUND: Transgender women (TW) are highly burdened by HIV. There is increasing interest in digital (i.e., through internet-based interfaces) HIV research; yet few studies have assessed potential biases of digital compared to site-based data collection. This study examined differences in characteristics between TW participating via site-based versus digital-only modes in an HIV incidence cohort. METHODS: Between March 2018-Aug 2020, a multisite cohort of 1,312 adult TW in the eastern and southern USA was enrolled in site-based and exclusively digital modes. We evaluated differences in baseline demographics, socio-structural vulnerabilities, healthcare access, gender affirmation, mental health, stigma, social support, and HIV acquisition risk comparing site-based vs digital modes using chi square tests and Poisson regression modeling with robust standard errors. RESULTS: The overall median age was 28 (interquartile range=23-35) years and over half identified as people of color (15% Black, 13% Multiracial, 12% Another Race, 18% Latina/e/x). A higher proportion of site-based (vs. digital mode) participants resided in the Northeast, were younger, identified as people of color, experienced socio-structural vulnerabilities, had a regular healthcare provider, received medical gender affirmation, endorsed mental health symptoms and stigma, reported HIV acquisition risk but also greater experience with biomedical HIV prevention (pre-exposure and post-exposure prophylaxis), and had larger social networks (all p<0.05). CONCLUSION: Site-based and digital approaches enrolled TW with different demographics, life experiences, and HIV acquisition risks. A hybrid cohort model may achieve a more diverse and potentially representative sample of TW than either site-based or online cohorts alone for HIV research.

A Microfinance Intervention With or Without Peer Support to Improve Mental Health Among Transgender and Nonbinary Adults (the Creating Access to Resources and Economic Support Study): Protocol for a Randomized Controlled Trial.

BACKGROUND: Transgender and nonbinary (TNB) people experience economic and psychosocial inequities that make them more likely to be subject to financial and mental health harms exacerbated by the COVID-19 pandemic. Sustainable, multilevel interventions are needed to address these harms. The onset of the COVID-19 pandemic galvanized many TNB-led organizations to provide emergency financial and peer support for TNB people negatively impacted by the pandemic. However, the efficacy of these interventions has not been evaluated. The Creating Access to Resources and Economic Support (CARES) study seeks to assess the efficacy of feasible, acceptable, and community-derived interventions to reduce economic and psychological harms experienced by transgender people in the wake of the COVID-19 pandemic. OBJECTIVE: The study aims to (1) compare the efficacy of microgrants with peer mentoring with that of microgrants without peer mentoring in reducing psychological distress, (2) examine mechanisms by which microgrants with or without peer mentoring may impact psychological distress, and (3) explore participants' intervention experiences and perceived efficacy. METHODS: We will enroll 360 TNB adults into an embedded, mixed methods, 3-arm, and 12-month randomized controlled trial. Participants will be randomized 1:1:1 to arm A (enhanced usual care), which will receive a single microgrant plus monthly financial literacy education, arm B (extended microgrants), which will receive enhanced usual care plus monthly microgrants, or arm C (peer mentoring), which will receive extended microgrants combined with peer mentoring. All intervention arms last for 6 months, and participants complete semiannual, web-based surveys at 0, 6, and 12 months as well as brief process measures at 3 and 6 months. A subset of 36 participants, 12 (33%) per arm, will complete longitudinal in-depth interviews at 3 and 9 months. RESULTS: Full recruitment began on January 8, 2024, and, as of July 26, 2024, a total of 138 participants have enrolled. Recruitment is expected to be completed no later than March 31, 2025, and the final study visit will take place in March 2026. CONCLUSIONS: This national, web-based study will demonstrate whether an intervention tailored to reduce material hardship and improve peer support among TNB adults will reduce psychological distress. Its equitable, community-academic partnership will ensure the rapid dissemination of study findings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05971160; https://clinicaltrials.gov/study/NCT05971160. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63656.

Enhanced Cohort Methods for HIV Research and Epidemiology (ENCORE): Protocol for a Nationwide Hybrid Cohort for Transgender Women in the United States.

BACKGROUND: In the United States, transgender women are disproportionately impacted by HIV and prioritized in the national strategy to end the epidemic. Individual, interpersonal, and structural vulnerabilities underlie HIV acquisition among transgender women and fuel syndemic conditions, yet no nationwide cohort monitors their HIV and other health outcomes. OBJECTIVE: Our objective is to develop a nationwide cohort to estimate HIV incidence, identify risk factors, and investigate syndemic conditions co-occurring with HIV vulnerability or acquisition among US transgender women. The study is informed by the Syndemics Framework and the Social Ecological Model, positing that stigma-related conditions are synergistically driven by shared multilevel vulnerabilities. METHODS: To address logistical and cost challenges while minimizing technology barriers and research distrust, we aim to establish a novel, hybrid community hub-supported digital cohort (N=3000). The digital cohort is the backbone of the study and is enhanced by hubs strategically located across the United States for increased engagement and in-person support. Study participants are English or Spanish speakers, are aged ≥18 years, identify as transgender women or along the transfeminine spectrum, reside in 1 of the 50 states or Puerto Rico, and do not have HIV (laboratory confirmed). Participants are followed for 24 months, with semiannual assessments. These include a questionnaire and laboratory-based HIV testing using self-collected specimens. Using residential zip codes, person-level data will be merged with contextual geolocated data, including population health measures and economic, housing, and other social and structural factors. Analyses will (1) evaluate the contribution of hub support to the digital cohort using descriptive statistics; (2) estimate and characterize syndemic patterns among transgender women using latent class analysis; (3) examine the role of contextual factors in driving syndemics and HIV prevention over time using multilevel regression models; (4) estimate HIV incidence in transgender women and examine the effect of syndemics and contextual factors on HIV incidence using Poisson regression models; and (5) develop dynamic, compartmental models of multilevel combination HIV prevention interventions among transgender women to simulate their impact on HIV incidence through 2030. RESULTS: Enrollment launched on March 15, 2023, with data collection phases occurring in spring and fall. As of February 24, 2024, a total of 3084 individuals were screened, and 996 (32.3%) met the inclusion criteria and enrolled into the cohort: 2.3% (23/996) enrolled at a hub, and 53.6% (534/996) enrolled through a community hub-supported strategy. Recruitment through purely digital methods contributed 61.5% (1895/3084) of those screened and 42.7% (425/996) of those enrolled in the cohort. CONCLUSIONS: Study findings will inform the development of evidence-based interventions to reduce HIV acquisition and syndemic conditions among US transgender women and advance efforts to end the US HIV epidemic. Methodological findings will also have critical implications for the design of future innovative approaches to HIV research. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59846.

Perceived Feasibility and Acceptability of HIV Prevention Research With Daily Oral PrEP Among Young Transgender Women (YTGW) Who Sell or Trade Sex in Bangkok and Pattaya, Thailand.

Young transgender women (YTGW) who sell or trade sex have among the highest HIV incidence rates in Thailand. Using qualitative methods, we assessed perceived acceptability, feasibility, and optimal design of a combination HIV prevention intervention including PrEP for YTGW. Key informant interviews were conducted during July 2016-July 2018 with 21 YTGW, aged 18-26 years, who sold sex and resided in Bangkok or Pattaya, Thailand. Grounded theory and content analysis were used for data analysis. Most YTGW interviewed reported high interest in HIV prevention research and believed participation in it supported sexual health. However, participants perceived HIV studies as complicated and time-consuming. Regarding PrEP, participants suggested more PrEP options beyond daily oral PrEP and expressed concerns related to perceived side effects of PrEP, including interaction with gender-affirming hormone therapy. Improving PrEP knowledge, being able to self-assess HIV risk, and reducing HIV/PrEP stigma could increase interest in research and PrEP uptake among YTGW.

Persistent Food Insecurity and Material Hardships: A Latent Class Analysis of Experiences among Venezuelan Refugees and Migrants in Urban Colombia.

The causes and conditions of displacement often increase the vulnerability of migrant and refugee populations to food insecurity, alongside other material hardships. We aimed to examine the multidimensional aspects and patterns of food insecurity and other material hardships in a cross-sectional sample of 6221 Venezuelan refugees and migrants in urban Colombia using a latent class analysis. Using multinomial and logistic regression models, we investigated the demographic and migratory experiences associated with identified classes and how class membership is associated with multiple health outcomes among Venezuelan refugees and migrants, respectively. Approximately two thirds of the sample was comprised cisgender women, and the participants had a median age of 32 years (IQR: 26-41). Four heterogeneous classes of food insecurity and material hardships emerged: Class 1-low food insecurity and material hardship; Class 2-high food insecurity and material hardship; Class 3-high income hardship with insufficient food intake; and Class 4-income hardship with food affordability challenges. Class 2 reflected the most severe food insecurity and material hardships and had the highest class membership; Venezuelans with an irregular migration status were almost 1.5 times more likely to belong to this class. Food insecurity and material hardship class membership was independently associated with self-rated health, mental health symptoms, and recent violence victimization and marginally associated with infectious disease outcomes (laboratory-confirmed HIV and/or syphilis infection). Social safety nets, social protection, and other interventions that reduce and prevent material hardships and food insecurity among refugees and migrants, alongside the host community, may improve public health, support development, and reduce healthcare costs. In the long term, regularization and social policies for migrants aimed at enhancing refugees' and migrants' social and economic inclusion may contribute to improving food security in this population.

Food Insecurity Is High in a Multi-Site Cohort of Transgender Women Vulnerable to or Living with HIV in the Eastern and Southern United States: Baseline Findings from the LITE Cohort.

The prevalence and correlates of food insecurity-the unavailability of food and limited access to it-have not been adequately considered among transgender women (TW), particularly alongside other health-related conditions burdening this population, such as HIV infection. This study examined the prevalence and correlates of food insecurity among TW. Between 2018 and 2020, 1590 TW in the Eastern and Southern U.S. completed a multi-site baseline assessment (socio-behavioral survey and HIV testing). Descriptive statistics were calculated and multivariable Poisson models with robust error variance were used to estimate prevalence ratios and 95% confidence intervals for correlates of food insecurity (dichotomized as sometimes-to-always vs. seldom-to-never running out of food). Eighteen percent of TW were living with HIV and nearly half of participants (44%) reported food insecurity. Correlates of food insecurity included being Black, multiracial, or another race/ethnicity; having < college education, low income, unstable housing, and high anticipated discrimination; and a history of sex work and sexual violence (all p < 0.05). Food insecurity was highly prevalent among TW. Current programs to provide food support do not adequately meet the needs of TW. HIV pr evention and care programs may benefit from addressing food insecurity.

Racial/ethnic differences in the association between transgender-related U.S. state policies and self-rated health of transgender women.

BACKGROUND: Policy protections for transgender adults in the United States are consistently associated with positive health outcomes. However, studies over-represent non-Latinx White transgender people and obscure variation in policies' intended goals. This study examined racial differences in the relationship between transgender-related policies and transgender women's self-rated health. Guided by Critical Race Theory, we hypothesized that policies conferring access to resources (e.g., healthcare) would be associated with better self-rated health among all participants while policies signifying equality (e.g., nondiscrimination laws) would be associated with better self-rated health only for White participants. METHODS: Using cross-sectional data collected between March 2018-December 2020 from 1566 transgender women, we analyzed 7 state-level 'access policies,' 5 'equality policies,' and sum indices of each. Participants represented 29 states, and 54.7% were categorized as people of color. We fit a series of multilevel ordinal regression models predicting self-rated health by each policy. Multivariate models were adjusted for relevant covariates at the individual- and state-level. We then tested moderation by race/ethnicity using interaction terms and generated stratified predicted probability plots. RESULTS: In bivariate models, 4 access policies, 2 equality policies, and both indices were associated with better self-rated health, but associations did not persist in adjusted models. Results from the multivariable models including interaction terms indicated that policies concerning private insurance coverage of gender-affirming care, private insurance nondiscrimination, credit nondiscrimination, and both indices were statistically significantly associated with better self-rated health for White participants and worse self-rated health for participants of color. CONCLUSIONS: The policies included in this analysis do not mitigate racism's effects on access to resources, indicating they may be less impactful for transgender women of color than White transgender women. Future research and policy advocacy efforts promoting transgender women's health must center racial equity as well as transgender people of color's priorities.

The impact of policy and policy communication on COVID-19 vaccination inequalities among Venezuelan refugees and migrants in Colombia: a comparative cross-sectional interrupted time-series analysis.

INTRODUCTION: Equitable access to vaccines for migrants and refugees is necessary to ensure their right to health and to achieve public health goals of reducing vaccine-preventable illness. Public health policies require regulatory frameworks and communication to effect uptake of effective vaccines among the target population. In Colombia, the National COVID-19 Vaccination Plan implicitly included Venezuelan refugees and migrants; however, initial communication of the policy indicated that vaccine availability was restricted to people with regular migration status. We estimated the impact of a public announcement, which clarified access for refugees and migrants, on vaccination coverage among Venezuelans living in Colombia. METHODS: Between 30 July 2021 and 5 February 2022, 6221 adult Venezuelans participated in a cross-sectional, population-based health survey. We used a comparative cross-sectional time-series analysis to estimate the effect of the October 2021 announcement on the average biweekly change in COVID-19 vaccine coverage of Venezuelans with regular and irregular migration status. RESULTS: 71% of Venezuelans had an irregular status. The baseline (preannouncement) vaccine coverage was lower among people with an irregular status but increased at similar rates as those with a regular status. After the announcement, there was a level change of 14.49% (95% CI: 1.57 to 27.42, p=0.03) in vaccination rates among individuals with irregular migration status with a 4.61% increase in vaccination rate per biweekly period (95% CI: 1.71 to 7.51, p=0.004). By February 2022, there was a 26.2% relative increase in vaccinations among individuals with irregular migration status compared with what was expected without the announcement. CONCLUSION: While there was no policy change, communication clarifying the policy drastically reduced vaccination inequalities across migration status. Lessons can be translated from the COVID-19 pandemic into more effective global, regional and local public health emergency preparedness and response to displacement.

Syphilis prevalence and correlates of infection among Venezuelan refugees and migrants in Colombia: findings of a cross-sectional biobehavioral survey.

Background: Population-based estimates of syphilis prevalence are critical to informing public health response. We aimed to measure syphilis prevalence among Venezuelan refugees and migrants in Colombia to inform public health programming. Methods: Between July 2021 and February 2022, we surveyed 6221 adult Venezuelan refugees and migrants in four cities in Colombia using respondent-driven sampling (RDS). Participants completed a survey and dual-rapid HIV/treponemal syphilis screening. Confirmatory laboratory-based rapid plasma reagin testing was conducted on whole blood samples. Active syphilis infection was defined as RPR titer ≥ 1:8 and no self-reported syphilis treatment. We used multivariable regression models to identify associations with active syphilis infection among subgroups by gender and history of pregnancy (cisgender men n = 2123, cisgender women n = 4044, transgender/nonbinary people n = 47, pregnant women n = 150). Findings: Population (RDS-weighted) prevalence of laboratory-confirmed syphilis was 5.1% (95% CI: 4.6-5.6). Syphilis prevalence was 5.8% (weighted) among men; lifetime sexually transmitted infections (STI) diagnosis, same-sex relationships, HIV infection, and partner number were independently associated with syphilis infection. Syphilis prevalence was 4.6% (weighted) in women; correlates of infection included: lifetime STI diagnosis, food insecurity, current engagement in sex work, current pregnancy, any unsafe night in Colombia, irregular migration status, and no healthcare utilization in Colombia. 14.9% (unweighted) of transgender participants had syphilis infection; correlates of infection included partner number and HIV infection. The prevalence of syphilis was 9.0% (weighted) among pregnant women, which was associated with lifetime STI diagnosis. Interpretation: Syphilis among Venezuelans in Colombia is high. Correlates of infection are distinct among demographic groups, spanning sexual and social vulnerabilities, suggesting tailored public health strategies. Funding: US President's Emergency Plan for AIDS Relief through the U.S. Centers for Disease Control and Prevention.

Stigma, social and structural vulnerability, and mental health among transgender women: A partial least square path modeling analysis.

INTRODUCTION: Existing literature suggests that transgender women (TW) may be at high risk for adverse mental health due to stress attributed to combined experiences of stigma and complex social and structural vulnerabilities. Little research has examined how these co-occurring experiences relate to mental health. We aimed to test a theoretically driven conceptual model of relationships between stigma, social and structural vulnerabilities, and mental health to inform future intervention tailoring. DESIGN/METHODS: Partial least square path modeling followed by response-based unit segmentation was used to identify homogenous clusters in a diverse community sample of United States (US)-based TW (N = 1418; 46.2% White non-Hispanic). This approach examined associations between latent constructs of stigma (polyvictimization and discrimination), social and structural vulnerabilities (housing and food insecurity, unemployment, sex work, social support, and substance use), and mental health (post-traumatic stress and psychological distress). RESULTS: The final conceptual model defined the structural relationship between the variables of interest within stigma, vulnerability, and mental health. Six clusters were identified within this structural framework which suggests that racism, ethnicism, and geography may be related to mental health inequities among TW. CONCLUSION: Our findings around the impact of racism, ethnicism, and geography reflect the existing literature, which unfortunately shows us that little change has occurred in the last decade for TW of color in the Southern US; however, the strength of our evidence (related to sampling structure and sample size) and type of analyses (accounting for co-occurring predictors of health, i.e., stigma and complex vulnerabilities, reflecting that of real-world patients) is a novel and necessary addition to the literature. Findings suggest that health interventions designed to offset the negative effects of stigma must include anti-racist approaches with components to reduce or eliminate barriers to resources that contribute to social and structural vulnerabilities among TW. Herein we provide detailed recommendations to guide primary, secondary, and tertiary prevention efforts. CLINICAL RELEVANCE: This study demonstrated the importance of considering stigma and complex social and structural vulnerabilities during clinical care and design of mental health interventions for transgender women who are experiencing post-traumatic stress disorder and psychological distress. Specifically, interventions should take an anti-racist approach and would benefit from incorporating social support-building activities.

Access to healthcare among transgender women living with and without HIV in the United States: associations with gender minority stress and resilience factors.

BACKGROUND: Transgender women (TW) experience significant inequities in healthcare access and health disparities compared to cisgender populations. Access to non-transition related healthcare is understudied among TW. We aimed to assess the association between access to care and gender minority stress and resilience factors among TW living with and without HIV in eastern and southern United States. METHODS: This study was a cross-sectional analysis of baseline data drawn from a cohort of 1613 adult TW from the LITE Study. The cohort permitted participation through two modes: a site-based, technology-enhanced mode and an exclusively online (remote) mode. Exploratory and confirmatory factor analyses determined measurement models for gender minority stress, resilience, and healthcare access. Structural equation modeling was used to assess the relationships between these constructs. Models were evaluated within the overall sample and separately by mode and HIV status. RESULTS: Higher levels of gender minority stress, as measured by anticipated discrimination and non-affirmation were associated with decreased access to healthcare. Among TW living with HIV, higher levels of anticipated discrimination, non-affirmation, and social support were associated with decreased healthcare access. Among TW living without HIV in the site-based mode, resilience was positively associated with positive healthcare experiences and inversely associated with barriers to healthcare access. Among TW living without HIV in the online mode, anticipated discrimination was associated with barriers to healthcare access; resilience was positively associated with positive healthcare experiences and inversely associated with barriers to healthcare access. CONCLUSIONS: Gender minority stress was associated with increased barriers to healthcare access among TW in the US, regardless of HIV status. Resilience factors did not mediate this effect. Interventions aiming to increase healthcare access among TW can be aided by efforts to mitigate drivers of gender minority stress and improve patient experiences in healthcare facilities.

Prevalence of Sexually Transmitted Infections Among Transgender Women With and Without HIV in the Eastern and Southern United States.

BACKGROUND: Data on the epidemiology of sexually transmitted infections (STIs) among transgender women (TGW) with and without human immunodeficiency virus (HIV) are limited. METHODS: We analyzed baseline data collected from a cohort of adult TGW across 6 eastern and southern US cities between March 2018 and August 2020 (n = 1018). Participants completed oral HIV screening, provided self-collected rectal and urogenital specimens for chlamydia and gonorrhea testing, and provided sera specimens for syphilis testing. We assessed associations with ≥1 prevalent bacterial STI using modified Poisson regression. RESULTS: Bacterial STI prevalence was high and differed by HIV status: 32% among TGW with HIV and 11% among those without HIV (demographic-adjusted prevalence ratio = 1.91; 95% confidence interval = 1.39-2.62). Among TGW without HIV, bacterial STI prevalence differed by geographic region, race and ethnicity, and gender identity, and was positively associated with reporting >1 sexual partner, hazardous alcohol use, homelessness, having safety concerns regarding transit to health care, and no prior receipt of gender-affirming health services. Among TGW with HIV, older age was inversely associated with bacterial STI. CONCLUSIONS: TGW had a high prevalence of bacterial STIs. The prevalence and correlates of bacterial STI differed by HIV status, highlighting the unique needs and risks of TGW with and without HIV. Tailored interventions may reduce sexual health-related inequities.

Patterns of Polysubstance Use in Young Black and Latinx Sexual Minority Men and Transgender Women and Its Association with Sexual Partnership Factors: The PUSH Study.

Background: Adult studies have demonstrated that polysubstance use increases HIV acquisition risk through increased sexual behaviors, however, few studies have examined polysubstance in young Black and Latinx sexual minority men (SMM) and transgender women (TW). Methods: We used cross-sectional data from 466 young Black and Latinx SMM and TW living in four high HIV-burden US cities enrolled in the PUSH Study, a status-neutral randomized control trial to increase HIV prevention and treatment adherence. We examined data for patterns of polysubstance use comparing age differences of use and explored associations between substance use and sexual partnership factors - inconsistent condom use, pressure to have condomless anal sex, and older partner, using bivariate and multivariate analyses. Results: Most participants described prior substance use with alcohol and cannabis being most common (76% each) and 23% described other illicit drug use, including stimulants, cocaine, hallucinogens, sedatives, opioids, and inhalants. Polysubstance use was common with nearly half (47%) of participants reporting alcohol and cannabis use, 20% reporting alcohol, cannabis, and one other illicit drug use, and 19% reporting alcohol or cannabis use plus one other illicit drug use. Polysubstance use was associated with greater adjusted odds of pressure to have condomless anal sex, older partner (>5 years older), and inconsistent condom use. Conclusions: Associations of polysubstance use with sexual practices and sexual partnerships that are known predictors of HIV acquisition or transmission among Black and Latinx SMM and TW underscore the need for combination interventions that include substance use treatment alongside antiretroviral-based and partner-based HIV prevention and treatment interventions.Trial Registration: ClinicalTrials.gov Identifier: NCT03194477.

Effects of Race and Gender Classifications on Atherosclerotic Cardiovascular Disease Risk Estimates for Clinical Decision-Making in a Cohort of Black Transgender Women.

Introduction: Despite their dynamic, socially constructed, and imprecise nature, both race and gender are included in common risk calculators used for clinical decision-making about statin therapy for atherosclerotic cardiovascular disease (ASCVD) prevention. Methods and Materials: We assessed the effect of manipulating six different race-gender categories on ASCVD risk scores among 90 Black transgender women. Results: Risk scores varied by operationalization of race and gender and affected the proportion for whom statins were recommended. Discussion: Race and gender are social constructs underpinning racialized and gendered health inequities. Their rote use in ASCVD risk calculators may reinforce and perpetuate existing inequities.

PrEP initiation and discontinuation among transgender women in the United States: a longitudinal, mixed methods cohort study.

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.

Cardiovascular Disease Risk Estimation for Transgender and Gender-Diverse Patients: Cross-Sectional Analysis of Baseline Data From the LITE Plus Cohort Study.

Introduction: Approximately 2% of the U.S. population identifies as transgender, and transgender people experience disproportionate rates of cardiovascular disease mortality. However, widely used cardiovascular disease risk estimators have not been validated in this population. This study sought to determine the impact on statin therapy recommendations using 3 different approaches to operationalizing sex in the American Health Association/American College of Cardiology Pooled Cohort Equation Risk Estimator. Methods: This is a cross-sectional analysis of baseline clinical data from LITE Plus, a prospective cohort study of Black and/or Latina transgender women with HIV. Data were collected from October 2020 to June 2022 and used to calculate Pooled Cohort Equation scores. Results: The 102 participants had a mean age of 43 years. A total of 88% were Black, and 18% were Latina. A total of 79% were taking gender-affirming hormones. The average Pooled Cohort Equation risk score was 6% when sex assigned at birth was used and statins would be recommended for the 31% with Pooled Cohort Equation >7.5%. The average risk score was 4%, and 18% met the criteria for statin initiation when current gender was used; the mean risk score was 5%, and 22% met the criteria for statin initiation when current hormone therapy was used. Conclusions: Average Pooled Cohort Equation risk scores vary substantially depending on the approach to operationalizing the sex variable, suggesting that widely used cardiovascular risk estimators may be unreliable predictors of cardiovascular disease risk in transgender populations. Collection of sex, gender, and hormone use in longitudinal studies of cardiovascular health is needed to address this important limitation of current risk estimators.

High PrEP uptake, adherence, persistence and effectiveness outcomes among young Thai men and transgender women who sell sex in Bangkok and Pattaya, Thailand: findings from the open-label combination HIV prevention effectiveness (COPE) study.

Background: Daily oral pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection, but no study has evaluated combination prevention interventions with PrEP for transgender women (TGW) and men who have sex with men (MSM) who sell sex. Methods: The Combination Prevention Effectiveness (COPE) study was a community-based, non-randomized implementation study in Bangkok and Pattaya, Thailand. Participants were HIV-negative MSM and TGW aged 18-26 years who reported exchanging sex with men in the prior 12 months and who met 2014 U.S. Public Health Service PrEP eligibility criteria. The intervention included quarterly HIV testing, semiannual testing for sexually transmitted infections, provision of condoms with lubricant, and the opportunity to initiate or end daily oral PrEP use at any time during study participation. Participants taking PrEP received monthly adherence counseling and short message service reminders. The primary outcome was HIV incidence rate ratio (IRR) on PrEP vs. not on PrEP. Secondary outcomes were PrEP initiation, PrEP use at 12 months, and PrEP adherence. Findings: From October 2017 to August 2019, 846 participants were enrolled: 531 (62.8%) immediately initiated PrEP; 104 (12.3%) subsequently initiated PrEP, and 211 (24.9%) never initiated PrEP. Among those initiating PrEP within 30 days of enrollment; 85.9% were on PrEP at the 12-months. When taking PrEP, participants reported adherent PrEP use at 94.2% of quarterly assessments. Ten HIV seroconversions occurred without PrEP use (incidence rate [IR] = 3.42 per 100 person-years [PY]; 95% CI = 1.64-6.30), while zero cases occurred with PrEP use (IR = 0.0 per 100PY; 95% CI = 0.0-0.62), with IRR = 0.0 (95% CI = 0.0-0.22; p < 0.001). Interpretation: Young Thai MSM and TGW who exchange sex can have high PrEP uptake, persistence and adherence, and low HIV incidence when offered in supportive community-based settings. Funding: U.S. National Institute of Allergy and Infectious Diseases; Centers for Disease Control and Prevention.

HIV infection and engagement in the care continuum among migrants and refugees from Venezuela in Colombia: a cross-sectional, biobehavioural survey.

BACKGROUND: Venezuela has experienced substantial human displacement since 2015. To inform HIV programmes and treatment distribution, we aimed to estimate HIV prevalence and associated indicators among migrants and refugees from Venezuela residing in Colombia, the largest receiving country. METHODS: We conducted a biobehavioural, cross-sectional survey using respondent-driven sampling among Venezuelan people aged 18 years or older who had arrived in Colombia since 2015 and resided in four cities (ie, Bogotá, Soacha, Soledad, and Barranquilla). Participants completed sociobehavioural questionnaires and rapid HIV and syphilis screening with laboratory-based confirmatory testing, CD4 cell counts, and viral load quantification. Policies related to migration status affect access to insurance and HIV services in Colombia, as in many receiving countries, so we provided legal assistance and navigation support to participants with HIV for sustained access to treatment. Population-based estimates were weighted for the complex sampling design. Penalised multivariable logistic regression analysis was used to identify correlates of viral suppression (HIV-1 RNA <1000 copies per mL). FINDINGS: Between July 30, 2021, and Feb 5, 2022, 6506 participants were recruited through respondent-driven sampling, of whom 6221 were enrolled. 4046 (65·1%) of 6217 were cisgender women, 2124 (34·2%) of 6217 were cisgender men, and 47 (0·8%) of 6217 were transgender or non-binary people. 71 (1·1%) of all 6221 participants had laboratory-confirmed HIV infection, resulting in a weighted population HIV prevalence of 0·9% (95% CI 0·6-1·4). Among participants living with HIV, 34 (47·9%) of 71 had been previously diagnosed with HIV and 25 (35·7%) of 70 had viral suppression. Individuals with irregular migration status compared with individuals with regular migration status (adjusted odds ratio 0·3, 95% CI 0·1-0·9) and with a most recent HIV test in Colombia compared with a most recent test in Venezuela (0·2, 0·1-0·8) were less likely to have suppressed viral loads. INTERPRETATION: HIV prevalence among migrants and refugees from Venezuela in Colombia suggests the HIV epidemic is close to being generalised, which could be addressed by the inclusion of migrants and refugees from Venezuela in local HIV services, improved access to and navigation support for HIV testing and care, and coordination with humanitarian programmes. There is an association between migration status and viral suppression, conferring both clinical and epidemiological implications. Therefore, legal support and access to insurance might lead to early detection of HIV and timely treatment for people with irregular migration status. FUNDING: US President's Emergency Plan for AIDS Relief through the US Centers for Disease Control and Prevention. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Qualitative assessment of the impacts of the COVID-19 pandemic on migration, access to healthcare, and social wellbeing among Venezuelan migrants and refugees in Colombia.

Background: Colombia hosts a large number of Venezuelan migrants and refugees who are uniquely vulnerable and have been markedly impacted by the COVID-19 pandemic. It is necessary to understand their experiences to inform future policy decisions both in Colombia and during disease outbreaks in other humanitarian contexts in the future. As part of a larger study focused on HIV among Venezuelans residing in Colombia, qualitative interviews were conducted to understand this population's experiences and access to healthcare. Methods: Interviews were conducted with Venezuelan migrants and refugees as well as stakeholders such as care providers, humanitarian workers, and government officials. Interviews were recorded, transcribed, and coded using thematic content analysis. Select quotes were translated and edited for length and/or clarity. Results: Venezuelan migrants and refugees reported high levels of housing instability, job instability, increased barriers to accessing healthcare, and complications in engaging in the HIV care continuum, among other impacts of the COVID-19 pandemic. Stakeholders reported complications in provision of care and obtaining medicines, difficulty maintaining contact with patients, increased discrimination and xenophobia targeting Venezuelan migrants and refugees, increased housing instability among Venezuelan migrants and refugees, and other impacts as a result of the COVID-19 pandemic. Conclusions: This study demonstrates the unique impacts of the COVID-19 pandemic among Venezuelans residing in Colombia by both compounding extant vulnerabilities and introducing new challenges, such as high rates of eviction. Colombia has enacted increasingly inclusive migration policies for Venezuelan refugees and migrants within the country; findings from this study underscore the necessity for such policies both in and outside of the Colombian context.