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.

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.

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.

Brief Report: Interruptions in HIV Prevention and Treatment During the COVID-19 Pandemic: A Cross-Sectional Study of Transgender and Gender Nonbinary Adults in the United States.

BACKGROUND: Transgender and gender nonbinary (TNB) people have been disproportionately affected by HIV and the COVID-19 pandemic. This study explored the prevalence of HIV prevention and treatment (HPT) interruptions during the pandemic and identified factors associated with these interruptions. SETTING: Data were drawn from LITE Connect, a US-based, nationwide, online, self-administered survey designed to examine the experiences of TNB adults during the COVID-19 pandemic. A convenience sample of 2134 participants were recruited between June 14, 2021, and May 1, 2022. METHODS: The analytic sample was restricted to participants taking antiretroviral medications to prevent or treat HIV before the onset of the pandemic (n = 153). We calculated descriptive statistics as well as Pearson χ 2 bivariate tests and multivariable models to identify factors associated with HPT interruptions during the pandemic. RESULTS: Thirty-nine percent of participants experienced an HPT interruption. We found a lower odds of HPT interruptions among participants living with HIV [adjusted odds ratios (aOR) 0.45; 95% Confidence Intervals (CI): 0.22, 0.92; P = 0.02] and essential workers [aOR 0.49; 95% CI: 0.23, 1.0; P = 0.06] and higher odds among people with chronic mental health conditions [aOR 2.6; 95% CI: 1.1, 6.2; P = 0.03]. When sex and education were included, we found a lower odds of interruptions among people with higher education. CI widened, but the magnitude and direction of effects did not change for the other variables. CONCLUSIONS: Focused strategies to address longstanding psychosocial and structural inequities are needed to mitigate HPT treatment interruptions in TNB people and prevent similar challenges during future pandemics.

HIV incidence and mortality in transgender women in the eastern and southern USA: a multisite cohort study.

BACKGROUND: Epidemiological monitoring of HIV among transgender women is minimal despite prioritisation of this group in the US National HIV/AIDS Strategy (2022-2025). We aimed to estimate HIV incidence in a multisite cohort of transgender women in the eastern and southern USA. Participant deaths were identified during follow-up; thus, we felt it was an ethical imperative to report mortality alongside HIV incidence. METHODS: In this study, we established a multisite cohort across two modes: a site-based, technology-enhanced mode in six cities (Atlanta, Baltimore, Boston, Miami, New York City, and Washington, DC) and an exclusively digital mode that spanned 72 eastern and southern US cities that matched the six site-based cities based on population size and demographics. Trans feminine adults (≥18 years) who were not living with HIV were eligible and followed up for at least 24 months. Participants completed surveys and oral fluid HIV testing with clinical confirmation. We ascertained deaths through community and clinical sources. We estimated HIV incidence and mortality using the number of HIV seroconversions and deaths, respectively, divided by person-years accumulated from enrolment. Logistic regression models were used to identify predictors of HIV seroconversion (primary outcome) or death. FINDINGS: Between March 22, 2018, and Aug 31, 2020, we enrolled 1312 participants with 734 (56%) in site-based and 578 (44%) in digital modes. At the 24-month assessment, 633 (59%) of 1076 eligible participants consented to extending participation. 1084 (83%) of 1312 participants were retained at this analysis based on the study definition of loss to follow-up. As of May 25, 2022, the cohort participants had contributed 2730 accumulated person-years to the analytical dataset. Overall HIV incidence was 5·5 (95% CI 2·7-8·3) per 1000 person-years and incidence was higher among Black participants and those living in the south. Nine participants died during the study. The overall mortality rate was 3·3 (95% CI 1·5-6·3) per 1000 person-years, and the rate was higher among Latinx participants. Identical predictors of HIV seroconversion and death included residence in southern cities, sexual partnerships with cisgender men, and use of stimulants. Participation in the digital cohort and seeking care for gender transition were inversely associated with both outcomes. INTERPRETATION: As HIV research and interventions are increasingly delivered online, differences by mode highlight the need for continued community and location-based efforts to reach the most marginalised transgender women. Our findings underscore community calls for interventions that address social and structural contexts that affect survival and other health concerns alongside HIV prevention. FUNDING: National Institutes of Health. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

SARS-CoV-2 Infection and Testing Experiences in a Nationwide Sample of Transgender and Gender-Diverse Adults, June-December 2021.

OBJECTIVES: COVID-19 surveillance data are rarely collected or disaggregated by gender identity in the United States. We quantified COVID-19 testing experiences and SARS-CoV-2 infection history among transgender and gender-diverse (TGD) people to inform testing strategies and public health responses. METHODS: From June 14 through December 16, 2021, TGD adults enrolled in a US nationwide online survey with optional SARS-CoV-2 antibody testing. We used multinomial regression analyses to identify correlates of suspected and confirmed SARS-CoV-2 infection (vs no known infection). We identified correlates of inability to access COVID-19 testing when needed using generalized linear models for binomial variables. RESULTS: Participants (N = 2092) reported trans masculine (30.5%), trans feminine (27.3%), and nonbinary (42.2%) gender identities. Ten percent of respondents had a confirmed history of SARS-CoV-2 infection, and 29.8% had a history of suspected SARS-CoV-2 infection. Nonbinary gender (adjusted prevalence ratio [aPR] = 1.68; 95% CI, 1.12-2.53), experiencing homelessness (aPR = 1.65; 95% CI, 1.05-2.60), and food insecurity (aPR = 1.45; 95% CI, 1.03-2.04) were associated with confirmed SARS-CoV-2 infection. Food insecurity (aPR = 1.38; 95% CI, 1.10-1.72), chronic physical health condition (aPR = 1.44; 95% CI, 1.15-1.80), chronic mental health condition (aPR = 3.65; 95% CI, 2.40-5.56), and increased anticipated discrimination scores (aPR = 1.03; 95% CI, 1.01-1.05) were associated with suspected SARS-CoV-2 infection. Thirty-four percent (n = 694 of 2024) of participants reported an inability to access COVID-19 testing when needed, which was associated with Latinx or Hispanic ethnicity, inconsistent telephone access, homelessness, disability, and transportation limitations. The majority (79.4%) reported a complete COVID-19 vaccine course at the time of participation. CONCLUSIONS: Inclusion of TGD people in public health surveillance and tailored public health strategies to address TGD communities' social and structural vulnerabilities may reduce barriers to COVID-19 testing.

MDMA-assisted psychotherapy; Inclusion of transgender and gender diverse people in the frontiers of PTSD treatment trials.

Introduction: Transgender and gender diverse (TGD) people experience stigma, discrimination, trauma, and post-traumatic stress disorder (PTSD) at higher rates compared to the general population; however, TGD people have been underrepresented in PTSD research. Clinical trials of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy demonstrate promising safety and efficacy for the treatment of PTSD. Issues related to equitable access, power imbalances in the therapeutic relationship, and vulnerable states of consciousness occasioned by MDMA are magnified when working with people affected by structural vulnerabilities and health disparities, and community engagement in research planning and implementation is essential. To inform the inclusion and safety of TGD people in future MDMA-assisted psychotherapy research, the aims of the current study were to: characterize TGD experiences with trauma-related mental health care, assess openness of TGD people to participate in experimental PTSD research, and to gather specific feedback on protocol design for conducting MDMA-assisted psychotherapy with TGD people. Materials and methods: We conducted three virtual focus group discussions (FGDs) with 5-6 participants each (N = 17). Eligible TGD participants had a history of receiving trauma-related mental health care. Each FGD was facilitated by two licensed clinicians who identified as TGD. Qualitative data analysis was conducted via an iterative process of identification of recurrent patterns and themes. Results: We have identified several key issues TGD people face when seeking and engaging in trauma-related mental health care, including barriers to receiving adequate gender-affirming and trauma-informed mental health care and frustration with providers lacking cultural humility. Suggested amendments to MDMA-assisted psychotherapy protocols include: routine collection of trans-inclusive gender identity data, implementing an explicit gender-affirming treatment approach, ensuring a culturally safe setting, and diversifying co-therapy dyads. Discussion: The inclusion of TGD voices in early conversations about emerging experimental PTSD interventions promotes equitable access, in the context of health and healthcare disparities, and helps researchers understand the needs of the community and tailor research to meet those needs. Through an ongoing conversation with the TGD community, we aim to incorporate a gender-affirming approach into existing research protocols and inform future applications of MDMA-assisted psychotherapy in addressing the effects of minority stress and boosting resilience.

PrEP awareness and engagement among transgender women in South Africa: a cross-sectional, mixed methods study.

BACKGROUND: The South African national HIV plan recommends pre-exposure prophylaxis (PrEP) for transgender women, whose HIV prevalence estimates are as high as 25% in sub-Saharan Africa. The aim of this study was to explore PrEP awareness, uptake, and willingness, as well as associated barriers and facilitators, in order to inform PrEP implementation efforts with transgender women in South Africa. METHODS: Using a community-engaged, convergent parallel mixed methods design, trained local transgender women data collectors recruited 213 transgender women participants (aged >18 years, assigned male sex at birth, and identifying as a gender different from male), via network referral and word-of-mouth in Cape Town, East London, and Johannesburg. A subset of 36 transgender women also participated in qualitative in-depth interviews. Quantitative analyses included descriptive statistics and negative binomial regression models to assess correlates of PrEP willingness. Qualitative interviews were audio-recorded, transcribed verbatim, and coded. Thematic content analysis was used to identify key themes. Quantitative and qualitative data were integrated for interpretation. FINDINGS: Participants were recruited between June 1 and Nov 30, 2018. 57 (45%) of 127 HIV-negative participants were PrEP-aware and only 14 (11%) of 129 were currently taking PrEP. HIV-negative participants experiencing social (eg, violence, poverty) and interpersonal (eg, discrimination, low transgender women community connectedness) hardship reported PrEP awareness more frequently than HIV-negative transgender women who did not. Willingness to take PrEP was low, at 56 (55%) of 102, among HIV-negative participants who were not currently taking PrEP, and negatively associated with transgender women community connectedness (multivariable prevalence ratio 0·87; 95% CI 0·77-0·99). Barriers to PrEP included taking a daily pill, side-effects, and cost. Participants urged greater education and engagement of transgender women in PrEP implementation. INTERPRETATION: South Africa is poised to scale up PrEP services for transgender women. Dedicated transgender clinics are planned to provide comprehensive care, including PrEP, for transgender women. It is critical to ensure transgender women are aware of and have accurate information about PrEP, and that health-care sites are prepared to provide quality care for transgender women. FUNDING: Gilead Sciences.