Lower levels of social support are associated with risk for future suicide attempts in a clinical sample of transgender and gender diverse adults.

PURPOSE: Transgender and gender diverse (TGD) adults are disproportionately affected by suicide. Social support and connection to the broader TGD community may help lower TGD adults' odds of having a suicide attempt (SA). The current study examined whether baseline levels of social support and community connectedness were associated with TGD adult's prospective odds of having a SA over 12 months of follow-up. METHODS: Longitudinal data for the current study came from a patient cohort of TGD adults enrolled in the LEGACY Project. Descriptive statistics and an attrition analysis were used to examine characteristics of the cohort and missingness over time. Logistic generalized estimating equation models were used to examine factors associated with patients' odds of having a past 6-month SA at 6- or 12-month follow-up. RESULTS: During the 12-month follow-up period, a total of 26 patients (3.1%; N = 830) reported having a SA. The 6-month incidence of SAs was approximately 2% at both 6- and 12-months of follow-up (6 months: N = 830; 12 months: N = 495). Baseline factors associated with increased odds of a future SA included gender identity (transfeminine vs. transmasculine: adjusted odds ratio [aOR] = 3.73, 95% confidence interval [CI] = 1.26-11.08; nonbinary vs. transmasculine: aOR = 3.09, 95% CI = 1.03-9.21), having a prior SA (aOR = 6.44, 95% CI = 2.63-15.79), and having moderate vs. high perceived social support (aOR = 4.25, 95% CI = 1.65-10.90). CONCLUSION: Lower levels of social support are associated with risk for future suicide attempts among TGD adults. Findings may inform screening practices for future suicide risk and the development of interventions to improve mental health outcomes for TGD adults.

Decreased Anogenital Gonorrhea and Chlamydia in Transgender and Gender Diverse Primary Care Patients Receiving Gender-Affirming Hormone Therapy.

BACKGROUND: Transgender and gender diverse (TGD) adults in the U.S. experience health disparities, including in anogenital sexually transmitted infections (STI). Gender-affirming hormone therapy (GAHT) is known to be medically necessary and improve health. Few studies have assessed the effect of GAHT on STI diagnoses. OBJECTIVE: To evaluate the effect of GAHT delivered in primary care as an intervention to improve STI outcomes for TGD adults. DESIGN: LEGACY is a longitudinal, multisite cohort study of adult TGD primary care patients from two federally qualified community health centers in Boston, MA, and New York, NY. PARTICIPANTS: Electronic health record data for eligible adult TGD patients contributed to the LEGACY research data warehouse (RDW). A total of 6330 LEGACY RDW patients were followed from 2016 to 2019, with 2555 patients providing STI testing data. MAIN MEASURES: GAHT exposure was being prescribed hormones, and the clinical outcome was anogenital gonorrhea or chlamydia diagnoses. Log-Poisson generalized estimating equations assessed the effect of prescription GAHT on primary outcomes, adjusting for age, race, ethnicity, gender identity, poverty level, health insurance, clinical site, and cohort years. KEY RESULTS: The median age was 28 years (IQR = 13); the racial breakdown was 20.4% Black, 8.1% Multiracial, 6.9% Asian/Pacific Islander, 1.8% Other; 62.8% White; 21.3% Hispanic/Latinx; 47.0% were assigned female at birth, and 16.0% identified as nonbinary. 86.3% were prescribed hormones. Among those tested, the percentage of patients with a positive anogenital STI diagnosis ranged annually from 10.0 to 12.5% between 2016 and 2019. GAHT prescription was associated with a significant reduction in the risk of anogenital STI diagnosis (aRR = 0.75; 95% CI = 0.59-0.96) over follow-up. CONCLUSIONS: GAHT delivered in primary care was associated with less STI morbidity in this TGD cohort over follow-up. Patients may benefit from individualized and tailored clinical care alongside GAHT to optimize STI outcomes.

The utilization and delivery of safer smoking practices and services: a narrative synthesis of the literature.

BACKGROUND: Providing sterile drug smoking materials to people who use drugs can prevent the acquisition of infectious diseases and reduce overdose risk. However, there is a lack of understanding of how these practices are being implemented and received by people who use drugs globally. METHODS: A systematic review of safer smoking practices was conducted by searching PubMed, PsycInfo, Embase for relevant peer-reviewed, English-language publications from inception or the availability of online manuscripts through December 2022. RESULTS: Overall, 32 peer-reviewed papers from six countries were included. 30 studies exclusively included people who use drugs as participants (n = 11 people who use drugs; generally, n = 17 people who smoke drugs, n = 2 people who inject drugs). One study included program staff serving people who use drugs, and one study included staff and people who use drugs. Sharing smoking equipment (e.g., pipes) was reported in 25 studies. People who use drugs in several studies reported that pipe sharing occurred for multiple reasons, including wanting to accumulate crack resin and protect themselves from social harms, such as police harassment. Across studies, smoking drugs, as opposed to injecting drugs, were described as a crucial method to reduce the risk of overdose, disease acquisition, and societal harms such as police violence. Ten studies found that when people who use drugs were provided with safer smoking materials, they engaged in fewer risky drug use behaviors (e.g., pipe sharing, using broken pipes) and showed improved health outcomes. However, participants across 11 studies reported barriers to accessing safer smoking services. Solutions to overcoming safer smoking access barriers were described in 17 studies and included utilizing peer workers and providing safer smoking materials to those who asked. CONCLUSION: This global review found that safer smoking practices are essential forms of harm reduction. International policies must be amended to help increase access to these essential tools. Additional research is also needed to evaluate the efficacy of and access to safer smoking services, particularly in the U.S. and other similar countries, where such practices are being implemented but have not been empirically studied in the literature.

Navigating intimate trans citizenship while incarcerated in Australia and the United States.

Trans women incarcerated throughout the world have been described as "vulnerable populations" due to significant victimization, mistreatment, lack of gender-affirming care, and human rights violations, which confers greater risk of trauma, self-harm, and suicide compared with the general incarcerated population. Most incarceration settings around the world are segregated by the person's sex characteristics (i.e., male or female) and governed by strong cis and gender normative paradigms. This analysis seeks to better understand and appreciate how the "instructions" and the "authorities" that regulate trans women's corporeal representation, housing options and sense of self-determination implicate and affect their agency and actions in handling intimacies related to their personal life. Drawing upon lived incarcerated experiences of 24 trans women in Australia and the United States, and employing Ken Plummer's notion of intimate citizenship, this analysis explores how trans women navigate choices and ways "to do" gender, identities, bodies, emotions, desires and relationships while incarcerated in men's prisons and governed by cis and gender normative paradigms. This critical analysis contributes to understanding how incarcerated trans women through grit, resilience, and ingenuity still navigate ways to embody, express and enact their intimate citizenship in innovative and unique ways.

US Black-White Differences in Mortality Risk Among Transgender and Cisgender People in Private Insurance, 2011-2019.

Objectives. To compare survival by gender and race among transgender and cisgender people enrolled in private insurance in the United States between 2011 and 2019. Methods. We examined Optum's Clinformatics Data Mart Database. We identified transgender enrollees using claims related to gender-affirming care. Our analytic sample included those we identified as transgender and a 10% random sample of cisgender enrollees. We limited our sample to those 18 years or older who were non-Hispanic Black or White. We identified 18 033 transgender and more than 4 million cisgender enrollees. We fit Kaplan-Meier survival curves and calculated standardized mortality ratios while adjusting for census region. Results. Black transfeminine and nonbinary people assigned male sex at birth were 2.73 times more likely to die than other Black transgender people and 2.38 and 3.34 times more likely than Black cisgender men and women, respectively; similar results were found when White transfeminine and nonbinary people assigned male sex at birth were compared with White cisgender cohorts. Conclusions. Our findings highlight glaring inequities in mortality risks among Black transfeminine and nonbinary people assigned male sex at birth and underscore the need to monitor mortality risks in transgender populations and address the social conditions that increase these risks. (Am J Public Health. 2022;112(10):1507-1514. https://doi.org/10.2105/AJPH.2022.306963).

Differences in All-Cause Mortality Among Transgender and Non-Transgender People Enrolled in Private Insurance.

Few studies have analyzed mortality rates among transgender (trans) populations in the United States and compared them to the rates of non-trans populations. Using private insurance data from 2011 to 2019, we estimated age-specific all-cause mortality rates among a subset of trans people enrolled in private insurance and compared them to a 10% randomly selected non-trans cohort. Overall, we found that trans people were nearly twice as likely to die over the period as their non-trans counterparts. When stratifying by gender, we found key disparities within trans populations, with people on the trans feminine to nonbinary spectrum being at the greatest risk of mortality compared to non-trans males and females. While we found that people on the trans masculine to nonbinary spectrum were at a similar risk of overall mortality compared to non-trans females, their overall mortality rate was statistically smaller than that of non-trans males. These findings provide evidence that some trans and non-trans populations experience substantially different mortality conditions across the life course and necessitate further study.

Understanding opioid overdose risk and response preparedness among people who use cocaine and other drugs: Mixed-methods findings from a large, multi-city study.

Background: Fatal overdoses involving cocaine (powdered or crack) and fentanyl have increased nationally and in Massachusetts. It is unclear how overdose risk and preparedness to respond to an overdose differs by patterns of cocaine and opioid use. Methods: From 2017 to 2019, we conducted a nine-community mixed-methods study of Massachusetts residents who use drugs. Using survey data from 465 participants with past-month cocaine and/or opioid use, we examined global differences (p < 0.05) in overdose risk and response preparedness by patterns of cocaine and opioid use. Qualitative interviews (n = 172) contextualized survey findings. Results: The majority of the sample (66%) used cocaine and opioids in the past month; 18.9% used opioids alone; 9.2% used cocaine and had no opioid use history; and 6.2% used cocaine and had an opioid use history. Relative to those with a current/past history of opioid use, significantly fewer of those with no opioid use history were aware of fentanyl in the drug supply, carried naloxone, and had received naloxone training. Qualitative interviews documented how people who use cocaine and have no history of opioid use are largely unprepared to recognize and respond to an overdose. Conclusions: Public health efforts are needed to increase fentanyl awareness and overdose prevention preparedness among people primarily using cocaine.

A Critical Discourse Analysis of an Australian Incarcerated Trans Woman's Letters of Complaint and Self-Advocacy.

This case study provides a critical discourse analysis of 121 letters of complaint and self-advocacy authored by Natasha Keating, a trans woman incarcerated in two Australian male correctional facilities from 2000 to 2007. During her incarceration, Natasha experienced victimization, misgendering, microaggression, and institutional discrimination. Despite this, Natasha embodied and "fought" against the injustices she experienced, whilst seeking to speak for other trans incarcerated persons also silenced and treated with indifference, contributing to changes in the carceral system. This original case study analyzes the discursive strategies Natasha employed to construct and reclaim an affirming self-identity through a deliberate campaign to effect social change and policy concessions within a system designed to curtail self-determination. Through her empathic and impassioned letter-writing approach, leveraging a military metaphor, this novel analysis showcases the significant implications her activism/agentism and determination had in naming and seeking to dismantle the systems of oppression trans incarcerated women experience.

Conceptual approach to developing quality measures for transgender patients.

BACKGROUND: Valid and reliable quality measures can help catalyze improvements in health care. The care of transgender patients is ripe for quality measurement, as there is increasing awareness of the increasing prevalence of this population and the urgency of improving the health care they receive. While best practices may not exist for some aspects of transgender health care, other aspects are characterized by well-developed and highly evidence-based recommendations. Our objective was to create a list of potential quality measures for transgender care. METHODS AND RESULTS: In consultation with our advisory panel, which consisted of clinical and academic experts in transgender medicine, we selected eight prominent clinical practice guidelines of transgender health care for review. Our four team investigators carefully reviewed all eight clinical practice guidelines. Through the course of multiple consensus-building meetings, we iteratively refined items until we had agreed upon a list of forty potential quality measures, all of which met the criteria for quality measures set forth in the Center for Medicare and Medicaid Services Blueprint for developing quality measures. CONCLUSIONS: This manuscript explains the origin of the quality measures we developed, and also provides a useful roadmap to any group hoping to develop quality measures for a field that has not previously had any.

Prevalence and correlates of non-fatal overdose among people who use drugs: findings from rapid assessments in Massachusetts, 2017-2019.

BACKGROUND: People who experience non-fatal overdose (NFOD) are at high risk of subsequent overdose. With unprecedented increases in fentanyl in the US drug supply, many Massachusetts (MA) communities have seen a surge in opioid-related overdoses. The objective of this study was to determine factors associated with lifetime and past year NFOD in at-risk MA communities. METHODS: We conducted multiple rapid assessments among people who use drugs (PWUD) in eight MA communities using non-probability sampling (purposive, chain referral, respondent-driven) methods. We collected sociodemographic, substance use, overdose history, substance use treatment, and harm reduction services utilization data. We examined the prevalence of NFOD (lifetime and past year) and identified factors associated with NFOD through multivariable logistic regression analyses in a subset of 469 study participants between 2017 and 2019. RESULTS: The prevalence of lifetime and last year non-fatal opioid overdose was 62.5% and 36.9%, respectively. Many of the study participants reported heroin (64%) and fentanyl (45%) use during the 30 days preceding the survey. Nonprescription buprenorphine and fentanyl use were independently associated with higher odds of lifetime NFOD, while marijuana use was associated with lower odds of lifetime NFOD (p < 0.05). Injection as the route of administration, benzodiazepine, nonprescription buprenorphine, heroin, and fentanyl use were independently associated with higher odds, while methadone use was associated with lower odds of past year NFOD (p < 0.05). CONCLUSION: We documented a high prevalence of past year and lifetime NFOD among PWUD in MA. Our findings provide indicators that can help inform interventions to prevent overdoses among PWUD, including overdose prevention, medication treatment, and naloxone distribution.

Beyond Gender Identity Disorder Diagnoses Codes: An Examination of Additional Methods to Identify Transgender Individuals in Administrative Databases.

BACKGROUND: Large administrative databases often do not capture gender identity data, limiting researchers' ability to identify transgender people and complicating the study of this population. OBJECTIVE: The objective of this study was to develop methods for identifying transgender people in a large, national dataset for insured adults. RESEARCH DESIGN: This was a retrospective analysis of administrative claims data. After using gender identity disorder (GID) diagnoses codes, the current method for identifying transgender people in administrative data, we used the following 2 strategies to improve the accuracy of identifying transgender people that involved: (1) Endocrine Disorder Not Otherwise Specified (Endo NOS) codes and a transgender-related procedure code; or (2) Receipt of sex hormones not associated with the sex recorded in the patient's chart (sex-discordant hormone therapy) and an Endo NOS code or transgender-related procedure code. SUBJECTS: Seventy-four million adults 18 years and above enrolled at some point in commercial or Medicare Advantage plans from 2006 through 2017. RESULTS: We identified 27,227 unique transgender people overall; 18,785 (69%) were identified using GID codes alone. Using Endo NOS with a transgender-related procedure code, and sex-discordant hormone therapy with either Endo NOS or transgender-related procedure code, we added 4391 (16%) and 4051 (15%) transgender people, respectively. Of the 27,227 transgender people in our cohort, 8694 (32%) were transmasculine, 3959 (15%) were transfeminine, and 14,574 (54%) could not be classified. CONCLUSION: In the absence of gender identity data, additional data elements beyond GID codes improves the identification of transgender people in large, administrative claims databases.

Recent Penile Sexual Contact Is Associated With an Increased Odds of High-Risk Cervical Human Papillomavirus Infection in Transgender Men.

BACKGROUND: Transgender men (TM) have a male, masculine, or nonfemale gender identity, yet were assigned female sex at birth on the basis of their external genitalia. The majority of TM are at risk of infection with one of several high-risk strains of the human papillomavirus (hr-HPV), acquired primarily through sexual contact, that cause 99.7% of cervical cancers. This study aimed to explore the association between sexual behaviors and current cervical hr-HPV infection in TM with a cervix. METHODS: The primary aim of this analysis was to test for an association between participant self-report of sexual contact with a penis in the past 1 year and current infection with cervical hr-HPV as measured by provider-collected cervical HPV DNA assay. This is a secondary analysis of a bio-behavioral sexual health study conducted at a health center in Boston, MA from 2015 to 2016. Analysis was conducted using logistic regression with significance level set at P less than 0.05; the primary analysis was adjusted for self-reported age, current tobacco use, years of testosterone use, and HPV vaccination status. RESULTS: Overall prevalence of hr-HPV was 15.9%. In adjusted analyses, participants reporting receptive penile vaginal sex with any of their most recent 3 sexual partners in the past 12 months had more than 5 times greater odds of current hr-HPV infection than those reporting no penile sex of any kind during this timeframe (odds ratio, 5.23; 95% confidence interval, 1.61-17.02). CONCLUSIONS: Vaginal-receptive penile sex in the last 12 months was associated with a 5-fold increased odds of cervical high-risk HPV infection among TM. Findings can inform future population level study of associations between sexual behaviors and hr-HPV risk, which could lead to more individualized approaches to screening.

Multilevel Barriers to Engagement in the HIV Care Continuum Among Residents of the State of Rhode Island Living with HIV.

An estimated 1.2 million people in the United States are living with HIV. Of those living with HIV, only 40% are engaged in HIV care, 37% are prescribed antiretroviral therapy (ART), and 30% are virally suppressed. Individual-, interpersonal-, and structural-level factors that represent barriers to engagement along the HIV care continuum are important to identify in order to inform priority areas and interventions. 296 adult residents of Rhode Island living with HIV between November 2015 and January 2016 were asked to participate in an observational study (Ryan White Part B Health Resources and Services Administration-funded consumer needs assessment) to identify the multilevel factors associated with engagement in the HIV care continuum outcomes (i.e., being retained in care, being prescribed ART, adhering to ART, and achieving viral suppression-all in the past 12 months). Multivariable logistic regression models were fit to model the four HIV care continuum outcomes. The majority of participants were over age 30 (92.5%), racial/ethnic minorities (67.1%), cisgender men (56.9%), and identified as straight/heterosexual (60.5%). Overall, 95.2% of participants were retained in care in the past 12 months, 93.0% were prescribed ART, 87.1% were currently adherent to ART, and 68.2% were virally suppressed. Factors positively associated with not being retained in HIV care in the past 12 months included having no income and challenges navigating the HIV care system. Being age 18-29 and having a provider who does not know how to treat people with HIV/AIDS were each positively associated with not being prescribed ART. Factors positively associated with not being adherent to ART included being age 18-29 and substance use in the past 12 months. Finally, having private insurance and having a provider who is not trustworthy were each positively associated with not being virally suppressed. Regardless of the fact that many of the individuals living with HIV in this sample are able to achieve an undetectable viral load, challenges with retention in HIV care and ART adherence threaten to undermine the clinical and public health benefits of treatment as prevention. Future longitudinal research conducted to better understand how to boost the effectiveness of treatment as prevention in this population should focus on examining the unique multilevel factors, polymorbidities, and conditions (mostly social determinants of health including housing, socioeconomic position, etc.) associated with suboptimal engagement across the stages of the HIV care continuum.

Social and Medical Gender Affirmation Experiences Are Inversely Associated with Mental Health Problems in a U.S. Non-Probability Sample of Transgender Adults.

A dearth of research has explored concurrently the associations between multiple forms of gender affirmation (or transitioning) and the mental health of transgender adults. In 2015, 288 U.S. transgender adults completed a cross-sectional, online survey assessing demographics, gender affirmation experiences, and mental health. Adjusting for age and discrimination experiences, we used mixed-effect logistic regression analyses to examine changes in self-reported suicidal ideation, suicide attempts, and non-suicidal self-injury (NSSI) before and after initiating the gender affirmation process, and linear regression analyses to examine associations between gender affirmation experiences and self-reported depressive, anxiety, and stress symptoms. Overall, 81.3% of participants identified along the female-to-male, trans masculine gender spectrum (of which 20.9% identified as non-binary) and 18.8% identified along the male-to-female, trans feminine gender spectrum (of which 7.4% identified as non-binary). Nearly all participants (98.6%) reported disclosing their gender identity to family or a coworker; 67.4% endorsed recently using hormones, and 31.3% endorsed a gender-affirming medical procedure. In multivariable models, participants were at greater odds of NSSI, contemplating suicide, and attempting suicide before initiating the gender affirmation process compared to after. In additional models, gender identity disclosure and medical procedure engagement were inversely associated with depressive and anxiety symptoms, whereas gender identity disclosure, hormone use, and medical procedure engagement were inversely associated with stress symptoms. Finally, the number of gender affirmation experiences endorsed was inversely associated with depressive, anxiety, and stress symptoms. Findings support the possibility that social and medical gender affirmation experiences may be protective against mental health problems in transgender adults.

A Randomized Pilot Study of a Group-Delivered HIV Risk Reduction Intervention for At-Risk Urban Men Who Have Sex with Men Who Regularly Attend Private Sex Events.

Across HIV prevention studies, as many as 25% of men who have sex with men (MSM) report meeting male partners at private sex events and attendance is associated with increased number of sexual partners, condomless anal sex (CAS), and HIV infection. Despite the need for effective HIV prevention interventions, no risk reduction interventions have been tested to reduce HIV sexual risk of MSM that regularly engage in sexual risk at private sex events. This randomized pilot study assessed the feasibility and acceptability of an HIV risk reduction intervention to reduce CAS among urban MSM (N = 14) reporting risk at a private sex event in the prior 12 months. The intervention arm received four group sessions (2 h/session) focusing on HIV risk reduction education and skills building. Both the intervention (n = 8) and control (n = 6) conditions received HIV testing and pre- and posttest risk reduction counseling and completed a sexual risk and psychosocial assessment visit at baseline and 3 months post-intervention. In addition, intervention participants completed a brief exit interview post-intervention. Mean age was 37 years, and 57% were racial/ethnic minorities. At follow-up, the intervention group reported greater reductions in sexual risk behavior in the past 3 months including number of CAS episodes, number of partners at private sex events, and CAS episodes at private sex events. The intervention group also reported reduced sexual compulsivity, increases in HIV disclosure, and reduced drug use at private sex events over study follow-up. Exit interviews revealed that participants found the intervention to be highly acceptable. Findings demonstrate feasibility of procedures, participant acceptability, and initial promise of a group-delivered HIV risk reduction intervention for MSM who attend and engage in CAS at private sex events. Further testing of this intervention in a larger pilot randomized controlled trial is warranted.

Correction to: Risk and protective factors for mental health morbidity in a community sample of female-to-male trans-masculine adults.

Following publication of the original article [1], we have been notified of the below corrections.

Risk and protective factors for mental health morbidity in a community sample of female-to-male trans-masculine adults.

BACKGROUND: Trans-masculine (TM) individuals, who are assigned female sex at birth and identify along the masculine gender spectrum, face mental health disparities relative to cisgender people. Limited research has sought to explore the multi-level risk and protective factors associated with mental health morbidity for TM populations. METHODS: Between August 2015-September 2016, 150 TM adults were enrolled in a one-time biobehavioral health study. A survey assessed socio-demographics, past 12-month everyday discrimination, lifetime intimate partner violence (IPV), resilience (using the Brief Resilience Scale), and other factors. Bivariate and multivariable logistic regression analyses examined associations between participant characteristics and four mental health statuses: post-traumatic stress disorder (PTSD), depression, anxiety, and non-suicidal self-injury (NSSI). RESULTS: In this sample (76.7% had a binary gender identity, i.e., man or transgender man; 74.7% were white, 70.0% were under age 30 years), 42.2% had PTSD based on past 30-day symptoms; 25.7% had depression based on past 7-day symptoms; 31.1% had anxiety based on past 7-day symptoms; and 31.3% had engaged in NSSI within the past 12-months. Results from multivariable models: 1) PTSD: unemployment, lifetime IPV and past 12-month discrimination were each associated with increased odds of PTSD, while having a partner was associated with the reduced odds of PTSD. 2) Depression: lower educational attainment and past 12-month discrimination were each associated with the increased odds of depression, while greater resilience was associated with the reduced odds of depression. 3) Anxiety: low annual household income and past 12-month discrimination were each associated with the increased odds of anxiety, while resilience was associated with the reduced odds of anxiety. 4) NSSI: past 12-month discrimination was associated with the increased odds of past 12-month NSSI, while higher age and greater resilience was associated with the reduced odds of NSSI (all p-values < 0.05). CONCLUSIONS: Unemployment, low income, limited education, everyday discrimination, and violence were risk factors for poor mental health, while being in a relationship, higher age, and personal resilience were protective against mental health morbidity. Findings highlight the need for interventions to address the individual, interpersonal, and societal factors that may be driving poor mental health in this population.

HIV prevention and HIV care among transgender and gender diverse youth: design and implementation of a multisite mixed-methods study protocol in the U.S.

BACKGROUND: In the U.S., transgender and gender diverse (TGD) populations face structural, interpersonal, and individual barriers to healthcare. Less is known, however, about the HIV prevention and treatment experiences of TGD youth in the U.S. The current study was developed to fill this research gap. METHODS: This article describes the research protocol for a multi-site, U.S.-based mixed-methods study that sought to identify the multi-level facilitators and barriers that influence participation of TGD youth in various stages of the HIV prevention (e.g., pre-exposure prophylaxis uptake) and care continua. A sample of diverse TGD youth ages 16-24 was recruited from 14 U.S. sites. TGD youth participants completed a one-time, in-person visit that included an informed consent process, computer-based quantitative survey, and in-depth qualitative interview assessing experiences accessing HIV prevention and/or care services. Providers serving TGD youth were recruited from the same 14 sites and completed a one-time visit via phone that included informed consent, demographic questionnaire, and in-depth qualitative interview assessing their experiences providing HIV prevention or treatment services to TGD youth. RESULTS: Overall, 186 TGD youth ages 16-24 and 59 providers serving TGD youth were recruited and enrolled from across the 14 U.S. sites. TGD youth participants had a mean age of 20.69; 77.3% youth of color; 59.7% trans-feminine; 15.5% trans-masculine; 24.9% non-binary; 53.6% family income under poverty level. Providers included medical and mental health providers as well as case manager/care coordinators, HIV test counselors, and health educators/outreach workers. Providers were 81.3% cisgender and 30.5% people of color. Successes with community-engagement strategies and gender-affirming research methods are reported. CONCLUSIONS: This study addresses critical gaps in current knowledge about the HIV prevention and care experiences of TGD youth. Findings have implications for the development of HIV interventions across levels to support the health and well-being of TGD youth. Future research is warranted to replicate and expand on lessons learned regarding recruitment and engagement of communities of TGD youth, including longitudinal designs to assess engagement across their developmental stages. Lessons learned working with TGD youth through developing and implementing the study protocol are shared. TRIAL REGISTRATION: Registered on ClinicalTrials.gov on 05/20/2015 (NCT02449629).

Positive STEPS - a randomized controlled efficacy trial of an adaptive intervention for strengthening adherence to antiretroviral HIV treatment among youth: study protocol.

BACKGROUND: HIV infection among youth in the United States is on the rise. A high level of antiretroviral therapy (ART) adherence is crucial to treatment success and can minimize the population burden of the disease. However, the overall rate of ART adherence among youth is generally suboptimal and no published efficacious interventions exist to address the specific needs of this population. This paper describes the design of a stepped-care, "adaptive" ART adherence intervention protocol for HIV-infected adolescents and young adults. METHODS: This is a randomized controlled trial (RCT) to establish the efficacy of "Positive STEPS," a behavioral and technology-based intervention to optimize ART adherence and viral suppression among HIV-infected youth, ages 16 to 29. Participants are equally randomized to 1) the Positive STEPS intervention, which begins with two-way daily text messaging as a reminder system to take their medications; participants progress to a more intensive in-person counseling intervention if text messaging is not sufficient to overcome barriers; or 2) or standard of care (SOC). At randomization, all participants receive standardized ART adherence education. During the 4 major study assessment visits (baseline, 4-, 8-, and 12-months), participants have their blood drawn to measure HIV viral load and complete a mix of computer-based self-administered and interviewer-administered behavioral and psychosocial measures. The primary outcomes are improvements in viral load and ART adherence measured via a medication-tracking device (i.e., Wisepill) and self-report. DISCUSSION: Behavioral interventions are greatly needed to improve ART adherence among HIV-infected adolescents and young adults and prevent onward transmission. If effective, the intervention tested here will be one of the first rigorously-designed efficacy trials to promote ART adherence in this population, using an approach that holds promise for being readily integrated into real-world clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT03092531 , registered March 28, 2017.

A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: project IMPACT study protocol.

BACKGROUND: In the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM. METHODS: This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits. DISCUSSION: Effective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT03175159 , registered June 5, 2017.