Robert Garofalo

Ann & Robert H. Lurie Children's Hospital of Chicago · Department of Pediatrics

Background: Limited prospective outcome data exist regarding transgender and nonbinary youth receiving gender-affirming hormones (GAH; testosterone or estradiol). Methods: We characterized the longitudinal course of psychosocial functioning during the 2 years after GAH initiation in a prospective cohort of transgender and nonbinary youth in the...

Studies on HIV self-testing (HIV-ST) have been limited to adults (age 18+). The study assessed use of HIV-ST among a diverse group of young men who have sex with men (YMSM) in the United States (US) and assessed differences in uptake by demographic characteristics and requirements for parental consent. This study demonstrated feasibility of HIV-ST...

The COVID-19 pandemic has disrupted sexual health services among those most vulnerable to HIV acquisition, such as adolescent men who have sex with men (AMSM). We sought to characterize the changes in sexual-risk behaviors, HIV and other STI testing, and pre-exposure prophylaxis (PrEP) use among a longitudinal cohort of AMSM aged 13 to 18 years bef...

Purpose: Research suggests social support may protect sexual minorities from the harmful effects of victimization that undermine mental and sexual health wellness; however, this relationship has been underexplored among a diverse youth population. We examined the association between lifetime homonegative victimization, perceived stress in the last...

Importance HIV transmission rates in the United States have increased among men who have sex with men. However, there are no published randomized trials examining interventions to reduce sexual risk for HIV acquisition in males younger than 18 years. Objective To determine the efficacy of MyPEEPS Mobile, a mobile-delivered HIV prevention intervent...

Background Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria’s youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminder...

Purpose: This study examined factors associated with past-year health care utilization among young gay, bisexual, and other men who have sex with men (YMSM) using Andersen's behavioral model of health service use. Methods: From 2018 to 2020, 751 YMSM (aged 13-18) recruited online and offline for the MyPEEPS mHealth HIV prevention study completed an...

Background: The purpose of this study was to adapt and pilot-test an employment support, primary HIV intervention tailored to the needs of adolescent men who have sex with men (AMSM) and adolescent transgender women (ATGW) of color. Setting: The intervention was implemented in two settings: controlled environment (Phase 1) and real-world communi...

Purpose: The objective of this study was to determine whether state-level policies that restrict minors' access to confidential HIV testing without parental consent may suppress HIV testing in young men who have sex with men (YMSM) in the United States. Methods: Secondary data from a national HIV prevention trial among YMSM aged 13-17 years (N=...

Importance: Nigeria has the fourth-largest HIV epidemic globally, yet high levels of social stigma inhibit HIV testing among Nigerian youths and young men who have sex with men (MSM). Objective: To report pilot data from iCARE Nigeria (Intensive Combination Approach to Roll Back the Epidemic in Nigerian Adolescents), a combination intervention u...

Background: Equations for estimated glomerular filtration rate (eGFR) based on serum creatinine include terms for sex/gender. For transgender and gender-diverse (TGD) youth, gender-affirming hormone (GAH) treatment may affect serum creatinine and in turn eGFR. Methods: TGD youth were recruited for this prospective, longitudinal, observational st...

Our team developed MyPEEPS (Male youth Pursuing Empowerment, Education, and Prevention around Sexuality) Mobile-a health application for young cisgender men who have sex with men to promote health and reduce sexual risk. The current study sought to better understand approaches for adapting MyPEEPS for transmasculine youth. Methods: Transmasculine...

Objective The aim of this study was to determine whether homophobic victimization was associated with alcohol consumption and riding with an intoxicated driver or driving a car while under the influence of alcohol or drugs among adolescent men who have sex with men (MSM). Methods Cross-sectional analysis used baseline data from a national HIV prev...

A large proportion of HIV infections among men who have sex with men occur within primary partnerships, however, there is a lack of research focused on serodiscordant male couples. We used baseline data collected as part of Project Stronger Together—a randomized controlled trial to improve treatment outcomes among 155 serodiscordant male couples. W...

Background The number of youth living with HIV in the United States (US) continues to rise, and racial, ethnic, and sexual minority youth including young men who have sex with men (YMSM) and young transgender women (YTGW) bear a disproportionate burden of the HIV epidemic. Due to social and healthcare system factors, many YMSM and YTGW do not seek...

Background Nigeria has the second highest number of people living with HIV (PLWH) globally, and evidence-based approaches are needed to achieve national goals to identify, treat, and reduce new infections. Youth between the ages of 15–24, including young men who have sex with men (YMSM), are disproportionately impacted by the Nigerian HIV epidemic....

Objective The widespread and frequent use of mobile technology among adolescents, including sexual minority adolescents, presents an opportunity for the development of mobile health (mHealth) technology to combat the continuing HIV epidemic among young men who have sex with men (YMSM). We analyzed perceptions of the quality and impact of an HIV pre...

Engagement in HIV care and a high level of antiretroviral therapy (ART) adherence for people living with HIV is crucial to treatment success and can minimize the population burden of the disease. Despite this, there is a critical gap in HIV prevention science around the development of interventions for serodiscordant male couples. This paper report...

Background: Consistent with the global trend, youth with HIV (YWH) in Nigeria have high rates of viral nonsuppression. Hence, novel interventions are needed. Setting: Infectious Diseases Institute, College of Medicine, University of Ibadan, Nigeria. Methods: In a single-arm trial, participants aged 15-24 years received 48 weeks of a combinatio...

Improving access to HIV testing among youth at high risk is essential for reaching those who are most at risk for HIV and least likely to access health care services. This study evaluates the usability of mLab, an app with image-processing feature that analyzes photos of OraQuick HIV self-tests and provides real-time, personalized feedback. mLab in...

In the United States, transgender women are disproportionately affected by HIV. However, few evidence-based prevention interventions exist for this key population. We describe two promising, locally developed interventions that are currently being implemented and evaluated through the Centers for Disease Control and Prevention Combination HIV Preve...

The TransLife Care (TLC) project was developed to address the structural factors that act as barriers to HIV care among transgender women of color. The purpose of this study was to evaluate the feasibility and initial efficacy of the TLC project; primary HIV care outcomes included linkage to HIV care, engagement in care, retention in care, use of A...

Purpose Transgender/gender-diverse (TGD) youth are treated with gonadotropin-releasing hormone agonists (GnRHas) to halt endogenous puberty and prevent the development of secondary sex characteristics discordant with their gender identity. This treatment may have significant impact on growth and height velocity (HV). Methods Participants were recr...

Sexual agreements (SAs)—guidelines that outline what type of sexual behaviors are permissible with sexual partners outside of their primary relationship—are often negotiated within same-sex male relationships to reduce their risk for HIV infection. However, HIV risk is not only a function of sexual behavior, but is also affected by factors such as...

Because of stigmatization of and discrimination against lesbian, gay, bisexual, transgender, and other sexual and gender minority (SGM) people in East Africa, there is paucity of SGM-focused sexual health research. Technology-based outreach efforts may represent a feasible way to reach and engage this population. They also may be a way to deliver i...

Transgender and nonbinary (TNB) people who also identify as black, indigenous, and/or people of color (BIPOC) may experience compounding stress related to their racial and gender minority identities. This case study describes supporting pride, activism, resiliency, and community (SPARC), a brief five-session telemedicine-based process group for TNB...

Mortality and morbidity from cardiovascular disease differ between men and women, and sex differences in lipid profiles may contribute to this difference. Starting at puberty, male individuals have more atherogenic cholesterol profiles, including lower high-density lipoprotein cholesterol (HDL-C) levels, than female individuals.¹ The degree to whic...

BACKGROUND: Gender-based stigma contributes to increased HIV prevalence, but little is known about psychosocial mechanisms linking stigma and HIV risk among young transgender women (YTW). SETTING: This study uses data from Project LifeSkills, a randomized controlled efficacy trial of an empowerment-based HIV prevention intervention for YTW (N=233)....

Sexual agreements are an important HIV risk reduction strategy enacted by men in male–male partnerships. Greater levels of relationship quality have been associated with sexual agreement formation and adherence. However, current evidence supporting the associations between relationship quality and sexual agreements for male dyads is based primarily...

Transgender women are disproportionately affected by HIV and experiences of social adversity that may interfere with engagement in care and viral suppression. We used latent class analysis to examine patterns of social adversity and their impact on HIV care continuum outcomes in an urban sample of transgender women of color. Participants (n = 224)...

Background: Men who have sex with men are disproportionately burdened by HIV/AIDS, and the advent of pre-exposure prophylaxis (PrEP) has provided an effective strategy to reduce the risk of HIV transmission. Research has shown that improving one partner's health-promoting behaviors increases the likelihood that their partner adopts healthier behav...

Purpose This study examined whether transmasculine, transfeminine, and nonbinary adolescents and young adults (AYA) experience different levels of gender minority stress and resilience. Methods Demographic and clinical information were abstracted from medical charts from AYA initiating gender-affirming care. Group comparisons between transgender a...

Purpose: We aimed to examine transgender youths' interest in receiving gender-affirming care via telemedicine or through primary care with telehealth support. Methods: We surveyed 12- to 26-year-old transgender youth receiving care in a multidisciplinary gender clinic. Descriptive statistics and bivariate analyses were used to assess relationshi...

Purpose: To characterize demographics, psychosocial functioning, and gender-related experiences in transgender youth enrolling versus declining participation in a multisite research study. Methods: Clinical data were abstracted from patient charts at two study sites. Continuous variables were compared using t-tests, and categorical variables were c...

Purpose: We assessed if young transgender women (YTW) with parents who are supportive of their transgender identity had lower odds of having suicidal ideation compared with YTW with unsupportive parents. Methods: This study analyzed baseline findings from a diverse sample of 297 sexually active, YTW 16-29 years of age who were enrolled in Project...

Despite the approval of PrEP for adolescents by the FDA in 2018, little is known about the awareness and attitudes about PrEP use among adolescent sexual minority males, who are at the greatest risk for HIV. We analyzed baseline data from the MyPEEPS Mobile study, a multi-site randomized controlled trial evaluating the effectiveness of a mobile beh...

Background: Young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth of color face substantial economic and health disparities. In particular, HIV risk and infection among these groups remains a significant public health issue. In 2017, 17% of all new HIV diagnoses were attributed to mal...

Background: HIV continues to have a disparate impact on young cisgender men who have sex with men (YMSM), young trans women (YTW), and gender-nonconforming (GNC) youth who are assigned male at birth. Outcomes are generally worse among youth of color. Experiences of discrimination and marginalization often limit educational attainment and may even...

Purpose This study aimed to characterize two developmental cohorts of transgender and nonbinary youth enrolled in the Trans Youth Care Network Study and describe their gender identity–related milestones and baseline mental health and psychosocial functioning. Methods Trans Youth Care participants were recruited from four pediatric academic medical...

Purpose: Development of incongruent secondary sex characteristics in transgender youth can intensify or trigger the onset of gender dysphoria. Guidelines from professional organizations recommend gonadotropin-releasing hormone agonists, including histrelin implants (Vantas and SupprelinLA) to suppress endogenous puberty. Although Vantas does not ha...

Purpose: Transgender and gender-nonconforming (TGNC) youth often report higher rates of chronic social stressors such as victimization, discrimination, and rejection. Some of these gender-based stressors may have long-range physical health consequences through inflammation pathways. This study evaluates the feasibility and acceptability of adding b...

Young transgender women aged 16–29 years experience high rates of carceral involvement, warranting greater inclusion of this community within decarceration research and practice. The present study investigates patterns of violence, exclusion, resilience, and arrest among a sample of 298 transgender women aged 16–29 years in Chicago, Illinois, and B...

Context Transgender youth may initiate gonadotropin-releasing hormone agonists (GnRHa) to suppress puberty, a critical period for bone-mass accrual. Low bone mineral density (BMD) has been reported in late-pubertal transgender girls prior to gender-affirming therapy, but little is known about BMD in early-pubertal transgender youth. Objective To d...

BACKGROUND Young transgender women (YTW) are a key population for HIV-related risk reduction, yet very few interventions have been developed to meet their needs. Mobile health interventions with the potential for both efficacy and wide reach are a promising strategy to reduce HIV risk among YTW. OBJECTIVE This study aims to adapt an efficacious gr...

Background Young transgender women (YTW) are a key population for HIV-related risk reduction, yet very few interventions have been developed to meet their needs. Mobile health interventions with the potential for both efficacy and wide reach are a promising strategy to reduce HIV risk among YTW. Objective This study aims to adapt an efficacious gro...

Background: In the United States, young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone and are situated within larger social...

Our study team developed the MyPEEPS Mobile App for improving HIV prevention behaviors in diverse young men. We conducted a randomized controlled trial and evaluated the preliminary outcomes in the first half (N=350) of our intended study sample. Higher self-efficacy for HIV prevention behaviors (p=0.0042) and more recent HIV tests in the past 3 mo...

Purpose: Pubertal suppression is standard of care for early pubertal transgender youth to prevent the development of undesired and distressing secondary sex characteristics incongruent with gender identity. Preliminary evidence suggests pubertal suppression improves mental health functioning. Given the widespread changes in brain and cognition that...

Background: Despite recent reductions, youth substance use continues to be a concern in the United States. Structured primary care substance use screening among adolescents is recommended, but not widely implemented. The purpose of this study was to describe the distribution and characteristics of adolescent substance use screening in outpatient c...

Purpose The purpose of this study was to describe baseline physical and laboratory characteristics of participants in the largest prospective study of transgender and gender-diverse (TGD) youth in the United States. Methods Participants were recruited from four clinics which specialize in the care of TGD youth before starting either GnRH analogs f...

Introduction In the USA, transgender women are among the most vulnerable to HIV. In particular, transgender women of colour face high rates of infection and low uptake of important HIV prevention tools, including pre-exposure prophylaxis (PrEP). This paper describes the design, sampling methods, data collection and analyses of the TURNNT (‘Trying t...

Research is critically needed to understand protective processes that may lessen the impact of intimate partner violence (IPV) on negative outcomes for transgender individuals. The current study utilized a latent class analysis to identify combinations of protective processes (i.e., collective self-esteem and social support) in relation to internal...

Importance Nonmedical prescription opioid use is a pressing public health issue in the United States. Transgender youth, including adolescent girls and young women who were assigned male at birth and currently identify as women, female, transgender women, or another diverse gender identity along the transfeminine gender spectrum, are more likely th...

BACKGROUND In the U.S., young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of human immunodeficiency virus (HIV) infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone, and are situated...

Transgender youths experience significant health disparities compared with their cisgender peers. Recent data suggest that use of gender-affirming language, specifically name and pronouns, in more life contexts is associated with improved mental health outcomes.

BACKGROUND HIV incidence among young adult men who have sex with men (MSM), particularly among Black and Latino men, continues to rise. As such, continued HIV prevention interventions for YMSM of color are of utmost importance. MyPEEPS Mobile is a comprehensive HIV prevention and sexual health education smartphone app initially created to promote s...

Background HIV incidence among young adult men who have sex with men (MSM), particularly among black and Latino men, continues to rise. As such, continued HIV prevention interventions for young MSM of color are of utmost importance. Male Youth Pursuing Empowerment, Education and Prevention around Sexuality (MyPEEPS) Mobile is a comprehensive HIV pr...

Background: Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interv...

We performed a pilot study among young African-American men who have sex with men (AAMSM) of real-time electronic adherence monitoring (EAM) in Chicago to explore acceptability and feasibility of EAM and to inform intervention development. We recruited 40 young AAMSM living with HIV on ART to participate in up to 3 months of monitoring with the Wis...

Background: Young people account for more than a quarter of new HIV infections in the US, with the majority of cases among young men who have sex with men; young transgender women are also vulnerable to infection. Substance use, particularly alcohol misuse, is a driver of sexual transmission and a potential barrier to engagement in the HIV prevent...

Background: Among men who have sex with men (MSM), there is now clear evidence that the risk of HIV transmission through condomless sex when the HIV-positive partner is virally suppressed is effectively zero. However, an understanding of the accuracy of reporting of viral load among serodiscordant same-sex male couples is missing from the literatu...

Background: Despite recent reductions, youth substance use continues to be a concern in the United States. Structured primary care screening is recommended, but not widely implemented. The purpose of this study was to describe substance use screening in a large academic medical center, assess related factors, and evaluate screening documentation to...

Background: Despite recent reductions, youth substance use continues to be a concern in the United States. Structured primary care substance use screening among adolescents is recommended, but not widely implemented. The purpose of this study was to describe the distribution and characteristics of adolescent substance use screening in outpatient cl...

Purpose: This article outlines the process of establishing the Trans Youth Care Research Network, composed of four academic clinics providing care for transgender and gender-diverse (TGD) youth. The Network was formed to design and implement research studies to better understand physiologic and psychosocial outcomes of gender-affirming medical care...

Background Antiretroviral therapy adherence remains a challenge, particularly for young African American men who have sex with men (YAAMSM). We enrolled 40 YAAMSM for 3 months of electronic adherence monitoring (EAM). These data may be useful in developing an antiretroviral EAM intervention that responds to missed doses with real-time text messages...

Intimate partner violence (IPV) among male couples is increasingly recognized as a public health concern. Research on IPV in opposite sex couples indicates frequent underreporting of IPV and high levels of discordance in reporting among dyads. Concordance studies inform refinement methods to measure the experience of IPV among dyads; however the la...

BACKGROUND HIV continues to have a disparate impact on youth assigned male at birth who have male sexual partners – young men who have sex with men (YMSM), young trans women (YTW), and gender nonconforming (GNC) youth. Outcomes are generally worse among youth of color. Experiences of discrimination and marginalization often limit educational attain...

BACKGROUND Young men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth of color face substantial economic and health disparities. In particular, HIV risk and infection among these groups remains a significant public health issue. In 2017, 17% of all new HIV diagnoses were attributed to male-to-male se...

To understand developmental milestones among young transgender women (YTW), we mapped age estimates per milestone by race/ethnicity and cohort age using baseline data from Project Lifeskills (n=298). Compared with older and white participants, younger black, Latina, Asian, and other/mixed race transgender (trans) women reported earlier experiences...

Background: Transgender children and adolescents (ie, those who experience incongruence between assigned sex at birth and internal gender identity) are poorly understood and an understudied population in the United States. Since 2008, medical care for transgender youth has generally followed guidelines developed by professional consensus, given th...

Objective: To report on the use of an eye-tracking retrospective think-aloud for usability evaluation and to describe its application in assessing the usability of a mobile health app. Materials and methods: We used an eye-tracking retrospective think-aloud to evaluate the usability of an HIV prevention mobile app among 20 young men (15-18 years...

An estimated one- to two-thirds of incident HIV infections among U.S. men who have sex with men (MSM) occur within the context of a primary relationship. The existing, yet limited, literature on sexual risk behavior among same-sex couples suggests that MSM with main partners are more often to report having lower perceived HIV risk, higher unrecogni...

Male couples often formulate sexual agreements, but little is known about the extent to which partners concur about their exact terms. Disagreements, particularly with respect to sex outside the relationship, may induce stress and potentially increase the risk of HIV and other sexually transmitted infections. Our study sought to describe concordanc...

BACKGROUND Transgender children and adolescents, those who experience incongruence between assigned sex at birth and internal gender identity, are a poorly understood and understudied population in the United States. Since 2008, medical care for transgender youth has generally followed guidelines developed by professional consensus given the paucit...

Objectives Our study team adapted the MyPEEPS (Male Youth Pursuing Empowerment, Education, and Prevention around Sexuality) curriculum, an evidence-based human immunodeficiency virus (HIV) prevention intervention, from a face-to-face, group-based intervention to an individual-level mobile responsive web-based intervention to improve HIV risk behavi...