Publications by authors named "Robert Garofalo"

143 Publications

A Uniquely Targeted, Mobile App-Based HIV Prevention Intervention for Young Transgender Women: Adaptation and Usability Study.

J Med Internet Res 2021 Mar 31;23(3):e21839. Epub 2021 Mar 31.

Fenway Institute, Boston, MA, United States.

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 group-based intervention to a mobile app, Project LifeSkills, to reduce HIV risk among YTW, and to test its acceptability and usability.

Methods: The group-based intervention was adapted to a mobile app, LifeSkills Mobile, with input from an expert advisory group and feedback from YTW collected during user-centered design sessions. A beta version of the app was then tested in a usability evaluation using a think-aloud protocol with debriefing interviews, recordings of screen activity, and assessments of usability via the Post-Study System Usability Questionnaire (PSSUQ) and the Health Information Technology Usability Evaluation Scale (Health-ITUES).

Results: YTW (n=8; age: mean 24 years, SD 3 years; racial or ethnic minority: 7/8, 88%) provided feedback on the app prototype in design sessions and then tested a beta version of the app in a usability trial (n=10; age: mean 24 years, SD 3 years; racial or ethnic minority: 8/10, 80%). Both usability ratings (Health-ITUES: mean 4.59, SD 0.86; scale range: 1-5) and ratings for satisfaction and accessibility (PSSUQ: mean 4.64, SD 0.90; scale range 1-5) were in the good to excellent range. No functional bugs were identified, and all mobile activities were deployed as expected. Participant feedback from the usability interviews indicated very good salience of the intervention content among the focal population. Participants' suggestions to further increase app engagement included adding animation, adding audio, and reducing the amount text.

Conclusions: We conclude that the LifeSkills Mobile app is a highly usable and engaging mobile app for HIV prevention among YTW.
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http://dx.doi.org/10.2196/21839DOI Listing
March 2021

Psychosocial Problems and Vulnerability to HIV in a Multi-City Prospective Cohort of Young Transgender Women in the United States: A Structural Equation Modeling Study.

J Acquir Immune Defic Syndr 2021 Apr;86(5):544-551

Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI.

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). YTW were recruited in Boston, MA, and Chicago, IL, between 2012 and 2015 and completed study assessment visits at baseline and months 4 and 12.

Methods: Using autoregressive structural equation modeling, we examined whether poor social support and psychological distress at 4 months mediate the prospective relationship between gender-based stigma at baseline and condomless anal and vaginal sex (CAVS) acts at 4 and 12 months; all models were adjusted for treatment arm, HIV serostatus, study site, and sociodemographics.

Results: Gender-based stigma at baseline was directly associated with increased CAVS at 4 months [adjusted incidence rate ratio (aIRR) = 1.18, 95% confidence interval (CI): (1.05 to 1.33)] and 12 months [aIRR = 1.17, 95% CI: (1.02 to 1.34)]. Gender-based stigma was also associated with higher psychological distress at 4 months [b = 0.70, 95% CI: (0.13 to 1.27)], which in turn was marginally associated with increased CAVS at 12 months [aIRR = 1.03, 95% CI: (1.00 to 1.06)]. Contrary to expectations, poor social support at 4 months was associated with decreased CAVS at 12 months [aIRR = 0.40, 95% CI: (0.28 to 0.59)].

Conclusions: Future HIV prevention interventions with YTW should consider addressing experiences of gender-based stigma and the psychological distress that may ensue from gender-based stigma. More research is needed to understand the influence of poor social support on sexual behaviors in this population.
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http://dx.doi.org/10.1097/QAI.0000000000002615DOI Listing
April 2021

Histrelin Implants for Suppression of Puberty in Youth with Gender Dysphoria: A Comparison of 50 mcg/Day (Vantas) and 65 mcg/Day (SupprelinLA).

Transgend Health 2021 Feb 15;6(1):36-42. Epub 2021 Feb 15.

Child and Adolescent Gender Center, Benioff Children's Hospital-San Francisco, University of California San Francisco, San Francisco, California, USA.

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 have a pediatric indication, it is anecdotally being used in pediatric gender centers throughout the United States because of its substantially lower cost. This retrospective study aimed to determine if both implants were effective in suppressing the hypothalamic-pituitary-gonadal axis in early-to-mid pubertal youth with gender dysphoria. Youth with gender dysphoria receiving care at the Center for Transyouth Health and Development at Children's Hospital Los Angeles (CHLA) or participants from an ongoing observational trial with a histrelin implant placed for pubertal suppression at Tanner stage 2 or 3 were included. Sex steroid (testosterone or estradiol) and gonadotropin measurements at baseline (T0) and then 2 to 12 months following implant placement (T1) were abstracted from medical records. Of the 66 eligible participants, 52% were designated female at birth. Most participants were white (60.6%). Twenty participants (30.3%) had a Vantas implant and 46 (69.7%) had a SupprelinLA implant. Mean age of insertion was 11.3 years. Gonadotropin and sex steroid levels were significantly decreased at T1 (2-12 months after insertion of implant), with no differences between implants. These results indicate that both implants are effective in suppressing puberty in early-to-mid pubertal youth with gender dysphoria. These data may inform decisions about insurance coverage of Supprelin and/or Vantas for youth with gender dysphoria.
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http://dx.doi.org/10.1089/trgh.2020.0055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906230PMC
February 2021

Stronger Together: Results from a Randomized Controlled Efficacy Trial of a Dyadic Intervention to Improve Engagement in HIV Care Among Serodiscordant Male Couples in Three US Cities.

AIDS Behav 2021 Feb 25. Epub 2021 Feb 25.

Center for LGBTQ Advocacy, Research, and Health, UCLA, Los Angeles, CA, USA.

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 reports on the results of a randomized controlled trial to assess the efficacy of Stronger Together, a dyadic counseling intervention aimed at increasing engagement in and optimizing HIV care among serodiscordant male couples in Atlanta, GA, Boston, MA, and Chicago, IL. Between 2014 and 2017, 159 male serodiscordant couples (total N = 318) in Atlanta, GA, Boston, MA, and Chicago, IL were enrolled and equally randomized to either the Stronger Together intervention arm (a three-session dyadic intervention involving HIV testing and adherence counseling) or a standard of care (SOC) control arm. Couples completed individual study assessments via an audio computer assisted self-interviewing (ACASI) system at baseline, 6, 12 and 18 months. Primary outcomes included being prescribed and currently taking ART, and fewer missed doses of ART in the past 30 days; because the trial was not powered to examine viral suppression, we examined this as an exploratory outcome. Longitudinal data analysis was by an intention-to-treat approach. Participants ages ranged from 18 to 69 (mean = 35.9), and are predominantly white (77.5%), and college educated (68.4% earned a college degree or higher). Participants randomized to the Stronger Together arm had a significantly greater odds of being prescribed and currently taking ART over time than those in the SOC arm (at 12 months OR 2.75, 95%CI 1.35-4.67, p-value 0.020, and at 18 months OR 2.91, 95%CI 1.61-4.88, p-value 0.013). Similarly, those in the Stronger Together arm had a significantly lower odds of missing a dose of ART in the past 30 days over time compared to those in the SOC arm (at 12 months OR 0.28, 95%CI 0.09-0.81, p-value 0.019, and at 18 months OR 0.25, 95%CI 0.07-0.82, p-value 0.023). Among male couples in serodiscordant relationships, the Stronger Together intervention resulted in significantly improved HIV treatment outcomes at both 12 and 18 months of follow-up. This trial is the first to date to demonstrate evidence of efficacy for a dyadic counseling intervention and has the potential to fill a critical gap in secondary HIV prevention interventions for serodiscordant male couples.
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http://dx.doi.org/10.1007/s10461-021-03199-8DOI Listing
February 2021

Young Transgender Women Survivors of Intimate Partner Violence: A Latent Class Analysis of Protective Processes.

Psychol Sex Orientat Gend Divers 2020 Dec 23;7(4):386-395. Epub 2020 Mar 23.

Division of Adolescent Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago,Chicago, Illinois.

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 internalizing mental health symptoms among young transgender women (YTW) survivors of IPV. Data from Project LifeSkills (2012-2015), a multisite trial for HIV sexual risk reduction intervention, were used for the present study. A subsample of 78 YTW (ages 16 to 29) who were IPV survivors (i.e., indicated lifetime IPV) were included in the analyses. Participants completed measures of general social support, perceived social support from their mother and friends, and collective self-esteem, as well as mental health symptoms. Three latent classes emerged: 1) YTW who perceived high levels of social support and collective self-esteem (48%), 2) YTW who perceived low levels of collective self-esteem, but average to high levels of social support from mother and friends (23%), and 3) YTW who perceived low levels of collective self-esteem and low to average levels of social support from mother and friends (29%). YTW in the overall low class had significantly higher levels of depressive, anxiety, and somatization symptoms, compared to the other two classes. These findings highlight how low levels of social support and collective self-esteem can place YTW survivors of IPV at significant risk for experiencing negative internalizing mental health symptoms.
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http://dx.doi.org/10.1037/sgd0000379DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7781223PMC
December 2020

Consensus Parameter: Research Methodologies to Evaluate Neurodevelopmental Effects of Pubertal Suppression in Transgender Youth.

Transgend Health 2020 11;5(4):246-257. Epub 2020 Dec 11.

Potocsnak Family Division of Adolescent and Young Adult Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.

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 occur during puberty, a critical question is whether this treatment impacts neurodevelopment. A Delphi consensus procedure engaged 24 international experts in neurodevelopment, gender development, puberty/adolescence, neuroendocrinology, and statistics/psychometrics to identify priority research methodologies to address the empirical question: is pubertal suppression treatment associated with real-world neurocognitive sequelae? Recommended study approaches reaching 80% consensus were included in the consensus parameter. The Delphi procedure identified 160 initial expert recommendations, 44 of which ultimately achieved consensus. Consensus study design elements include the following: a minimum of three measurement time points, pubertal staging at baseline, statistical modeling of sex in analyses, use of analytic approaches that account for heterogeneity, and use of multiple comparison groups to minimize the limitations of any one group. Consensus study comparison groups include untreated transgender youth matched on pubertal stage, cisgender (i.e., gender congruent) youth matched on pubertal stage, and an independent sample from a large-scale youth development database. The consensus domains for assessment includes: mental health, executive function/cognitive control, and social awareness/functioning. An international interdisciplinary team of experts achieved consensus around primary methods and domains for assessing neurodevelopmental effects (i.e., benefits and/or difficulties) of pubertal suppression treatment in transgender youth.
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http://dx.doi.org/10.1089/trgh.2020.0006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7759272PMC
December 2020

Opportunities to Harness Technology to Deliver HIV Prevention / Healthy Sexuality Programming to Sexual and Gender Minority Adults Living in East Africa.

AIDS Behav 2021 Apr 29;25(4):1120-1128. Epub 2020 Oct 29.

Division Chief of Adolescent Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Department of Pediatrics, Northwestern University, Chicago, IL, USA.

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 important yet sensitive sexual health information in a stigma-free, anonymous atmosphere. We explored the feasibility of recruiting and surveying East African SGM adults online, and examined their interest in technology-based sexual health programming. Over a 14-month period, 2451 respondents were surveyed. They were, on average, 26.7 years of age. Fifty-four percent identified as lesbian, gay, and/or bisexual (LGB); a similar percentage (49%) reported having sex with a same-sex partner. Sixteen percent identified as gender minority (i.e. transgender or non-binary); and 29% were assigned female at birth. Almost half (48%) of SGM adults expressed interest in an SGM-focused healthy sexuality program delivered online. Enthusiasm also was noted for email (43%) and text messaging (41%). Compared to face-to-face settings, technology-based settings were more commonly  appraised  as the safest mode through which one could engage in sexual health programming. People who had a same sex partner and those who identified as sexual minority were especially likely to want to engage in technology-based programs. Interest in technology-based programming was similar for adults across gender identities, sex assigned at birth, and age however. Findings suggest that technology may be an underutilized opportunity to reach and engage SGM East Africans in a safe and private manner. Given levels of acceptability indicated by SGM adults across age, sex assigned at birth, and gender and sexual identities in this study, it seems possible that technology-based sexual health and HIV prevention and intervention programs could have the potential to be transformative in East Africa.
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http://dx.doi.org/10.1007/s10461-020-03059-xDOI Listing
April 2021

Comparison of Gender Minority Stress and Resilience Among Transmasculine, Transfeminine, and Nonbinary Adolescents and Young Adults.

J Adolesc Health 2021 Mar 10;68(3):615-618. Epub 2020 Oct 10.

Pritzker Department of Psychiatry and Behavioral Health, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois; Potocsnak Family Division of Adolescent Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois; Department of Psychiatry & Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

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 and nonbinary groups were examined using one-way analyses of variance and Tukey's honestly significant difference post hoc tests.

Results: Participants were 638 transgender and nonbinary AYA (65.5% transmasculine, 24.6% transfeminine, and 9.9% nonbinary). Transmasculine and transfeminine AYA reported more discrimination (ps = .008 and .006, respectively) compared to non-binary AYA. Transfeminine and nonbinary AYA reported more negative future expectations (ps = .006 and .016, respectively) and pride (ps ≤ .001 and .032, respectively) than transmasculine AYA.

Conclusions: Findings suggest that transmasculine, transfeminine, and nonbinary AYA experience different levels of gender minority stress and resilience. Future research is warranted to further examine between-group differences and differential impact on mental health outcomes.
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http://dx.doi.org/10.1016/j.jadohealth.2020.06.014DOI Listing
March 2021

Examining the Longitudinal Predictive Relationship Between HIV Treatment Outcomes and Pre-exposure Prophylaxis Use by Serodiscordant Male Couples.

J Acquir Immune Defic Syndr 2021 Jan;86(1):38-45

Department of Epidemiology, Brown University School of Public Health, Providence, RI.

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 behaviors. We examined the longitudinal relationship between favorable HIV treatment outcomes with current PrEP use among HIV serodiscordant male partners.

Setting: Data are from Project Stronger Together, a randomized controlled trial that recruited serodiscordant male couples from Atlanta, GA; Boston, MA; and Chicago, IL.

Methods: Serodiscordant couples completed assessments at baseline, 6, 12, 18, and 24 months. We analyzed longitudinal data from 120 HIV serodiscordant male partners to assess the relationship between the HIV-negative partner's current PrEP use and their HIV-positive partner's current ART use, ART adherence, and viral load using generalized estimating equation models.

Results: Fewer than half of the HIV-negative partners were on PrEP at baseline and nearly two-thirds of their HIV-positive partners were virally suppressed. HIV-negative male partners who had partners with an undetectable viral load had greater odds of being a current PrEP user than HIV-negative partners with partners with a detectable viral load.

Conclusion: Our study highlights the need to develop dyad-level interventions to improve HIV medication use/adherence by HIV serodiscordant male couples. Our findings also suggest that dyad-level interventions may be able to leverage our understanding of how partners can influence each other's health-promoting behaviors to develop programs that improve health outcomes for both partners.
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http://dx.doi.org/10.1097/QAI.0000000000002522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736462PMC
January 2021

Transgender Youths' Perspectives on Telehealth for Delivery of Gender-Affirming Care.

J Adolesc Health 2020 Sep 23. Epub 2020 Sep 23.

UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, Pittsburgh, Pennsylvania; University of Pittsburgh, Pittsburgh, Pennsylvania.

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 relationships between demographic and gender-related characteristics and interest in receiving care via telemedicine.

Results: Almost half (47%) of the 204 youth surveyed expressed interest in receiving gender care via telemedicine. Additionally, youth with lower levels of perceived parental support were more likely to express an interest in utilizing telemedicine (p = .001). Approximately half (45%) of youth were interested in receiving gender care in the primary care setting, with a majority expressing willingness to do so if their primary care provider had telehealth support.

Conclusions: Many transgender youth expressed interest in receiving gender care via telehealth, particularly for ongoing care and monitoring. Increased interest in telemedicine was seen among youth with lower perceived parental support.
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http://dx.doi.org/10.1016/j.jadohealth.2020.08.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7510534PMC
September 2020

Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting.

JMIR Res Protoc 2020 Sep 11;9(9):e18051. Epub 2020 Sep 11.

Department of Medicine, University of Chicago, Chicago, IL, United States.

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 and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2.

Objective: This paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting.

Methods: The employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy.

Results: Phase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot.

Conclusions: This study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned.

Trial Registration: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310.

International Registered Report Identifier (irrid): DERR1-10.2196/18051.
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http://dx.doi.org/10.2196/18051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7519435PMC
September 2020

Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting.

JMIR Res Protoc 2020 Sep 11;9(9):e18051. Epub 2020 Sep 11.

Department of Medicine, University of Chicago, Chicago, IL, United States.

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 and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2.

Objective: This paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting.

Methods: The employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy.

Results: Phase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot.

Conclusions: This study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned.

Trial Registration: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310.

International Registered Report Identifier (irrid): DERR1-10.2196/18051.
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http://dx.doi.org/10.2196/18051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7519435PMC
September 2020

Psychosocial Characteristics of Transgender Youth Seeking Gender-Affirming Medical Treatment: Baseline Findings From the Trans Youth Care Study.

J Adolesc Health 2020 Aug 21. Epub 2020 Aug 21.

Division of Adolescent and Young Adult Medicine, Center for Transyouth Health and Development, Children's Hospital Los Angeles, Los Angeles, California; Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, California.

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 centers in the U.S. before initiating medical treatment for gender dysphoria either with gonadotropin-releasing hormone agonists (GnRHa) or gender-affirming hormones (GAH). GnRHa cohort data were collected from youth and a parent; GAH cohort data were collected from youth only.

Results: A total of 95 youth were enrolled in the GnRHa cohort. Mean age was 11.22 years (standard deviation = 1.46), and the majority were white (52.6%) and designated male at birth (51.6%). Elevated depression symptoms were endorsed by 28.6% of GnRHa cohort youth, and 22.1% endorsed clinically significant anxiety. Approximately one fourth (23.6%) endorsed lifetime suicidal ideation, with 7.9% reporting a past suicide attempt. A total of 316 youth were enrolled in the GAH cohort. The mean age was 16.0 years (standard deviation = 1.88), and the majority were white (62%) and designated female at birth (64.9%). Elevated depression symptoms were endorsed by 51.3% of the GAH cohort, and 57.3% endorsed clinically significant anxiety. Two-thirds (66.6%) endorsed lifetime suicidal ideation, with 24.6% reporting a past suicide attempt. Life satisfaction was lower among both cohorts compared with population-based norms.

Conclusions: GnRHa cohort youth appear to be functioning better from a psychosocial standpoint than GAH cohort youth, pointing to possible benefits of accessing gender-affirming treatment earlier in life.
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http://dx.doi.org/10.1016/j.jadohealth.2020.07.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897328PMC
August 2020

Low Bone Mineral Density in Early Pubertal Transgender/Gender Diverse Youth: Findings From the Trans Youth Care Study.

J Endocr Soc 2020 Sep 2;4(9):bvaa065. Epub 2020 Jul 2.

Division of Pediatric Endocrinology, Department of Pediatrics, University of California, San Francisco, San Francisco, California.

Context: Transgender youth may initiate GnRH 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 before gender-affirming therapy, but little is known about BMD in early-pubertal transgender youth.

Objective: To describe BMD in early-pubertal transgender youth.

Design: Cross-sectional analysis of the prospective, observational, longitudinal Trans Youth Care Study cohort.

Setting: Four multidisciplinary academic pediatric gender centers in the United States.

Participants: Early-pubertal transgender youth initiating GnRHa.

Main Outcome Measures: Areal and volumetric BMD Z-scores.

Results: Designated males at birth (DMAB) had below-average BMD Z-scores when compared with male reference standards, and designated females at birth (DFAB) had below-average BMD Z-scores when compared with female reference standards except at hip sites. At least 1 BMD Z-score was < -2 in 30% of DMAB and 13% of DFAB. Youth with low BMD scored lower on the Physical Activity Questionnaire for Older Children than youth with normal BMD, 2.32 ± 0.71 vs. 2.76 ± 0.61 ( = 0.01). There were no significant deficiencies in vitamin D, but dietary calcium intake was suboptimal in all youth.

Conclusions: In early-pubertal transgender youth, BMD was lower than reference standards for sex designated at birth. This lower BMD may be explained, in part, by suboptimal calcium intake and decreased physical activity-potential targets for intervention. Our results suggest a potential need for assessment of BMD in prepubertal gender-diverse youth and continued monitoring of BMD throughout the pubertal period of gender-affirming therapy.
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http://dx.doi.org/10.1210/jendso/bvaa065DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7433770PMC
September 2020

Awareness, Willingness, and Perceived Efficacy of Pre-exposure Prophylaxis among Adolescent Sexual Minority Males.

J Urban Health 2020 10;97(5):749-757

Columbia University, School of Nursing, New York, NY, USA.

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 behavioral HIV prevention intervention. A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV. On the other hand, only about one third (34.6%) of participants indicated that taking a daily HIV pill would be "very" or "completely" effective in preventing HIV when having sex without a condom. These findings suggest that high awareness and willingness to use PrEP across various adolescent subgroups present opportunities for increased PrEP advocacy among this young age group.
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http://dx.doi.org/10.1007/s11524-020-00447-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7560632PMC
October 2020

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 1): Protocol for Determining Essential Intervention Components Using Qualitative Interviews and Focus Groups.

JMIR Res Protoc 2020 Aug 10;9(8):e16384. Epub 2020 Aug 10.

Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.

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 more directly limit access to gainful employment. Though seemingly distal, these experiences influence young people's proximity to HIV risk by limiting their access to health care and potentially moving them toward sex work as a means of income as well as increased substance use. Work2Prevent (W2P) aims to achieve economic stability through employment as a structural-level intervention for preventing adolescent and young adult HIV infection. The study will pilot-test an effective, theoretically driven employment program (increased individual income and independence [iFOUR]), for HIV-positive adults, and adapt it to the needs of black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years who are vulnerable to HIV exposure.

Objective: This paper aimed to describe the protocol for the exploratory phase of W2P. The purpose of this phase was to determine the essential components needed for a structural-level employment intervention aimed at increasing job-seeking self-efficacy and career readiness among black and Latinx YMSM, YTW, and GNC youth aged 16 to 24 years.

Methods: The exploratory phase of the W2P study consisted of in-depth interviews and focus groups with members of the target community as well as brief interviews with lesbian, gay, bisexual, transgender, and queer (LGBTQ)-inclusive employers. The study team will conduct in-depth interviews with up to 12 YMSM and 12 YTW and GNC youth, up to 10 focus groups with a maximum of 40 YMSM and 40 YTW and GNC youth, and up to 40 brief interviews with LGBTQ-inclusive employers. Participants will be recruited through a community-based recruiter, passive recruitment in community spaces and on social media, and active recruitment by research staff in community spaces serving LGBTQ youth.

Results: In-depth interviews were conducted with 21 participants, and 7 focus groups were conducted with 46 participants in total. In addition, 19 brief interviews with LGBTQ-inclusive employers were conducted. The analysis of the data is underway.

Conclusions: Preliminary findings from the formative phase of the study will be used to inform the tailoring and refinement of the iFOUR adult-based intervention into the youth-focused W2P intervention curriculum. Perspectives from YMSM, YTW, GNC youth, and LGBTQ-inclusive employers offer a multidimensional view of the barriers and facilitators to adolescent and young adult LGBTQ employment. This information is critical to the development of a culturally appropriate and relevant youth-focused intervention.

Trial Registration: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310.

International Registered Report Identifier (irrid): DERR1-10.2196/16384.
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http://dx.doi.org/10.2196/16384DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7445600PMC
August 2020

An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability.

JMIR Res Protoc 2020 Aug 10;9(8):e16401. Epub 2020 Aug 10.

Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.

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 male-to-male sexual contact among adolescents and young adults aged 13 to 24 years. However, such disparities cannot be attributed to individual-level factors alone but rather are situated within larger social and structural contexts that marginalize and predispose YMSM, YTW, and GNC youth of color to increased HIV exposure. Addressing social and structural risk factors requires intervention on distal drivers of HIV risk, including employment and economic stability. The Work2Prevent (W2P) study aims to target economic stability through job readiness and employment as a structural-level intervention for preventing adolescent and young adult HIV among black and Latinx YMSM, YTW, and GNC youth. This study seeks to assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce sexual risk behaviors.

Objective: The goal of the research is to pilot-test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color. This intervention was adapted from Increased Individual Income and Independence, an existing evidence-based employment program for HIV-positive adults during phase 1 of the W2P study.

Methods: The employment intervention will be pilot-tested among vulnerable YMSM, YTW, and GNC youth of color in a single-arm pre-post trial to assess feasibility, acceptability, and preliminary estimates of efficacy.

Results: Research activities began in March 2018 and were completed in November 2019. Overall, 5 participants were enrolled in the pretest and 51 participants were enrolled in the pilot.

Conclusions: Interventions that address the social and structural drivers of HIV exposure and infection are sorely needed in order to successfully bend the curve in the adolescent and young adult HIV epidemic. Employment as prevention has the potential to be a scalable intervention that can be deployed among this group.

Trial Registration: ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310.

International Registered Report Identifier (irrid): DERR1-10.2196/16401.
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http://dx.doi.org/10.2196/16401DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7445605PMC
August 2020

Preliminary Results from a Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Young Men.

Stud Health Technol Inform 2020 Jun;270:1365-1366

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.

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 months (p=0.0156) were reported by the intervention group compared to control. Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001). Preliminary results indicate that some sexual risk behaviors were reduced among the intervention group in the preliminary analytic sample.
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http://dx.doi.org/10.3233/SHTI200444DOI Listing
June 2020

A chart review of substance use screening and related documentation among adolescents in outpatient pediatric clinics: implications for practice.

Subst Abuse Treat Prev Policy 2020 05 25;15(1):36. Epub 2020 May 25.

The Potocsnak Family Division of Adolescent & Young Adult Medicine, Ann & Robert H. Lurie Children's Hospital, 225 E. Chicago Avenue, Box 161, Chicago, IL, 60611, USA.

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 clinics in a large academic medical center and assess related factors (i.e., patient age, race/ethnicity, gender, and insurance type) to inform and improve the quality of substance use screening in practice.

Methods: We abstracted a random sample of 127 records of patients aged 12-17 and coded clinical notes (e.g., converted open-ended notes to discrete values) to describe screening cases and related characteristics (e.g., which substances screened, how screened). We then analyzed descriptive patterns within the data to calculate screening rates, characteristics of screening, and used multiple logistic regression to identify related factors.

Results: Among 127 records, rates of screening by providers were 72% (each) for common substances (alcohol, marijuana, tobacco). The primary method of screening was use of clinical mnemonic cues rather than standardized screening tools. A total of 6% of patients reported substance use during screening. Older age and racial/ethnic minority status were associated with provider screening in multiple logistic regression models.

Conclusions: Despite recommendations, low rates of structured screening in primary care persist. Failure to use a standardized screening tool may contribute to low screening rates and biased screening. These findings may be used to inform implementation of standardized and structured screening in the clinical environment.

Clinical Trial Registration: not applicable.
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http://dx.doi.org/10.1186/s13011-020-00276-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7249384PMC
May 2020

Physiological and Metabolic Characteristics of a Cohort of Transgender and Gender-Diverse Youth in the United States.

J Adolesc Health 2020 09 14;67(3):376-383. Epub 2020 May 14.

Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts.

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 for pubertal suppression or gender-affirming hormone treatment. Anthropometric and laboratory measurements were abstracted from the medical chart. Baseline characteristics including height, weight, body mass index, blood pressure, and laboratory measurements were compared with those of age-matched National Health and Nutritional Examination Survey comparison group.

Results: Seventy-eight TGD youth with a median age of 11 years (range 8-14 years) were recruited before pubertal suppression, of whom 41 (53%) were designated male at birth, and 296 participants with a median age of 16 years (range 12-20 years) were recruited before beginning gender-affirming hormones, of whom 99 (33%) were designated male at birth. The mean high-density lipoprotein cholesterol was lower in the study participants when compared with that of National Health and Nutritional Examination Survey participants (50.6 ± 12.3 mg/dL vs. 53.3 ± 13.3 mg/dL, p = .001). Otherwise, the study cohorts were similar in terms of body mass index, proportion of overweight and obesity, blood pressure, and baseline laboratory variables.

Conclusions: Before starting gender-affirming treatment, TGD youth are physiologically similar to the general population of children and adolescents in the United States, with the exception of slightly lower high-density lipoprotein cholesterol. Evaluation of this cohort over time will define the physiological effects of pubertal blockade and gender-affirming hormone treatment.
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http://dx.doi.org/10.1016/j.jadohealth.2020.03.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7483238PMC
September 2020

Patterns of Exposure to Socio-structural Stressors and HIV Care Engagement Among Transgender Women of Color.

AIDS Behav 2020 Nov;24(11):3155-3163

The Potocsnak Family Division of Adolescent and Young Adult Medicine, Ann & Robert H. Lurie Children's Hospital, Chicago, IL, USA.

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) were median age 29 and 86% non-Hispanic Black. Lack of resources, unemployment, and housing instability were reported by over 50%, and 41% reported history of incarceration. Latent class analysis identified 2 distinct classes representing higher and lower levels of social adversity. In latent class regression, membership in the higher social adversity class was associated with statistically significantly lower odds of viral suppression and HIV care engagement in univariate analysis; when adjusted for age, race, and recruitment site the association remained statistically significant for viral suppression (aOR 0.38, 95% CI 0.18-0.79; chi-square = 6.681, d.f. = 1, p = 0.010), though not for HIV care engagement. Our findings highlight the impact of socio-structural barriers on engagement in the HIV care continuum among transgender women.
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http://dx.doi.org/10.1007/s10461-020-02874-6DOI Listing
November 2020

A Dyadic Perspective on Sexual Agreements Among Same-Sex Male Couples in the United States.

AIDS Behav 2020 Nov;24(11):3107-3123

Center for Sexuality and Health Disparities, University of Michigan, Ann Arbor, MI, USA.

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 on the responses of just one partner. Understanding that relationship quality and decisions about sexual agreements are inherently influenced by both partners, the present analysis uses dyadic-level data to examine the sexual agreements among 199 HIV serodiscordant and seroconcordant male dyads (n = 398 individuals). Specifically, the analysis examines measures of love, trust, and conflict style as they relate to (1) the type of agreement established, (2) concordance in agreement reporting, (3) satisfaction with the agreement, and (4) broken agreements. A discrepancy in love between partners was associated with the type of agreement established, whether they reported the same agreement type, and whether one of the partners reported a broken agreement, but it was not associated with either partner's satisfaction with the agreement. A discrepancy in trust was associated with agreement concordance and agreement breaks, but it was not associated with the type of agreement established or satisfaction with the agreement. Lastly, a discrepancy in conflict style was associated with each of the agreement outcomes. Future research and intervention efforts should focus on understanding the behavioral and communication skills necessary for couples to make successful sexual agreements.
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http://dx.doi.org/10.1007/s10461-020-02865-7DOI Listing
November 2020

A Mobile Sexual Health App on Empowerment, Education, and Prevention for Young Adult Men (MyPEEPS Mobile): Acceptability and Usability Evaluation.

JMIR Form Res 2020 Apr 7;4(4):e17901. Epub 2020 Apr 7.

School of Nursing, Columbia University, New York, NY, United States.

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 prevention and sexual health education smartphone app initially created to promote sexual health and HIV prevention among adolescent sexual minority young men aged 13 to 18 years.

Objective: The objective of this study was to critically appraise the acceptability and usability of MyPEEPS Mobile for young adult MSM aged 19 to 25 years.

Methods: Study participants used the mobile app, completed usability questionnaires and in-depth interviews, and reported their experience using the app. Analysis of interview data was guided by the Unified Theory of Acceptance and Use of Technology (UTAUT) to better understand the usability and acceptability of this intervention for young adults. Interview data were coded using the following constructs from the UTAUT model: performance expectancy, effort expectancy, and social influence.

Results: A total of 20 young adult MSM (n=10 in Chicago, Illinois, and n=10 in New York, New York) were enrolled in the study. Participants reported that MyPEEPS Mobile was free of functional problems (Health Information Technology Usability Evaluation Scale scores and Post-Study System Usability Questionnaire scores consistent with high usability), easy to use, and useful, with an engaging approach that increased acceptability, including the use of avatars and animation, and inclusive representation of the diverse identities by race and ethnicity, gender identity, and sexual orientation. Recommended areas for improving MyPEEPS Mobile for the target demographic included more adult-oriented graphics, advanced educational content, scenarios for youth with more sexual experience, and search function to increase accessibility of key content.

Conclusions: Overall, young adult MSM aged 19 to 25 years described the MyPEEPS Mobile as educational, informative, and usable for their sexual health education and HIV prevention needs, and they provided actionable recommendations to optimize its use and applicability for this age group.
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http://dx.doi.org/10.2196/17901DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7175191PMC
April 2020

Longitudinal cohort of HIV-negative transgender women of colour in New York City: protocol for the TURNNT ('Trying to Understand Relationships, Networks and Neighbourhoods among Transgender women of colour') study.

BMJ Open 2020 04 1;10(4):e032876. Epub 2020 Apr 1.

Department of Epidemiology, Columbia University Mailman School of Public Health, New York, New York, USA

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 to Understand Relationships, Networks and Neighbourhoods among Transgender women of colour') study. In collaboration with communities of transgender women of colour, TURNNT aims to explore the complex social and environmental (ie, neighbourhood) structures that affect HIV prevention and other aspects of health in order to identify avenues for intervention.

Methods And Analyses: TURNNT is a prospective cohort study, which will recruit 300 transgender women of colour (150 Black/African American, 100 Latina and 50 Asian/Pacific Islander participants) in New York City. There will be three waves of data collection separated by 6 months. At each wave, participants will provide information on their relationships, social and sexual networks, and neighbourhoods. Global position system technology will be used to generate individual daily path areas in order to estimate neighbourhood-level exposures. Multivariate analyses will be conducted to assess cross-sectional and longitudinal, independent and synergistic associations of personal relationships (notably individual social capital), social and sexual networks, and neighbourhood factors (notably neighbourhood-level social cohesion) with PrEP uptake and discontinuation.

Ethics And Dissemination: The TURNNT protocol was approved by the Columbia University Institutional Review Board (reference no. AAAS8164). This study will provide novel insights into the relationship, network and neighbourhood factors that influence HIV prevention behaviours among transgender women of colour and facilitate exploration of this population's health and well-being more broadly. Through community-based dissemination events and consultation with policy makers, this foundational work will be used to guide the development and implementation of future interventions with and for transgender women of colour.
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http://dx.doi.org/10.1136/bmjopen-2019-032876DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7170618PMC
April 2020

Prevalence and Risk Factors of Nonmedical Prescription Opioid Use Among Transgender Girls and Young Women.

JAMA Netw Open 2020 03 2;3(3):e201015. Epub 2020 Mar 2.

Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.

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 than their cisgender peers to report illicit substance use and meet diagnostic criteria for substance use disorders. However, relatively little is known about the experiences of these populations in the current era of opioid addiction and misuse.

Objective: To report the prevalence of and risk factors associated with lifetime nonmedical prescription opioid use in a high-risk community sample of transgender adolescent girls and young women who are sexually active.

Design, Setting, And Participants: This cross-sectional study used 2012 to 2015 baseline data from Project LifeSkills, a randomized clinical trial of a behavioral intervention to reduce the risk of HIV acquisition and transmission among a diverse sample of transgender adolescent girls and young women recruited from Boston, Massachusetts, and Chicago, Illinois. A total of 297 transgender girls and women aged 16 to 29 years who were sexually active were included in this analysis. Data were analyzed from June 2019 to August 2019.

Exposures: Transgender woman identification.

Main Outcomes And Measures: Self-reported lifetime nonmedical prescription opioid use.

Results: Among 297 transgender adolescent girls and young women (mean [SD] age, 23.4 [3.5] years), 145 (48.8%) identified as non-Hispanic/Latinx black, 76 (25.6%) identified as non-Hispanic/Latinx white, 37 (12.5%) identified as Hispanic/Latinx, 7 (2.4%) identified as non-Hispanic/Latinx Asian, and 32 (10.8%) identified as multiracial or other race/ethnicity. Thirty-five participants (11.8%) reported lifetime nonmedical prescription opioid use. Young transgender women who smoked cigarettes monthly or less (adjusted odds ratio, 3.92; 95% CI, 1.10-13.89) and who smoked daily (adjusted odds ratio, 5.69; 95% CI, 1.87-17.33) had greater odds of nonmedical prescription opioid use compared with those who did not smoke. Additionally, participants who identified as a sexual orientation other than heterosexual, gay, lesbian, or bisexual had significantly greater odds of lifetime nonmedical prescription opioid use compared with those who identified as heterosexual (adjusted odds ratio, 3.69; 95% CI, 1.07-12.72).

Conclusions And Relevance: These findings suggest that transgender adolescent girls and young women have similar prevalence of lifetime nonmedical prescription opioid use compared with the US general population prevalence of 12.5%. These findings may serve as a call-to-action for public health surveillance studies and evidence-based interventions to be comprehensively tailored to examine and respond to specific trends of substance use, particularly opioid use disorder, among transgender populations.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.1015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7076341PMC
March 2020

Affirming Transgender Youths' Names and Pronouns in the Electronic Medical Record.

JAMA Pediatr 2020 05;174(5):501-503

Division of General Academic Pediatrics, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.

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http://dx.doi.org/10.1001/jamapediatrics.2019.6071DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042913PMC
May 2020

A randomized controlled efficacy trial of an mHealth HIV prevention intervention for sexual minority young men: MyPEEPS mobile study protocol.

BMC Public Health 2020 Jan 15;20(1):65. Epub 2020 Jan 15.

Columbia University, School of Nursing, New York, NY, USA.

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 interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group.

Methods: This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up.

Discussion: Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group.

Trial Registration: ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.
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http://dx.doi.org/10.1186/s12889-020-8180-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6964028PMC
January 2020

Experience with antiretroviral electronic adherence monitoring among young African American men who have sex with men living with HIV: findings to inform a triaged real-time alert intervention.

AIDS Care 2020 09 15;32(9):1092-1101. Epub 2020 Jan 15.

Massachusetts General Hospital Center for Global Health, Boston, MA, USA.

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 Wisepill device. Participants were interviewed at baseline, in response to the first true adjudicated 1-dose, 3-day, and 7-day misses, and at the end of monitoring. Reasons for missing doses and the acceptability and feasibility of electronic monitoring were assessed using mixed methods. The median participant observation time was 90 days ( = 40). For 21 participants with 90 days of follow-up, <90% and <80% adherence occurred in 82% and 79%, respectively in at least one of their monitored months ( = 63 monitored months). The participants generally found the proposed intervention acceptable and useful. Although seven participants said the device attracted attention, none said it led to disclosure of their HIV status. This study found real-time EAM to be generally acceptable and feasible among YAAMSM living with HIV in Chicago. Future work will develop a triaged real-time EAM intervention including text alerts following detection of nonadherence.
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http://dx.doi.org/10.1080/09540121.2020.1713975DOI Listing
September 2020

Brief Report: Accuracy in Self-Report of Viral Suppression Among HIV-Positive Men With HIV-Negative Male Partners.

J Acquir Immune Defic Syndr 2020 03;83(3):210-214

Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA.

Background: Among men who have sex with men, 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 literature.

Setting: This analysis uses data from the baseline sample of Stronger Together, a randomized controlled efficacy trial of an innovative dyadic intervention to enhance antiretroviral therapy adherence for HIV serodiscordant male couples in 3 US cities (Atlanta, Boston, and Chicago).

Methods: Biomarker-confirmed and self-reported measures of viral load were used to assess the accuracy of self-report of viral suppression. In this descriptive analysis, the percentage of men who inaccurately reported being virally suppressed is compared across demographic, relationship, and HIV care characteristics.

Results: Results confirm those of other recent studies that have shown relatively high levels of inaccuracy in reporting of viral suppression. Although 72.5% of men could accurately report their viral load status, 20% reported that they were virally suppressed when they did not have a biomarker-confirmed measure of viral suppression.

Conclusion: These results highlight the need to provide interventions to men who have sex with men living with HIV to support access to care and ensure current knowledge of viral load and to continue to support primary prevention of HIV through condom use and pre-exposure prophylaxis. For couples, particularly serodiscordant male couples, interventions that can teach the couple how to collaborate to achieve and maintain viral suppression for the positive partner are an urgent and pragmatic programmatic priority that can equip couples with the knowledge required to correctly implement U = U strategies.
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http://dx.doi.org/10.1097/QAI.0000000000002240DOI Listing
March 2020