Sam Wilson Beckham

BACKGROUND Transgender men and transmasculine people who have sex with men (TMSM) are at elevated risk for HIV acquisition, have unmet HIV prevention needs, and have low uptake of antiretroviral pre-exposure prophylaxis (PrEP). To our knowledge, there are no published efficacious behavioral interventions to decrease HIV risk specifically for TMSM; this includes peer-delivered strategies that demonstrate high acceptability in this population. OBJECTIVE This paper describes the development, refinement, and optimization of theory-informed, peer-delivered digital interventions—which were feasible to implement and highly acceptable among the participant population—designed to increase PrEP uptake and adherence among adult transmasculine people who have sex with individuals assigned male at birth within the context of a full-scale, randomized factorial trial. METHODS Between March 2023-March 2025, we used an iterative community-engaged approach that included: (1) community and key stakeholder input, (2) theory- and evidence-informed manualized content with iterative refinement, (3) interventionist training and preparation, and (4) process evaluation and fidelity monitoring. Two theoretical frameworks and one theory of behavior change guided content development, structure, format and evaluation: The Healthcare Accessibility Framework, the Gender Affirmation Framework, and the Information, Motivation, and Behavioral Skills Model of behavior change. RESULTS A 4-member Community Advisory Board of transmasculine individuals partnered with the research team to co-design interventions and study procedures. Additional input was obtained through one-on-one key stakeholder consultations with nine topic experts, clinicians, and community experts at partner organizations. Iterative refinement incorporated evidence synthesis, manual drafting, mock sessions, and structured feedback loops resulting in two refined virtually delivered interventions: (1) PrEP4T, a 6-session one-on-one peer navigation intervention (60-90 minutes/session) emphasizing goal setting, harm reduction, and supportive referrals; and (2) LS4TM, a 6-session peer-facilitated group-based behavioral intervention (2 hours/session), focusing on sexual health knowledge, gender affirmation, communication, and social support. A digital standard of care (SOC) resource guide of curated, gender-affirming sexual health, HIV prevention, and community resources was also developed. Interventionist training included approximately 15 hours of knowledge/skill building (asynchronous and live didactic sessions) and at least 12 hours of applied practice (mock sessions with structured feedback). Process evaluation and fidelity relied on participant- and interventionist-completed case reporting forms, reflecting community prioritization of interventionist and participant comfort during sessions. Key lessons learned included the importance of flexible, manualized intervention content structures that support fidelity while allowing personalized adaptation; using gender-affirming language through mirroring and dual phrasing; centering “voice” and “choice” in HIV prevention decision-making; incorporating behavior change scaffolding (e.g., goal setting, elicit-provide-elicit techniques); offering hands-on peer navigation and curated SOC resources to address structural access barriers; and leveraging digital tools to enhance engagement, shared learning, and community connection. CONCLUSIONS Co-designing with transmasculine communities through an iterative, community-engaged development and refinement processes was essential for producing culturally responsive, theoretically-grounded, and gender-affirming HIV prevention interventions. Our findings can inform future peer-delivered and digital HIV prevention strategies tailored to the needs of specific populations, grounded in community partnerships and lived experience. CLINICALTRIAL ClinicalTrials.gov NCT06182280; https://clinicaltrials.gov/ct2/show/NCT06182280 INTERNATIONAL REGISTERED REPORT RR2-10.2196/76831

Background: Transgender, nonbinary, and gender diverse (TGD) young adults face a disproportionately high mental health burden, including 2- to 4-fold increased risk of suicidality and depressive distress compared to their cisgender peers. Family and community support are protective factors that may mitigate these adverse outcomes, representing key targets for mental health interventions. Objective: This randomized controlled trial (RCT) evaluates the effectiveness of TransHealthGUIDE, a novel digital, app-based education and support intervention aimed at reducing past 3-month suicidal ideation and past 2-week depressive distress among TGD young adults. Participants are randomized 1:1 to an immediate intervention arm or a 6-month deferred intervention arm (waitlist control). Methods: From 2021 to 2024, a multidisciplinary team of academic and community partners conducted formative research and codeveloped a digital app containing 33 self-paced modules, communication, and interactive resources. The content is grounded in the Social Ecological Suicide Prevention Model and the Gender Minority Stress and Resilience Framework, designed to enhance family support and community connection for TGD young adults and their families. TGD young adults (ages 18-24 years) and their caregivers are prospectively enrolled and randomized in 10 US states (California, Connecticut, Illinois, Maryland, Massachusetts, New Jersey, New York, Oregon, Vermont, and Washington, DC). Participants complete self-reported surveys at baseline, 6 months, and 12 months, assessing sociodemographics, family support, community connection, suicidal ideation, depressive distress, and intervention acceptability. App usage and engagement are tracked via metadata. The target sample size is 500 TGD young adults, with 50% (n=250) identifying as people of color and 125 TGD young adult-caregiver dyads. Results: TGD young adult and caregiver communities, including our community advisory board (CAB), have guided all aspects of the project: study design (eg, waitlist control), survey development (eg, self-reported rather than clinician-administered suicidality measures and inclusion of social justice activism as a form of support), intervention content (eg, text, infographics, interviews with TGD people and caregivers, and simulations), and digital app safety features (eg, a quick-exit button for privacy). Recruitment and study screening began on January 21, 2025. As of May 2, 2025, a total of 149 individuals completed a study screener, with 132 (88.6%) of 149 found eligible. Enrollment visits began on April 23, 2025. As of May 2, 2025, five TGD young adults have been enrolled. Ongoing engagement with the CAB will inform iterative improvements throughout the trial. Conclusions: Scalable, app-based interventions tailored to meet the needs of TGD young people hold promise for population-level mental health impact. This RCT—targeting suicidality and depressive distress via education and support for both TGD young adults and their caregivers—addresses a critical gap in mental health interventions for this underserved population. Trial Registration: ClinicalTrials.gov NCT06177600; https://clinicaltrials.gov/study/NCT06177600 International Registered Report Identifier (IRRID): DERR1-10.2196/78619

Background: In the United States, transgender men and transmasculine people who have sex with men (TMSM) face an increased risk of HIV and encounter unique barriers to HIV prevention services, including preexposure prophylaxis (PrEP). Peer-based, digitally delivered support interventions that address these barriers in 1-on-1 or small-group settings may be effective in increasing PrEP engagement. Objective: This study aims to compare the efficacy of digitally delivered individual and small-group peer-based strategies for improving PrEP uptake and adherence among at-risk adult TMSM without HIV. Methods: The Transmasculine One-on-One and Group Empowerment for Targeted HIV Reduction (TOGETHR) study was a digital, open-label, randomized 2×2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies designed to increase PrEP engagement in 300 PrEP-indicated TMSM without HIV. Participants were randomized to 1 of 4 conditions: (A) standard of care (SOC) package (information and PrEP locator tools), (B) SOC + PrEP for TMSM (PrEP4T; individual peer-based HIV prevention intervention), (C) SOC + LifeSkills for TMSM (LS4TM; group peer-based HIV prevention intervention), or (D) SOC + PrEP4T and LS4TM (both individual and group interventions). Interventions were delivered over a 6-week period. The study enrolled adults 18 years or older who were “transgender men or transmasculine,” sexually active with 1 or more partners who had a penis and were assigned male sex at birth, living without HIV, behaviorally at risk for HIV acquisition, and residing in geographic hot spots identified in the US Ending the HIV Epidemic initiative. Results: Study protocols and procedures were codeveloped with our community advisory board, including eligibility criteria, operationalization of geographic stratification, study branding, and detailed recruitment plans. Recruitment and enrollment began on April 1, 2024, and as of March 20, 2025, 103 TMSM had been enrolled. The median age was 26 (IQR 24-31) years. Among the 103 participants, 39 (37.9%) identified as Black, Indigenous, and People of Color, and 18 (17.5%) as Latine; 36 (35.0%) identified as “transgender man or trans man”; 31 (30.1%) as transmasculine; and 15 (14.6%) as nonbinary, genderqueer, or gender nonconforming. Additionally, 69 (67.0%) had at least a four-year college degree, and only 7 (6.8%) had no health insurance. Granger causality tests indicated that recruitment activities via social media (P=.006) and transgender-inclusive dating platforms (P=.02) were most effective and predicted higher baseline enrollment survey completion 2 weeks later. On March 21, 2025, the National Institutes of Health terminated the grant award, citing gender ideology and stating, “it is the policy of NIH not to prioritize such research programs.” Conclusions: This study was part of a critical research pathway to identify effective strategies for preventing HIV acquisition in TMSM, a group traditionally underserved in HIV prevention, and to inform prevention packages that incorporate peer-delivered interventions. Strong engagement with the TMSM community was central to the study’s success and provided valuable insights for future HIV prevention research and practice. Trial Registration: ClinicalTrials.gov NCT06182280; https://clinicaltrials.gov/ct2/show/NCT06182280 International Registered Report Identifier (IRRID): DERR1-10.2196/76831

BACKGROUND Transgender, nonbinary, and gender diverse (TGD) young adults face a disproportionately high mental health burden, including 2- to 4-fold increased risk of suicidality and depressive distress compared to their cisgender peers. Family and community support are protective factors that may mitigate these adverse outcomes, representing key targets for mental health interventions. OBJECTIVE This randomized controlled trial (RCT) evaluates the effectiveness of TransHealthGUIDE, a novel digital, app-based education and support intervention aimed at reducing past 3-month suicidal ideation and past 2-week depressive distress among TGD young adults. Participants are randomized 1:1 to an immediate intervention arm or a 6-month deferred intervention arm (waitlist control). METHODS From 2021 to 2024, a multidisciplinary team of academic and community partners conducted formative research and codeveloped a digital app containing 33 self-paced modules, communication, and interactive resources. The content is grounded in the Social Ecological Suicide Prevention Model and the Gender Minority Stress and Resilience Framework, designed to enhance family support and community connection for TGD young adults and their families. TGD young adults (ages 18-24 years) and their caregivers are prospectively enrolled and randomized in 10 US states (California, Connecticut, Illinois, Maryland, Massachusetts, New Jersey, New York, Oregon, Vermont, and Washington, DC). Participants complete self-reported surveys at baseline, 6 months, and 12 months, assessing sociodemographics, family support, community connection, suicidal ideation, depressive distress, and intervention acceptability. App usage and engagement are tracked via metadata. The target sample size is 500 TGD young adults, with 50% (n=250) identifying as people of color and 125 TGD young adult-caregiver dyads. RESULTS TGD young adult and caregiver communities, including our community advisory board (CAB), have guided all aspects of the project: study design (eg, waitlist control), survey development (eg, self-reported rather than clinician-administered suicidality measures and inclusion of social justice activism as a form of support), intervention content (eg, text, infographics, interviews with TGD people and caregivers, and simulations), and digital app safety features (eg, a quick-exit button for privacy). Recruitment and study screening began on January 21, 2025. As of May 2, 2025, a total of 149 individuals completed a study screener, with 132 (88.6%) of 149 found eligible. Enrollment visits began on April 23, 2025. As of May 2, 2025, five TGD young adults have been enrolled. Ongoing engagement with the CAB will inform iterative improvements throughout the trial. CONCLUSIONS Scalable, app-based interventions tailored to meet the needs of TGD young people hold promise for population-level mental health impact. This RCT—targeting suicidality and depressive distress via education and support for both TGD young adults and their caregivers—addresses a critical gap in mental health interventions for this underserved population. CLINICALTRIAL ClinicalTrials.gov NCT06177600; https://clinicaltrials.gov/study/NCT06177600 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/78619

BACKGROUND In the United States, transgender men and transmasculine people who have sex with men (TMSM) face an increased risk of HIV and encounter unique barriers to HIV prevention services, including preexposure prophylaxis (PrEP). Peer-based, digitally delivered support interventions that address these barriers in 1-on-1 or small-group settings may be effective in increasing PrEP engagement. OBJECTIVE This study aims to compare the efficacy of digitally delivered individual and small-group peer-based strategies for improving PrEP uptake and adherence among at-risk adult TMSM without HIV. METHODS The Transmasculine One-on-One and Group Empowerment for Targeted HIV Reduction (TOGETHR) study was a digital, open-label, randomized 2×2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies designed to increase PrEP engagement in 300 PrEP-indicated TMSM without HIV. Participants were randomized to 1 of 4 conditions: (A) standard of care (SOC) package (information and PrEP locator tools), (B) SOC + PrEP for TMSM (PrEP4T; individual peer-based HIV prevention intervention), (C) SOC + LifeSkills for TMSM (LS4TM; group peer-based HIV prevention intervention), or (D) SOC + PrEP4T and LS4TM (both individual and group interventions). Interventions were delivered over a 6-week period. The study enrolled adults 18 years or older who were “transgender men or transmasculine,” sexually active with 1 or more partners who had a penis and were assigned male sex at birth, living without HIV, behaviorally at risk for HIV acquisition, and residing in geographic hot spots identified in the US Ending the HIV Epidemic initiative. RESULTS Study protocols and procedures were codeveloped with our community advisory board, including eligibility criteria, operationalization of geographic stratification, study branding, and detailed recruitment plans. Recruitment and enrollment began on April 1, 2024, and as of March 20, 2025, 103 TMSM had been enrolled. The median age was 26 (IQR 24-31) years. Among the 103 participants, 39 (37.9%) identified as Black, Indigenous, and People of Color, and 18 (17.5%) as Latine; 36 (35.0%) identified as “transgender man or trans man”; 31 (30.1%) as transmasculine; and 15 (14.6%) as nonbinary, genderqueer, or gender nonconforming. Additionally, 69 (67.0%) had at least a four-year college degree, and only 7 (6.8%) had no health insurance. Granger causality tests indicated that recruitment activities via social media (P=.006) and transgender-inclusive dating platforms (P=.02) were most effective and predicted higher baseline enrollment survey completion 2 weeks later. On March 21, 2025, the National Institutes of Health terminated the grant award, citing gender ideology and stating, “it is the policy of NIH not to prioritize such research programs.” CONCLUSIONS This study was part of a critical research pathway to identify effective strategies for preventing HIV acquisition in TMSM, a group traditionally underserved in HIV prevention, and to inform prevention packages that incorporate peer-delivered interventions. Strong engagement with the TMSM community was central to the study’s success and provided valuable insights for future HIV prevention research and practice. CLINICALTRIAL ClinicalTrials.gov NCT06182280; https://clinicaltrials.gov/ct2/show/NCT06182280 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/76831

This scoping review sought to synthesize human immunodeficiency virus (HIV) and sexually transmitted infection (STI) prevalence, incidence, risk behaviors, and risk perceptions among transmasculine (TM) individuals globally. Eligible articles were peer-reviewed observational and interventional studies published in English between August 2, 2014 and November 2, 2021. Four electronic databases were systematically searched: PubMed, Embase, PsycInfo, and Sociological Abstracts and reference lists hand-searched. Results are presented using numerical summary and thematic analysis. Studies meeting inclusion criteria (n=39) spanned 12 countries and 2 multi-region studies. Laboratory-confirmed HIV prevalence ranged from 0% to 4% and self-reported HIV prevalence from 0% to 8%. Laboratory-confirmed STI diagnoses ranged from 1.2% to 7.7% for chlamydia, 0% to 10.5% for gonorrhea, 0% to 6% for syphilis, 1% to 8% for hepatitis C, and 0% to 8% for hepatitis B. Self-reported lifetime diagnosis of any STI ranged from 5.8% to 53.7%. No studies assessed HIV or STI incidence. Lifetime HIV testing prevalence varied from 23% to 89%. Lifetime STI testing prevalence ranged from 31.1% to 70.8%. Pre- and post-exposure prophylaxis use and knowledge were assessed in seven studies. Qualitative studies addressed HIV vulnerabilities and protective factors, including stigma and social, medical, and legal supports. Although TM individuals are vulnerable to HIV and STI, incidence data are lacking. There is a dearth of research on the experiences, risk factors, and sexual behaviors of TM individuals, especially those who are nonbinary or ethnoracially minoritized. The collection of gender identity data in routine HIV surveillance is recommended. Services and interventions developed by and for TM individuals are needed.

Background: In the United States, transgender, nonbinary, and gender diverse (TGD) young adults experience a higher risk of depression compared to their cisgender peers. Understanding factors associated with increased risk of depression within the TGD young adult population is important to guide clinical care as well as inform the development of interventions to reduce mental health disparities. Objective: This exploratory study investigated the prevalence and correlates of positive screening for depressive symptoms among TGD young adults to inform the design, development, and implementation of national interventions aimed at improving mental health in this at-risk population. Methods: In August 2022, a cross-sectional, nationwide online survey was conducted among TGD young adults aged 18‐25 (N=104) in the United States. Measures included sociodemographic variables, family characteristics, mental health care utilization, and the two-item Patient Health Questionnaire-2 (PHQ-2) screener for depression. Poisson regression models with robust variance estimation were fitted to estimate adjusted prevalence ratios (aPR) and 95% CI for correlates of PHQ-2 depression (score ≥3). Results: The study sample had a mean age of 22 (SD 2) years; 48/104 (46%) individuals identified as Black, Indigenous, or other People of Color, and 69/104 (66%) were nonbinary. Overall, 44 (42%) individuals screened positive for depression using PHQ-2. In a multivariable model adjusted for age, race and ethnicity, US census region, and health insurance status, factors associated with increased depression prevalence using PHQ-2 included low versus high family support (aPR 1.54, 95% CI 1.05‐2.27) and identifying with a nonChristian religion versus being unaffiliated (aPR 1.66, 95% CI 1.04‐2.63). Factors associated with reduced depression prevalence included living in a rural versus suburban area (aPR 0.48, 95% CI 0.26‐0.92) and receiving mental health therapy versus not (aPR 0.71, 95% CI 0.53‐0.97). Conclusions: The high prevalence of depressive symptoms among TGD young adults in this study sample highlights the need for comprehensive mental health evaluation and support in this population. Depression risk is increased among certain subgroups, such as those with low family support. These findings are valuable in informing the development of interventions that aim to improve mental health outcomes among TGD young people.