28 Clinical Trials for Various Conditions
The investigators will conduct a randomized controlled trial (RCT) comparing two different educational approaches on the healthcare of transgender and gender expansive (TGE) youth. Finding best practices to educate healthcare providers and the community at large stand to make an impact on the mental health of TGE youth by helping them feel more welcome and better understood by the communities in which they live. The study aims are to evaluate two educational interventions: 1) The inclusion of a video clip component of two TGE youth (Video \[V\] vs No video \[N\]) into a one-hour didactic; and 2) The delivery of the same didactic content by a cis- \[C\] vs a trans-gender \[TG\] woman.
Transgender women living with Human Immunodeficiency Virus (HIV) may prioritize gender-affirming hormonal therapy over antiretroviral drug therapy. Hormonal therapy typically consists of oral estradiol and spironolactone, which induce drug-metabolizing enzymes after prolonged administration. This study evaluates the bi-directional potential drug interaction between the antiretroviral drug, doravirine, when co-administered with estradiol and spironolactone.
The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes for transgender and nonbinary (referred to as trans) people seeking genital gender-affirming surgery (GGAS). Trans people have gender identities that are different from the sex they were assigned at birth. Due to discrimination based on their gender identity in settings such as schools, the workplace, housing and health care, trans people face much higher rates of distress as well as poorer health and quality of life. Trans people are often unable to access necessary surgeries and hormone therapy to help align their bodies with their gender identities due to a lack of trained medical providers and limited insurance coverage for gender-affirming care. The most common GGAS that trans people seek is vaginoplasty, which is the surgical creation of vaginal anatomy. Because of the high demand for this surgery and limited number of medical centers that offer it, trans people face lengthy wait times and complicated health system processes, increasing stress, negative mental health effects and social isolation. Social and peer-support interventions have been shown to decrease isolation and improve health. Social support during the GGAS process was also identified by the Transgender and Non-Binary Surgery - Allied Research Collective (TRANS-ARC) as the top research priority. Due to limited information on this topic, the STRIVE study was developed to meet this need. The research team's goals are to: * Compare the effectiveness of two approaches to presurgical preparation for vaginoplasty: a virtual group-based peer support intervention led by trans peers who have had GGAS, or usual care delivered by gender-affirming surgical teams, enhanced with patient education materials. * Determine if the intervention improves meeting presurgical criteria for vaginoplasty. * Evaluate if patients, peer supporters and healthcare staff find the intervention acceptable. The research team will conduct a pragmatic randomized controlled trial, meaning participants will be assigned by chance to one of two groups: peer-support group or usual care enhanced with written and web-based education materials. This study is pragmatic because it is happening under real-life conditions to understand if the intervention will work in practice. The research team will work with five academic gender-affirming surgery programs across the country to recruit and enroll 260 trans adults ages 18 and older who are seeking vaginoplasty. Participants assigned to the peer support group will receive the intervention virtually over the course of three months, facilitated by peer facilitators from Trans Lifeline. The usual care group will receive education from their gender-affirming surgical team, with in-depth materials that cover the same topics as the virtual course. The primary outcome to be measures at six months is coping self-efficacy, reported by patients, using a survey which assesses perceived ability to deal with stressors. The research team will explore additional outcomes at 12 months, including meeting GGAS presurgical criteria and other outcomes deemed important to trans community partners, surgeons and other gender-affirming providers (e.g., psychological stress, social support, resilience, quality of life, presurgical knowledge, surgical delays and cancellations). Postsurgical outcomes, including surgical satisfaction and other related outcomes, will be measured at 24 months. Finally, the team will conduct in-depth interviews with participants who undergo the intervention to understand their experiences at the beginning of the study and after six months. Researchers will also interview peer supporters and clinicians to understand how to improve and implement the support intervention more broadly. In designing this study, the research team worked closely with trans community members and patients, health services and policy researchers, gender-affirming surgeons, advocates, gender program administrators and representatives from social support organizations. Collaboration with and input from the trans community during the conduct of this study will be critical to ensure that the STRIVE study is patient centered. Results from this study will be shared in multiple forms, including clinical guideline recommendations, policy briefs, patient-centered reports, web-based information and summaries for clinicians and researchers. Trans people seeking gender-affirming surgery can use the study findings to understand options for social support to improve quality of life and health outcomes. Clinicians, gender program administrators, health insurance companies and health policy advisors can use the findings from this study to better support and prepare patients who are seeking gender-affirming surgery.
Truvada (Emtricitabine or FTC and tenofovir disoproxil fumarate or TDF) has been approved for HIV prevention since 2012. Drug concentrations after receipt of oral Truvada for HIV Pre Exposure Prophylaxis (or PrEP) appeared to be lower in transgender women compared to Men who Have Sex with Men (MSM) in the iPrEx study, the landmark study of PrEP for HIV prevention. Concentrations were especially low among transgender women (TGW) reporting use of feminizing hormones. Reasons for the lower drug concentrations may be behavioral or biomedical, or a combination of both. While there are no systemic drug-drug interactions between TDF and oral contraception, there are known interactions involving these classes of medications with drug transporters that could affect drug concentrations in target tissues. Drug-drug interactions with natural estrogens and anti-androgenic agents used for gender affirming hormone therapy among transgender women have not been studied, neither have interactions between emtricitabine and female hormones. Concerns about the impact of PrEP on gender affirming hormone therapy is the main barrier for uptake of PrEP among transgender women. In addition, very little is known about TDF/FTC pharmacokinetics in transgender men using testosterone hormonal therapy. Drug-drug interactions with masculinizing hormones have never been properly investigated as trans gender men have not been formally involved in PrEP clinical trials or demonstrations projects.This small study will assess pharmacokinetic drug-drug interactions between tenofovir disoproxil fumarate/emtricitabine and cross-sex hormone therapy. The I-BrEATHe study is a substudy of the Triumph study, a culturally-relevant community-led PrEP demonstration project in transgender communities. The I- BrEATHe pharmacokinetic substudy will provide Truvada daily using directly observed therapy in 24 transgender women and 24 transgender men over a one month period, and will measure drug and hormone therapy levels in blood collected from participants.
Transgender men (TGM) have a high incidence of sexually transmitted infected (STIs), including HIV, HPV and bacterial N. gonorrhea and C. trachomatis. In addition, TGM who start testosterone therapy (TT) experience significant vaginal morbidity that causes vaginal dryness and pain, due to the estrogen-inhibiting effects of TT on vaginal epithelium. Vaginal dysbiosis is a known contributor of increased STI risk and vaginal symptoms. In a future study, the investigators are planning a randomized trial of a 6-month oral Lactobacillus probiotics intervention in TGM on TT at the Callen-Lorde Community Health Center (CLCHC), New York City to determine whether this intervention can improve vaginal health in TGM on TT. In this study, the investigators will conduct a pilot and feasibility study to precede the main trial. The investigators will randomize 30 TGM on TT to receive either the intervention (consisting of Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001) or placebo (maltodextrin) for 4 weeks, evaluating the intervention's impact on vaginal microbiota and clinical outcomes, as well as its feasibility, acceptability, and adherence. This study will take place at the CLCHC Brooklyn site, aiming to gain pilot data, address feasibility and acceptability, and plan for the main trial accordingly.
Transgender individuals are those with a gender identity opposite the sex they were assigned at birth. Approximately 1% of the population is transgender, equating to \~60,000 transgender Wisconsinites. A transgender boy or man is someone with a 46,XX karyotype and typical female genitalia but a male gender identity and desire for more male-typical gender expression. Gender-affirming testosterone (hormonal) treatment (GAHT) is the cornerstone of masculinizing therapy for transgender men and boys, resulting in estrogen (E2) suppression and circulating testosterone (T) levels equivalent to cisgender males. Historically, GAHT was initiated after an E2-driven puberty, but the last decade has seen an explosion of referrals for GAHT in transboys, many of whom are exposed to only low E2 levels before puberty is halted with blocker therapy. Knowledge of risks incurred by GAHT rely on low-quality studies, precluding conclusive assessment of GAHT's long-term impact on cardiometabolic outcomes. Data on transboys receiving GAHT before completion of E2-driven puberty are sparser and no studies have addressed mechanisms by which GAHT may affect vascular physiology. The investigators aim to determine the cardiometabolic impact of GAHT in transboys/men and to determine if any differences identified are mechanistically dependent on the timing of GAHT relative to puberty.
This study will evaluate an intervention's feasibility, acceptability and efficacy potential in a one-arm trial with Romanian transgender and gender diverse (e.g., gender non-binary) (TGD) individuals who report depression or anxiety. The intervention will consist of 16 1-hour sessions delivered by our trained therapists on Zoom. These sessions are based on 6 principles of LGBTQ-affirming CBT, as follows: (1) normalizing mood and anxiety as a common response to LGBTQ related stress; (2) challenging persistent, inflexible LGBQ-related stress-induced cognitions; (3) encouraging assertive behavior and open self-expression to effectively cope with the consequences of LGBTQ-related stress; (4) validating lesbian, gay, bisexual, and transgender (LGBTQ) clients' unique strengths; (5) building authentic relationships as an essential resource for LGBTQ people's mental health; and (6) recognizing intersectional identities as a source of stress and resilience.
This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.
The trial studies the efficacy of subcutaneous (SQ) testosterone compared to intramuscular (IM) testosterone therapy during the first 6 months of pubertal induction in transgender male adolescents. Describes rate of adverse effects, masculinizing effects and quality of life while receiving testosterone. Evaluates clinic utilization required for testosterone therapy.
This is a randomized controlled trial to test the effectiveness of an interactive educational app-based digital intervention that provides knowledge and support to transgender and gender-diverse (TGD) young adults ages 18-24 years and their caregivers. The goal of the study is to examine the effects of exposure to the app on TGD young adult mental health outcomes. Participants will be randomized to an Immediate Arm (access to a digital platform, plus usual care) or a Deferred Arm (usual care; access to the digital platform at 6 mo). Usual care consists of access to published resources and community support organizations, if available. The list of resources will include contact information for a suicide prevention hotline. For each Arm, the intervention period will last 6 months, followed by 6 months of observation, during which access to the intervention is maintained. Assessments will be performed at baseline, 3, 6, and 12 months to document changes in mental health outcomes, and the two groups will be compared. The investigators plan to enroll 500 TGD young adults and their caregivers, with at least 50% (250 participants) to identify as Black, Indigenous, People of Color (BIPOC) and 50% (125 TGD young adults, 125 caregivers) to be young adult-caregiver dyads. Ongoing process reassessments will be performed to maximize effectiveness of the intervention, including focus groups and in-depth interviews with TGD young adults, caregivers, and providers, as well as analysis of data collected through the digital platform and participant surveys. Investigators will account for sociodemographic characteristics such as race and ethnicity, age, gender identity, education status, existing mental health conditions, and history of suicidal ideation or attempt. Data will be analyzed across racial minority groups to ensure that the intervention is effective for all racial minorities; if there are discrepancies in effectiveness, additional mixed methods evaluation will be performed to identify and address potential causes.
Depressive symptoms and disorders are among the most common adult health conditions with a lifetime prevalence of 15-20% and are a leading cause of disability /morbidity worldwide. Although evidence-based approaches such as cognitive behavioral therapy (CBT), antidepressant medications, and depression collaborative care and quality improvement (QI) programs integrating depression care into primary health care can improve depression outcomes and disparities, racial / ethnic disparities continue to persist. Concurrently, according to a 2011 Institute of Medicine (IOM) report, little information exists on how to address the high rates of depression among sexual and gender minorities. Our study randomizes depressed, LGBTQ (lesbian, gay, bisexual, transgendered, queer), racial / ethnic minority adults to an evidence-based agency-level, depression quality improvement (QI) training \[Resources for Services (RS)\] and technical support alone or to a resiliency class (RC+), a 7-session resiliency, cognitive behavioral therapy class to enhance mood + automated mobile text reminders about basic reminders and care follow-up impact on improving adult patients' depressive symptoms. Depression QI (RS) training will be offered to three clusters of four to five LGBTQ-focused programs: two clusters in LA (Hollywood and South LA) and one cluster in NO. Clusters are comprised of one primary care, one mental health, and two to three community agencies (e.g., faith-based, social services/support, advocacy). All programs will receive depression QI training. Enrolled adult depressed patients (n=320) will be randomized individually to RC+ or RS (depression QI) alone to assess effects on primary outcomes: depressive symptoms \[8-item patient health questionnaire (PHQ-8) score and secondary outcomes: mental health quality of life \[12-item mental composite score (MCS-12) ≤ 40\], Resilience (Brief Resilience Scale), mental wellness, and physical health quality of life \[12-item physical composite (PCS-12)score\] at 6- and 12-month follow-up.
The study is a 2-arm cluster randomized controlled trial to be conducted with 450 trans women to assess the effectiveness of the Trans Women Connected mobile app. Those in the treatment arm will be provided with the Trans Women Connected app, to be downloaded to their own device, and asked to use it during a month period. Those in the control arm will be asked to download a general health app and use it during a month period. Participants will complete brief online surveys at baseline, immediately following the app-use period (1-month post baseline), and at 3- and 6-months following baseline. The baseline and follow-up assessments will collect data on demographic characteristics, measures related to our primary and secondary outcomes, and psychosocial measures. The primary outcome measures are self-reported sexually transmitted infection (STI)/HIV testing and sex without a condom, with secondary measures including sexual risk behaviors, health care visits, perceived social support/connectedness, pre-exposure prophylaxis (PrEP) use, self-efficacy in negotiation/communication, and comfort with gender identity and appearance. In addition, process data, such as forum content, and usage data will be collected and analyzed.
This study plans to learn more about differences in heart disease risk after gender-affirming orchiectomy (i.e., testes removal) in older transgender (trans) women compared to younger trans women.
Phase I: Eligible participants (n=20) will be recruited to participate in a feasibility evaluation of the client intake module to be developed. Participants will complete pre- and post-intervention knowledge assessment outcome measures. The gain score, defined as the difference between the pre-training and post-training score, will be calculated for each participant. Each participant will spend up to 2 hours interacting with the intervention. Additionally, an implementation focus group (n=6) of administrators, educators, and key decision-makers will be conducted to assess the feasibility of implementing the proposed training suite in their programs. Phase II: During Phase II, participants (n=100) will complete in two standardized patient encounters pre- and post-intervention to evaluate the efficacy of the proposed training suite. Participants assigned to the intervention group will receive 10 hours of training with the product and will be asked to complete a Training Experience Questionnaire after their post-intervention standardized patient encounter. Control group participants will receive the APA guidelines for Psychological Practice with Transgender and Gender Non-Conforming People for review. Control group participants will submit their notes taken while reviewing the guidelines. It is expected that the intervention group will show increased knowledge, skill, awareness, and cultural competency when working with the target population as measured by the Standardized Patient encounters as rated on a Standardized Patient Checklist. Additionally, the team anticipates the experimental group participants will rate the training suite as easy to use, relevant, and realistic.
Transgender and gender nonconforming (TGNC) individuals face a number of health disparities, many of which can be tied to a lack of access to or use of primary care. Stigma and misunderstanding make simple doctor's visits into ordeals only worth enduring for the most serious of problems. This project addresses those issues by enlisting TGNC people as experts on their own experience. TGNC individuals will form a year-long cohort that will form the basis for this research. Collectively, they will define the scope of challenges faced when seeking healthcare, what medical advocacy training they desire, and how to address groups of healthcare providers and staff. Healthcare providers, including MDs, nurses, and Physicians Assistants (PAs), will attend two facilitated sessions with the TGNC cohort to meet as peers with knowledge exchanged in both directions. Similar meetings will occur with clinic staff, as TGNC individuals have expressed how stigma begins from the moment they call a medical office. Our hypothesis is that when TGNC individuals are given the tools to navigate the healthcare system and the ability to speak with medical professionals as peers, rather than patients, through a participatory action research design they will be better able to access appropriate care through increased confidence and mutual support. The complementary hypothesis for medical providers is that direct interaction with a variety of TGNC individuals who articulate their needs will decrease stigma and increase comfort when treating TGNC people as patients. As a partnership between academic, medical, and community institutions, this project has the potential to directly impact the lives of TGNC individuals who participate and indirectly impact others served by the LGBT Center. This proposal works on three levels: 1) at the academic level - an assessment of participatory action research as an intervention to decrease health disparities, 2) at the individual level - the potential for individuals to increase personal knowledge and skills, and 3) at the institutional level - as actors within the TGNC community develop relationships with individual healthcare providers, medical clinics and activist groups and community partners and educational institutions are concurrently forming networks that will have positive, although probably more diffuse, impact on TGNC individuals as these institutions come together to support TGNC health care.
The overall goal of the larger 3-aim study is to develop and pilot test a training intervention to increase mental health providers' use of gender-affirming practices with gender minority youth (GMY; children, adolescents, and young adults whose gender is different from their birth-assigned sex). Aim 3 (registered here) of the study is an open trial pilot study at a multi-clinic mental health agency, aimed at examining the feasibility and acceptability of conducting a future randomized controlled trial (RCT).
The proposed research will use a community-based participatory research (CBPR) approach to engage with community organizations to design and implement a project that trains therapists to provide effective, supportive, and engaged therapy to two-spirit, transgender, and nonbinary (2STNB) clients most impacted by barriers in accessing mental health care. 10 2STNB licensed mental health therapists will be identified and 50 2STNB of their clients will be enrolled and can expect to be on study for 10-20 months.
This project seeks to adapt and pilot a trauma-informed combination intervention named 'Kickin' it with the Gurlz' that was designed with, for, and by transgender women of color to improve HIV care continuum outcomes. The intervention components include a violence and gender affirmation screening tool, a peer-led adaptation of Seeking Safety, and individual-level peer navigation sessions. The project will examine the feasibility, acceptability, and preliminary promise of the multicomponent by conducting a one-arm pilot with 30 transgender women of color who have a history of trauma. Participants will complete baseline, immediate post-intervention, and 3-month follow up assessments.
The mLab App combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide real-time feedback on home-based HIV test results. Theoretically-guided by the Health Information Technology Usability Evaluation Model (Health-ITUEM), the proposed project will refine and test a next-generation diagnostic intervention delivered on a mobile platform to improve HIV testing and linkage-to-care outcomes among youth living with and at-risk for HIV. Given the pervasiveness, low cost, and convenience of mobile technology, the investigators hope that the App can help achieve the goals of the National HIV/AIDS Strategy in the US by increasing the number of persons living with HIV who know their serostatus, decreasing HIV-related disparities, and ultimately reducing the risk of HIV transmission and acquisition.
This observational research study will evaluate medical gender affirmation delivered in primary care as an intervention to reduce disparities in HIV-related outcomes (e.g., low rates of PrEP uptake for HIV-uninfected patients, high rates of viral suppression for HIV-infected patients) for transgender patients in two urban federally-qualified community health centers.
The purpose of this study is to assess the acceptability and effectiveness of utilizing vaginal self-swabs for HPV DNA testing as compared to provider-collected cervical swabs for HPV, as well as to investigate the prevalence of other Sexually Transmitted Infections (STIs) among sexually active female-to-male (FTM) transgender adults.
The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.
The proposed study will test a mHealth peer navigation intervention for trans women living with HIV in a trans public health clinics to increase initiation and engagement in mental health and substance use services. The peer will navigate and provide support in-person and via mobile phone with HIPAA-compliant text messaging. Ecological momentary assessments will be conducted to enhance self-monitoring of mental health stress and coping-related substance use.
The purpose of this study is to assess how family relationships are related to health and nutrition behaviors among transgender and gender diverse youth and young adults.
Text Me, Alexis! is a three-arm randomized controlled trial (RCT) to determine the optimal and most cost-effective intervention for advancing trans women living with HIV to full viral suppression. Participants will be randomized (1:1:1) to Peer Health Navigation (PHN) alone, SMS (text messaging) alone, or PHN+SMS. Participants in the PHN alone and PHN+SMS arms will receive unlimited navigation sessions over 3 months. Participants in the SMS alone and PHN+SMS arms will receive 3 daily theory-based text messages for 90 days for a total of 270 unique scripted messages.
This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 year old) sexual minority men and transgender and gender diverse teens (ASMM/TGD). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm and asses our primary effectiveness outcome of objective HIV testing (e.g., photo of test results).
* The goal of this clinical trial entitled, PrEP2Prevent: An Online PrEP Navigation and Activation Intervention for YMSM, is to develop and test a method for supporting access to an HIV prevention medication called Pre-Exposure Prophylaxis (PrEP) in young men who have sex with men and young transgender and non-binary individuals. The main questions it aims to answer are: * What are some of the experiences and barriers providers have seen regarding this population accessing PrEP * Using information gathered from PrEP providers and navigators, develop a mobile health platform and PrEP related content that will be tested by members of the population to see if the features are usable and the content is understandable. * Enroll 150 study participants to see if utilizing the mobile health platform and receiving supportive sessions related to motivation and barriers to accessing PrEP is achievable. * Participants will * Be given access to the mobile health Platform called PrEPresent, which provides them with access to prevention related content, the ability to schedule with a patient navigator and create customizable goals * Complete a baseline, 3 month and 6 month assessment about personal health, health history and technology, along with a PrEP adherence rapid urine test * Complete up to 4 sessions to assist participants in the intervention group with discussing any barriers to accessing PrEP
PrEPTECH Phase 2 is a 2-arm randomized controlled trial to assess the effectiveness of a telehealth intervention in increasing PrEP uptake among cisgender men and transgender women who have sex with men over six months. Participants (N = 400) will be randomized equally into one of two study conditions, treatment with a telehealth intervention called PrEPTECH or a control condition consisting of treatment as usual plus access to a listing of online and local PrEP resources, and assessed via surveys at baseline and at 90 and 180 days after baseline. Randomization of participants will be stratified by participant sub-group (adult men who have sex with men, adolescent men who have sex with men, and transgender women). The baseline and follow-up assessments will include questions on demographic characteristics, measures related to our primary and secondary outcomes, and psychosocial measures. The primary outcomes measure is self-reported PrEP initiation at 3-month post enrollment, the percentage of participants reporting having taken at least one dose of PrEP medication by that time point. In addition, usage data and medical data will be collected and analyzed.