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NCT06807580
This study aims to study the effects of Oral Progesterone in Transgender Women. The primary goal is to study the effect of progesterone on psychological distress and secondarily on sleep quality, breast size, quality of life and gender congruence and cardiovascular risk.
NCT07145281
The goal of this clinical trial is to learn about the effects of different routes of estradiol administration on blood clotting in transgender women starting gender-affirming hormone therapy. The main questions it aims to answer are: Does sublingual estradiol reduce free Protein S levels compared to oral estradiol with cyproterone acetate? Does sublingual estradiol accelerate activation of the clotting system, as measured by thrombin generation? Researchers will compare sublingual estradiol to oral estradiol plus cyproterone acetate to see if the way estradiol is taken changes blood clotting risk. Participants will: Take either sublingual estradiol (2 mg daily in divided doses) or oral estradiol (2 mg daily) with cyproterone acetate (10 mg daily) for 6 months Provide blood samples at baseline and after 6 months to measure hormone levels and clotting factors Attend clinic visits for monitoring, including safety checks and routine laboratory tests
NCT04128488
In this study, investigators plan to evaluate the cardiometabolic effects of initiating gender-affirming hormone therapy among transgender women with and without HIV. As part of this study, participants will undergo cardiovascular and metabolic phenotyping within 3 months of starting and after 12 months of gender-affirming hormone therapy. Cardiovascular phenotyping will include cardiac MRI/MRS imaging to evaluate cardiac function and structure. Metabolic phenotyping will include oral glucose tolerance testing, abdominal MR imaging to evaluate visceral adiposity, and whole body, lumbar, and hip DEXA imaging to evaluate fat and lean body mass as well as bone mineral density, respectively. Traditional markers of CVD risk as well as immune, hormonal, and coagulation parameters will also be assessed longitudinally.
NCT06202898
The overall hypothesis is that stabilizing transgender women financially while providing them tailored counselling will increase their odds of them linking to substance use services, PrEP services if they do not have HIV, and transgender women who are living with HIV will be more adherent to their ART treatment.
NCT03580512
This will be a prospective study that will enroll up to 2000 MSM and TG from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.
NCT03856580
Transgender women (TW) have unique challenges related to HIV prevention medication adherence. Left unaddressed, these challenges will prevent TW from accessing the promising long-acting HIV prevention tools in the development pipeline. This study will develop a replicable process to tailor the delivery of these tools and an adherence intervention (that will include an mHealth app) to the needs of TW, using the example of inert injectable cabotegravir. Work builds on a pilot study to identify tailored methods to deliver injectable cabotegravir in TW, such as self-injection and injection by a healthcare provider at at "drop-in" clinic. The investigators will use qualitative methods (e.g., interviews, group discussions called "Design Sessions") to design the adherence intervention and the mHealth app. Then, investigators will execute a partially randomized patient-preference trial to determine if TW are able to use tailored injection strategies (self-injection or injection by a healthcare provider at "drop-in clinics") to improve adherence, compared to a control group of TW who will engage a protocol based on HPTN-083/084. This will serve as a "proof of concept" for the future R01 that will test this on a larger scale. Research and training will take place at NYSPI/Columbia, in affiliation with, 1) Project AFFIRM, a study of transgender identity (R01HD079603; PI: Bockting), that will provide infrastructure for critical research activities (e.g., recruitment), and 2) SLAP-HIV, a clinical trial to produce a long-acting form of cabotegravir (e.g., injection; UM1 AI120184; PI: Hope). SLAP-HIV will provide clinical oversight (e.g., ensure tailored delivery strategies are feasible).
NCT06116201
Transgender women who transitioned from male to female by hormone therapy demonstrate similar physical fitness and vascular function to males or females.
NCT04491422
Transgender women (trans women; assigned male sex at birth but identify as female) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Trans women have a 13 times greater risk of acquiring HIV than adults aged 15-49 years in the general population, and in Africa, trans women have nearly twice the HIV prevalence (25%) of men who have sex with men \[MSM\] (14%). Oral pre-exposure prophylaxis (PrEP) is an effective prevention tool that could change the trajectory of the HIV epidemic among the 25 million trans women globally, yet its use has been suboptimal in this vulnerable population. Same-day PrEP initiation is feasible and acceptable and improves retention in PrEP care in resource-rich settings. Same-day initiation of emtricitabine/tenofovir alafenamide (F/TAF), a new PrEP regimen, has not to our knowledge previously been evaluated as PrEP in African trans women. F/TAF is potentially more efficacious and safer than emtricitabine/tenofovir disoproxil fumarate (F/TDF) as shown in the recent DISCOVER trial. However, concerns about drug-drug interactions between feminizing hormonal therapy (FHT) and PrEP are a key potential adherence barrier for trans women. While PrEP drugs do not lower FHT levels, FHT decreases plasma TFV and (emtricitabine) FTC levels. Little is known about FHT use among African trans women taking F/TAF or how concerns about F/TAF-FHT interactions may influence PrEP adherence. Moreover, interventions to support PrEP adherence in this population are needed. Feedback about PrEP use has been shown to potentially improve PrEP adherence among MSM but has not been utilized among trans women. Key knowledge gaps include: 1) whether same-day PrEP can be successfully implemented for African trans women, 2) the impact of drug-level feedback on PrEP adherence, and 3) how use of FHT may influence PrEP adherence. To address these questions, this protocol describes a randomized trial to evaluate the feasibility and acceptability of same day initiation of F/TAF PrEP, evaluate impact of drug-level feedback on PrEP adherence and characterize PrEP persistence, and in-depth interviews to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. This will be the first clinical trial, to our knowledge, to evaluate F/TAF as PrEP for HIV-negative trans women in sub-Saharan Africa.
NCT03899896
The voice is a reflection of our identity. In the case of transgender women, there may be a gap between perceived male voice and female appearance. Indeed, hormonal treatment in transgender women has no effect on the voice quality. This gap can have negative consequences on everyday life in banal situations such as telephonic contact leading to limited use of phone calls and social isolation. Differences between female and male voices seem to be socially determined and do not depend directly on sexual dimorphism of the phonatory organs. Speech therapy might thus be indicated as a vocal support for transgender women. Only few studies have examined the impact of perceived voice on the quality of life of transgender women.