Clinical trials: Transgender Women
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth…
- Trial name
- PURPOSE 2 (NCT04925752)
- Testing
- Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN)
- Where
- 93 sites in United States, Argentina and 6 more
- Volunteers
- 3,292 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV Infections, Sexually Transmitted Diseases
Increasing Engagement and Improving HIV Outcomes Via HealthMPowerment
The overall goal of this 3-arm randomized trial is to test whether a network-driven online intervention tailored for intersectional stigma amelioration can elicit online social support, promote intervention engagement, and…
- Conditions
- HIV Infections, Sexually Transmitted Diseases, Stigma, Social
- Trial name
- NCT03678181
- Testing
- Information Resources, Social Support, HIV Testing
- Where
- 3 sites in United States
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
HIV Infections, HIV Primary Infection
A Couples-based Intervention for Transgender Women and Their Partners
This project seeks to test the efficacy of a couples-based HIV prevention program in large-scale randomized controlled trial (RCT) to reduce HIV risk among transgender woman and their partners.
- Trial name
- T2 (NCT04067661)
- Testing
- CHIP, Control
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Pelvic Floor Disorders
Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation
Currently, perioperative pelvic floor physical therapy (PFPT) is not standard of care for all patients who undergo vaginoplasty surgery.
- Trial name
- FLOWER (NCT05690555)
- Testing
- Preoperative and Postoperative Pelvic Floor Physical Therapy (PFPT), No Pelvic Floor Physical Therapy (PFPT), Postoperative PFPT
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- The Cleveland Clinic
HIV
Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo
This study includes an adapted multilevel intervention, Abriendo Puertas (Opening Doors), including individual counseling, peer navigation, and community mobilization for transfeminine people living with HIV in the Dominican…
- Trial name
- NCT06316102
- Testing
- Gender Affirming Abriendo Puertas (Opening Doors) (GAP)
- Where
- Dominican Republic
- Volunteers
- 139 people
- Sponsor
- University of North Carolina, Chapel Hill
Urinary Incontinence, Stress
Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence
Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free…
- Trial name
- NCT02506309
- Testing
- TOT - inside-out trans-obturator tape/sling, SIS - Innovative fixation single incision sling
- Volunteers
- 168 people
- Sponsor
- Brno University Hospital
HIV Preexposure Prophylaxis
Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who…
- Trial name
- Impower-024 (NCT04652700)
- Testing
- ISL, FTC/TDF, FTC/TAF
- Where
- 25 sites in United States, Brazil and 5 more
- Volunteers
- 494 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hiv, HIV/AIDS
AllyQuest Adherence App Intervention for HIV-positive Men Who Have Sex With Men and Transgender Women: Pilot Trial
AllyQuest (AQ) is a theory-informed smart phone application that supports HIV medication adherence for young men who have sex with men and young transgender women who have sex with men (YMSM/YTW) via behavior change, social…
- Conditions
- Hiv, HIV/AIDS, Medication Adherence, Sexual Behavior
- Trial name
- AQ2 (NCT03916484)
- Testing
- AllyQuest HIV Medication Adherence app-delivered intervention, AllyQuest HIV Medication Adherence app-delivered intervention + NSC
- Where
- 6 sites in United States
- Volunteers
- 71 people
- Sponsor
- University of North Carolina, Chapel Hill
Transgenderism
Transgender Estradiol Affirming Therapy
The purpose of this open label, pilot, randomized clinical trial is to evaluate the effectiveness, safety and tolerability of estrogen use in transgender female and the degree of testosterone suppression achieved in this…
- Trial name
- TREAT (NCT05010707)
- Testing
- Transdermal patch, Pro-thrombotic markers, Metabolic markers
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Uterine Cervical Neoplasms, Sexually Transmitted Diseases
Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients
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…
- Trial name
- NCT02401867
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV Prevention
ATN 151 Work-to-Prevent: Employment as HIV Prevention
The investigators aim to pilot-test a novel social and structural-level HIV intervention for YMSM and YTW of color ages 16-24.
- Trial name
- W2P (NCT03313310)
- Testing
- Employment Intervention
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Violence, Sexual
Empowerment Self-Defense Training for the Prevention of Victimization of Transgender Women
The proposed project aims to develop and refine a tailored Empowerment Self Defense (ESD) violence prevention training for diverse TW through a series of sequential Aims: a) develop an initial draft of an ESD violence prevention…
- Trial name
- NCT04934189
- Testing
- Empowerment Self Defense Training
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Hunter College of City University of New York
Transgender Health, Gender Dysphoria
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
Transgender women living with Human Immunodeficiency Virus (HIV) may prioritize gender-affirming hormonal therapy over antiretroviral drug therapy.
- Conditions
- Transgender Health, Gender Dysphoria, Transgender Women, Human Immunodeficiency Virus
- Trial name
- IDENTIFY (NCT04283656)
- Testing
- Doravirine/Lamivudine/Tenofovir, Spironolactone 100mg, Estradiol 2mg
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Thomas Jefferson University
HIV Prevention
Reducing Intersectional Stigma Among High-Risk Women in Brazil to Promote Uptake of HIV Testing and PrEP
This is a randomized controlled trial of a multi-level intervention to prevent HIV acquisition among transgender women (N=400) in São Paulo, Brazil.
- Trial name
- PRISM Brazil (NCT04114955)
- Testing
- Manas por Manas
- Where
- 2 sites in Brazil
- Volunteers
- 392 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV
Optimal Intervention to Full Viral Suppression: Text Me, Alexis!
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.
- Trial name
- NCT06408350
- Testing
- Text Me, Alexis!
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Friends Research Institute, Inc.
HIV Infections
Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)
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.
- Trial name
- NCT03803683
- Testing
- mLab App, HIV Prevention Information, HIV Home Tests
- Where
- 2 sites in United States
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Rebecca Schnall, RN, MPH, PhD
HIV Prevention
Rectal Microbicide Acceptability, Tolerability and Adherence
MTN-035 is a multi-site, randomized-sequence, three-period, open label crossover study that will enroll approximately 210 participants randomized (1:1:1:1:1:1) to one of six sequences of rectal microbicide placebo product…
- Trial name
- NCT03671239
- Where
- 7 sites in United States, Malawi and 3 more
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Microbicide Trials Network
Fetal Hypoxia, Fetal Distress
Trans-abdominal Fetal Pulse Oximetry
The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy.
- Conditions
- Fetal Hypoxia, Fetal Distress, Fetal Acidemia, Fetal or Neonatal Effect of Complication of Labor
- Trial name
- NCT05147584
- Testing
- Dual fetal oxygen sensors
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
HIV I Infection
Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
Transgender women (TW) are a key population and priority for HIV treatment. More research is needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral treatment (ART) regimens for TW on…
- Trial name
- GETITRIgHT (NCT06005610)
- Testing
- Estradiol
- Where
- 18 sites in United States, Mexico and 2 more
- Volunteers
- 93 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acceptability of Health Care, HIV Infections
Addressing Violence and HIV Care Among Transgender Women
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.
- Trial name
- NCT04813484
- Testing
- Kickin it with the Gulz
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Michigan