Clinical Trial

North Jersey Community Research Initiative (NJCRI) Study on Transgender Liver Health

Enrolling by Invitation
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Summary
Primary Objective: Assess disparities in liver health outcomes among transgender individuals on GAHT by evaluating liver function markers (transaminases, bilirubin levels, etc), as well as liver elasticity and presence of liver steatosis or Nonalcoholic Fatty Liver Disease (NAFLD) through FibroScan. A total of 60 participants will be recruited throughout the study, with a ratio of 1:1 between transgender participants who have been on GAHT more than 6 months ( = or \> 182 days), and transgender participants who have been on GAHT for less than 6 months ( \< 181 days) at the start of the study. Secondary Objectives: Assess liver health-related risk factors (e.g. obesity, alcohol consumption) in transgender population. Investigate the association between specific hormone regimens and liver function in transgender individuals. Explore potential modifiers of liver health outcomes, such as age, social barriers determinants of health, duration of hormone therapy and adherence to medical guidelines. Change in Quality of Life from baseline to last study visit.
Trial Details
NCT Number NCT07746999
Lead Sponsor Corey DeStefano
Collaborators: Gilead Sciences, North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI)
Conditions HEPATITIS C (HCV)
Enrollment 60 participants
Start Date 2025-03-15
Primary Completion 2027-03-15 (estimated)
Study Completion 2027-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-05