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

NCT07746999 | Enrolling By Invitation DMC

• 1 other identifier: CO-US-987-7234
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HEPATITIS C (HCV)

Keywords

liver disease; viral hepatitis

Outcome Measures

Primary Outcomes (2)

• Assess disparities in liver health outcomes among transgender individuals

  Assess disparities in liver health outcomes among transgender individuals

  Baseline through December 2027

• Assess Elasticity of liver

  GAHT by evaluating liver function markers by Fibroscan

  Baseline through December 2027

Secondary Outcomes (5)

• Assess Liver Health Risk Factors

  baseline to December 2027

• Liver function in Transgender individuals

  baseline to December 2027

• Explore potential modifiers of liver health outcomes

  baseline to December 2027

• Change in Quality of Life at baseline visit

  baseline to December 2027

• Change in Quality of Life at last visit

  baseline to December 2027

Study Arms (1)

Transgender >6 months on GAHT and Transgender <6 months on GAHT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Transgender individuals (18 years or older).
• Individuals who are able to write and/or read in English. -

You may not qualify if:

• Inability to provide informed consent
• Individuals with known decompensated liver cirrhosis.

Sponsors & Collaborators

• Corey DeStefano: lead
• Gilead Sciences: collaborator
• North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI): collaborator

Study Sites (1)

North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI)

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Hepatitis C; Liver Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Digestive System Diseases

Study Officials

• Diana Finkel, DO

  North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 365 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: August 5, 2026
• Study Start: March 15, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Locations

US (1)