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

Gender-affirming hormone therapy (GAHT) plays a crucial role in the healthcare of transgender individuals, aligning their physical characteristics with their gender identity. GAHT has been recognized for its positive impact on mental health and well-being of transgender individuals. Research consistently demonstrates that a GAHT is associated with improvement in gender dysphoria, psychological distress and overall quality of life. Hormone therapy facilities the alignment of physical characteristics with gender identity, alleviating feelings of gender incongruence and enhancing self-esteem and body satisfaction. Additionally, GAHT has been shown to reduce symptoms of depression, anxiety, providing transgender individuals with opportunity to live authentically and comfortably in their affirmed gender. These findings underscore the importance of access to comprehensive transgender healthcare, including hormone therapy, in promoting the mental health and well-being of transgender population.

Extant literature supports the conclusion that GAHT improves various aspects of mental health and quality of life for transgender people. Additional, though limited, research exploring the physical effects of GAHT suggests that GAHT may have both positive and negative effects on metabolism, bone health, cardiovascular health, and cancer risk. However, the impact of GAHT on liver health remains a topic of ongoing investigation. Some studies suggest that GAHT may influence liver function markers, potentially increasing the risk of liver-related complications, though results are mixed on the clinical significance . Understanding these effects is essential for optimizing the healthcare of transgender populations and ensuring the safety and efficacy of hormone therapy regimens.

NJCRI, having an established gender affirming care clinic since 2017, is interested in studying the liver health in our transgender population. Our aim is to identify risk factors that can affect liver health in this community.

STUDY DESIGN:

This is an observational prospective case-control study conducted at NJCRI over a period of 12 months.

STUDY ACTIVITIES:

Informed consent process. Eligible participants need to sign the informed consent prior start of any study procedure.

Eligible subjects will be screened with rapid HCV test and HIV test at every study visit. Clinical laboratory assessment will also be performed at baseline which includes, a comprehensive metabolic panel (CMP), Hormone profile (estradiol and testosterone), HgbA1C, Cholesterol levels. A copy of de-identified blood work will be attached to the study chart. Those who have tested positive for HCV and HIV will be referred to a clinic for care.

Review of Medications will be performed on every study visit. All new medication and stop-date will be recorded on the concomitant medication log.

Physical Examination which includes Vital Signs (Height, Weight, BMI, Waist Circumference) will be performed at every visit.

Liver health-related risk factors will be assessed through validated standardized questionnaires. These include measures specific to the experiences of transgender individuals, such as the Gender Congruence and Life Satisfaction Scale (GCLS) scales from the Gender Minority Stress and Resilience Measure and its modified version, as well as questions adapted from the 2015 US Transgender Survey, the Trans Pop Study, the National HIV Behavioral Surveillance among Transgender Women, and Project VOICE. Additional health measures include the Kessler Psychological Distress Scale and the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool. AUDIT-C questionnaire will be used to assess alcohol consumption. The survey will be collected at every study visit, which will take approximately 20-25 minutes to complete. Individuals with arising mental and physical ailments will be referred to an appropriate health care provider and/or service.

Fibroscan will be performed at baseline, halfway through the study, and at the end of last study visit. (Visit 1, Visit 4, and Visit 5 only)

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.

STUDY PROCEDURES:

All study personnel must undergo protocol training prior to the start of any study procedure, and the site training log and delegation of authority log should be completed.

Recruitment:

Recruitment will be conducted primarily at NJCRI's gender-affirming clinic. This study will also be partnering with LGBTQ+ community organizations, healthcare facilities specializing in transgender care, and online platforms to aid with recruitment as necessary.

Informed Consents:

All participants will provide written informed consent before enrollment.

Data Collection:

ReDCap will be utilized as the primary platform for secure and efficient data collection, management, and analysis throughout the research project.

Demographic, anthropometric measures and clinical data collection through structured interview and medical record review.

Blood sample collection for liver function test (transaminases, bilirubin), hormonal profiles, and HIV and Hepatitis status.

Assessment of liver health-related risk factors through a validated standardized questionnaire.

The Controlled Attenuation Parameter (CAP) score (dB/m) along with liver stiffness measurement (E \[kPa\]) will be recorded during the transient Elastography or Fibroscan

Data Analysis:

Statistical analysis will be performed to compare liver function markers and risk factors between two groups.

Regression analysis will be conducted to identify predictors of liver health outcomes among transgender individuals.

LIMITATIONS:

Generalizability of findings may be limited to the transgender population receiving care or services through NJCRI and/or with its partner organizations.

CONCLUSION:

The Transgender Liver Health Study aims to address the gap in knowledge regarding the impact of GAHT on liver function among transgender individuals, by elucidating the relationship between hormone therapy and liver health.

This study seeks to inform clinical practice and optimize healthcare delivery for the transgender population.

• Assess Liver Health Risk Factors [Time frame: baseline to December 2027]
• Liver function in Transgender individuals [Time frame: baseline to December 2027]
• Explore potential modifiers of liver health outcomes [Time frame: baseline to December 2027]
• Change in Quality of Life at baseline visit [Time frame: baseline to December 2027]
• Change in Quality of Life at last visit [Time frame: baseline to December 2027]