Disentangling the biopsychosocial effects of gender-affirming hormone therapy on social health: A protocol for a multi-arm prospective cohort study (AFFIRM Relationships)

Introduction: Gender-affirming hormone therapy (GAHT) is associated with improvements in gender congruence and changes in psychosocial functioning, yet its effects on social health are not yet known. Social health, i.e., someone having adequate quantity and quality of relationships to meet their needs for meaningful connection, is a key determinant of quality of life. Understanding potential changes in social health during GAHT is therefore essential to information provision for trans and gender diverse (TGD) people. The study, AFFIRM Relationships, aims to prospectively examine how GAHT affects social health and to isolate the biological effects of hormonal intervention relative to other gender-affirming treatments (i.e., mastectomy and voice training). Methods: We will conduct a multi-arm prospective longitudinal cohort study of TGD people who start GAHT, gender-affirming voice training, or gender-affirming mastectomy, prospectively following participants from before starting treatment to 3, 6, 12 and 24 months after starting treatment. We will examine changes in social health, including potential changes in social networks. We aim to disentangle the ways in which social health changes after GAHT, by examining changes in psychosocial functioning and the potential roles of social stigma and gender congruence. Furthermore, we will compare the effects of GAHT, which induces a systemic biological change, to the effects of voice training and mastectomy, which are non-systemic interventions, to better understand the unique biological effects of GAHT.Ethics and dissemination: Ethical approval for this study was granted by the Medical Ethical Committee of Amsterdam UMC (study no. 2024.0927). Results from this study will be disseminated via academic peer-reviewed publications, adapted into guidelines for clinical care, and we will co-design dissemination strategies for the TGD community together with a group of lived experienced experts (LEEs).