Background : In April 2018, Patient-Centered Outcomes Research Institute (PCORI) funded a prospective multi-site clinic-based cohort of 4,500 diverse TGNB patients from two urban health centers, Callen-Lorde Community Health Center (New York, NY) and Fenway Health (Boston, MA). This mixed methods study aims to longitudinally evaluate the effects of medical gender affirmation on HIVPC/HIVCC outcomes and examine whether medical gender affirmation predicts 12-month prospective improvements in psychological functioning and health-related quality of life in TGNB patients initiating hormone therapy. The study will enroll adult TGNB primary care patients over a 12- month period and follow participants prospectively for 12 months of follow-up and compile multiple biobehavioral data sources, including electronic patient-reported outcomes and electronic health records (EHR) data. To inform study design, implementation and analysis, the research team hosted a series of focus groups with current TGNB patients that would be eligible for recruitment into the cohort.
Methods : Research staff at Callen-Lorde Community Health Center and the Fenway Institute conducted focus groups (two per site respectively) of transgender and non-binaryTGNB patients to assess 1) acceptability of study research aims, topics covered, study design, recruitment and retention; 2) patient research priorities; 3) previous positive and negative experiences engaging with research projects and 4) motivations to participate in longitudinal research studies. Between August and October 2018, 28 transgender and non-binary TGNB patients participated (mean age = 34, range =18-66) with mixed genders 13 identifying as female-identified, 12 identifying as male-identified, 3 identifying as non-binary) racial and ethnic representation (3 Asian/Pacific Islander, 5 Black/African American, 12 White, 5 Multiracial, 3 Another Race; 8 persons of various races identifying as Hispanic/Latino) in 4 focus groups, facilitated by two research staff of transgender experience for each group.
Results : Participants critically examined the importance of meaningfully engaging TGNB patients at every step of the research process. Many participants explained that their motivation to participate in TGNB-focus research projects included participating on studies 1) run by a TGNB principal investigator; 2) facilitated by TGNB staff that reflects the target population; 3) recommended by their primary care provider; 4) maintains continuous engagement with a community advisory board; 5) compensates participants for their time; and 6) uses research questions developed by the local TGNB community. For non-compensated research studies, all groups emphasized that studies must be a very low burden to patients and be seamlessly integrated into their medical care, particularly for a longitudinal study.
Conclusions : Lack of requisite knowledge about medical gender affirmation and HIVPC/HIVCC outcomes impedes the design, implementation, and evaluation of health care models that may reduce HIV disparities for TGNB people. Patient-centered care must address and bring to the forefront the key health concerns of TGNB patients, such as access to and initiation of hormones. While knowledge obtained from the cohort will inform the delivery of health care responsive to the specific concerns of TGNB communities, it is essential that the attunement of instruments assessing these factors must be directly informed by and in collaboration with the TGNB patients to make these data meaningful.