dbGaP Study Accession: phs002658

NIH Institute/Center: NIAID

RADx Data Program: RADx-UP

DOI: 10.60773/yrkh-gy81

Release Date: 08/31/2023

Updated Date: 04/17/2024

Study Description: Transgender (TG) people are a NIH-designated health disparities population with high morbidity and mortality across multiple health conditions, including HIV infection, mental health, and substance use. These conditions are a product of, and are exacerbated by, historical and ongoing discrimination and inequities in access to healthcare. In early 2020, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) was recognized as a global pandemic. To date, no data exists on COVID-19 disease in TG people. There is an urgent need to understand the burden of COVID-19 disease, investigate its impact on other health conditions and vulnerabilities burdening TG populations, and identify future public health intervention targets. This project aimed to fill this gap. To accomplish these goals, disparities in access to testing among TG people were identified and mitigated. The parent LITE study enrolled a baseline sample of more than 1,500 TG women in the eastern and southern U.S. to assess HIV risk across 24 months of biobehavioral follow-up using technology-enhanced, digital methods of data capture. Leveraging the LITE infrastructure and in partnership with two community-based organizations, this research aided in the development of LITE-CONNECT, a rapid, community-engaged mixed-methods assessment that enrolled over 2,000 TG men and women across the U.S. The objective of this supplemental study was to characterize access and barriers to COVID-19 testing, provide access to and evaluate the use of home-based COVID-19 antibody testing to identify past infection and potential immunity, connect TG men and women to available community-based COVID-19 testing and support services, and identify community-based solutions to support access to COVID-19 testing, interventions, and care among TG people. Results from this study were rapidly used to inform community-based efforts and national COVID-19 response that were inclusive of TG people. The research provided critical and timely insights about COVID-19 disease in TG people in a space in which almost no information currently exists. Early identification of disparities in COVID-19 morbidity and in access to COVID-19 testing and care was critical to ensuring access to services as the pandemic continues. Existing infrastructure and community collaborations were leveraged to gather new data, including unprecedented data from TG men, to guide urgently needed interventions to improve and optimize the health and wellbeing of TG people in the context of the COVID-19 pandemic.

Principal Investigator: Wirtz, Andrea

Has Data Files: Yes

Study Domain: Self-Testing (At-Home or OTC); Community Outreach Programs

Data Collection Method: Survey

Keywords: Disparities in Access to Testing; Burden of Illness

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

Study Sites: Brigham Womens Hospital; UNC Chapel Hill (Note: data are only collected and managed by JHU).

Data Types: Clinical; Questionnaires/Surveys; Social; Behavioral

Study Start Date: 09/23/2020

Study End Date: 07/31/2022

Species: Human Data

Estimated Cohort Size: 2000

Study Population Focus: Sexual and Gender Minorities; Adults; Older Adults or Elderly; People Living with HIV/AIDs

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9790855/

Acknowledgement Statement: This study was supported through funding, 3UH3AI133669-04S1, for the National Institute of Allergy and Infectious Diseases (NIAID) as part of the RADx-UP program. Research conducted under the LITE Connect study was led by Andrea Wirtz (mPI), Johns Hopkins University and Sari Reisner (mPI), Brigham Women's Hospital with co-investigators, Carter Brown, Black Transgender Advocacy Coalition; Marissa Miller, TransSolutions Center; Tonia Poteat, UNC Chapel Hill; and Will Beckham, Johns Hopkins University. We acknowledge the dedication of Dee Adams, study staff, and Brad Thorson and colleagues at Molecular Testing Labs. We appreciate the time and contributions of study participants without whom this research would not be possible. Approved users should acknowledge the provision of data access by dbGaP for accession phs002658.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-135

NIH Grant or Contract Number(s): 3UH3AI133669-04S1

Consent/Data Use Limitations: General Research Use