Skip to main content
This repository is under review for potential modification in compliance with Administration directives.
Study Information

dbGaP Study Accession: phs002658

NIH Institute/Center: NIAID

RADx Data Program: RADx-UP

Release Date: 08/31/2023

DOI: 10.60773/yrkh-gy81

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.

Updated Date: 04/17/2024

Principal Investigator: Wirtz, Andrea

Has Data Files: Yes

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

Data Collection Method: Survey

Keywords: Burden of Illness; Disparities in Access to Testing

Study Design: Longitudinal Cohort

Multi-Center Study: Yes

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

Data Types: Behavioral; Clinical; Questionnaire or Survey; Social

Study Start Date: 09/23/2020

Study End Date: 07/31/2022

Species: Human

Sample Size: 2133

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

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

Variable Information
Total Variables: 195
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_raceWhat is your race?
nih_ethnicityAre you of Hispanic or Latino origin? May include Spanish origin.
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_educationWhat is the highest level of education you have achieved outside or in the United States?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_disabilityDo you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities?
nih_vape_freqVaping Frequency: Do you now use electronic cigarettes every day, some days, rarely, or not at all?
nih_cig_smoke_freqNicotine Frequency: Do you now smoke cigarettes?
nih_smoking_ynDo you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)?
nih_history_smokingHistory of Smoking
nih_alcohol_ynAlcohol use (Yes or No)
nih_alcohol_frequencyHow often did you have a drink containing alcohol ?
nih_asthmaAsthma
nih_cancer_past_yrCancer diagnosis and/or treatment within the past 12 months
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_mental_health_disorderMental health disorder
nih_sickle_cell_diseaseSickle cell disease
nih_immunocompromisedImmunocompromised condition
nih_autoimmAutoimmune disease
nih_copdChronic obstructive pulmonary disease (COPD)
nih_chronic_lungOther chronic lung disease
nih_depressionDepression
nih_alc_sub_abuseAlcohol or substance use disorder
nih_iv_drug_useIntravenous drug use
nih_other_chronic_condOther chronic condition
nih_health_statusWould you say that (your) health in general is excellent, very good, good, fair, or poor?
age_yrsAge For babies less than 1 year old, do not write the age in months. Write 0 as the age. (Years)
bio_sex_birth_2What was your sex assigned at birth on your birth certificate?
cc_asthma_2Asthma
cc_asud_2Alcohol or substance use disorder
cc_autoimm_2Autoimmune disease
cc_cancer_2Cancer diagnosis and/or treatment within the past 12 months
cc_chronickd_2Chronic kidney disease (CKD)
cc_clung_2Other chronic lung disease
cc_copd_2Chronic obstructive pulmonary disease (COPD)
cc_cvd_2Cardiovascular disease (CVD or heart disease)
cc_depression_2Depression
cc_diabetes_2Diabetes
cc_hypertension_2Hypertension (HTN, high blood pressure)
cc_imm_2Immunocompromised condition
cc_intrav_2Intravenous drug use
cc_otherchroniccond_2Other chronic condition
cc_othermh_2Other mental health disorder
cc_sickle_2Sickle Cell Anemia
current_employment_statusWe would like to know about what you do -- are you working now, looking for work, retired, keeping house, a student, or something else?
hi_coverage_typeWhat is the primary kind of health insurance or health care plan that you have now? (Exclude plans that pay for only one type of Service (such as, nursing home care, accidents, family planning, or dental care) and plans that only provide extra cash when hospitalized. )
race_ethn_hispanicAre you of Hispanic, Latino, or Spanish origin?
self_reported_disabilityDo you have a disability that interferes with your ability to carry out daily activities? Examples of daily activities include walking, climbing stairs, shopping, balancing a checkbook, bathing or dressing.
smoker_cur_stat_2Do you now smoke cigarettes?
vaper_cur_statDo you now use electronic cigarettes every day, some days, rarely, or not at all?
alcohol_date_mdy-
alcohol_daysperweek-
consentdt_mdy-
consent_given-
covid_pandemic_challenges_abod_2-
covid_pandemic_challenges_wate_2-
covid_test_approval-
covid_test_collect_datetime-
covid_test_collection_setting-
covid_test_date_mdy-
covid_test_performed_location-
covid_test_result-
covid_test_result_datetime-
covid_test_result_sent_datetime-
covid_test_specimen_collector-
covid_test_specimen_type-
covid_test_study_setting-
covid_test_tar_dis_stat_2___1-
covid_test_type-
covid_vaccine-
cov_pan_chal_hlth_2-
cov_pan_chal_med_2-
cov_pan_chlng_trans_2-
cov_tst_mthd_2-
edu_years_of_school-
employed_ew-
employed_healthcare_2-
family_income-
flu_vaccinehistind_2-
flu_vaccine_season_3-
gender_identity_term_2-
hi_loss_covid-
hlthstat_date_mdy-
household_congregate_3-
household_homeless-
housing_date_mdy-
isolate_maintain_job-
jobloss_covid19_2-
language_english-
language_home___1-
language_home___2-
language_home___3-
language_home___4-
language_home___5-
language_home___6-
language_home___7-
language_home___8-
language_home___9-
language_home___90-
language_home___99-
language_spoken___10-
language_spoken___9-
med_hx_date_mdy-
needed_healthcare-
needed_mhcare-
positivemonth_covidtest_2-
positiveyear_covidtest_3-
quarantine_maintain_job-
race_ethn_asian_detail_3___1-
race_ethn_asian_detail_3___2-
race_ethn_asian_detail_3___3-
race_ethn_asian_detail_3___4-
race_ethn_asian_detail_3___5-
race_ethn_asian_detail_3___99-
race_ethn_hispanic_detail_2___1-
race_ethn_hispanic_detail_2___2-
race_ethn_hispanic_detail_2___3-
race_ethn_hispanic_detail_2___4-
race_ethn_hispanic_detail_2___5-
race_ethn_hispanic_detail_2___6-
race_ethn_hispanic_detail_2___7-
race_ethn_hispanic_detail_2___8-
race_ethn_hispanic_detail_2___99-
race_ethn_islander_detail_2___1-
race_ethn_islander_detail_2___10-
race_ethn_islander_detail_2___11-
race_ethn_islander_detail_2___12-
race_ethn_islander_detail_2___13-
race_ethn_islander_detail_2___14-
race_ethn_islander_detail_2___2-
race_ethn_islander_detail_2___3-
race_ethn_islander_detail_2___4-
race_ethn_islander_detail_2___5-
race_ethn_islander_detail_2___6-
race_ethn_islander_detail_2___7-
race_ethn_islander_detail_2___8-
race_ethn_islander_detail_2___9-
race_ethn_islander_detail_2___99-
race_ethn_race___1-
race_ethn_race___15-
race_ethn_race___2-
race_ethn_race___3-
race_ethn_race___4-
race_ethn_race___5-
race_ethn_race___99-
recentmonth_covidtest_2-
recentresult_covidtest-
recentyear_covidtest_3-
redcap_event_name-
redcap_repeat_instance-
redcap_repeat_instrument-
self_reported_health_status_assessment-
sex_orient_id-
smoker_number-
sociodem_date_mdy-
test_accesseasy_2-
test_accesswhere_2-
test_date_mdy-
tested_for_covid-
tested_positive_for_covid-
vacc_date_mdy-
vaccine_avail-
vaccine_concerns_3___1-
vaccine_concerns_3___10-
vaccine_concerns_3___2-
vaccine_concerns_3___3-
vaccine_concerns_3___4-
vaccine_concerns_3___5-
vaccine_concerns_3___6-
vaccine_concerns_3___7-
vaccine_concerns_3___8-
vaccine_concerns_3___9-
vaccine_concerns_3___99-
vaccine_reasons_3___1-
vaccine_reasons_3___10-
vaccine_reasons_3___11-
vaccine_reasons_3___2-
vaccine_reasons_3___3-
vaccine_reasons_3___4-
vaccine_reasons_3___5-
vaccine_reasons_3___6-
vaccine_reasons_3___7-
vaccine_reasons_3___8-
vaccine_reasons_3___9-
vaccine_reasons_3___99-
work_closecont_2-
work_ppe_2-
work_ppe_date_mdy-
work_wash_2-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002658_Project 32_Project Aims_30JUL2020.pdf31.90 KB
READMEproject32_README.html274.82 KB
Data Files
Total Files: 8
Data Files: 3
Metadata Files: 3
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project32_DATA_transformcopy.csvTabular Data - Harmonizedcsv2133
project32_DDE_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2133

project32_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2133