Study Information

dbGaP Study Accession: phs003082

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

DOI: 10.60773/s244-bp16

Release Date: 08/29/2023

Updated Date: 04/17/2024

Study Description: People with criminal legal system involvement (CLSI) have experienced five times as many COVID-19 infections and have three times the risk of death compared to general population in the U.S. Heavily impacted by COVID-19 and squarely within NIH health disparities populations, people with CLSI are often poor and disproportionately from racial and ethnic minority groups. Despite the increased risk of COVID-19, it is expected that only one-half of people with CLSI will get vaccinated. Ongoing COVID-19 testing in communities and among groups that are not vaccinated will be key to containing the pandemic. The messaging that COVID-19 testing will still be important may not be getting through to people who are at risk - a critical driver of disparities. This team had a unique opportunity to boost testing literacy, access, and uptake using mobile health (mHealth) technologies (text and Web) to reach women with CLSI in community settings who are part of the existing Tri-City Cohort drawn from geographically and socio-politically diverse cities: Birmingham, AL, Kansas City, MO/KS, and Oakland, CA. This application was highly responsive to the RADx-UP Phase II call for research that tests interventions to reduce COVID-19 disparities among underserved populations. The team was positioned to embed the study into an existing Web-based women's health literacy intervention platform (www.shewomen.org, 2R01CA181047) for women leaving jail. The study was also able to immediately push the mHealth COVID-19 testing literacy intervention to 508 women that have already recruited to a three-city cervical health study of women with CLSI (R01CA226838), and to promptly make this scalable intervention widely available to people with CLSI. The study engaged the women as stakeholders to study regional and individual differences in COVID-19 testing and vaccine literacy, access, and uptake. This study used findings to rapidly develop an mHealth intervention focused on COVID-19 literacy, and then pushed the intervention to CLSI women in the three cities to boost COVID-19 literacy, testing, access, and uptake, and vaccination. Findings were used to develop dissemination strategies with stakeholders to push the mHealth intervention to the two million women and 11 million men who interface with the criminal legal system annually in the U.S.

Principal Investigator: Ramaswamy, Megha

Has Data Files: Yes

Study Domain: Testing Rate/Uptake; Vaccination Rate/Uptake; Digital Health Applications; Social Determinants of Health; Virological Testing

Data Collection Method: Survey; Interview or Focus Group

Keywords: Health Literacy; mHealth; Individual-Level Data; Improving Access to COVID-related Interventions; COVID Education

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Questionnaires/Surveys; Behavioral; Other

Data Types, Other: Interviews

Study Start Date: 01/01/2022

Study End Date: 11/30/2022

Species: Human Data

Estimated Cohort Size: 508

Study Population Focus: Adults; Older Adults or Elderly; Incarcerated/Institutionalized (or Criminal Legal System Involvement); Underserved/Vulnerable Population; Lower Socioeconomic Status (SES) Population; Racial and Ethnic Minorities

Study Website URL: https://www.kumc.edu/school-of-medicine/academics/departments/population-health/research/sexual-health-empowerment/projects.html

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05582746

Acknowledgement Statement: This study was supported through funding, 1U01MD017415-01, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. We would like to acknowledge the participants for giving their time and perspectives. We would like to thank the field staff in Kansas City, Oakland and Birmingham. Approved users should acknowledge the provision of data access by dbGaP for accession phs003082.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: RFA-OD-21-008

NIH Grant or Contract Number(s): 1U01MD017415-01

Consent/Data Use Limitations: General Research Use

Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs003082_Project 95_Protocol.pdf140.46 KB
READMEproject95_README.html281.40 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project95_DATA_transformcopy.csvTabular Data - Harmonizedcsv572
project95_DATA_origcopy.csvTabular Data - Non-harmonizedcsv572