Evaluating Public Health Interventions to Improve COVID-19 Testing Among Underserved Populations

COVID-19 Clinical Trial

Official title:

Understanding Factors Influencing COVID-19 Testing and Vaccination in Immigrant, Low-income and Unhoused Populations, and Testing Targeted Interventions [3U54GM115516=04S2 RADx-UP]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270694
• Other study ID #: 1795294
• Status: Completed
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: November 8, 2023

Study information

• Verified date: November 2023
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The COVID-19 pandemic has disproportionately affected people from underserved and vulnerable populations such as low-income/uninsured, unhoused, and immigrant communities. These populations in the US are at a higher risk of acquiring COVID-19 because of poverty, type of occupation, greater use of public transit, living in multigenerational housing, lack of access to quality healthcare, and more. Despite greater risk of being infected and dying of COVID-19, those in disadvantaged communities are less likely to get tested. The investigators are collaborating with community partners in Cumberland County, Maine to implement a public health intervention focused on making COVID-19 testing more accessible to underserved populations. The intervention includes a one-time in-person training on how to take an at-home COVID-19 test and then provision of at-home COVID-19 testing kits to make testing more accessible. Five testing kits are provided at the time of training and then provided every two months for a year, for a total of 35 testing kits.

In this study, the investigators will evaluate the impact of the at-home testing kit intervention on COVID-19 testing behavior, knowledge and attitudes. The investigators will accomplish this aim by following a community cohort, with a goal of recruiting 150 participants - 15 participants from each of our 10 population groups of interest (three groups that access different health services for low-income/uninsured, unhoused individuals, and six different immigrant groups). The investigators will administer surveys to the cohort participants every month over a 12 month period. Every month the survey will ask about testing behavior, and every other month the survey will also ask about knowledge and attitudes towards testing. In order to ensure access to COVID-19 tests, the cohort participants will be provided at-home testing kits throughout the course of the study. The primary outcome of interest is "recommended testing behavior," which is defined as taking a rapid COVID-19 test when experiencing symptoms of COVID-19 or after a close contact exposure.

The investigators hypothesize that knowledge about testing, favorable attitudes towards testing, and recommended testing behavior will increase as a result of participation in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Individual accesses services from one of these three public health facilities - community free clinic, needle exchange program, or STD clinic

• Individual is currently unhoused or living in a Housing First development

• Individual immigrated to the US, primarily from one of these six country groups - Somalia, Angola, Iraq or Syria, Burundi or Rwanda, Democratic Republic of the Congo, or a country in Latin America

Exclusion criteria:

• Individual is <18 years old

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Public Health Intervention Package
The intervention package consists of two components: At the time of study enrollment, participants will attend an in-person training on how to properly take an at-home COVID-19 test. Study staff will verbally walk through the steps of the test with the participant while the participant administers the test on themselves, with the opportunity to ask questions and receive corrective feedback, as needed. To make COVID-19 testing more accessible, participants will be provided five at-home COVID-19 testing kits at the training and then every other month throughout the course of the year-long study for a total of 35 kits.

Locations

Country	Name	City	State
United States	Greater Portland Health	Portland	Maine
United States	Portland Community Free Clinic	Portland	Maine
United States	Preble Street Learning Collaborative	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Kathleen Fairfield	MaineHealth

Country where clinical trial is conducted

United States, 

References & Publications (7)

Clark E, Fredricks K, Woc-Colburn L, Bottazzi ME, Weatherhead J. Disproportionate impact of the COVID-19 pandemic on immigrant communities in the United States. PLoS Negl Trop Dis. 2020 Jul 13;14(7):e0008484. doi: 10.1371/journal.pntd.0008484. eCollection 2020 Jul. No abstract available. — View Citation

Laurencin CT, McClinton A. The COVID-19 Pandemic: a Call to Action to Identify and Address Racial and Ethnic Disparities. J Racial Ethn Health Disparities. 2020 Jun;7(3):398-402. doi: 10.1007/s40615-020-00756-0. Epub 2020 Apr 18. — View Citation

Millett GA, Jones AT, Benkeser D, Baral S, Mercer L, Beyrer C, Honermann B, Lankiewicz E, Mena L, Crowley JS, Sherwood J, Sullivan PS. Assessing differential impacts of COVID-19 on black communities. Ann Epidemiol. 2020 Jul;47:37-44. doi: 10.1016/j.annepidem.2020.05.003. Epub 2020 May 14. — View Citation

Moore JT, Ricaldi JN, Rose CE, Fuld J, Parise M, Kang GJ, Driscoll AK, Norris T, Wilson N, Rainisch G, Valverde E, Beresovsky V, Agnew Brune C, Oussayef NL, Rose DA, Adams LE, Awel S, Villanueva J, Meaney-Delman D, Honein MA; COVID-19 State, Tribal, Local, and Territorial Response Team. Disparities in Incidence of COVID-19 Among Underrepresented Racial/Ethnic Groups in Counties Identified as Hotspots During June 5-18, 2020 - 22 States, February-June 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 21;69(33):1122-1126. doi: 10.15585/mmwr.mm6933e1. — View Citation

Nayak A, Islam SJ, Mehta A, Ko YA, Patel SA, Goyal A, Sullivan S, Lewis TT, Vaccarino V, Morris AA, Quyyumi AA. Impact of Social Vulnerability on COVID-19 Incidence and Outcomes in the United States. medRxiv. 2020 Apr 17:2020.04.10.20060962. doi: 10.1101/2020.04.10.20060962. Preprint. — View Citation

Price-Haywood EG, Burton J, Fort D, Seoane L. Hospitalization and Mortality among Black Patients and White Patients with Covid-19. N Engl J Med. 2020 Jun 25;382(26):2534-2543. doi: 10.1056/NEJMsa2011686. Epub 2020 May 27. — View Citation

Sy KTL, Martinez ME, Rader B, White LF. Socioeconomic Disparities in Subway Use and COVID-19 Outcomes in New York City. Am J Epidemiol. 2021 Jul 1;190(7):1234-1242. doi: 10.1093/aje/kwaa277. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recommended testing proportion	The primary outcome will measure how many times a participant tested themselves out of the total number of times they should have tested based on public health recommendations.; Metric = Number of times participant took an at-home COVID-19 antigen rapid test when it is recommended (i.e. experienced symptoms and/or had a close contact exposure) / Number of times participant experienced symptoms and/or had a close contact exposure; Participants will be sent a survey every month over the course of 12 months for a total of 12 surveys. The participant will be asked if they had been in close contact with someone with COVID-19 in the past month and if they experienced COVID-19 symptoms in the past month. The survey will then ask the participant to self-report on whether or not they took an at-home COVID-19 rapid antigen test. The data from all 12 surveys will be combined to calculate an overall "recommended testing proportion" for each participant.	Every month for up to 12 months (for a total of 12 time points)
Secondary	COVID-19 Testing Perceptions (Knowledge and Attitudes)	The secondary outcome measures will include various knowledge and attitude questions that capture the participants' perceptions towards COVID-19 testing. These questions have 5-pt Likert response options.; Metric = Average testing perception for each knowledge/attitude item; Participants will answer COVID-19 testing knowledge and attitude questions at the time of enrollment and then answer the same questions every 2 months over the course of 12 months for a total of 7 time points. We will calculate an average across the responses for each item.	At time of enrollment and every 2 months for up to 12 months (for a total of 7 time points)