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

NCT05270694 | Completed Results

• 1 other identifier: 1795294
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

COVID-19

Keywords

COVID-19 testing; Low-income populations; Immigrant populations; Unhoused populations; Uninsured populations

Outcome Measures

Primary Outcomes (1)

• Recommended Testing Proportion

  Primary outcome measures how many times a participant tested out of the total number of times they should have tested based on public health recommendations (i.e. symptomatic and/or had close contact exposure). Participants are sent a survey every month over the course of 12 months. The participant is asked if, in the past month, they had been in close contact with someone with COVID-19 and/or experienced COVID-19 symptoms. The survey then asks 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 is summed to calculate a single value for "recommended testing proportion" for each participant. Metric = total # of times participant took COVID-19 rapid test when recommended / total # of times participant should have taken COVID-19 rapid test when recommended e.g. participant tested 7 times in total / 10 times in total when participant should have tested = 0.70 recommended testing across the 12 month time frame

  12 months

Secondary Outcomes (5)

• 1) Confidence in Ability to Use COVID-19 Tests

  12 months

• 2) Perceived Severity of Illness From COVID-19

  12 months

• 3) Perceived Usefulness of COVID-19 Testing

  12 months

• 4) Norms Around COVID-19 Testing

  12 months

• 5) Commitment to COVID-19 Testing

  12 months

Study Arms (1)

COVID-19 Testing

EXPERIMENTAL

The cohort participants will attend an in-person training on how to take an at-home COVID-19 test and also be provided with five at-home test kits at the training and every other month for a total of 35 kits over the course of a year.

Behavioral: Public Health Intervention Package

Interventions

Public Health Intervention Package BEHAVIORAL

The intervention package consists of two components: 1. 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. 2. 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.

COVID-19 Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individual is \<18 years old

Sponsors & Collaborators

• Kathleen Fairfield: lead
• MaineHealth: collaborator

Study Sites (3)

Greater Portland Health

Portland, Maine, 04101, United States

Location

Portland Community Free Clinic

Portland, Maine, 04101, United States

Location

Preble Street Learning Collaborative

Portland, Maine, 04101, United States

Location

Related 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.

  PMID: 32658925 BACKGROUND

• 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.

  PMID: 32306369 BACKGROUND

• 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 [Preprint]. 2020 Apr 17:2020.04.10.20060962. doi: 10.1101/2020.04.10.20060962.

  PMID: 32511437 BACKGROUND

• 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.

  PMID: 32459916 BACKGROUND

• 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.

  PMID: 33372209 BACKGROUND

• 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.

  PMID: 32817602 BACKGROUND

• 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.

  PMID: 32419766 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

A major limitation was that all participants received the at-home COVID-19 tests; therefore, there was no control group for direct comparison. This approach helped facilitate research engagement among a population traditionally underrepresented in biomedical research, by allowing all participants to engage with the testing program. However, further study with a control group is needed to determine the true effect of this at-home testing program on desired testing behavior in these populations.

Results Point of Contact

• Title: Dr. Kathleen Fairfield
• Organization: MaineHealth Institute for Research

kathleen.fairfield@mainehealth.org

207-661-7614

Study Officials

• Kathleen Fairfield, MD, DrPH

  MaineHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician Scientist, and Associate Professor of Medicine, Public Health & Community Medicine at Tufts University School of Medicine

Model Details: 150 participants will be enrolled into the cohort, with 15 participants from each of the 10 specific populations of interest (3 groups that access different health services for low-income/uninsured, unhoused individuals, and 6 different immigrant groups)

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 8, 2022
• Study Start: April 13, 2022
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-03

Locations

US (3)