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

Primary Purpose

COVID-19

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Public Health Intervention Package
Sponsored by
Kathleen Fairfield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19 focused on measuring COVID-19 testing, Low-income populations, Immigrant populations, Unhoused populations, Uninsured populations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Greater Portland Health
  • Portland Community Free Clinic
  • Preble Street Learning Collaborative

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COVID-19 Testing

Arm Description

The cohort participants will be exposed to a public health messaging campaign and provided with at-home tests to improve acceptability and access to COVID-19 testing.

Outcomes

Primary Outcome Measures

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 two weeks over the course of 12 months for a total of 26 surveys. The survey will ask the participant to self-report on whether or not they took an at-home COVID-19 rapid antigen test. The participant will also be asked if they had been in close contact with someone with COVID-19 in the past 2 weeks and/or if they experienced COVID-19 symptoms in the past two weeks.The data from all 26 surveys will be combined to calculate an overall "recommended testing proportion" for each participant.

Secondary Outcome Measures

Campaign Exposure Questionnaire
This secondary outcome will measure what percentage of cohort participants were exposed to each campaign activity. Metric = Number of participants who report exposure to activity / Total number of cohort participants Participants will be sent a survey every 2 months over the course of 12 months for a total of 6 time points. Throughout this same time period the campaign activities will take place in the larger community. The survey will include a "campaign exposure questionnaire" that asks a series of questions about whether or not the participant had experienced (seen, heard about, attended) any of the campaign activities that would have taken place in the prior 2 months. An exposure percentage will be calculated for each campaign activity assessed across the 7 questionnaires.
COVID-19 Testing Knowledge Score
This secondary outcome will measure how much knowledge a participant has about COVID-19 testing Metric = Testing knowledge score calculated based on responses to several questions Participants will take a "COVID-19 testing knowledge questionnaire" at the time of enrollment and then take the same questionnaire every 2 months over the course of 12 months for a total of 7 time points. The questionnaire will included several questions that assess knowledge related to COVID-19 testing, such as when a person should seek testing. A score will be constructed based on these questions to create an overall knowledge metric which will be calculated at each time point.
COVID-19 Testing Attitudes Score
This secondary outcome will measure how strongly a participant holds positive attitudes towards the behavior of COVID-19 testing. Metric = Score calculated based on responses to several attitudes questions Participants will take a "COVID-19 testing attitudes questionnaire" at the time of enrollment and then take the same questionnaire every 2 months over the course of 12 months for a total of 7 time points. The questionnaire will included several Likert-scale questions that assess attitudes towards COVID-19 testing, such as perceptions of how easy it is to get tested and personal beliefs about the importance of testing. A score will be constructed based on these questions to create an overall attitudes metric which will be calculated at each time point.

Full Information

First Posted
February 9, 2022
Last Updated
April 26, 2023
Sponsor
Kathleen Fairfield
Collaborators
MaineHealth
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1. Study Identification

Unique Protocol Identification Number
NCT05270694
Brief Title
Evaluating Public Health Interventions to Improve COVID-19 Testing Among Underserved Populations
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]
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
November 7, 2023 (Anticipated)
Study Completion Date
November 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kathleen Fairfield
Collaborators
MaineHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 develop a public health intervention focused on making COVID-19 testing more acceptable and accessible to underserved populations. The intervention is based on qualitative formative research and includes a community-level communication campaign to make testing more acceptable and provision of at-home COVID-19 testing kits to make testing more accessible. In this study, the investigators will evaluate the impact of the public health intervention on COVID-19 testing behavior, knowledge and attitudes. The investigators will accomplish this aim by following a community cohort of 150 participants, with 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 other month over a 12 month period. The surveys will evaluate knowledge and attitudes towards testing and testing behavior. 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 getting 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 testing, Low-income populations, Immigrant populations, Unhoused populations, Uninsured populations

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 Testing
Arm Type
Experimental
Arm Description
The cohort participants will be exposed to a public health messaging campaign and provided with at-home tests to improve acceptability and access to COVID-19 testing.
Intervention Type
Behavioral
Intervention Name(s)
Public Health Intervention Package
Intervention Description
The intervention package consists of two components: To make COVID-19 testing more acceptable, there will be a communication campaign that aims to promote COVID-19 testing and is designed based on qualitative formative research (N.B. the campaign is currently being developed; the investigators will update the registration with details of campaign activities and messages once they are finalized) To make COVID-19 testing more accessible, participants will be provided five at-home COVID-19 testing kits per month throughout the course of the study
Primary Outcome Measure Information:
Title
Recommended testing proportion
Description
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 two weeks over the course of 12 months for a total of 26 surveys. The survey will ask the participant to self-report on whether or not they took an at-home COVID-19 rapid antigen test. The participant will also be asked if they had been in close contact with someone with COVID-19 in the past 2 weeks and/or if they experienced COVID-19 symptoms in the past two weeks.The data from all 26 surveys will be combined to calculate an overall "recommended testing proportion" for each participant.
Time Frame
Every two weeks for up to 12 months (for a total of 26 time points)
Secondary Outcome Measure Information:
Title
Campaign Exposure Questionnaire
Description
This secondary outcome will measure what percentage of cohort participants were exposed to each campaign activity. Metric = Number of participants who report exposure to activity / Total number of cohort participants Participants will be sent a survey every 2 months over the course of 12 months for a total of 6 time points. Throughout this same time period the campaign activities will take place in the larger community. The survey will include a "campaign exposure questionnaire" that asks a series of questions about whether or not the participant had experienced (seen, heard about, attended) any of the campaign activities that would have taken place in the prior 2 months. An exposure percentage will be calculated for each campaign activity assessed across the 7 questionnaires.
Time Frame
Every 2 months for up to 12 months (for a total of 6 time points)
Title
COVID-19 Testing Knowledge Score
Description
This secondary outcome will measure how much knowledge a participant has about COVID-19 testing Metric = Testing knowledge score calculated based on responses to several questions Participants will take a "COVID-19 testing knowledge questionnaire" at the time of enrollment and then take the same questionnaire every 2 months over the course of 12 months for a total of 7 time points. The questionnaire will included several questions that assess knowledge related to COVID-19 testing, such as when a person should seek testing. A score will be constructed based on these questions to create an overall knowledge metric which will be calculated at each time point.
Time Frame
At time of enrollment and every 2 months for up to 12 months (for a total of 7 time points)
Title
COVID-19 Testing Attitudes Score
Description
This secondary outcome will measure how strongly a participant holds positive attitudes towards the behavior of COVID-19 testing. Metric = Score calculated based on responses to several attitudes questions Participants will take a "COVID-19 testing attitudes questionnaire" at the time of enrollment and then take the same questionnaire every 2 months over the course of 12 months for a total of 7 time points. The questionnaire will included several Likert-scale questions that assess attitudes towards COVID-19 testing, such as perceptions of how easy it is to get tested and personal beliefs about the importance of testing. A score will be constructed based on these questions to create an overall attitudes metric which will be calculated at each time point.
Time Frame
At time of enrollment and every 2 months for up to 12 months (for a total of 7 time points)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Fairfield, MD, DrPH
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Portland Health
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Portland Community Free Clinic
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Preble Street Learning Collaborative
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32658925
Citation
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.
Results Reference
background
PubMed Identifier
32306369
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.
Results Reference
background
PubMed Identifier
32511437
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.
Results Reference
background
PubMed Identifier
32459916
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.
Results Reference
background
PubMed Identifier
33372209
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.
Results Reference
background
PubMed Identifier
32817602
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.
Results Reference
background
PubMed Identifier
32419766
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.
Results Reference
background

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

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