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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05270694
Recruitment Status : Recruiting
First Posted : March 8, 2022
Last Update Posted : April 26, 2022
Sponsor:
Collaborator:
MaineHealth
Information provided by (Responsible Party):
Kathleen Fairfield, MaineHealth

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.


Condition or disease Intervention/treatment Phase
COVID-19 Behavioral: Public Health Intervention Package Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
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]
Actual Study Start Date : April 13, 2022
Estimated Primary Completion Date : April 13, 2023
Estimated Study Completion Date : September 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COVID-19 Testing
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.
Behavioral: Public Health Intervention Package

The intervention package consists of two components:

  1. 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)
  2. 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 Measures :
  1. Recommended testing proportion [ Time Frame: Every two weeks for up to 12 months (for a total of 26 time points) ]

    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 :
  1. Campaign Exposure Questionnaire [ Time Frame: Every 2 months for up to 12 months (for a total of 6 time points) ]

    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.


  2. COVID-19 Testing Knowledge Score [ Time Frame: At time of enrollment and every 2 months for up to 12 months (for a total of 7 time points) ]

    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.


  3. COVID-19 Testing Attitudes Score [ Time Frame: At time of enrollment and every 2 months for up to 12 months (for a total of 7 time points) ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05270694


Contacts
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Contact: Gloria Sclar, MPH (703) 472-0522 Gloria.Sclar@mainehealth.org

Locations
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United States, Maine
Greater Portland Health Recruiting
Portland, Maine, United States, 04101
Contact: Elizabeth Jackson         
Portland Community Free Clinic Recruiting
Portland, Maine, United States, 04101
Contact: Kathleen Fairfield, MD         
Preble Street Learning Collaborative Recruiting
Portland, Maine, United States, 04101
Contact: Caroline Fernandes         
Sponsors and Collaborators
Kathleen Fairfield
MaineHealth
Investigators
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Principal Investigator: Kathleen Fairfield, MD, DrPH MaineHealth
Publications:

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Responsible Party: Kathleen Fairfield, Physician Scientist, and Associate Professor of Medicine, Public Health & Community Medicine at Tufts University School of Medicine, MaineHealth
ClinicalTrials.gov Identifier: NCT05270694    
Other Study ID Numbers: 1795294
First Posted: March 8, 2022    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathleen Fairfield, MaineHealth:
COVID-19 testing
Low-income populations
Immigrant populations
Unhoused populations
Uninsured populations
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases