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Completed

NCT Number: NCT05270694

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greater Portland Health, Portland, Maine, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Public Health Intervention Package

Behavioral

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.

Primary outcomes

  1. Recommended Testing Proportion

    Time frame: 12 months

    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

Secondary outcomes

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

    Time frame: 12 months

    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. 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 during this 12 month period.

    Metric = Average testing perception for each knowledge/attitude item

    Item 1: How confident are you in your ability to properly conduct an at-home COVID-19 test? 1 = Not confident; 2 = A little confident; 3 = Confident; 4 = Quite confident; 5 = Very confident

    *Higher score is desired (i.e. indicates greater confidence)

  2. 2) Perceived Severity of Illness From COVID-19

    Time frame: 12 months

    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. 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 during this 12 month time period.

    Metric = Average testing perception for each knowledge/attitude item

    Item 2: Imagine you test positive for COVID-19. How severely do you think your health would be impacted? 1 = Not severe; 2 = A little severe; 3 = Severe; 4 = Quite severe; 5 = Very severe

    *Higher score is desired (i.e. indicates greater perceived severity around COVID illness)

  3. 3) Perceived Usefulness of COVID-19 Testing

    Time frame: 12 months

    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. 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 during this 12 month time period.

    Metric = Average testing perception for each knowledge/attitude item

    Item 3: Composite of two questions How important is it to you that you get tested for COVID-19 when you are experiencing symptoms or had a close contact?

    1 = Not important; 5 = Very important How useful do you think it is to take a COVID-19 test when you are experiencing symptoms or had a close contact?

    1 = Not at all useful; 5 = Very useful

    *Higher score is desired

  4. 4) Norms Around COVID-19 Testing

    Time frame: 12 months

    Secondary outcomes include various knowledge and attitude questions that capture the participants' perceptions towards COVID-19 testing. These questions have 5-pt Likert response options. 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 during this 12 month period.

    Metric = Average testing perception for each knowledge/attitude item

    Item 4: Combines two questions Among the people you know, how many take a COVID-19 test when they are experiencing symptoms or had a close contact?

    1 = (Almost) none of them; 5 = (Almost) all of them Overall, among the people who are important to you, how much do they approve or disapprove of taking a COVID-19 test when you have symptoms or a close contact?

    1 = disapprove a lot; 5 = approve a lot

    *Higher score is desired

  5. 5) Commitment to COVID-19 Testing

    Time frame: 12 months

    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. 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 during this 12 month time period.

    Metric = Average testing perception for each knowledge/attitude item

    Item 5: How committed are you to taking a COVID-19 test when you are experiencing symptoms or had a close contact? 1 = Not at all committed; 2 = Somewhat committed; 3 = Committed; 4 = Quite committed; 5 = Very committed

    *Higher score is desired (i.e. indicates greater commitment towards testing)

Sponsors and collaborators

Lead sponsor

Kathleen Fairfield

Other

Collaborators

  • MaineHealth

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2022
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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