COVID-19
Conditions
Keywords
COVID-19 testing, Low-income populations, Immigrant populations, Unhoused populations, Uninsured populations
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.
Interventions
BEHAVIORALPublic Health Intervention Package
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.
Sponsors
MaineHealth
Kathleen Fairfield
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Testing Proportion | 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
| Measure | Time frame | Description |
|---|---|---|
| 1) Confidence in Ability to Use COVID-19 Tests | 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) Perceived Severity of Illness From COVID-19 | 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) Perceived Usefulness of COVID-19 Testing | 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) Norms Around COVID-19 Testing | 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) Commitment to COVID-19 Testing | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COVID-19 Testing 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.
Public Health Intervention Package: 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. | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Medical issues impacted ability to participate | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | COVID-19 Testing |
|---|---|
| Age, Continuous | 45.5 Years STANDARD_DEVIATION 15 |
| Age, Customized 18-24 years | 7 Participants |
| Age, Customized 25-39 years | 33 Participants |
| Age, Customized 40-59 years | 34 Participants |
| Age, Customized 60 years or older | 19 Participants |
| Education level 8th grade or less | 5 Participants |
| Education level Bachelor's degree or higher | 36 Participants |
| Education level Prefer not to answer | 2 Participants |
| Education level Some/all high school | 28 Participants |
| Education level Some college/technical degree/vocational | 22 Participants |
| Employed currently | 42 Participants |
| Health insurance Don't know | 4 Participants |
| Health insurance Private | 27 Participants |
| Health insurance Public (Medicare, Medicaid, Tricare) | 45 Participants |
| Health insurance Uninsured | 17 Participants |
| Immigrant | 39 Participants |
| Low income by federal poverty guidelines | 51 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black/African-American | 34 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants |
| Race/Ethnicity, Customized Not reported | 3 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 45 Participants |
| Received COVID-19 vaccine | 84 Participants |
| Region of Enrollment United States | 93 participants |
| Self-reported health Excellent | 16 Participants |
| Self-reported health Fair | 15 Participants |
| Self-reported health Good | 28 Participants |
| Self-reported health Poor | 3 Participants |
| Self-reported health Very good | 31 Participants |
| Self-reported substance use | 28 Participants |
| Sex/Gender, Customized Female | 50 Participants |
| Sex/Gender, Customized Male | 42 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants |
| Unhoused or history of chronic homelessness | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 102 |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
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
Time frame: 12 months
Population: Only 84 of the 93 participants reported an incident in at least one of their surveys that should have prompted COVID-19 testing (i.e. symptoms or exposure); therefore, only 84 participants are included in the analysis of testing behavior. Here we report the average recommended testing proportion among all 84 participants (e.g. participants on average tested 66% of the times they should have done so, according to CDC guidelines)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COVID-19 Testing | Recommended Testing Proportion | 0.66 proportion of times tested asrecommended | Standard Deviation 0.29 |
Secondary
1) Confidence in Ability to Use COVID-19 Tests
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)
Time frame: 12 months
Population: Out of the 93 enrolled participants, 1 participant never completed a survey with this item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COVID-19 Testing | 1) Confidence in Ability to Use COVID-19 Tests | 4.16 units on a scale | Standard Deviation 0.78 |
Secondary
2) Perceived Severity of Illness From COVID-19
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)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COVID-19 Testing | 2) Perceived Severity of Illness From COVID-19 | 2.15 units on a scale | Standard Deviation 0.89 |
Secondary
3) Perceived Usefulness of COVID-19 Testing
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COVID-19 Testing | 3) Perceived Usefulness of COVID-19 Testing | 4.12 units on a scale | Standard Deviation 1.02 |
Secondary
4) Norms Around COVID-19 Testing
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COVID-19 Testing | 4) Norms Around COVID-19 Testing | 2.78 units on a scale | Standard Deviation 0.92 |
Secondary
5) Commitment to COVID-19 Testing
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)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COVID-19 Testing | 5) Commitment to COVID-19 Testing | 4.05 units on a scale | Standard Deviation 0.83 |