An interventional study of Public Health Intervention Package in COVID-19, sponsored by Kathleen Fairfield. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Kathleen Fairfield · Not applicable, Interventional, and Other
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 102 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Kathleen Fairfield as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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
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.
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
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
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
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
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
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
| Milestone | COVID-19 Testing |
|---|---|
| Started | 102 |
| Completed | 93 |
| Not completed | 9 |
| Withdrew: Death | 1 |
| Withdrew: Medical issues impacted ability to participate | 2 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Withdrawal by subject | 3 |
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
| proportion of times tested asrecommended | COVID-19 Testing |
|---|---|
| Recommended Testing Proportion | 0.66 ± 0.29 |
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)
| units on a scale | COVID-19 Testing |
|---|---|
| 1) Confidence in Ability to Use COVID-19 Tests | 4.16 ± 0.78 |
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)
| units on a scale | COVID-19 Testing |
|---|---|
| 2) Perceived Severity of Illness From COVID-19 | 2.15 ± 0.89 |
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
| units on a scale | COVID-19 Testing |
|---|---|
| 3) Perceived Usefulness of COVID-19 Testing | 4.12 ± 1.02 |
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
| units on a scale | COVID-19 Testing |
|---|---|
| 4) Norms Around COVID-19 Testing | 2.78 ± 0.92 |
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)
| units on a scale | COVID-19 Testing |
|---|---|
| 5) Commitment to COVID-19 Testing | 4.05 ± 0.83 |
Collected over Adverse events were tracked for 12 months (the duration of time each participant was enrolled in the study from baseline to the final survey at the 12 month mark).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COVID-19 Testing | 1/102 (1%) | 0/102 (0%) | 0/102 (0%) |
Participants completed an enrollment survey and then were asked to complete a COVID-19 testing survey every 4 weeks for one year. All participants who completed their enrollment survey are included in this baseline analysis table (i.e. it is not dependent on how many COVID-19 testing surveys they completed).
| Age, Continuous(Years) | COVID-19 Testing |
|---|---|
| Mean | 45.5 ± 15 |
| Age, Customized(Participants) | COVID-19 Testing |
|---|---|
| 18-24 years | 7 |
| 25-39 years | 33 |
| 40-59 years | 34 |
| 60 years or older | 19 |
| Sex/Gender, Customized(Participants) | COVID-19 Testing |
|---|---|
| Female | 50 |
| Male | 42 |
| Non-binary | 1 |
| Race/Ethnicity, Customized(Participants) | COVID-19 Testing |
|---|---|
| White, Non-Hispanic | 45 |
| Black/African-American | 34 |
| Hispanic | 5 |
| Asian | 3 |
| Native American | 1 |
| Other | 2 |
| Not reported | 3 |
| Region of Enrollment(participants) | COVID-19 Testing |
|---|---|
| United States | 93 |
| Received COVID-19 vaccine(Participants) | COVID-19 Testing |
|---|---|
| Count of participants | 84 |
| Education level(Participants) | COVID-19 Testing |
|---|---|
| 8th grade or less | 5 |
| Some/all high school | 28 |
| Some college/technical degree/vocational | 22 |
| Bachelor's degree or higher | 36 |
| Prefer not to answer | 2 |
| Self-reported health(Participants) | COVID-19 Testing |
|---|---|
| Excellent | 16 |
| Very good | 31 |
| Good | 28 |
| Fair | 15 |
| Poor | 3 |
6 further baseline measures are reported on the registry.
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