COVID-19NCT05270694

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

A study testing Public Health Intervention Package in people with COVID-19, run by Kathleen Fairfield at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Public Health Intervention Package
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 3 sitesUnited States
Study dates: 13 Apr 2022to 8 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Individual is <18 years old

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Greater Portland Health
Portland, Maine, 04101
Portland Community Free Clinic
Portland, Maine, 04101
Preble Street Learning Collaborative
Portland, Maine, 04101

Other trials in United States

About this study

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]

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.

Conditions: COVID-19
Being tested: Public Health Intervention Package
Keywords: COVID-19 testing, Low-income populations, Immigrant populations, Unhoused populations, Uninsured populations
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Public Health Intervention PackageBehavioural
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.

Study groups in NCT05270694
Study group	Role	What they receive
COVID-19 Testing	Experimental	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. Receives: Behavioral: Public Health Intervention Package

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 months

Secondary outcomes (5)

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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 20228 Nov 2023

First posted8 Mar 2022
Study start13 Apr 2022
Primary completion8 Nov 2023
Study completion8 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05270694
Sponsor's protocol ID: 1795294
Status last verified: Mar 2025
First submitted: 9 Feb 2022
Last updated: 16 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 32658925
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.
PubMed 32306369
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 [Preprint]. 2020 Apr 17:2020.04.10.20060962. doi: 10.1101/2020.04.10.20060962.
PubMed 32511437
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.
PubMed 32459916
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.
PubMed 33372209
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.
PubMed 32817602
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.
PubMed 32419766

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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]
ClinicalTrials.gov ID: NCT05270694
Acronym / sponsor ID: 1795294
Conditions: COVID-19
Keywords: COVID-19 testing, Low-income populations, Immigrant populations, Unhoused populations, Uninsured populations
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Kathleen FairfieldUniversity, hospital or other
Collaborators: MaineHealth
Study start: 13 Apr 2022 (actual)
Primary completion: 8 Nov 2023 (actual)
Study completion: 8 Nov 2023 (actual)
First posted: 8 Mar 2022 (actual)
Results: Posted 16 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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)

Arm	Type	Receives
COVID-19 Testing	Experimental	Behavioral: Public Health Intervention PackageThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Individual is <18 years old

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Public Health Intervention PackageThe 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.	Behavioural	COVID-19 Testing

Primary outcome

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

5 secondary outcomes

1) Confidence in Ability to Use COVID-19 Tests
Time frame: 12 months
2) Perceived Severity of Illness From COVID-19
Time frame: 12 months
3) Perceived Usefulness of COVID-19 Testing
Time frame: 12 months
4) Norms Around COVID-19 Testing
Time frame: 12 months
5) Commitment to COVID-19 Testing
Time frame: 12 months

Results and safety

Results posted to the registry on 16 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COVID-19 Testing	102	93

Primary outcome: Recommended Testing Proportion

Time frame: 12 months. Mean (Standard Deviation). Unit: proportion of times tested asrecommended

Measure	COVID-19 Testing n = 84
Value	0.66 (0.29)

Population analysed: 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)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COVID-19 Testing	0 of 102 (0%)	0 of 102 (0%)	1 of 102

Limitations and caveats (from the sponsor): A major limitation was that all participants received the at-home COVID-19 tests; therefore, there was no control group for direct comparison. This approach helped facilitate research engagement among a population traditionally underrepresented in biomedical research, by allowing all participants to engage with the testing program. However, further study with a control group is needed to determine the true effect of this at-home testing program on desired testing behavior in these populations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32658925Clark 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.
Background: PubMed 32306369Laurencin 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.
Background: PubMed 32511437Nayak 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 [Preprint]. 2020 Apr 17:2020.04.10.20060962. doi: 10.1101/2020.04.10.20060962.
Background: PubMed 32459916Price-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.
Background: PubMed 33372209Sy 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.
Background: PubMed 32817602Moore 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.
Background: PubMed 32419766Millett 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathleen Fairfield, MD, DrPH principal investigator

MaineHealth

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Public Health Intervention Package in people with COVID-19, run by Kathleen Fairfield at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Testing Proportion (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05270694, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.