Trial Outcomes & Findings for Evaluating Public Health Interventions to Improve COVID-19 Testing Among Underserved Populations (NCT NCT05270694)

Last Updated: 2025-04-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

102 participants

Primary outcome timeframe

12 months

Results posted on

2025-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	102
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1
Overall Study Medical issues impacted ability to participate	2
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COVID-19 Testing n=93 Participants 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.
Age, Continuous	45.5 Years STANDARD_DEVIATION 15 • n=113 Participants
Age, Customized 18-24 years	7 Participants n=113 Participants
Age, Customized 25-39 years	33 Participants n=113 Participants
Age, Customized 40-59 years	34 Participants n=113 Participants
Age, Customized 60 years or older	19 Participants n=113 Participants
Sex/Gender, Customized Female	50 Participants n=113 Participants
Sex/Gender, Customized Male	42 Participants n=113 Participants
Sex/Gender, Customized Non-binary	1 Participants n=113 Participants
Race/Ethnicity, Customized White, Non-Hispanic	45 Participants n=113 Participants
Race/Ethnicity, Customized Black/African-American	34 Participants n=113 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=113 Participants
Race/Ethnicity, Customized Asian	3 Participants n=113 Participants
Race/Ethnicity, Customized Native American	1 Participants n=113 Participants
Race/Ethnicity, Customized Other	2 Participants n=113 Participants
Race/Ethnicity, Customized Not reported	3 Participants n=113 Participants
Region of Enrollment United States	93 participants n=113 Participants
Received COVID-19 vaccine	84 Participants n=113 Participants
Education level 8th grade or less	5 Participants n=113 Participants
Education level Some/all high school	28 Participants n=113 Participants
Education level Some college/technical degree/vocational	22 Participants n=113 Participants
Education level Bachelor's degree or higher	36 Participants n=113 Participants
Education level Prefer not to answer	2 Participants n=113 Participants
Self-reported health Excellent	16 Participants n=113 Participants
Self-reported health Very good	31 Participants n=113 Participants
Self-reported health Good	28 Participants n=113 Participants
Self-reported health Fair	15 Participants n=113 Participants
Self-reported health Poor	3 Participants n=113 Participants
Employed currently	42 Participants n=113 Participants
Health insurance Private	27 Participants n=113 Participants
Health insurance Public (Medicare, Medicaid, Tricare)	45 Participants n=113 Participants
Health insurance Uninsured	17 Participants n=113 Participants
Health insurance Don't know	4 Participants n=113 Participants
Immigrant	39 Participants n=113 Participants
Low income by federal poverty guidelines	51 Participants n=113 Participants
Unhoused or history of chronic homelessness	30 Participants n=113 Participants
Self-reported substance use	28 Participants n=113 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	COVID-19 Testing n=84 Participants 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.
Recommended Testing Proportion	0.66 proportion of times tested asrecommended Standard Deviation 0.29

SECONDARY outcome

Timeframe: 12 months

Population: Out of the 93 enrolled participants, 1 participant never completed a survey with this item.

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)

Outcome measures

Outcome measures
Measure	COVID-19 Testing n=92 Participants 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.
1) Confidence in Ability to Use COVID-19 Tests	4.16 units on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	COVID-19 Testing n=84 Participants 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.
2) Perceived Severity of Illness From COVID-19	2.15 units on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	COVID-19 Testing n=84 Participants 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.
3) Perceived Usefulness of COVID-19 Testing	4.12 units on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	COVID-19 Testing n=84 Participants 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.
4) Norms Around COVID-19 Testing	2.78 units on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	COVID-19 Testing n=84 Participants 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.
5) Commitment to COVID-19 Testing	4.05 units on a scale Standard Deviation 0.83

Adverse Events

COVID-19 Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kathleen Fairfield

MaineHealth Institute for Research

Phone: 207-661-7614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place