Trial Outcomes & Findings for COVID-19 Testing in Underserved and Vulnerable Populations (NCT NCT05315908)

Results Overview

The percentage of patients who undergo testing within one month of initial contact (automated call vs text messaging) and by the end of the study period (to consider individuals who could not come to the clinic within one month)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9120 participants

Primary outcome timeframe

1 month

Results posted on

2024-02-28

Participant Flow

Community health center staff will mail an introductory letter to eligible individuals describing the importance of COVID-19 testing, inviting them to receive a test, offering opt out instructions, and noting that follow-up contact (phone call, text message) will take place if they do not opt out. Patients who do not opt out and those whose mail is not returned will be randomized one week after the introductory letter is mailed.

Participants will be randomized to one of two arms: test messaging and automated call

Participant milestones

Participant milestones
Measure	Automated Call Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19	Text Messaging Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19
Overall Study STARTED	4489	4631
Overall Study COMPLETED	12	25
Overall Study NOT COMPLETED	4477	4606

Reasons for withdrawal

Reasons for withdrawal
Measure	Automated Call Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19	Text Messaging Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19
Overall Study Lost to Follow-up	4477	4606

Baseline Characteristics

One participants has missing value for demographic variables.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Automated Call n=12 Participants Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19	Text Messaging n=25 Participants Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19	Total n=37 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 13 • n=12 Participants	57 years STANDARD_DEVIATION 13 • n=25 Participants	61 years STANDARD_DEVIATION 13 • n=37 Participants
Sex: Female, Male Female	8 Participants n=12 Participants • One participants has missing value for demographic variables.	11 Participants n=24 Participants • One participants has missing value for demographic variables.	19 Participants n=36 Participants • One participants has missing value for demographic variables.
Sex: Female, Male Male	4 Participants n=12 Participants • One participants has missing value for demographic variables.	13 Participants n=24 Participants • One participants has missing value for demographic variables.	17 Participants n=36 Participants • One participants has missing value for demographic variables.
Race/Ethnicity, Customized Asian	2 Participants n=12 Participants • One participants has missing value for demographic variables.	1 Participants n=24 Participants • One participants has missing value for demographic variables.	3 Participants n=36 Participants • One participants has missing value for demographic variables.
Race/Ethnicity, Customized Non-Hispanic White	2 Participants n=12 Participants • One participants has missing value for demographic variables.	3 Participants n=24 Participants • One participants has missing value for demographic variables.	5 Participants n=36 Participants • One participants has missing value for demographic variables.
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=12 Participants • One participants has missing value for demographic variables.	0 Participants n=24 Participants • One participants has missing value for demographic variables.	1 Participants n=36 Participants • One participants has missing value for demographic variables.
Race/Ethnicity, Customized Hispanic	7 Participants n=12 Participants • One participants has missing value for demographic variables.	20 Participants n=24 Participants • One participants has missing value for demographic variables.	27 Participants n=36 Participants • One participants has missing value for demographic variables.

PRIMARY outcome

Timeframe: 1 month

Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, our team was forced to terminate the intervention study and pivot to alternate strategies. Because the study was terminated, the data of the percentage of patients who undergo testing by the end of the study period (automated call vs text messaging) was not collected.

The percentage of patients who undergo testing within one month of initial contact (automated call vs text messaging) and by the end of the study period (to consider individuals who could not come to the clinic within one month)

Outcome measures

Outcome measures
Measure	Automated Call n=4489 Participants Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19	Text Messaging n=4631 Participants Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19
Percentage of Tested Patients	12 Participants	25 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, we were forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities. Because of extremely low participants, there was no power to conduct statistical analysis for primary and secondary outcomes.

Number (%) of patients who complete COVID-19 test (total and by clinic)

Outcome measures

Outcome measures
Measure	Automated Call n=4489 Participants Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19	Text Messaging n=4631 Participants Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19
Number (%) Tested (Total and by Clinic)	12 Participants	25 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, our team was forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities.

Number (%) of patients with positive COVID-19 test (total and by clinic)

Outcome measures

Outcome measures
Measure	Automated Call n=12 Participants Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19	Text Messaging n=25 Participants Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19
Number (%) Infected (Total and by Clinic)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, our team was forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities. Because the study was terminated, the data of timeliness from time of contact to testing was not collected.

From time of contact to testing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, we were forced to terminate the intervention study and pivot to alternate strategies. Because of extremely small number of participants, there was no power to conduct statistical analysis for both primary and secondary outcomes.

Number of patients who receive flu vaccine

Outcome measures

Outcome measures
Measure	Automated Call n=12 Participants Patients receive up to two automated phone calls in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19	Text Messaging n=25 Participants Patients receive up to two text messages in English or Spanish depending the patients' language indicated in their electronic health record (EHR), between the hours of 10:00am and 9:00pm Monday through Friday. Community outreach method: The method includes automated call and text messaging to increase testing for COVID-19
Number Vaccinated With Flu Vaccine	9 Participants	21 Participants

SECONDARY outcome

Timeframe: 1 month

Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, we were forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities. Because the study was terminated, this data was not collected.

The proportion of study participants with eligible household members who refer household member(s) for COVID-19 testing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 month

Population: Because of extremely low testing uptake, slow accrual at participating health centers and continuously changing COVID pandemic, we were forced to terminate the intervention study and pivot to alternate strategies. This would allow us to continue our efforts to deliver as many COVID-19 tests as possible to help limit the spread of COVID-19 in underserved communities. Because the study was terminated, this data was not collected.

The number of household members referred for COVID-19 testing

Outcome measures

Outcome data not reported

Adverse Events

Automated Call

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Text Messaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jesse Nodora

University of California San Diego

Phone: (858) 822-3686

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place