Trial Outcomes & Findings for SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Text Message Study (NCT NCT05533918)
NCT ID: NCT05533918
Last Updated: 2025-01-16
Results Overview
Number of patients that accept an offer to receive an at-home test kit and verify mailing address
COMPLETED
NA
31439 participants
Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]
2025-01-16
Participant Flow
This study recruited participants in partnership with the Association for Utah Community Health and its affiliated Community Health Centers (CHCs). Three CHCs with 12 primary care clinics participated. Eligible patients had an appointment at one of the participating CHCs in the last 3 years, were 18 years and older, and had a valid cellphone number in the CHC EHR.
1. Opted out- opted out at introductory message but before randomization 2. Reported not having a smart phone 3. Did not respond to introductory message
Participant milestones
| Measure |
Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 10 Day
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 30 Day
Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.
Intervention message frequency is every 30 days for a total of 3 messages.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7861
|
7860
|
7856
|
7862
|
|
Overall Study
COMPLETED
|
6879
|
7277
|
6861
|
7298
|
|
Overall Study
NOT COMPLETED
|
982
|
583
|
995
|
564
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Text Message Study
Baseline characteristics by cohort
| Measure |
Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day
n=7861 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day
n=7860 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 10 Day
n=7856 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 30 Day
n=7862 Participants
Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.
Intervention message frequency is every 30 days for a total of 3 messages.
|
Total
n=31439 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.43 years
STANDARD_DEVIATION 16.31 • n=5 Participants
|
42.12 years
STANDARD_DEVIATION 16.05 • n=7 Participants
|
42.02 years
STANDARD_DEVIATION 16.13 • n=5 Participants
|
42.17 years
STANDARD_DEVIATION 16.20 • n=4 Participants
|
42.18 years
STANDARD_DEVIATION 16.17 • n=21 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
4491 Participants
n=5 Participants
|
4417 Participants
n=7 Participants
|
4420 Participants
n=5 Participants
|
4456 Participants
n=4 Participants
|
17784 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
3370 Participants
n=5 Participants
|
3442 Participants
n=7 Participants
|
3435 Participants
n=5 Participants
|
3406 Participants
n=4 Participants
|
13653 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Sex · Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian/Alaska Native
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
77 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
317 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
88 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
394 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hawaiian/Pacific Islander
|
58 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
205 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino/a
|
4218 Participants
n=5 Participants
|
4250 Participants
n=7 Participants
|
4323 Participants
n=5 Participants
|
4283 Participants
n=4 Participants
|
17074 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Multi-race
|
73 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
315 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown
|
979 Participants
n=5 Participants
|
974 Participants
n=7 Participants
|
905 Participants
n=5 Participants
|
941 Participants
n=4 Participants
|
3799 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Non-Hispanic
|
2342 Participants
n=5 Participants
|
2306 Participants
n=7 Participants
|
2301 Participants
n=5 Participants
|
2309 Participants
n=4 Participants
|
9258 Participants
n=21 Participants
|
|
Language
English
|
3834 Participants
n=5 Participants
|
3798 Participants
n=7 Participants
|
3808 Participants
n=5 Participants
|
3772 Participants
n=4 Participants
|
15212 Participants
n=21 Participants
|
|
Language
Spanish
|
3398 Participants
n=5 Participants
|
3415 Participants
n=7 Participants
|
3429 Participants
n=5 Participants
|
3463 Participants
n=4 Participants
|
13705 Participants
n=21 Participants
|
|
Language
Other
|
88 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
347 Participants
n=21 Participants
|
|
Language
Unknown
|
541 Participants
n=5 Participants
|
562 Participants
n=7 Participants
|
545 Participants
n=5 Participants
|
527 Participants
n=4 Participants
|
2175 Participants
n=21 Participants
|
|
Urban/Rural
Urban
|
7098 Participants
n=5 Participants
|
7091 Participants
n=7 Participants
|
7090 Participants
n=5 Participants
|
7097 Participants
n=4 Participants
|
28376 Participants
n=21 Participants
|
|
Urban/Rural
Rural
|
763 Participants
n=5 Participants
|
769 Participants
n=7 Participants
|
766 Participants
n=5 Participants
|
765 Participants
n=4 Participants
|
3063 Participants
n=21 Participants
|
|
CHC
CHC 1
|
5280 Participants
n=5 Participants
|
5281 Participants
n=7 Participants
|
5279 Participants
n=5 Participants
|
5284 Participants
n=4 Participants
|
21124 Participants
n=21 Participants
|
|
CHC
CHC 2
|
884 Participants
n=5 Participants
|
884 Participants
n=7 Participants
|
882 Participants
n=5 Participants
|
881 Participants
n=4 Participants
|
3531 Participants
n=21 Participants
|
|
CHC
CHC 3
|
1697 Participants
n=5 Participants
|
1695 Participants
n=7 Participants
|
1695 Participants
n=5 Participants
|
1697 Participants
n=4 Participants
|
6784 Participants
n=21 Participants
|
|
SCALE-UP I Randomization
Not enrolled in SCALE-UP I
|
2688 Participants
n=5 Participants
|
2689 Participants
n=7 Participants
|
2682 Participants
n=5 Participants
|
2687 Participants
n=4 Participants
|
10746 Participants
n=21 Participants
|
|
SCALE-UP I Randomization
TM
|
2253 Participants
n=5 Participants
|
2255 Participants
n=7 Participants
|
2258 Participants
n=5 Participants
|
2258 Participants
n=4 Participants
|
9024 Participants
n=21 Participants
|
|
SCALE-UP I Randomization
TM+PN
|
2920 Participants
n=5 Participants
|
2916 Participants
n=7 Participants
|
2916 Participants
n=5 Participants
|
2917 Participants
n=4 Participants
|
11669 Participants
n=21 Participants
|
|
Insurance Status
Private
|
1878 Participants
n=5 Participants
|
1772 Participants
n=7 Participants
|
1798 Participants
n=5 Participants
|
1858 Participants
n=4 Participants
|
7306 Participants
n=21 Participants
|
|
Insurance Status
Public
|
1193 Participants
n=5 Participants
|
1160 Participants
n=7 Participants
|
1165 Participants
n=5 Participants
|
1233 Participants
n=4 Participants
|
4751 Participants
n=21 Participants
|
|
Insurance Status
Uninsured
|
4790 Participants
n=5 Participants
|
4928 Participants
n=7 Participants
|
4893 Participants
n=5 Participants
|
4771 Participants
n=4 Participants
|
19382 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]Number of patients that accept an offer to receive an at-home test kit and verify mailing address
Outcome measures
| Measure |
Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day
n=7861 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day
n=7860 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 10 Day
n=7856 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 30 Day
n=7862 Participants
Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.
Intervention message frequency is every 30 days for a total of 3 messages.
|
|---|---|---|---|---|
|
Reach-Accept Testing
|
509 Participants
|
423 Participants
|
351 Participants
|
329 Participants
|
SECONDARY outcome
Timeframe: Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]Number of patients that reply to an offer to receive an at-home rapid test kit
Outcome measures
| Measure |
Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day
n=7861 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day
n=7860 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 10 Day
n=7856 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 30 Day
n=7862 Participants
Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.
Intervention message frequency is every 30 days for a total of 3 messages.
|
|---|---|---|---|---|
|
Reach-Engage Testing
|
785 Participants
|
637 Participants
|
603 Participants
|
554 Participants
|
SECONDARY outcome
Timeframe: Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]Population: Groups analyzed for this outcome are only PN groups/arms. No Patient Navigation (NoPN) groups were not analyzed for this outcome since patient navigation was not offered to those groups.
Number of PN participants that request a Patient Navigator.
Outcome measures
| Measure |
Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 10 Day
n=7856 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 30 Day
n=7862 Participants
Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.
Intervention message frequency is every 30 days for a total of 3 messages.
|
|---|---|---|---|---|
|
PN-Request
|
0 Participants
|
0 Participants
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message]Population: Groups analyzed for this outcome are only PN groups/arms. No Patient Navigation (NoPN) groups were not analyzed for this outcome since patient navigation was not offered to those groups.
Number of PN participants that speak to a Patient Navigator
Outcome measures
| Measure |
Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 10 Day
n=7856 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 30 Day
n=7862 Participants
Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.
Intervention message frequency is every 30 days for a total of 3 messages.
|
|---|---|---|---|---|
|
PN-Engage
|
0 Participants
|
0 Participants
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Daily [up to 90 days post intervention messaging)Number of participants that opt out throughout the duration of the intervention
Outcome measures
| Measure |
Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day
n=7861 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day
n=7860 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 10 Day
n=7856 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 30 Day
n=7862 Participants
Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.
Intervention message frequency is every 30 days for a total of 3 messages.
|
|---|---|---|---|---|
|
Opt-out
|
982 Participants
|
583 Participants
|
995 Participants
|
564 Participants
|
SECONDARY outcome
Timeframe: 90 days post intervention messagingPopulation: Participants were only analyzed if they requested a COVID-19 test kit and responded to follow up messages. Not all participants completed both requirements.
Participants who self-reported testing as completed. Reported only for participants who requested COVID-19 test kits from the study and responded to follow-up messages.
Outcome measures
| Measure |
Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day
n=284 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day
n=247 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 10 Day
n=196 Participants
Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages.
|
Text Messaging (TM) + Patient Navigation (PN) + 30 Day
n=200 Participants
Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed.
RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination.
Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit.
Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy.
There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types.
Intervention message frequency is every 30 days for a total of 3 messages.
|
|---|---|---|---|---|
|
Self Reported Testing
|
94 Participants
|
86 Participants
|
63 Participants
|
72 Participants
|
Adverse Events
Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day
Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day
Text Messaging (TM) + Patient Navigation (PN) + 10 Day
Text Messaging (TM) + Patient Navigation (PN) + 30 Day
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place