Trial Outcomes & Findings for SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Conversational Agent Study (NCT NCT05533359)

NCT ID: NCT05533359

Last Updated: 2025-01-15

Results Overview

Number of patients who requested a test kit and confirmed their mailing address.

Recruitment status

COMPLETED

Study phase

Target enrollment

2117 participants

Primary outcome timeframe

Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message] Every 10 or 30 days from intervention messaging for 90 days dependent on group randomization.

Results posted on

2025-01-15

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. Specific to the Conversational Agent group: these patients had also replied to a TM that they did have a Smart Phone.

1. Opted Out- opted out after receiving introductory text but before randomization 2. Smart Phone- Participant responded that they do have a Smart Phone

Participant milestones

Participant milestones
Measure	Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 10 Day Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 30 Day Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 10 Day Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 30 Day Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + Patient Navigation (PN) + 10 Day Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + Patient Navigation (PN) + 30 Day Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.
Overall Study STARTED	261	264	264	262	265	265	270	266
Overall Study COMPLETED	247	262	237	249	242	262	255	257
Overall Study NOT COMPLETED	14	2	27	13	23	3	15	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Conversational Agent Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day n=261 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 10 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 30 Day n=262 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 10 Day n=265 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 30 Day n=265 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + Patient Navigation (PN) + 10 Day n=270 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + Patient Navigation (PN) + 30 Day n=266 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Total n=2117 Participants Total of all reporting groups
Age, Continuous	49.38 Years STANDARD_DEVIATION 14.55 • n=5 Participants	49.88 Years STANDARD_DEVIATION 15.38 • n=7 Participants	48.83 Years STANDARD_DEVIATION 14.93 • n=5 Participants	48.34 Years STANDARD_DEVIATION 14.23 • n=4 Participants	48.89 Years STANDARD_DEVIATION 14.22 • n=21 Participants	47.92 Years STANDARD_DEVIATION 14.40 • n=8 Participants	49.79 Years STANDARD_DEVIATION 15.36 • n=8 Participants	49.13 Years STANDARD_DEVIATION 13.85 • n=24 Participants	49.02 Years STANDARD_DEVIATION 14.62 • n=42 Participants
Sex/Gender, Customized Sex · Female	179 Participants n=5 Participants	163 Participants n=7 Participants	188 Participants n=5 Participants	181 Participants n=4 Participants	182 Participants n=21 Participants	191 Participants n=8 Participants	186 Participants n=8 Participants	181 Participants n=24 Participants	1451 Participants n=42 Participants
Sex/Gender, Customized Sex · Male	82 Participants n=5 Participants	101 Participants n=7 Participants	75 Participants n=5 Participants	81 Participants n=4 Participants	83 Participants n=21 Participants	74 Participants n=8 Participants	84 Participants n=8 Participants	85 Participants n=24 Participants	665 Participants n=42 Participants
Sex/Gender, Customized Sex · Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Race/Ehtnicity · American Indian/Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Race/Ehtnicity · Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 Participants	14 Participants n=42 Participants
Race/Ethnicity, Customized Race/Ehtnicity · Black/African American	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	0 Participants n=24 Participants	19 Participants n=42 Participants
Race/Ethnicity, Customized Race/Ehtnicity · Hawaiian/Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	8 Participants n=42 Participants
Race/Ethnicity, Customized Race/Ehtnicity · Hispanic or Latino/a	152 Participants n=5 Participants	144 Participants n=7 Participants	137 Participants n=5 Participants	139 Participants n=4 Participants	140 Participants n=21 Participants	142 Participants n=8 Participants	144 Participants n=8 Participants	160 Participants n=24 Participants	1158 Participants n=42 Participants
Race/Ethnicity, Customized Race/Ehtnicity · Unknown	19 Participants n=5 Participants	22 Participants n=7 Participants	25 Participants n=5 Participants	21 Participants n=4 Participants	21 Participants n=21 Participants	22 Participants n=8 Participants	22 Participants n=8 Participants	19 Participants n=24 Participants	171 Participants n=42 Participants
Race/Ethnicity, Customized Race/Ehtnicity · White Non-Hispanic	84 Participants n=5 Participants	86 Participants n=7 Participants	93 Participants n=5 Participants	92 Participants n=4 Participants	97 Participants n=21 Participants	93 Participants n=8 Participants	93 Participants n=8 Participants	81 Participants n=24 Participants	719 Participants n=42 Participants
Race/Ethnicity, Customized Race/Ehtnicity · Multi-race	1 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	0 Participants n=24 Participants	25 Participants n=42 Participants
Language English	125 Participants n=5 Participants	128 Participants n=7 Participants	127 Participants n=5 Participants	141 Participants n=4 Participants	124 Participants n=21 Participants	134 Participants n=8 Participants	130 Participants n=8 Participants	117 Participants n=24 Participants	1026 Participants n=42 Participants
Language Spanish	123 Participants n=5 Participants	126 Participants n=7 Participants	123 Participants n=5 Participants	113 Participants n=4 Participants	128 Participants n=21 Participants	121 Participants n=8 Participants	125 Participants n=8 Participants	134 Participants n=24 Participants	993 Participants n=42 Participants
Language Other	5 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	7 Participants n=8 Participants	5 Participants n=24 Participants	35 Participants n=42 Participants
Language Unknown	8 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants	6 Participants n=8 Participants	8 Participants n=8 Participants	10 Participants n=24 Participants	63 Participants n=42 Participants
Urban/Rural Urban	227 Participants n=5 Participants	230 Participants n=7 Participants	231 Participants n=5 Participants	230 Participants n=4 Participants	228 Participants n=21 Participants	231 Participants n=8 Participants	233 Participants n=8 Participants	230 Participants n=24 Participants	1840 Participants n=42 Participants
Urban/Rural Rural	34 Participants n=5 Participants	34 Participants n=7 Participants	33 Participants n=5 Participants	32 Participants n=4 Participants	37 Participants n=21 Participants	34 Participants n=8 Participants	37 Participants n=8 Participants	36 Participants n=24 Participants	277 Participants n=42 Participants
Insurance Status Private	63 Participants n=5 Participants	80 Participants n=7 Participants	69 Participants n=5 Participants	88 Participants n=4 Participants	71 Participants n=21 Participants	85 Participants n=8 Participants	76 Participants n=8 Participants	78 Participants n=24 Participants	610 Participants n=42 Participants
Insurance Status Public	47 Participants n=5 Participants	44 Participants n=7 Participants	44 Participants n=5 Participants	45 Participants n=4 Participants	43 Participants n=21 Participants	38 Participants n=8 Participants	40 Participants n=8 Participants	42 Participants n=24 Participants	343 Participants n=42 Participants
Insurance Status Uninsured	151 Participants n=5 Participants	140 Participants n=7 Participants	151 Participants n=5 Participants	129 Participants n=4 Participants	151 Participants n=21 Participants	142 Participants n=8 Participants	154 Participants n=8 Participants	146 Participants n=24 Participants	1164 Participants n=42 Participants
CHC CHC 1	160 Participants n=5 Participants	162 Participants n=7 Participants	165 Participants n=5 Participants	162 Participants n=4 Participants	163 Participants n=21 Participants	162 Participants n=8 Participants	166 Participants n=8 Participants	166 Participants n=24 Participants	1306 Participants n=42 Participants
CHC CHC 2	35 Participants n=5 Participants	36 Participants n=7 Participants	34 Participants n=5 Participants	33 Participants n=4 Participants	36 Participants n=21 Participants	34 Participants n=8 Participants	36 Participants n=8 Participants	34 Participants n=24 Participants	278 Participants n=42 Participants
CHC CHC 3	66 Participants n=5 Participants	66 Participants n=7 Participants	65 Participants n=5 Participants	67 Participants n=4 Participants	66 Participants n=21 Participants	69 Participants n=8 Participants	68 Participants n=8 Participants	66 Participants n=24 Participants	533 Participants n=42 Participants
SCALE-UP I Randomization Not enrolled in SCALE UP I	83 Participants n=5 Participants	81 Participants n=7 Participants	82 Participants n=5 Participants	80 Participants n=4 Participants	86 Participants n=21 Participants	83 Participants n=8 Participants	86 Participants n=8 Participants	83 Participants n=24 Participants	664 Participants n=42 Participants
SCALE-UP I Randomization TM	79 Participants n=5 Participants	81 Participants n=7 Participants	81 Participants n=5 Participants	79 Participants n=4 Participants	79 Participants n=21 Participants	80 Participants n=8 Participants	81 Participants n=8 Participants	81 Participants n=24 Participants	641 Participants n=42 Participants
SCALE-UP I Randomization TM+PN	99 Participants n=5 Participants	102 Participants n=7 Participants	101 Participants n=5 Participants	103 Participants n=4 Participants	100 Participants n=21 Participants	102 Participants n=8 Participants	103 Participants n=8 Participants	102 Participants n=24 Participants	812 Participants n=42 Participants

PRIMARY outcome

Timeframe: Every 10 or 30 days dependent on group randomization [up to 90 days post intervention message] Every 10 or 30 days from intervention messaging for 90 days dependent on group randomization.

Number of patients who requested a test kit and confirmed their mailing address.

Outcome measures

Outcome measures
Measure	Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day n=261 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 10 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 30 Day n=262 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 10 Day n=265 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 30 Day n=265 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + Patient Navigation (PN) + 10 Day n=270 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + Patient Navigation (PN) + 30 Day n=266 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.
Reach-Accept Testing	47 Participants	41 Participants	41 Participants	45 Participants	142 Participants	139 Participants	151 Participants	123 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

Outcome measures
Measure	Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day n=261 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 10 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 30 Day n=262 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 10 Day n=265 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 30 Day n=265 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + Patient Navigation (PN) + 10 Day n=270 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + Patient Navigation (PN) + 30 Day n=266 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.
Reach-Engage Testing	90 Participants	73 Participants	78 Participants	68 Participants	155 Participants	154 Participants	171 Participants	145 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 participants who were assigned to PN groups who requested patient navigation.

Outcome measures

Outcome measures
Measure	Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 10 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 30 Day n=262 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 10 Day Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 30 Day Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + Patient Navigation (PN) + 10 Day n=270 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + Patient Navigation (PN) + 30 Day n=266 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.
PN-Request	0 Participants	0 Participants	3 Participants	3 Participants	0 Participants	0 Participants	3 Participants	1 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 participants who were in PN groups who talked to a patient navigator.

Outcome measures

Outcome measures
Measure	Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 10 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 30 Day n=262 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 10 Day Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 30 Day Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + Patient Navigation (PN) + 10 Day n=270 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + Patient Navigation (PN) + 30 Day n=266 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.
PN-Engage	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Daily [up to 90 days post intervention message]

Number of participants who replied to stop receiving study interventions. Participants could opt-out at any time regardless of message timing.

Outcome measures

Outcome measures
Measure	Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day n=261 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 10 Day n=264 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 30 Day n=262 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 10 Day n=265 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 30 Day n=265 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + Patient Navigation (PN) + 10 Day n=270 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + Patient Navigation (PN) + 30 Day n=266 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.
Opt Out	14 Participants	2 Participants	27 Participants	13 Participants	23 Participants	3 Participants	15 Participants	9 Participants

SECONDARY outcome

Timeframe: 90 days post intervention message

Population: Reported only for participants who requested COVID-19 test kits from the study and responded to follow-up messages.

Participant 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

Outcome measures
Measure	Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day n=38 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day n=34 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 10 Day n=34 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Conversational Agent (CA) + Patient Navigation (PN) + 30 Day n=31 Participants Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 10 Day n=105 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + No Patient Navigation (NoPN) + 30 Day n=101 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages.	Text Message (TM) + Patient Navigation (PN) + 10 Day n=105 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages.	Text Message (TM) + Patient Navigation (PN) + 30 Day n=84 Participants Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages.
Self-reported Testing	18 Participants	16 Participants	13 Participants	13 Participants	32 Participants	37 Participants	41 Participants	25 Participants

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Guilherme Del Fiol

University of Utah

Phone: 801-581-4080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place