Trial Outcomes & Findings for Examining How a Text Message-based Educational Intervention Influences COVID-19 Testing (NCT NCT07074171)

NCT ID: NCT07074171

Last Updated: 2026-01-06

Results Overview

The number of participants who self-reported use of COVID-19 antigen test or PCR Test using individual-level data in the past 60 days

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

384 participants

Primary outcome timeframe

Baseline

Results posted on

2026-01-06

Participant Flow

Under the protocol, historical controls were not considered enrolled in this study, so they are not included in the enrollment number.

Participant milestones

Participant milestones
Measure
Text Message-based Education Intervention
A text message-based COVID-19 education intervention with support from community health workers. Text message-based education intervention: The intervention consisted of enhanced behavioral and educational text messages, up to three messages each week, providing updates on COVID-19 testing and vaccination. The text messages included digitally delivered intervention content such as a video with low-literacy instructions for administering the rapid antigen tests, guidance if they tested positive (e.g., quarantine, notify contacts, wearing a mask), and other relevant strategies and content focused on increasing COVID-19 testing and vaccination.
Historical Control Group
Participants in this Historical Control Group completed the prior Phase II embedded study, in which they received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys only. Historical Control: Participants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study.
Overall Study
STARTED
384
397
Overall Study
COMPLETED
349
397
Overall Study
NOT COMPLETED
35
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examining How a Text Message-based Educational Intervention Influences COVID-19 Testing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Text Message-based Education Intervention
n=384 Participants
A text message-based COVID-19 education intervention with support from community health workers. Text message-based education intervention: The intervention consisted of enhanced behavioral and educational text messages, up to three messages each week, providing updates on COVID-19 testing and vaccination. The text messages included digitally delivered intervention content such as a video with low-literacy instructions for administering the rapid antigen tests, guidance if they tested positive (e.g., quarantine, notify contacts, wearing a mask), and other relevant strategies and content focused on increasing COVID-19 testing and vaccination.
Historical Control Group
n=397 Participants
Participants in this Historical Control Group completed the prior Phase II embedded study, in which they received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys only. Historical Control: Participants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study.
Total
n=781 Participants
Total of all reporting groups
Age, Customized
<= 18 years
2 Participants
n=37 Participants
4 Participants
n=56 Participants
6 Participants
n=82 Participants
Age, Customized
Between 18 and 65 years
279 Participants
n=37 Participants
291 Participants
n=56 Participants
570 Participants
n=82 Participants
Age, Customized
>= 65 years
102 Participants
n=37 Participants
91 Participants
n=56 Participants
193 Participants
n=82 Participants
Age, Customized
Unknown or Not Reported
1 Participants
n=37 Participants
11 Participants
n=56 Participants
12 Participants
n=82 Participants
Sex/Gender, Customized
Female
263 Participants
n=37 Participants
246 Participants
n=56 Participants
509 Participants
n=82 Participants
Sex/Gender, Customized
Male
121 Participants
n=37 Participants
150 Participants
n=56 Participants
271 Participants
n=82 Participants
Sex/Gender, Customized
Unknown or Not Reported
0 Participants
n=37 Participants
1 Participants
n=56 Participants
1 Participants
n=82 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
259 Participants
n=37 Participants
247 Participants
n=56 Participants
506 Participants
n=82 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
125 Participants
n=37 Participants
149 Participants
n=56 Participants
274 Participants
n=82 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=37 Participants
1 Participants
n=56 Participants
1 Participants
n=82 Participants
Region of Enrollment
United States
384 participants
n=37 Participants
397 participants
n=56 Participants
781 participants
n=82 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Data were only collected from participants who answered the question.

The number of participants who self-reported use of COVID-19 antigen test or PCR Test using individual-level data in the past 60 days

Outcome measures

Outcome measures
Measure
Text Message-based Education Intervention
n=348 Participants
A text message-based COVID-19 education intervention with support from community health workers. Text message-based education intervention: The intervention consisted of enhanced behavioral and educational text messages, up to three messages each week, providing updates on COVID-19 testing and vaccination. The text messages included digitally delivered intervention content such as a video with low-literacy instructions for administering the rapid antigen tests, guidance if they tested positive (e.g., quarantine, notify contacts, wearing a mask), and other relevant strategies and content focused on increasing COVID-19 testing and vaccination.
Historical Control Group
n=395 Participants
Participants in this Historical Control Group completed the prior Phase II embedded study, in which they received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys only. Historical Control: Participants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study.
Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test
31 Participants
22 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Data were only collected from participants who answered the question.

The number of participants who self-reported use of COVID-19 antigen test or PCR Test using individual-level data in the past 60 days

Outcome measures

Outcome measures
Measure
Text Message-based Education Intervention
n=348 Participants
A text message-based COVID-19 education intervention with support from community health workers. Text message-based education intervention: The intervention consisted of enhanced behavioral and educational text messages, up to three messages each week, providing updates on COVID-19 testing and vaccination. The text messages included digitally delivered intervention content such as a video with low-literacy instructions for administering the rapid antigen tests, guidance if they tested positive (e.g., quarantine, notify contacts, wearing a mask), and other relevant strategies and content focused on increasing COVID-19 testing and vaccination.
Historical Control Group
n=394 Participants
Participants in this Historical Control Group completed the prior Phase II embedded study, in which they received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys only. Historical Control: Participants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study.
Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test
60 Participants
46 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Data were only collected from participants who answered the question.

Outcome measures

Outcome measures
Measure
Text Message-based Education Intervention
n=349 Participants
A text message-based COVID-19 education intervention with support from community health workers. Text message-based education intervention: The intervention consisted of enhanced behavioral and educational text messages, up to three messages each week, providing updates on COVID-19 testing and vaccination. The text messages included digitally delivered intervention content such as a video with low-literacy instructions for administering the rapid antigen tests, guidance if they tested positive (e.g., quarantine, notify contacts, wearing a mask), and other relevant strategies and content focused on increasing COVID-19 testing and vaccination.
Historical Control Group
n=395 Participants
Participants in this Historical Control Group completed the prior Phase II embedded study, in which they received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys only. Historical Control: Participants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study.
Number of Participants Who Self-reported Receiving COVID-19 Vaccination
263 Participants
292 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Data were only collected from participants who answered the question.

Outcome measures

Outcome measures
Measure
Text Message-based Education Intervention
n=349 Participants
A text message-based COVID-19 education intervention with support from community health workers. Text message-based education intervention: The intervention consisted of enhanced behavioral and educational text messages, up to three messages each week, providing updates on COVID-19 testing and vaccination. The text messages included digitally delivered intervention content such as a video with low-literacy instructions for administering the rapid antigen tests, guidance if they tested positive (e.g., quarantine, notify contacts, wearing a mask), and other relevant strategies and content focused on increasing COVID-19 testing and vaccination.
Historical Control Group
n=391 Participants
Participants in this Historical Control Group completed the prior Phase II embedded study, in which they received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys only. Historical Control: Participants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study.
Number of Participants Who Self-reported Receiving COVID-19 Vaccination
259 Participants
12 Participants

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Population: Data were not collected for this outcome measure because the corresponding question was not included in the study survey. Therefore, no data were available for any participants. This outcome measure will not be collected in the future. The study protocol was not amended to reflect this.

Mitigation measures if a positive test is obtained include mask wearing, isolating, and notifying close contacts.

Outcome measures

Outcome data not reported

Adverse Events

Text Message-based Education Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Historical Control Group

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

Belinda M Reininger, DrPH

The University of Texas Health Science Center at Houston

Phone: 956-755-0654

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place