Skip to content

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

Addressing COVID-19 Testing Disparities in Vulnerable Populations Using a Community JITAI (Just in Time Adaptive Intervention) Approach: RADx-Underserved Populations (RADxUP) Phase III

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07074171
Enrollment
384
Registered
2025-07-20
Start date
2023-04-03
Completion date
2024-12-12
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Testing Behaviors

Keywords

COVID-19, decision making, testing behaviors, vulnerable populations

Brief summary

In this Phase III study, the investigators will build off of the Phase II embedded study with some adjustments to the design to address new research priorities that examine an intervention that is network informed and delivered through community health worker interactions plus digitally-delivered intervention content with the goal of increasing COVID-19 testing and vaccination. This model, if proven effective, can be scaled up to address COVID-19 and other future pandemics. The investigators will utilize the sample of intervention priority census block groups (PBGs) used in Phase II and will recruit and enroll participants not previously enrolled in either phase I or II from these PBGs using convenience sampling methods. The investigators will use a historical control group consisting of participants from our control arm in Phase II who completed both their baseline and follow-up surveys embedded in the study.

Detailed description

The Phase III study design focuses on vulnerable communities selected to intervention and control conditions and takes advantage of the fact that these communities were randomized to conditions using methods to ensure balanced arms. In Phase III, the investigators will combine the two intervention conditions \[Testing Navigation Intervention (TNI) and Facilitated Self-Sampling Intervention (FSSI), and will receive the Multilevel Community network-informed Just-In-Time-Adaptive Intervention (MC-NET-JITAI). The study will include PBGs from each of the two intervention conditions in Phase II; they will be matched to the comparison PBGs on variables such as size, vaccination and testing rates, and the disparities index with the control group. The intervention will last 8 weeks; individuals will be recruited and asked to complete a survey. Participants who live in a PBG randomized to the intervention arm will be invited to participate in the trial for that arm. In each of the selected intervention PBGs, individuals will be selected via convenience sampling procedures. Recruitment of participants to the MC-NET-JITAI will take place at the participant's home or at one of the community organizations that our participants look to and interact with around COVID-19 topics identified through the social network data. Community Health Workers (CHW) will consent and enroll participants in the MC-NET-JITAI from the randomized PBGs. MC-NET-JITAI will include CHWs providing the participant with a batch of 4 rapid antigen tests that can be shared with people in the household or other close contacts if needed, a COVID-19 resource flier tailored to the study region and updated information about COVID-19 testing and vaccination. The intervention will consist of enhanced behavioral and educational text messages, up to three messages each week, providing updates on COVID-19 testing and vaccination. The text messages will include 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. The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow up via text, email and/or phone with the participants during the two months post-enrollment. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online, over the phone, or in person two months after the initial intervention. Study data will be compared to historical control data from the previous phase II Embedded Study.

Interventions

BEHAVIORALText 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.

Participants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study.

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
University of Texas at Tyler
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes

Inclusion criteria

* having a smartphone that accepts text messages

Exclusion criteria

* having been diagnosed with COVID-19 in the past 30 days based on a positive test (antigen or PCR) or a clinical diagnosis * having tested for COVID-19 with PCR or antigen test within the past 30 days * not being available in the recruitment area in the next 60 days * having been an embedded study participant * having been a snowball study participant.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR TestBaselineThe number of participants who self-reported use of COVID-19 antigen test or PCR Test using individual-level data in the past 60 days

Secondary

MeasureTime frameDescription
Number of Participants Who Self-reported Receiving COVID-19 VaccinationBaseline
Number of Participants Who Self-reported Used Mitigation Measures if a Positive Test is ObtainedBaseline, 8 weeksMitigation measures if a positive test is obtained include mask wearing, isolating, and notifying close contacts.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

ArmCount
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.
384
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.
397
Total781

Baseline characteristics

CharacteristicText Message-based Education InterventionHistorical Control GroupTotal
Age, Customized
<= 18 years
2 Participants4 Participants6 Participants
Age, Customized
>= 65 years
102 Participants91 Participants193 Participants
Age, Customized
Between 18 and 65 years
279 Participants291 Participants570 Participants
Age, Customized
Unknown or Not Reported
1 Participants11 Participants12 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
259 Participants247 Participants506 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
125 Participants149 Participants274 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Region of Enrollment
United States
384 participants397 participants781 participants
Sex/Gender, Customized
Female
263 Participants246 Participants509 Participants
Sex/Gender, Customized
Male
121 Participants150 Participants271 Participants
Sex/Gender, Customized
Unknown or Not Reported
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3840 / 397
other
Total, other adverse events
0 / 3840 / 397
serious
Total, serious adverse events
0 / 3840 / 397

Outcome results

Primary

Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test

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

Time frame: Baseline

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Message-based Education InterventionNumber of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test31 Participants
Historical Control GroupNumber of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test22 Participants
Primary

Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test

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

Time frame: 8 weeks

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Message-based Education InterventionNumber of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test60 Participants
Historical Control GroupNumber of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test46 Participants
Secondary

Number of Participants Who Self-reported Receiving COVID-19 Vaccination

Time frame: Baseline

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Message-based Education InterventionNumber of Participants Who Self-reported Receiving COVID-19 Vaccination263 Participants
Historical Control GroupNumber of Participants Who Self-reported Receiving COVID-19 Vaccination292 Participants
Secondary

Number of Participants Who Self-reported Receiving COVID-19 Vaccination

Time frame: 8 weeks

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Text Message-based Education InterventionNumber of Participants Who Self-reported Receiving COVID-19 Vaccination259 Participants
Historical Control GroupNumber of Participants Who Self-reported Receiving COVID-19 Vaccination12 Participants
Secondary

Number of Participants Who Self-reported Used Mitigation Measures if a Positive Test is Obtained

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

Time frame: 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.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026