COVID-19 Testing BehaviorsNCT07074171
Examining How a Text Message-based Educational Intervention Influences COVID-19 Testing
A study testing Text message-based education intervention in people with COVID-19 Testing Behaviors, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Testing Behaviors
- What is being tested?
- Text message-based education intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Apr 2023to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having a smartphone that accepts text messages
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Texas Health Science Center at Houston School of Public Health Brownsville Regional Campus
Brownsville, Texas, 78520
The University of Texas Health Science Center at Houston School of Public Health Houston Main Campus
Houston, Texas, 77030
The University of Texas at Tyler
Tyler, Texas, 75799
About this study
Official title: Addressing COVID-19 Testing Disparities in Vulnerable Populations Using a Community JITAI (Just in Time Adaptive Intervention) Approach: RADx-Underserved Populations (RADxUP) Phase III
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.
Read the 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.
- Conditions
- COVID-19 Testing Behaviors
- Being tested
- Text message-based education intervention, Historical Control
- Keywords
- COVID-19, decision making, testing behaviors, vulnerable populations
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message-based education interventionBehavioural
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 ControlOther
Participants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study.
| Study group | Role | What they receive |
|---|---|---|
| Text message-based education intervention | Experimental | A text message-based COVID-19 education intervention with support from community health workers. Receives: Behavioral: Text message-based education intervention |
| Historical Control Group | Other | 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. Receives: Other: Historical Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: 8 weeks
Secondary outcomes (3)
Number of Participants Who Self-reported Receiving COVID-19 Vaccination
Measured: Baseline
Number of Participants Who Self-reported Receiving COVID-19 Vaccination
Measured: 8 weeks
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.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start3 Apr 2023
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19 Testing BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), University of Texas at Tyler
- Responsible party
- Principal investigator, Belinda Reininger, The University of Texas Health Science Center, Houston
- Investigators
- Maria E Fernandez, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074171
- Sponsor's protocol ID
- HSC-SPH-20-1372 Phase 3 Study
- Other IDs
- U01TR004355
- Status last verified
- Dec 2025
- First submitted
- 16 Jul 2025
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing COVID-19 Testing Disparities in Vulnerable Populations Using a Community JITAI (Just in Time Adaptive Intervention) Approach: RADx-Underserved Populations (RADxUP) Phase III
- ClinicalTrials.gov ID
- NCT07074171
- Acronym / sponsor ID
- HSC-SPH-20-1372 Phase 3 Study
- Conditions
- COVID-19 Testing Behaviors
- Keywords
- COVID-19, decision making, testing behaviors, vulnerable populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS), University of Texas at Tyler
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text message-based education intervention | Experimental | Behavioral: Text message-based education interventionA text message-based COVID-19 education intervention with support from community health workers. |
| Historical Control Group | Other | Other: Historical ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having a smartphone that accepts text messages
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message-based education interventionThe 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. | Behavioural | Text message-based education intervention |
| Historical ControlParticipants received CDC-designed COVID-19 testing brochures and completed pre- and post-intervention surveys as part of the Phase II embedded study. | Other | Historical Control Group |
Primary outcome
Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test
Time frame: Baseline
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
Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test
Time frame: 8 weeks
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
3 secondary outcomes
Number of Participants Who Self-reported Receiving COVID-19 Vaccination
Time frame: Baseline
Number of Participants Who Self-reported Receiving COVID-19 Vaccination
Time frame: 8 weeks
Number of Participants Who Self-reported Used Mitigation Measures if a Positive Test is Obtained
Time frame: Baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria E Fernandez, PhD principal investigator
The University of Texas Health Science Center, Houston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message-based education intervention in people with COVID-19 Testing Behaviors, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.