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| ID | Type | Description | Link |
|---|---|---|---|
| U01TR004355 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| University of Texas at Tyler | OTHER |
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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.
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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text message-based education intervention | Experimental | A text message-based COVID-19 education intervention with support from community health workers. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text message-based education intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Self-reported Receiving COVID-19 Vaccination | Baseline | |
| Number of Participants Who Self-reported Receiving COVID-19 Vaccination | 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria E Fernandez, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston School of Public Health Brownsville Regional Campus | Brownsville | Texas | 78520 | United States |
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Under the protocol, historical controls were not considered enrolled in this study, so they are not included in the enrollment number.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Data were only collected from participants who answered the question. | Posted | Count of Participants | Participants | Baseline |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Belinda M Reininger, DrPH | The University of Texas Health Science Center at Houston | 956-755-0654 | Belinda.M.Reininger@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2024 | Dec 12, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 13, 2024 | Dec 12, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D065386 | Historically Controlled Study |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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|
| Historical Control | Other | 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 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. |
| Baseline, 8 weeks |
| The University of Texas Health Science Center at Houston School of Public Health Houston Main Campus | Houston | Texas | 77030 | United States |
| The University of Texas at Tyler | Tyler | Texas | 75799 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 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 | Data were only collected from participants who answered the question. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Number of Participants Who Self-reported Receiving COVID-19 Vaccination | Data were only collected from participants who answered the question. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants Who Self-reported Receiving COVID-19 Vaccination | Data were only collected from participants who answered the question. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 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. | 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. | Posted | Baseline, 8 weeks |
|
|
| 0 |
| 384 |
| 0 |
| 384 |
| 0 |
| 384 |
| EG001 | 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. | 0 | 397 | 0 | 397 | 0 | 397 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |