COVID-19 Testing Behaviors
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Self-reported Receiving COVID-19 Vaccination | Baseline | — |
| Number of Participants Who Self-reported Used Mitigation Measures if a Positive Test is Obtained | Baseline, 8 weeks | Mitigation 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
| Arm | Count |
|---|---|
| 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 |
| Total | 781 |
Baseline characteristics
| Characteristic | Text Message-based Education Intervention | Historical Control Group | Total |
|---|---|---|---|
| Age, Customized <= 18 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Customized >= 65 years | 102 Participants | 91 Participants | 193 Participants |
| Age, Customized Between 18 and 65 years | 279 Participants | 291 Participants | 570 Participants |
| Age, Customized Unknown or Not Reported | 1 Participants | 11 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 259 Participants | 247 Participants | 506 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants | 149 Participants | 274 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 384 participants | 397 participants | 781 participants |
| Sex/Gender, Customized Female | 263 Participants | 246 Participants | 509 Participants |
| Sex/Gender, Customized Male | 121 Participants | 150 Participants | 271 Participants |
| Sex/Gender, Customized Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 384 | 0 / 397 |
| other Total, other adverse events | 0 / 384 | 0 / 397 |
| serious Total, serious adverse events | 0 / 384 | 0 / 397 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Message-based Education Intervention | Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test | 31 Participants |
| Historical Control Group | Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test | 22 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Message-based Education Intervention | Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test | 60 Participants |
| Historical Control Group | Number of Participants Who Self-Reported Use of a COVID-19 Antigen or PCR Test | 46 Participants |
Number of Participants Who Self-reported Receiving COVID-19 Vaccination
Time frame: Baseline
Population: Data were only collected from participants who answered the question.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Message-based Education Intervention | Number of Participants Who Self-reported Receiving COVID-19 Vaccination | 263 Participants |
| Historical Control Group | Number of Participants Who Self-reported Receiving COVID-19 Vaccination | 292 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Text Message-based Education Intervention | Number of Participants Who Self-reported Receiving COVID-19 Vaccination | 259 Participants |
| Historical Control Group | Number of Participants Who Self-reported Receiving COVID-19 Vaccination | 12 Participants |
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.