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

The University of Texas System (UT)

Status: Completed

Conditions: COVID-19 Testing Behaviors

Treatments: Other: Historical Control; Behavioral: Text message-based education intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07074171

U01TR004355 (U.S. NIH Grant/Contract)

HSC-SPH-20-1372 Phase 3 Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 384 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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384 participants in 2 patient groups

Text message-based education intervention

Experimental group

Description:

A text message-based COVID-19 education intervention with support from community health workers.

Treatment:

Behavioral: Text message-based education intervention

Historical Control Group

Other group

Description:

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.

Treatment:

Other: Historical Control