In this Phase III study, the investigators will build off of the Phase II embedded studywith some adjustments to the design to address new research priorities that examine anintervention that is network informed and delivered through community health workerinteractions plus digitally-delivered intervention content with the goal of increasingCOVID-19 testing and vaccination. This model, if proven effective, can be scaled up toaddress COVID-19 and other future pandemics. The investigators will utilize the sample ofintervention priority census block groups (PBGs) used in Phase II and will recruit andenroll participants not previously enrolled in either phase I or II from these PBGs usingconvenience sampling methods. The investigators will use a historical control groupconsisting of participants from our control arm in Phase II who completed both theirbaseline 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.
Behavioral: 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.
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.
The University of Texas Health Science Center at Houston School of Public Health Brownsville Regional Campus
Brownsville, Texas, United States
The University of Texas Health Science Center at Houston School of Public Health Houston Main Campus
Houston, Texas, United States
The University of Texas at Tyler
Tyler, Texas, United States
Maria E Fernandez, PhD, Principal Investigator
The University of Texas Health Science Center, Houston