This study will examine the effectiveness of a 6-week behavioral intervention forpatients who are recently diagnosed with COVID-19. Patients and their households will berandomized to one of two groups (Standard of Care vs. Enhanced Standard of Care).Patients in the Standard-of-Care group will receive established clinical care andfollow-up. Patients in the Enhanced Standard-of-Care group will receive standard-of-careplus tailored, real-time text messaging and virtual counseling delivered bypromotores/as. The investigators hypothesize that households in the EnhancedStandard-of-Care group will have fewer (any new) household COVID-19 infectivity ratescompared to households in the standard-of-care group post-intervention.
The study team will develop and test a novel tailored behavioral intervention for
patients of a Federally Qualified Health Center who are recently diagnosed with COVID-19.
The study is a pragmatic, quality improvement randomized controlled trial (RCT). This
research is looking to enroll 256 index patients and their households. Index patients and
their households will be invited to participate in the COVID Prevention Program, which
includes free COVID-19 testing for exposed household members. Index patients will be
randomized to one of two groups: (a) the Standard-of-Care comparison group who will
receive established clinical care and follow-up, or (b) the Enhanced Standard-of-Care
group, who will receive standard-of-care plus tailored, real-time mobile/virtual
counseling delivered by promotores/as. The intervention will use theory- and
evidence-based strategies for behavior change and maximize the use of mobile phone
applications and technologies to capture real-time behavioral, social, and contextual
data (via Ecological Momentary Assessment). The intervention will utilize motivational
interviewing techniques to tailor strategies to index patients' home environment/context
and social/emotional needs. The intervention will target immediate risk of household
spread, followed by risk of community spread. The primary outcome assessed will be a new
positive antibody test within a household (post-baseline), as assessed by a blood draw
collected by a certified phlebotomist. Secondary research outcomes will be assessed via
self-report surveys. Surveys will include socioeconomic status indicators and
demographics, as well as measures of mental health (e.g., depression), physical health
(chronic conditions), health behaviors (social distancing, hand washing & wearing face
covering), as well as comorbidities and risk factors for severe COVID-19 outcomes.
Primary and secondary outcomes will be measured at 5 timepoints: baseline, 6-weeks,
6-months, 12-months, and 24-months.
Behavioral: COVID Prevention Program (CPP)
This project is a promotor/a-led COVID-19 Prevention Program (CPP) for Latino patients of
a Federally Qualified Health Center (FQHC) who are recently diagnosed with SARS-CoV-2.
The program will implement immediate risk reduction strategies to prevent household
spread of COVID-19, followed by risk reduction strategies to prevent community spread.
Patients and household members who agree to participate will be patients of the FQHC (the
covered entity) and will have completed a broad consent that authorizes program
activities (e.g., COVID-19 testing, individualized counseling). Patients are free to
refuse to participate in the CPP without impact on other services they may receive at the
clinic. Research activities will be managed by study's measurement team, which involves
surveys conducted on index patients at baseline, 1-, 6-, 12-, and 24-months. Written
informed consent will be obtained for all research activities occurring outside of
clinical care.
Inclusion Criteria:
- Adult patients of a federally qualified health center (+18yrs)
- Test positive for COVID-19
Exclusion Criteria:
- Planning to move out of state in the next year
- Cognitive impairment that is contraindicated to receiving counseling and following
behavioral strategies (e.g., schizophrenia, Down syndrome)
- Living in a transitionary home or homeless.
San Diego State University Research Foundation
San Diego, California, United States
Noe C Crespo, M.P.H, Ph.D., Principal Investigator
San Diego State University Research Foundation