Clinical trial NCT05697068: Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos
Official title: Tailored Behavioral Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: SARS-CoV-2 Infection
Keywords: SARS-CoV-2
COVID-19
Prevention
Secondary Infection
Hispanics
Latinos
Household
Community
Clinic
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Family Health Centers of San Diego
First posted: 2023-01-25
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Index patients will be randomly assigned (in real-time) to one of the two experimental groups using a predetermined randomization schedule (blocks of 40 randomly assigned numbers, stratified by study condition). Enrollment and randomization will be conducted in groups/waves of 40 index patients per wave. Enrollment and randomization will continue for each wave until 40 index patients have been randomized.
Primary purpose: PREVENTION

Brief summary: This study will examine the effectiveness of a 6-week behavioral intervention for patients who are recently diagnosed with COVID-19. Patients and their households will be randomized 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 and follow-up. Patients in the Enhanced Standard-of-Care group will receive standard-of-care plus tailored, real-time text messaging and virtual counseling delivered by promotores/as. The investigators hypothesize that households in the Enhanced Standard-of-Care group will have fewer (any new) household COVID-19 infectivity rates compared to households in the standard-of-care group post-intervention.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of households with SARS-CoV-2 Antibodies
timeFrame: Baseline & 1-, 6-, 12-, and 24-months post-baseline.
Secondary outcomes:
measure: Number of households with SARS-CoV-2 Active Infection
timeFrame: Baseline, 3-5 days post-baseline, and 7-9 days post-baseline.
Other outcomes:
measure: Number of participants with risk reduction behaviors
timeFrame: Baseline & 1-, 6-, 12-, and 24-months post-baseline.
Locations:
city: San Diego
country: United States
facility: San Diego State University Research Foundation
state: California
Study officials:
affiliation: San Diego State University Research Foundation
name: Noe C Crespo, M.P.H, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: