An interventional study of COVID Prevention Program (CPP) in SARS-CoV-2 Infection, sponsored by San Diego State University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by San Diego State University · Not applicable, Interventional, and Prevention
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.
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.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 256 is above the median of 100 across 4,100 interventional studies indexed under COVID-19.
Browse COVID-19 studies →San Diego State University is the lead sponsor of 145 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who test positive will receive a call from the provider who conducted the test to notify them of the test result and provide standard-of-care counseling (e.g., health education, link them to resources). Index patients are entered into a COVID-19 patient registry in the Federally Qualified Health Center's electronic health record system (which also is linked to the clinic's COVID-19 dashboard) and monitored closely, with telemedicine follow-ups provided by skilled clinical staff every two-to-three days, and in-person follow-ups provided as needed.
Behavioral: COVID Prevention Program (CPP)
In addition to the aforementioned standard-of-care actions, index patients in the enhanced standard-of-care group will receive tailored phone/mobile counseling (motivational interviewing) focused on implementing strategies to prevent immediate household spread of COVID-19, followed by weekly text messaging for a total of 6 weeks.
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.
Number of households with SARS-CoV-2 Antibodies
Antibodies assessed by a blood draw collected by a certified phlebotomist. SARS-CoV-2 Nucleocapsid and Spike Protein IgG, used to accurately determine prior infection and/or vaccination.
Time frame: Baseline & 1-, 6-, 12-, and 24-months post-baseline.
Number of households with SARS-CoV-2 Active Infection
Active infection assessed by self-administered anterior nasal swab. SARS-CoV-2 RT-PCR used to determine if exposed household member has been infected and/or can exit quarantine early.
Time frame: Baseline, 3-5 days post-baseline, and 7-9 days post-baseline.
Number of participants with risk reduction behaviors
Secondary outcomes measured via self-report surveys. Surveys include socioeconomic status indicators and demographics, measures of mental health (e.g., depression), physical health (chronic conditions) and health behaviors (social distancing, hand washing \& wearing face covering), comorbidities, and risk factors for severe COVID-19 outcomes.
Time frame: Baseline & 1-, 6-, 12-, and 24-months post-baseline.
Plan to share: No
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This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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San Diego State University