Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05697068
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-01-20
Brief Title:
Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos
Sponsor:
San Diego State University
Organization:
San Diego State University
Study Overview
Official Title:
Tailored Behavioral Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 promotoresas 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 mobilevirtual counseling delivered by promotoresas 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 environmentcontext and socialemotional 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None