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COVID Prevention Counseling and Text Messaging for COVID-19
N/A
Recruiting
Led By Noe C Crespo, M.P.H, Ph.D.
Research Sponsored by San Diego State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline & 1-, 6-, 12-, and 24-months post-baseline.
Awards & highlights
Study Summary
This trial will look at how well tailored counseling and text messaging can help reduce COVID-19 spread after diagnosis. Patients are randomly assigned to one of two groups, with one receiving extra support.
Who is the study for?
This trial is for adult patients over 18 years old who have tested positive for COVID-19 and are clients of a federally qualified health center. It's not suitable for those planning to move out of state within a year, individuals with cognitive impairments like schizophrenia or Down syndrome, or people without stable housing.Check my eligibility
What is being tested?
The study tests a 6-week behavioral intervention called the COVID Prevention Program (CPP) against standard care. Participants will be randomly placed in two groups: one receiving usual clinical follow-up and another getting enhanced care with tailored text messages and virtual counseling from promotores/as.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, participants may experience stress or discomfort related to frequent communication and adherence to prevention strategies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline & 1-, 6-, 12-, and 24-months post-baseline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline & 1-, 6-, 12-, and 24-months post-baseline.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of households with SARS-CoV-2 Antibodies
Secondary outcome measures
Number of households with SARS-CoV-2 Active Infection
Other outcome measures
Number of participants with risk reduction behaviors
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Standard-of-CareExperimental Treatment1 Intervention
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.
Group II: Standard-of-CareActive Control1 Intervention
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.
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Who is running the clinical trial?
San Diego State UniversityLead Sponsor
153 Previous Clinical Trials
84,077 Total Patients Enrolled
2 Trials studying COVID-19
42,852 Patients Enrolled for COVID-19
Family Health Centers of San DiegoOTHER
6 Previous Clinical Trials
14,317 Total Patients Enrolled
1 Trials studying COVID-19
20 Patients Enrolled for COVID-19
Noe C Crespo, M.P.H, Ph.D.Principal InvestigatorSan Diego State University Research Foundation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older and a patient at a federally qualified health center.I do not have a cognitive condition like schizophrenia or Down syndrome that would prevent me from following counseling.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Standard-of-Care
- Group 2: Standard-of-Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any recruitment opportunities for this research project?
"According to the clinicaltrials.gov database, this medical trial is actively accepting participants as of January 20th, 2023. The study was initially posted on April 11th 2022 and has since been revised multiple times."
Answered by AI
What is the total sample size for this research project?
"Correct. According to the data published on clinicaltrials.gov, this medical trial launched on April 11th 2022 is actively looking for participants. 256 individuals are required from a single location, and the information was last updated January 20th 2023."
Answered by AI
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