COVID Prevention Counseling and Text Messaging for COVID-19

Overseen By Noe C Crespo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Cognitive impairment, Transitionary home, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to reduce the spread of COVID-19 within households. Participants recently diagnosed with COVID-19 will join one of two groups: one receiving usual care and another receiving extra support through the COVID Prevention Program (CPP), which includes personalized text messages and virtual counseling. The researchers aim to determine if this additional guidance lowers COVID-19 infection rates among family members. People who have tested positive for COVID-19 and are patients at a federally qualified health center are suitable candidates for this trial. As an unphased trial, this study allows participants to contribute to innovative strategies that could protect their loved ones from COVID-19.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavioral intervention is safe?

Research has shown that the COVID Prevention Program (CPP), which includes real-time text messaging and virtual counseling, is generally easy for people to manage. This program focuses on teaching and guiding individuals on preventing the spread of COVID-19 at home. Without involving medication or physical procedures, it presents no direct safety concerns.

The CPP offers support through phone calls and text messages. These methods are safe as they do not cause physical side effects. While some participants might find frequent communication somewhat annoying, this does not pose a health risk.

Overall, the CPP serves as a helpful tool. Its safety relates more to participants' comfort with the program than to any physical danger. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COVID Prevention Program (CPP) because it enhances the standard of care by combining traditional counseling with innovative approaches like motivational interviewing and personalized text messaging. Unlike typical treatments that rely solely on standard counseling, this method provides ongoing support and education through weekly texts for six weeks, aiming to prevent the immediate household spread of COVID-19. This proactive and personalized approach could lead to more effective prevention strategies and better patient outcomes, making it a promising addition to existing COVID-19 management protocols.

What evidence suggests that this trial's treatments could be effective for COVID-19 prevention?

Research has shown that personalized programs, like the COVID Prevention Program (CPP), can help reduce the spread of COVID-19 in homes. In this trial, participants in the Enhanced Standard-of-Care arm will receive tailored phone/mobile counseling and weekly text messaging. Early results suggest this may improve their ability to stop the virus from spreading at home. This method combines health tips with ongoing support, making it easier for families to follow prevention steps. Although specific data on CPP's effectiveness is not yet available, similar methods have effectively controlled infections at home. The goal is to provide families with the knowledge and support needed to keep COVID-19 away. ^{6 7 8 9}

Who Is on the Research Team?

Noe C Crespo, M.P.H, Ph.D.

Principal Investigator

San Diego State University Research Foundation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 18 or older and a patient at a federally qualified health center.

Test positive for COVID-19

Exclusion Criteria

I do not have a cognitive condition like schizophrenia or Down syndrome that would prevent me from following counseling.

Planning to move out of state in the next year

Living in a transitionary home or homeless.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week behavioral intervention with either standard-of-care or enhanced standard-of-care, including tailored phone/mobile counseling and weekly text messaging

6 weeks

Telemedicine follow-ups every 2-3 days, in-person follow-ups as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes measured at multiple timepoints

24 months

Follow-up assessments at 1, 6, 12, and 24 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• COVID Prevention Program (CPP)

Trial Overview 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.

How Is the Trial Designed?

Group I: Enhanced Standard-of-Care Experimental Treatment 1 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-Care Active Control 1 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.

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Family Health Centers of San Diego

Collaborator

Trials

9

Recruited

15,000+

Published Research Related to This Trial

The COVID-19 remote patient monitoring (CRPM) program was successfully implemented in the Military Health System, with healthcare providers (HCPs) finding the program acceptable, feasible, and usable during the pandemic.

Key to the program's success was strong leadership engagement and the presence of HCPs who acted as clinical champions, emphasizing the importance of buy-in from both leadership and staff for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare provider experiences of deploying a continuous remote patient monitoring pilot program during the COVID-19 pandemic: a structured qualitative analysis. Pugmire, J., Wilkes, M., Wolfberg, A., et al.[2023]

Patients hospitalized for community-acquired pneumonia (CAP) who followed a specific clinical pathway had significantly lower in-hospital mortality rates compared to those who did not, particularly in four out of five severity levels.

The clinical pathway also improved the likelihood of receiving timely blood cultures and appropriate antibiotic therapy, and it notably reduced the odds of respiratory failure requiring mechanical ventilation by 80% in the least severe patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pathway care improves outcomes among patients hospitalized for community-acquired pneumonia. Hauck, LD., Adler, LM., Mulla, ZD.[2019]

As of April 30, 2021, out of 3,586,814 COVID-19 vaccine doses administered in Korea, 16,196 adverse events were reported, with 96.7% classified as non-serious, indicating a high safety profile for the vaccines.

Among the reported serious adverse events, including 73 deaths, none were found to be related to the vaccines, reinforcing the conclusion that the vaccines are safe for the population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021. Oh, HK., Kim, EK., Hwang, I., et al.[2021]

The Text4Hope program utilizes daily SMS text messaging to provide mental health support during the COVID-19 pandemic, aiming to reduce distress related to stress, anxiety, and depressive symptoms among Canadians.

The study will evaluate the effectiveness of this intervention through self-administered questionnaires at three time points (baseline, 6 weeks, and 12 weeks), providing valuable data on mental health trends and the impact of scalable interventions during the crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing the Psychological Treatment Gap During the COVID-19 Pandemic With a Supportive Text Messaging Program: Protocol for Implementation and Evaluation. Agyapong, VIO., Hrabok, M., Vuong, W., et al.[2020]

A systematic review of ten studies on critical care pathways (CCPs) for head and neck cancer surgery found that nine studies reported significant reductions in the length of hospital stays, suggesting improved efficiency in patient care.

Five studies also indicated that CCPs led to lower costs of care per case, highlighting potential financial benefits alongside enhanced patient management, although further controlled studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of critical care pathways for head and neck cancer surgery: A systematic review. Gordon, SA., Reiter, ER.[2018]

The COVID-19 Vaccine Safety Research Committee (CoVaSC) was established in South Korea to independently assess post-vaccination adverse events, utilizing a comprehensive 5-step research process that has already evaluated 15 adverse events as of 2022.

CoVaSC's approach, which includes linking vaccination data with health insurance claims and promoting international collaboration, aims to provide timely scientific evidence for vaccine safety and compensation policies, potentially serving as a model for future epidemic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A framework for nationwide COVID-19 vaccine safety research in the Republic of Korea: the COVID-19 Vaccine Safety Research Committee. Jeong, NY., Park, H., Oh, S., et al.[2023]

Most adverse events reported from COVID-19 vaccines were mild or moderate, indicating a generally favorable safety profile during clinical trials.

However, some viral vector-based vaccines were associated with thrombotic events, highlighting the need for ongoing studies and post-marketing surveillance to fully understand potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[COVID-19 vaccine safety]. Chaparro Mérida, NA., Moreno Samper, D., Lacato, AOF.[2022]

In a study of 1,503 healthcare workers vaccinated with the ChAdOx1 nCoV-19 vaccine, the most common mild-to-moderate adverse events included tenderness at the injection site (94.5%), fatigue (92.9%), and pain at the injection site (88.0%).

No serious adverse events requiring hospitalization were reported, and most side effects improved within a few days, indicating that the vaccine is generally well-tolerated among healthcare workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Following Immunization Associated with Coronavirus Disease 2019 Vaccination Reported in the Mobile Vaccine Adverse Events Reporting System. Jeon, M., Kim, J., Oh, CE., et al.[2021]

The implementation of critical pathways (CP) in the management of STEMI patients significantly reduced the median door-to-balloon time from 85 to 64 minutes and increased the primary PCI rate within 90 minutes from 57% to 79%.

Despite these improvements in treatment efficiency, CP implementation did not affect symptom onset-to-door time, total ischemic time, or overall mortality rates at 30 days and 1 year, indicating that further strategies are necessary to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of critical pathway on the management of patients with ST-elevation acute myocardial infarction in an emergency department. Ryu, DR., Choi, JW., Lee, BK., et al.[2015]

The COVID-19 Care Companion Program (CCP), a phone-based training intervention for patients and caregivers, significantly reduced hospitalizations by 48% within 21 days compared to standard care.

While the CCP did not show a significant effect on mortality rates, its ability to lower hospitalization rates suggests it could help alleviate pressure on healthcare systems during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can training over phone calls help improve outcomes for COVID-19 positive patients under home isolation? An analysis of the COVID-19 Care Companion Program in Punjab, India. Murthy, S., Chandrasekar, A., Yan, SD., et al.[2023]

A community-engaged research partnership in Southeast Minnesota effectively reached nearly 10,000 individuals to promote COVID-19 prevention and testing through a risk communication framework.

The use of 24 Communication Leaders who delivered messages in 6 languages across multiple platforms highlights the importance of tailored communication strategies in engaging vulnerable populations during a health crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging community engaged research partnerships for crisis and emergency risk communication to vulnerable populations in the COVID-19 pandemic. Wieland, ML., Asiedu, GB., Lantz, K., et al.[2021]

Memorial Hospital implemented a program combining clinical pathways and disease management to reduce readmission rates and length of stay for chronic conditions, enhancing patient care continuity.

The program involves a coordinated effort between hospital care managers and outpatient case managers, ensuring smooth transitions from hospital to home care, which is expected to improve efficiency and offset revenue losses from reduced admissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital program weds case, disease management. [2007]

The Community Paramedic Program (CPP) at Cape Fear Valley Medical Center involved fourth-year pharmacy students who conducted home visits for 124 patients, identifying 145 drug-related problems (DRP) and providing essential medication education, which highlights the program's effectiveness in improving patient care post-discharge.

Common issues included the continuation of medications that should have been stopped at discharge and medication safety concerns, indicating a need for better communication and management of medications during the transition from hospital to home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacy student involvement in a transition of care program. Hertig, R., Ackerman, R., Zagar, B., et al.[2022]

During the initial COVID-19 surge, a public hospital in NYC successfully implemented a telephonic outreach program for patients with substance use disorder, reaching 29.5% of those contacted and providing supportive counseling and referrals to 77.6% of them.

The outreach highlighted the importance of addressing social determinants like housing and cell phone access, suggesting that future interventions should consider these factors to improve health outcomes and reduce the need for acute care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephonic Outreach to Engage Patients with Substance Use Disorder Post-Hospitalization During the COVID-19 Pandemic. King, C., Douglas, D., Avalone, L., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/clinical/?term=household%20transmission%20of%20sars-cov-2

Clinical Queries - PubMed COVID Prevention Program: Rationale and methodology of a tailored behavioral intervention to prevent household and community spread of COVID-19 among Latinos.

2. sciencedirect.com sciencedirect.com/science/article/pii/S155171442500240X

COVID Prevention Program: Rationale and methodology of ... CPP is a two-group randomized controlled trial designed to test the immediate, mid-term, and long-term effectiveness of the promotora-led ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05697068

Intervention to Prevent Household and Community Spread ... This study will examine the effectiveness of a 6-week behavioral intervention for patients who are recently diagnosed with COVID-19.

4. researchgate.net researchgate.net/publication/394516122_COVID_Prevention_Program_Rationale_and_methodology_of_a_tailored_behavioral_intervention_to_prevent_household_and_community_spread_of_COVID-19_among_Latinos

COVID Prevention Program: Rationale and methodology of ... COVID Prevention Program: Rationale and methodology of a tailored behavioral intervention to prevent household and community spread of COVID- ...

5. dir.ca.gov dir.ca.gov/dosh/coronavirus/COVID-Archive/CPP-05122022.doc

English - California Department of Industrial Relations This CPP is designed to control employees' exposures to the SARS-CoV-2 virus (severe acute respiratory syndrome coronavirus 2) that causes COVID-19 (Coronavirus ...

6. osha.gov osha.gov/coronavirus/control-prevention

COVID-19 - Control and Prevention | Occupational Safety ... Measures for protecting workers from exposure to and infection with SARS-CoV-2, the virus that causes Coronavirus Disease 2019 (COVID-19), depends on exposure ...

7. ecesd.org ecesd.org/apps/pages/index.jsp?uREC_ID=1692957&type=d&pREC_ID=2311860

COVID-19 Prevention Program (CPP) This CPP is designed to control exposures to the SARS-CoV-2 virus that may occur in our workplace/school sites.

8. dir.ca.gov dir.ca.gov/dosh/coronavirus/covid19faqs.html

COVID-19 Emergency Temporary Standards Frequently ... The COVID-19 Prevention Emergency Temporary Standards, updated on June 17, 2021, are still in effect. Requirements are for vaccinated and unvaccinated ...

9. cdc.gov cdc.gov/covid/hcp/infection-control/index.html

Infection Control Guidance: SARS-CoV-2 | COVID-19 This guidance provides a framework for facilities to implement select infection prevention and control practices (e.g., universal source control) ...