CRISOL Contigo: a Multi-level Intervention to Reduce the Disproportionate Toll of COVID-19 Among Latino Communities in Philadelphia.

NCT04646616 | Completed Results

• 1 other identifier: 3R21MD012352-02S1
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

Latinos have been one of the racial/ethnic groups most impacted by the COVID-19 pandemic, and evidence of effective strategies to curb the pandemic, reduce disparities, and mitigate its impact is lacking and very urgent. The goal of this competitive revision is to expand an ongoing academic-community partnership to adapt, implement, and evaluate a multi-level intervention to mitigate the multi-dimensional toll of COVID19 among Latino immigrant communities in Philadelphia.

Conditions

Covid19; Mental Health Issue; Violence

Keywords

Latino health; Immigrant health; Syndemic

Outcome Measures

Primary Outcomes (2)

• Mean Number of Five Protective COVID-19 Risk Measures

  This measure is the sum of the five protective COVID-19 risk measures: Use of mask, frequent hand washing, social distancing (including the ability to telework, and avoid crowded indoor spaces), and avoidance of contact with high-risk individuals. Scale ranged (0-5). The higher the score, the higher the number of protective behaviors

  Baseline and 3 months

• Number of Participants Who Lack Access to Health Care

  This measure is a composite dichotomous outcome variable, that indicates not having health insurance or not having a regular primary care provider.

  Baseline and 3 months

Secondary Outcomes (2)

• Number of Participants With SAVAME (Substance Abuse, Violence, HIV/AIDS, Mental Health)-Related Factors

  Baseline and 3 months

• Lack of Access to SAVAME Services

  Baseline and 3 months

Study Arms (1)

Community popular opinion leader (POL)

EXPERIMENTAL

After successful completion of the new COVID-19 training module, POLs will reach out to members of their social networks to model and diffuse social norms to reduce the risk of COVID-19 infection and transmission, screen for symptoms and counsel regarding COVID-19, SAVAME syndemic factors, and refer at-risk or affected individuals to appropriate community services (e.g. free COVID-19 testing and treatment, mental health services, substance use services, violence prevention, support groups, etc.). As in other POL based interventions and pragmatic trials, POLs be asked to follow up with their community contacts to monitor their situation and provide additional support, but there will be flexibility with the frequency and number of follow up contacts depending on their needs identified and the preferences of the community contact. POLs will be continually supported by the research team via face-to-face biweekly booster sessions (if COVID-19 situation requires it) or by zoom.

Other: Community popular opinion leader (POL) based intervention

Interventions

Community popular opinion leader (POL) based intervention OTHER

A community popular opinion leader (POL) based intervention to promote measures to reduce COVID-19 risk, transmission, access to testing and treatment, reduction of the impact of COVID-19, and addressing the Substance Abuse, Violence, HIV/AIDS, and MEntal health (SAVAME) syndemic in the community. POLs will interact within their networks counseling regarding COVID-19 and SAVAME factors. The POLs will refer individuals to appropriate community services. POLs will record basic sociodemographic characteristics of all community contacts, the issue addressed, and their response to it. The first 300 community contacts will be invited to complete a baseline and 3-month follow up surveys (via internet or phone). The content of the surveys includes: 1) COVID-19 related questions (knowledge, impact, symptoms, risk factors, access to testing and care, acceptability contact tracing, vaccine) 2) Biological risk factors, 3) Social determinants of health, 4) SAVAME outcomes and access to services.

Community popular opinion leader (POL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported Latino or Hispanic
• Living in Philadelphia

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University Dornsife School of Public Health

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Genes, pol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Genes, Viral; Genes, Microbial; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Genome, Microbial; Genome, Viral

Results Point of Contact

• Title: Dr. Mariana Lazo
• Organization: Drexel University School of Public Health

ml3629@drexel.edu

2673596058

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Community Health and Prevention

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: November 30, 2020
• Study Start: January 15, 2021
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: July 5, 2023
• Results First Posted: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)