- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646616
CRISOL Contigo: a Multi-level Intervention to Reduce the Disproportionate Toll of COVID-19 Among Latino Communities in Philadelphia. (CRISOL Contigo)
CRISOL: Building Community Resilience and Integrating Efforts to Understand and Address Syndemic Health Conditions Afflicting Young LatinoImmigrants
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Drexel University Dornsife School of Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-reported Latino or Hispanic
- Living in Philadelphia
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Community popular opinion leader (POL)
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Number of Five Protective COVID-19 Risk Measures
Time Frame: Baseline and 3 months
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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
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Baseline and 3 months
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Number of Participants Who Lack Access to Health Care
Time Frame: Baseline and 3 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With SAVAME (Substance Abuse, Violence, HIV/AIDS, Mental Health)-Related Factors
Time Frame: Baseline and 3 months
|
Substance abuse (yes/no), defined as binge drinking (>=4 or >=5 drinks on one occasion for women, and men, respectively), or use of drugs other than those required for medical reasons (at least once a week).
Intimate partner violence (yes/no), defined as experiencing verbal or physical violence, categorized using answers to the following questions: In the 30 days, how often has a partner or spouse, "Yelled at you or said things to you that made you feel bad about yourself, embarrassed you in front of others, or frightened you?", "Done things like push, grab, hit, slap, kick, or throw things at you during an argument or because they were angry with you?".
Any answer other than never was considered yes.
HIV/AIDS (yes/no), defined as having a history of a positive test.
Mental health (Yes/no), defined as depressive (CES-D-10 >=10) or anxiety (GAD-7 >=5) symptoms.
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Baseline and 3 months
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Lack of Access to SAVAME Services
Time Frame: Baseline and 3 months
|
Self-report lack of access to any SAVAME (Substance abuse, Intimate partner violence, HIV/AIDS, or Mental health symptomatology) services, overall among all the participants
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Baseline and 3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3R21MD012352-02S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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