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

Study Overview
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Brief Summary
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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.

Detailed Description
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This goal of this competitive revision is to expand our original project to adapt, implement and evaluate a multi-level intervention to mitigate the multi-dimensional toll of COVID19 among Latino immigrant communities in Philadelphia. Evidence of effective strategies to curb the pandemic, reduce disparities and mitigate its impact is lacking and very urgent. In the US, Latino immigrants are one of the groups hardest hit by this pandemic, with recent steep increases in COVID-19 deaths among this group corroborating their continued increased risk of infection and increased susceptibility. Latino immigrants have long exhibited disparities in diabetes, obesity and hypertension, factors known to increase COVID-19 related severity, and also in Substance Abuse, Violence exposure, HIV/AIDS, and MEntal health (SAVAME) syndemic. These syndemic conditions have been worsened in the context of COVID-19. Latino immigrants represent a hard-to-reach and marginalized population, with extremely limited access to adequate health care and safety nets. This group faces many structural barriers, and social vulnerabilities, that hinder their capacity to access COVID-19 testing and treatment services and to adhere to public health interventions and measures to decrease the spread of COVID-19. Latinos often rely on a thin and fragmented network of health and social services organizations. Intervention to mitigate the impact of COVID-19 on this population will need to have a broad stakeholder engagement and address a wide range of health determinants. Peer-driven interventions have been effective for the prevention and control of infectious diseases such as HIV, STIs among Latino populations. Strengthening the links between community members and these organizations and promoting inter-organizational coordination to meet syndemic health, behavioral, economic, and legal needs of Latino communities are essential elements to mitigate the impact of COVID-19 on this low-resource population. In direct response to the NOT-MD-20-022/PAR PA-18-935, our ongoing community-academic partnership proposes to evaluate CRISOL Contigo, a multi-level intervention to address the needs created or magnified by the COVID-19 pandemic among Latino communities in Philadelphia. CRISOL Contigo includes a peer-driven program and mobilization of Latino-serving organizations. In aim 1, the investigative team will adapt an ongoing Popular Opinion Leader (POL) program to address the unique health, social, and economic needs related to COVID-19 and the SAVAME syndemic. In aim 2, the investigative team will assess the efficacy of CRISOL Contigo to improve COVID-19 related preventive health behaviors and use and access to COVID-19 related testing and care (co-primary outcomes). In aim 3, the investigative team will examine the impact of CRISOL Contigo on community assets, interagency collaborations, and coordination among the Latino-serving organizations in Philadelphia. There are almost 20 million Latino immigrants in the US, and they play a central role in sustaining the vital parts of the US economy Tailored, multi-level interventions that consider the unique needs of Latinos are urgently needed to mitigate the impact of this and future outbreaks of COVID-19 on this disadvantaged population.

Official Title
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CRISOL: Building Community Resilience and Integrating Efforts to Understand and Address Syndemic Health Conditions Afflicting Young LatinoImmigrants

Conditions
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Covid19, Mental Health Issue, Violence

Intervention / Treatment
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* Other: Community popular opinion leader (POL) based intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported Latino or Hispanic Living in Philadelphia Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community popular opinion leader (POL)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With SAVAME (Substance Abuse, Violence, HIV/AIDS, Mental Health)-Related Factors | 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. | Baseline and 3 months | 
| Lack of Access to SAVAME Services | 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 | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Latino health, Immigrant health, Syndemic