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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04646616
Acronym
CRISOL Contigo
Enrollment
178
Registered
2020-11-30
Start date
2021-01-15
Completion date
2022-03-04
Last updated
2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Mental Health Issue, Violence

Keywords

Latino health, Immigrant health, Syndemic

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.

Detailed description

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.

Interventions

OTHERCommunity popular opinion leader (POL) based intervention

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.

Sponsors

Drexel University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Self-reported Latino or Hispanic * Living in Philadelphia

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Mean Number of Five Protective COVID-19 Risk MeasuresBaseline and 3 monthsThis 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
Number of Participants Who Lack Access to Health CareBaseline and 3 monthsThis measure is a composite dichotomous outcome variable, that indicates not having health insurance or not having a regular primary care provider.

Secondary

MeasureTime frameDescription
Number of Participants With SAVAME (Substance Abuse, Violence, HIV/AIDS, Mental Health)-Related FactorsBaseline and 3 monthsSubstance 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.
Lack of Access to SAVAME ServicesBaseline and 3 monthsSelf-report lack of access to any SAVAME (Substance abuse, Intimate partner violence, HIV/AIDS, or Mental health symptomatology) services, overall among all the participants

Countries

United States

Participant flow

Participants by arm

ArmCount
Community Popular Opinion Leader (POL)
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.
178
Total178

Baseline characteristics

CharacteristicCommunity Popular Opinion Leader (POL)
Age, Continuous38.4 years
STANDARD_DEVIATION 9.7
Baseline Income Category
$1000-$2000 usd
38 Participants
Baseline Income Category
<$1000 usd
86 Participants
Baseline Income Category
>$2000 usd
21 Participants
Baseline Income Category
Missing/Don't know
33 Participants
Education Category
High school or more
32 Participants
Education Category
Missing
2 Participants
Education Category
More than Primary & <= High School
111 Participants
Education Category
Primary or below
33 Participants
Prevalence of COVID-19 positive51 Participants
Race/Ethnicity, Customized
Latino Black
4 Participants
Race/Ethnicity, Customized
Latino Native American
11 Participants
Race/Ethnicity, Customized
Latino Other
119 Participants
Race/Ethnicity, Customized
Latino White
12 Participants
Race/Ethnicity, Customized
Prefer not to answer, Unknown, More than one
39 Participants
Region of Enrollment
United States
178 participants
Sex: Female, Male
Female
135 Participants
Sex: Female, Male
Male
43 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 178
other
Total, other adverse events
0 / 178
serious
Total, serious adverse events
0 / 178

Outcome results

Primary

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

Time frame: Baseline and 3 months

Population: Each of the rows indicates the mean (SD) of protective behaviors at baseline and 3 months follow up

ArmMeasureGroupValue (MEAN)Dispersion
Community Popular Opinion Leader (POL)Mean Number of Five Protective COVID-19 Risk MeasuresBaseline2.79 score on a scaleStandard Deviation 1.23
Community Popular Opinion Leader (POL)Mean Number of Five Protective COVID-19 Risk Measures3 Months2.66 score on a scaleStandard Deviation 1.33
Comparison: This is a single-group study. Selected outcomes were measured at baseline (first interaction with the community popular opinion leader (POL) and 3 months after.p-value: 0.2895% CI: [-0.12, 0.39]t-test, 2 sided
Primary

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.

Time frame: Baseline and 3 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Community Popular Opinion Leader (POL)Number of Participants Who Lack Access to Health CareBaseline121 Participants
Community Popular Opinion Leader (POL)Number of Participants Who Lack Access to Health Care3 Months122 Participants
Comparison: Two sample test of proportions, testing whether the proportion of participants who lack health access at baseline and 3 months is equal (null hypothesis)p-value: 0.8595% CI: [-0.08, 0.07]Test of proportions
Secondary

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

Time frame: Baseline and 3 months

Population: Defined as self-report lack of access to any SAVAME services, overall among all the participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Community Popular Opinion Leader (POL)Lack of Access to SAVAME ServicesBaseline52 Participants
Community Popular Opinion Leader (POL)Lack of Access to SAVAME Services3 Months43 Participants
Comparison: Test of proportions. Testing whether the proportion of participants who lack access to SAVAME related services at baseline and 3 months is equal (null hypothesis)p-value: 0.2395% CI: [-0.04, 0.18]Test of proportions
Secondary

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.

Time frame: Baseline and 3 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Community Popular Opinion Leader (POL)Number of Participants With SAVAME (Substance Abuse, Violence, HIV/AIDS, Mental Health)-Related FactorsBaseline64 Participants
Community Popular Opinion Leader (POL)Number of Participants With SAVAME (Substance Abuse, Violence, HIV/AIDS, Mental Health)-Related Factors3 Months48 Participants
Comparison: Test of proportions. Testing whether the proportion of participants who had a SAVAME factor at baseline and 3 months is equal (null hypothesis)p-value: 0.1995% CI: [-0.04, 0.19]Test of proportions

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026