Covid19CRISOL ContigoNCT04646616
CRISOL Contigo: a Multi-level Intervention to Reduce the Disproportionate Toll of COVID-19 Among Latino Communities in Philadelphia.
A study testing Community popular opinion leader (POL) based intervention in people with Covid19 and Mental Health Issue, run by Drexel University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Mental Health Issue, Violence
- What is being tested?
- Community popular opinion leader (POL) based intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 4 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported Latino or Hispanic
- Living in Philadelphia
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University Dornsife School of Public Health
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19, Mental Health Issue, Violence
- Being tested
- Community popular opinion leader (POL) based intervention
- Keywords
- Latino health, Immigrant health, Syndemic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community popular opinion leader (POL) based interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Community popular opinion leader (POL) based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline and 3 months
Secondary outcomes (2)
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.
Measured: 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
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start15 Jan 2021
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Martinez Donate, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646616
- Sponsor's protocol ID
- 3R21MD012352-02S1
- Acronym
- CRISOL Contigo
- Status last verified
- Jun 2023
- First submitted
- 25 Nov 2020
- Last updated
- 5 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRISOL: Building Community Resilience and Integrating Efforts to Understand and Address Syndemic Health Conditions Afflicting Young LatinoImmigrants
- ClinicalTrials.gov ID
- NCT04646616
- Acronym / sponsor ID
- CRISOL Contigo / 3R21MD012352-02S1
- Conditions
- Covid19, Mental Health Issue, Violence
- Keywords
- Latino health, Immigrant health, Syndemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Posted 5 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community popular opinion leader (POL) | Experimental | Other: Community popular opinion leader (POL) based interventionAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-reported Latino or Hispanic
- Living in Philadelphia
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community popular opinion leader (POL) based interventionA 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. | Other | Community popular opinion leader (POL) |
Primary outcome
Mean Number of Five Protective COVID-19 Risk Measures
Time frame: Baseline and 3 months
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
Number of Participants Who Lack Access to Health Care
Time frame: Baseline and 3 months
This measure is a composite dichotomous outcome variable, that indicates not having health insurance or not having a regular primary care provider.
2 secondary outcomes
Number of Participants With SAVAME (Substance Abuse, Violence, HIV/AIDS, Mental Health)-Related Factors
Time frame: Baseline and 3 months
Lack of Access to SAVAME Services
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community popular opinion leader (POL) based intervention in people with Covid19 and Mental Health Issue, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Five Protective COVID-19 Risk Measures (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.