- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04910542
Epidemiologic Intelligence Network (EpI-Net) to Promote COVID-19 Testing (EpI-Net)
Epidemiologic Intelligence Network (EpI-Net) to Promote COVID-19 Testing and Prevention Practices Among Socially Vulnerable Communities in Puerto Rico
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claris Vega, BS
- Phone Number: 2193 787-840-2575
- Email: cvega@psm.edu
Study Contact Backup
- Name: Melissa M Marzan, PhD
- Phone Number: 5697 7878402575
- Email: mmarzan@psm.edu
Study Locations
-
-
-
Ponce, Puerto Rico, 00717
- Recruiting
- Ponce Medical School Foundation
-
Contact:
- Melissa Marzan, PhD
- Phone Number: 5697 7878402575
- Email: mmarzan@psm.edu
-
Contact:
- Claris Vega, BS
- Phone Number: 2193 7878402675
- Email: cvega@psm.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Community Leaders Eligibility Criteria: After the team's identified the community, with the support of the community partners and the Community Scientific Advisory Committee, we will invite community leaders to be part of the EpI-Net training. The inclusion criteria for the community leaders to be trained in EpI-Net activities are: (1) >21 years of age, (2) living in a socially vulnerable community for COVID-19 according to the CDC-SVI; (3) self-identified as a Latino/Hispanic and; (4) be able to provide support for the EpI- Net implementation process in their communities.
- In-depth Interview Participants' Eligibility Criteria: The eligibility criteria for the qualitative interviews will be: (1) >21 years old, (2) living in a socially vulnerable community for COVID-19 according to the CDC-SVI (Ref); (3) self-identified as a Latino/Hispanic; (4) be part of the participant municipalities at the RCMI-CEC program or PRPHT network and (5) be able to complete an interview.
- Communities' Eligibility Criteria: Based on factors associated with COVID-19 complications such as high chronic disease prevalence (including obesity rates), age group distribution, population density and socioeconomic status, and COVID-19 positivity rates, we will preliminarily identify potential municipalities to be impacted by this project.Those preliminar municipalities are: Ponce, Guánica, Vieques, San Juan, Loíza, Vega Alta, Aibonito, Yauco, Mayagüez and Naranjito. Once municipalities are identified, the team will rely on the CDC-SVI index to identify the communities (within these municipalities) with higher socially vulnerability.
- Community Survey Eligibility Criteria: The eligibility criteria for the community survey will be: (1) >21 years old, (2) living in a socially vulnerable community for COVID-19 according to the CDC-SVI (Ref); (3) self-identified as a Latino/Hispanic; (4) be part of the participant municipalities at the RCMI-CEC program or PRPHT network and (5) be able to complete an interview.
- Epidemiological Syndromic Surveillance System (ESSS) Eligibility Criteria: Participants eligible to complete the ESSS are residents of Puerto Rico, 18 years of age and older.
Exclusion Criteria:
- Children and adolescents are excluded from participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: EpI-Net community intervention
The Epidemiological Intelligence Network Intervention (Epi-Net) is a group of field epidemiology tools for test, trace and isolate using a community-based approach.
The overall goal of Epi-Net is to increase uptake of COVID-19 testing and prevention practices among socially vulnerable communities in Puerto Rico.
The intervention intends to impact COVID-19 risk perception, decrease COVID-19 testing barriers, increase testing uptake and increase health promotion strategies.
|
The Epidemiological Intelligence Network Intervention (Epi-Net) is a group of field epidemiology tools for test, trace and isolate using a community-based approach.
The overall goal of Epi-Net is to increase uptake of COVID-19 testing and prevention practices among socially vulnerable communities in Puerto Rico.
The intervention intends to impact COVID-19 risk perception, decrease COVID-19 testing barriers, increase testing uptake and increase health promotion strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change COVID-19 testing uptake
Time Frame: Five months per community
|
By June 2022, EpI-Net intervention will have provided 2,700 COVID-19 RT-PCR tests among six socially vulnerable communities in PR.
i.COVID-19 test results by EpI-NET uploaded to REDCap servers. c.TESTING ASSESSMENT i.% of participants who received a COVID-19 RT-PCR tests for the first time.
|
Five months per community
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Covid-19 positivity rates <5%
Time Frame: Five months per community
|
Assessment a.Baseline COVID-19 positivity rate vs 5 months COVID-19 positivity rate. i.Have you ever tested positive for COVID-19?/Yes;/No/I don't know/Prefer not to answer ii.In which month did you first test positive for COVID-19?/January/February/March/ April/May/June/July;/August;/September/October/November/December iii.In what year did you first test positive for COVID-19? /2019/2020/2021 iv.In what month did you have your most recent COVID-19 test?/January/February/March/ April/May/June/July;/August;/September/October/November/December v.What year was the most recent COVID-19 test done?/2019/2020/2021 vi.What was the result of your most recent COVID-19 test?/Negative/Positive/I never obtained the results/Undetermined/I don't know/Prefer not to answer |
Five months per community
|
Covid-19 prevention practices awareness of >25%
Time Frame: Five months per community
|
Assessment a.Baseline COVID-19 prevention practices awareness vs 5 months COVID-19 prevention practices awareness i.What messages have you heard in your VV about preventing the spread of COVID-19?/Wear a protective face cover/Disinfect different surfaces/Wash hands frequently with soap and water/Avoid group meetings/Disinfect packages, boxes, or mail/Disinfect grocery bags or packages/Wash fruits, vegetables and other food products with bleach/Take medications/Take vitamins or essential oils/Do not travel abroad/Do not travel within the island/Other/I have not heard any messages/Don't know/Prefer not to answer ii.Currently,how worried are you or the members of your VV by the contagion of COVID-19? /Very/Somewhat/Not prepared at all/Don't know/Prefer not to answer iii.How prepared was your VV for the COVID-19 pandemic and related stay-at-home orders?/Very/Somewhat/Not prepared at all/Don't know/Prefer not to answer |
Five months per community
|
Covid-19 prevention practices uptake of >25%
Time Frame: Five months per community
|
Assessment Baseline COVID-19 prevention practices uptake vs 5 months COVID-19 prevention practices uptake. i.Someone who has completed quarantine does not pose a risk of infection to the public or to themselves ii.Do you or a member of your VV think you had COVID-19 but were never tested? In response to the COVID-19 pandemic are you or members of your VV; iii. currently wearing a mask in public places? iv.currently avoiding meetings? v.currently conduct food washing (eg, bags)? vi.currently do vegetable washing? vii.currently wear gloves in public? viii.currently have hand disinfectant if you can't wash your hands? ix. In the past 30 days how often have you and the members of your VV left your home? In the past 30 days have you or members of your VV visited; x.a Beauty salon, massage center? xi.a Public park or beach? xii.the Interior of the restaurant? xiii.an Open-air restaurant? xiv.a Doctor's office? |
Five months per community
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eida M Castro, PsyD, Ponce Medical School Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3R21MD013674-02S2 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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