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Clinical Trials/NCT04910542
NCT04910542
Completed
N/A

Epidemiologic Intelligence Network (EpI-Net) to Promote COVID-19 Testing and Prevention Practices Among Socially Vulnerable Communities in Puerto Rico

Ponce Medical School Foundation, Inc.1 site in 1 country3,301 target enrollmentMarch 9, 2021
ConditionsCovid19

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19
Sponsor
Ponce Medical School Foundation, Inc.
Enrollment
3301
Locations
1
Primary Endpoint
Change COVID-19 testing uptake
Status
Completed
Last Updated
last year

Overview

Brief Summary

The investigators propose a mixed-methods intervention design to evaluate the acceptability of epidemic intelligence (EpI-Net) intervention using Community Engagement (CE) principles to promote COVID-19 testing and prevention practices in socially vulnerable communities in PR. The team hypothesizes that the integration of lay community leaders, trained in the use of COVID-19 prevention technology tools (EpI-Net), will result in increased COVID-19 testing uptake and prevention practices among the targeted socially and epidemiologically vulnerable communities in Puerto Rico.

Detailed Description

On March 11, 2020, the World Health Organization (WHO) officially declared the SARS-CoV-2 (COVID-19) outbreak a pandemic. In Puerto Rico (PR), the first COVID-19 case was confirmed early March 2020. To date, cases have exponentially increased partly due to the lifting of locked-down restriction by the PR government, limited COVID-19 testing, and contact tracing. As a major Public Health Emergency (PHE), the COVID-19 pandemic has disproportionally affected racial and ethnic minorities as well as patients with chronic health conditions. Specifically, residents of PR are socially and epidemiologically vulnerable with one of the highest prevalence rates for chronic diseases (diabetes, hypertension, obesity, HIV) prevalence rates and arbovirus-related diseases, such as Zika and Dengue. Puerto Ricans living on the island are also particularly vulnerable to the current overlapping of the COVID-19 pandemic and natural disasters (earthquake, hurricanes/storms). Limited access to molecular COVID-19 testing throughout PR has been a significant challenge. Without adequate testing, estimates for SARS-CoV-2 (COVID-19) infection rates are limited, and targeted prevention efforts (focused testing) be inadequate. Ponce Research Institute (PRI) with the support of Ponce Health Sciences University (PHSU) - leads the COVID-19 outreach efforts in PR related to earthquake aftershocks, tropical storms, and the COVID-19 pandemic. The PHSU-PRI Research Center for Minority Institutions-Community Engagement Core (RCMI-CEC) leaders in collaboration with community leaders, implemented the COVID-19 prevention education initiative which targets socially vulnerable populations in southern Puerto Rico (the earthquake and aftershocks epicenter). Also, PHSU-PRI epidemiologists (led by Dr. Marzán-Rodríguez, MPI) developed a web-based COVID-19 Epidemiologic Surveillance System (ESSS) in collaboration with the Puerto Rico Public Health Trust (PRPHT, a community partner for this grant) with more than 46,000 surveys completed up to September 2020. The ESSS tool is an online geocoded survey that identifies real-time COVID-19-related symptoms during the last 24 hours; and thus, prioritizes communities for COVID-19 testing. The ESSS tool can be easily accessed on the PRPHT website. Leveraging the current PHSU-PRI COVID-19 prevention efforts and the ESSS infrastructure, the research team proposes a mixed-methods approach for intervention trials for dissecting the impact of an epidemic intelligence (EpI-Net) community-based intervention aimed at increasing COVID-19 testing uptake and prevention practices among socially vulnerable communities in PR. Under Aim 1, the team will train lay community leaders on the use and application of COVID-19 early detection epidemic intelligence tools. Under Aim 2, the team will identify and understand the individual (beliefs and behaviors), social, cultural, and contextual factors facilitating the adoption and adherence to routine COVID-19 testing and prevention practices. Under Aim 3, the team will test EpI-Net intervention preliminary impact on increasing COVID-19 testing uptake and prevention practices among socially vulnerable communities in PR. The working hypothesis is that the integration of lay community leaders, trained in the use of COVID-19 prevention technology tools (EpI-Net), will result in increased COVID-19 testing uptake and prevention practices among the targeted socially and epidemiolocal vulnerable communities in Puerto Rico.

Registry
clinicaltrials.gov
Start Date
March 9, 2021
End Date
May 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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. 1. Tabulation of PCR tests by test ID and date of sample collection. 2. Tabulation of PCR test results received by the molecular laboratory. 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. 1. Have you ever been tested for COVID-19? 1. No 2. Yes 3. Prefer not to answer 2. How did you get tested for your most recent test? 1. Nasal Swab (Antigen) 2. Swab in the nose and throat (PCR) 3. Blood 4. Saliva

Secondary Outcomes

  • Change Covid-19 positivity rates <5%(Five months per community)
  • Covid-19 prevention practices awareness of >25%(Five months per community)
  • Covid-19 prevention practices uptake of >25%(Five months per community)

Study Sites (1)

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