Clinical trial NCT04910542: Epidemiologic Intelligence Network (EpI-Net) to Promote COVID-19 Testing
Official title: Epidemiologic Intelligence Network (EpI-Net) to Promote COVID-19 Testing and Prevention Practices Among Socially Vulnerable Communities in Puerto Rico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Ponce Medical School Foundation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: Harvard School of Public Health (HSPH)
First posted: 2021-06-02
Enrollment: 3301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study employs a mixed-methods design for intervention trials. This method is appropriate for epidemiological interventions framed under community engagement practices.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Change COVID-19 testing uptake
timeFrame: Five months per community
Secondary outcomes:
measure: Change Covid-19 positivity rates <5%
timeFrame: Five months per community
measure: Covid-19 prevention practices awareness of >25%
timeFrame: Five months per community
measure: Covid-19 prevention practices uptake of >25%
timeFrame: Five months per community
Other outcomes:
Locations:
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation
Study officials:
affiliation: Ponce Medical School Foundation
name: Eida M Castro, PsyD
role: PRINCIPAL_INVESTIGATOR
References: