NCT04910542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,301

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

March 30, 2021

Last Update Submit

March 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change COVID-19 testing uptake

    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

    Five months per community

Secondary Outcomes (3)

  • 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 Arms (1)

EpI-Net community intervention

OTHER

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.

Other: Epi-Net Intervention

Interventions

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.

EpI-Net community intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Children and adolescents are excluded from participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ponce Medical School Foundation

Ponce, Puerto Rico, 00717, Puerto Rico

Location

Related Publications (1)

  • Marzan-Rodriguez M, Muniz-Rodriguez K, Morales LM, Martinez IS, Torres-Borrero N, Castro-Figueroa EM. Epidemiological intelligence community network intervention: a community response for COVID-19 community transmission. BMC Public Health. 2023 Jun 1;23(1):1044. doi: 10.1186/s12889-023-15727-3.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Eida M Castro, PsyD

    Ponce Medical School Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: This study employs a mixed-methods design for intervention trials. This method is appropriate for epidemiological interventions framed under community engagement practices.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

June 2, 2021

Study Start

March 9, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

At this moment, no individual personal data will be available to others researchers

Locations