NCT05148936

Brief Summary

To create and evaluate effective COVID-19 testing uptake strategies that focus on underserved individuals who are exposed but have not accessed testing, and underserved individuals who are not routinely tested because they are unaware of their exposure or risk status in order to increase testing among these populations and reduce Covid-19 related disparities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32,750

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Oct 2020

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

October 25, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

2.8 years

First QC Date

March 31, 2021

Last Update Submit

June 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Test uptake

    Testing volume by study arm as cumulative count per hours testing site operated

    Through study completion, expected to be 20 months

Secondary Outcomes (3)

  • Test access

    Through study completion, expected to be 20 months

  • Test Impact (COVID-19 diagnoses)

    Through study completion, expected to be 20 months

  • Test Impact (number needed to screen)

    Through study completion, expected to be 20 months

Study Arms (4)

At home testing (Aim 1)

EXPERIMENTAL

High-risk friends and family of contacts exposed to COVID-19 will be provided with COVID-19 testing provided at home by a healthcare worker.

Other: COVID-19 Testing Home-based (Aim 1)

Mobile testing (Aim 1)

ACTIVE COMPARATOR

High-risk friends and family of contacts exposed to COVID-19 will be referred to study operated mobile testing sites in the community for COVID-19 testing.

Other: COVID-19 Testing Mobile (Aim 1)

Mobile testing approach 1 (Aim 2)

OTHER

Mobile testing utilizing active outreach

Other: COVID-19 Testing Mobile Approach 1 (Aim 2)

Mobile testing approach 2 (Aim 2)

OTHER

Mobile testing utilizing baseline outreach approaches

Other: COVID-19 Testing Mobile Approach 2 (Aim 2)

Interventions

Implementation of Antigen and PCR testing at participant homes

At home testing (Aim 1)

Implementation of Antigen and PCR testing at mobile test sites

Mobile testing (Aim 1)

Implementation of Antigen and PCR testing at mobile test sites - active outreach

Mobile testing approach 1 (Aim 2)

Implementation of Antigen and PCR testing at mobile test sites - baseline outreach

Mobile testing approach 2 (Aim 2)

Eligibility Criteria

Age6 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • African American, Arabic speaking, Filipino, and Latino/a populations

You may not qualify if:

  • Younger than 6, not in focus populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Households

San Diego, California, 92182, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Susan M Kiene, PhD

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster Randomized Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2021

First Posted

December 8, 2021

Study Start

October 25, 2020

Primary Completion

August 25, 2023

Study Completion

August 25, 2023

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Plan to share with Rad-X UP Coordinating Center

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Shared on a periodic basis. RPPR shared with NIH on a 6-month basis
Access Criteria
Anonymized data access

Locations