NCT05139927

Brief Summary

COVID-19 testing is essential to controlling the COVID-19 pandemic to break transmission chains and reduce community transmission. However, Black and Latino/Hispanic populations in lower status frontline essential occupations such as food preparation, retail, building maintenance, personal services, and in-home health care have serious barriers to COVID-19 testing and, therefore, insufficient testing rates. The proposed study will use the multiphase optimization strategy framework to address the problem of low COVID-19 testing rates for this population: We will test the effects of four distinct candidate intervention components and then create an efficient multicomponent made up of the most effective combination of the components that can be rapidly scaled up in community settings to boost COVID-19 testing rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
438

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jun 2022

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

First Submitted

Initial submission to the registry

November 29, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 16, 2025

Completed
Last Updated

May 16, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

November 29, 2021

Results QC Date

April 8, 2025

Last Update Submit

April 30, 2025

Conditions

Keywords

multiphase optimization strategy (MOST)COVID-19 testingBlack and Latinofrontline essential workers

Outcome Measures

Primary Outcomes (1)

  • COVID-19 Testing at Follow-up Assessment

    COVID-19 testing at the 6- and/or 12-week follow-up assessment (at least one instance)

    by the 12-week FU

Study Arms (16)

Condition 1

EXPERIMENTAL

Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation

Behavioral: Motivational interviewing (MI) counselingBehavioral: Text messages (TMs) and quiz questions (QQs)Behavioral: Peer educationBehavioral: Access to COVID testing

Condition 2

EXPERIMENTAL

Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit

Behavioral: Motivational interviewing (MI) counselingBehavioral: Text messages (TMs) and quiz questions (QQs)Behavioral: Peer educationBehavioral: Access to COVID testing

Condition 3

EXPERIMENTAL

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation

Behavioral: Text messages (TMs) and quiz questions (QQs)Behavioral: Peer educationBehavioral: Access to COVID testing

Condition 4

EXPERIMENTAL

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit

Behavioral: Text messages (TMs) and quiz questions (QQs)Behavioral: Peer educationBehavioral: Access to COVID testing

Condition 5

EXPERIMENTAL

Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation

Behavioral: Motivational interviewing (MI) counselingBehavioral: Peer educationBehavioral: Access to COVID testing

Condition 6

EXPERIMENTAL

Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit

Behavioral: Motivational interviewing (MI) counselingBehavioral: Peer educationBehavioral: Access to COVID testing

Condition 7

EXPERIMENTAL

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation

Behavioral: Peer educationBehavioral: Access to COVID testing

Condition 8

EXPERIMENTAL

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit

Behavioral: Peer educationBehavioral: Access to COVID testing

Condition 9

EXPERIMENTAL

Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation

Behavioral: Motivational interviewing (MI) counselingBehavioral: Text messages (TMs) and quiz questions (QQs)Behavioral: Access to COVID testing

Condition 10

EXPERIMENTAL

Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit

Behavioral: Motivational interviewing (MI) counselingBehavioral: Text messages (TMs) and quiz questions (QQs)Behavioral: Access to COVID testing

Condition 11

EXPERIMENTAL

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation

Behavioral: Text messages (TMs) and quiz questions (QQs)Behavioral: Access to COVID testing

Condition 12

EXPERIMENTAL

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit

Behavioral: Text messages (TMs) and quiz questions (QQs)Behavioral: Access to COVID testing

Condition 13

EXPERIMENTAL

Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation

Behavioral: Motivational interviewing (MI) counselingBehavioral: Access to COVID testing

Condition 14

EXPERIMENTAL

Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit

Behavioral: Motivational interviewing (MI) counselingBehavioral: Access to COVID testing

Condition 15

EXPERIMENTAL

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation

Behavioral: Access to COVID testing

Condition 16

EXPERIMENTAL

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit

Behavioral: Access to COVID testing

Interventions

Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes. The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances.

Condition 1Condition 10Condition 13Condition 14Condition 2Condition 5Condition 6Condition 9

This intervention lasts 6 weeks. This component is grounded in principles of behavioral economics. Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed. Participants first receive a brief orientation to the component (15 min.), and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent. TMs and QQs are programmed into the Telerivet program and sent automatically. Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer. Participants earn modest prizes based on their points.

Condition 1Condition 10Condition 11Condition 12Condition 2Condition 3Condition 4Condition 9
Peer educationBEHAVIORAL

This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min. training). Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages. These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study.

Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8

Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed. Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19. Level 2: 1 month after enrollment, participants will be contacted by phone. If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.

Condition 1Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Silver School of Social Work

New York, New York, 10003, United States

Location

Related Publications (1)

  • Gwadz M, Cleland CM, Lizardo M, Hawkins RL, Bangser G, Parameswaran L, Stanhope V, Robinson JA, Karim S, Hollaway T, Ramirez PG, Filippone PL, Ritchie AS, Banfield A, Silverman E. Using the multiphase optimization strategy (MOST) framework to optimize an intervention to increase COVID-19 testing for Black and Latino/Hispanic frontline essential workers: A study protocol. BMC Public Health. 2022 Jun 21;22(1):1235. doi: 10.1186/s12889-022-13576-0.

MeSH Terms

Conditions

COVID-19

Interventions

Motivational InterviewingCounseling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Directive CounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesCommunity Health Services

Results Point of Contact

Title
Marya Gwadz, PhD
Organization
NYU

Study Officials

  • Marya Gwadz, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Full factorial experiment testing 4 behavioral intervention components. There are 16 conditions needed to test the effects of the 4 components. Each condition comprises a combination of components. In the sections that follow, we describe the 16 conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 1, 2021

Study Start

June 1, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

May 16, 2025

Results First Posted

May 16, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations