NCT04873401

Brief Summary

This two-year project will adapt and conduct a trial examining the ability of two recruitment strategies, chain-referral and credible messenger, to reach those who use opioids and other substances in order to increase their uptake of onsite point of care COVID-19 testing that will be delivered in two community based organizations (CBOs): Alliance for Positive Change and Argus Health Inc. In Phase 1, Adapt two implementation strategies to support COVID-19 testing uptake and sustainability, adapting elements of existing efficacious social network-based interventions via a CBPR approach. In Phase 2, we will examine and compare the efficacy of two sets of implementation strategies on (i) reach, (ii) testing uptake, (iii) service delivery (i.e. quarantine, medical care, contact tracing) and (iv) sustainability for individuals who use opioids and other drugs. In Phase 3, Elucidate and compare the system/organizational-, staff-, and individual-level factors that influence implementation (i.e. fidelity, acceptability, feasibility, sustainability) of the strategies to develop a plan for dissemination and scale-up in other CBOs who serve opioid and other substance using individuals in NYC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
498

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Apr 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 18, 2023

Completed
Last Updated

April 21, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 24, 2021

Results QC Date

January 25, 2023

Last Update Submit

March 30, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Participants Who Agreed to Take a COVID-19 Rapid Test of Those Enrolled

    Number of participants who agreed to take a COVID-19 rapid test out of those who were enrolled (n=498)

    Baseline

  • Mean Number of COVID-19 Rapid Tests Taken

    Mean number of COVID-19 rapid tests taken among those who took at least 1 test (n=478)

    Baseline

  • Uptake of the Recruitment Strategy Into the Community

    Total number of coupons redeemed (Chain referral arm) out of coupons delivered OR total number of people approached in the community via credible messengers (Credible messenger arm) who enrolled in the study

    Baseline

  • Reach of the Recruitment Strategy Into the Community

    Number of people reached or approached via coupon (CR) based on number of coupons distributed or via peer/direct contact (CM), who may or may not have enrolled in the study

    Baseline

Secondary Outcomes (3)

  • Participant Acceptability of Recruitment Strategy and Testing Program Scale

    Baseline

  • Sustainability of the Testing Program

    Sustainment

  • Feasibility of Recruitment and Testing Protocols

    Sustainment

Study Arms (2)

Chain Referral

EXPERIMENTAL

In the chain-referral intervention, a discrete number of "seeds" will be recruited from the community partners, trained and incentivized to recruit and refer members of their social networks to receive COVID-19 testing; these recruits are then trained to do the same.

Behavioral: Chain-referral

Credible Messenger

EXPERIMENTAL

In the credible messenger intervention, peers identified as popular and socially influential individuals within their respective communities with lived experience are trained to engage within formal and informal social networks to promote behavior change.

Behavioral: Credible Messenger

Interventions

Chain-referralBEHAVIORAL

In the chain-referral intervention, a discrete number of "seeds" will be recruited from the community partners, trained and incentivized to recruit and refer members of their social networks to receive COVID-19 testing. The peer recruiters are paid for each suvcessful and eligible recruit who enrolls to be tested. Those individuals are then themselves trained to recruit peers from their social networks to receive COVID-19 testing. This is repeated over a period of 4-6 months.

Chain Referral

In the credible messenger intervention, peers noted to be popular and socially influential individuals with lived experience will be trained to engage within community settings and areas to encourage community members to receive COVID-19 testing at the community partnering agencies. Peers will recruit community members over a period of 4-6 months.

Credible Messenger

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endorse opioid use in the past 6 months
  • Speak English or Spanish
  • Age 18+

You may not qualify if:

  • Deny history of opioid use (but will be offered COVID-19 testing)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

COVID-19Substance-Related Disorders

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Katherine Elkington
Organization
New York State Psychiatric Institute

Study Officials

  • Katherine Elkington, PhD

    New York State Psychiatric Institute

    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
CROSSOVER
Model Details: Groups are randomly assigned to either condition/arm; after 6 months they each cross over into the other arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

March 24, 2021

First Posted

May 5, 2021

Study Start

April 20, 2021

Primary Completion

March 18, 2022

Study Completion

January 1, 2023

Last Updated

April 21, 2026

Results First Posted

April 18, 2023

Record last verified: 2026-03

Locations