NCT04924803

Brief Summary

People who inject drugs (PWID) experience disproportionate risk of being infected with SARS-CoV-2, the virus that causes COVID-19, yet due to stigma, fear of mistreatment, and other factors, PWID are far less likely to be vaccinated compared to other populations. In response, we propose to continue our collaboration with a prominent community based organization serving African American and Latino PWID. Our project will explore baseline hesitancy to vaccinate among PWID, identify barriers to vaccination, and then develop and evaluate messaging designed to increase COVID-19 vaccination among our target population of PWID through a clinical trial.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
545

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
active not recruiting

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

June 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

June 21, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

3.4 years

First QC Date

June 9, 2021

Last Update Submit

March 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Vaccination uptake at baseline

    Did the participant vaccinate when offered?

    baseline

  • Vaccination uptake at follow-up

    Did the participant vaccinate when offered?

    up to 6 weeks

  • Vaccination series completion

    Did the participant receive a second vaccine dose to complete the vaccination series?

    up to 12 weeks

Secondary Outcomes (4)

  • SARS-CoV-2 literacy at baseline

    baseline

  • SARS-CoV-2 literacy at follow-up

    up to 12 weeks

  • Secondary

    baseline

  • Secondary

    up to 12 weeks

Study Arms (2)

No video condition

EXPERIMENTAL

Participants in the no video condition will receive weekly text messages designed to increase vaccination among our sample.

Behavioral: No video

Video text condition

EXPERIMENTAL

Participants in the video text condition will receive the text messages designed to increase vaccination among our sample, along with links to iteratively developed intervention videos

Behavioral: Video Text

Interventions

No videoBEHAVIORAL

Weekly text messages

No video condition
Video TextBEHAVIORAL

Weekly text messages including links to intervention videos

Video text condition

Eligibility Criteria

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

You may qualify if:

  • Participants must be age 18 years or older, able to provide informed consent, able to read and understand English or Spanish. Participants must report injection drug use in the past 90 days. Participants also must not have previously vaccinated against SARS-CoV-2.

You may not qualify if:

  • Pregnant women will be excluded. Likewise, adults unable to consent, individuals who are not yet adults (infants, children, teenagers) and prisoners will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OnPoint NYC

New York, New York, 10035, 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 14, 2021

Study Start

June 21, 2022

Primary Completion

November 25, 2025

Study Completion

February 27, 2026

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations