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Active, not recruitingNCT04924803Updated Mar 21, 2025

Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs

An interventional study of No video and Video Text in Covid19, sponsored by NDRI-USA, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by NDRI-USA, Inc. · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
545
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

People who inject drugs (PWID) experience disproportionate risk of being infected with SARS-CoV-2, the virus that causes COVID-19. Unfortunately, due to stigma, fear of mistreatment, and other factors, PWID are far less likely to be vaccinated compared to other populations. African American and Latino populations also face disproportionate risk of infection and far greater COVID-19 death rates compared to White populations, yet due to issues including longstanding medical mistrust are also far less likely to vaccinate. For African American and Latino PWID, COVID-related risks increase even further and vaccination becomes even more unlikely.

In response, we propose to continue our collaboration with New York Harm Reduction Educators (NYHRE) a prominent New York City community based organization serving African American and Latino PWID. To increase SARS-CoV-2 vaccination among our target population, we will first assemble a community advisory board (CAB) that we will consult at all phases of the project.

Next, we will recruit a separate sample of PWID (n=500) via respondent driven sampling to evaluate intervention materials as part of a clinical trial. Upon enrollment, participants will be offered a free vaccination against SARS-CoV-2. Those who do not initially vaccinate will be randomized into one of two intervention groups: a no video group, and a video text group. The no video group will receive weekly text messages designed to address barriers to vaccination identified in formative research. The video text group will receive the same texts, along with links to videos we develop with NYHRE staff and clients to address barriers to SARS-CoV-2 vaccination. Our intervention will track response rates in both groups. Primary outcome measures will be vaccination within the initial weeks following enrollment and the subsequent intervention period by treatment group. Additional outcomes will include vaccination rates by demographic, including race/ethnicity and primary language (i.e. do English speaking participants respond differently to specific intervention components compared to monolingual Spanish speakers).

If shown successful this approach can be replicated with additional populations that experience health disparities, and in different languages across the United States.

02

Conditions studied

  • Covid19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 545 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

NDRI-USA, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Pregnant women will be excluded. Likewise, adults unable to consent, individuals who are not yet adults (infants, children, teenagers) and prisoners will be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
545 participants (actual)

Study arms

  • Experimental
    No video condition

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

    Behavioral: No video

  • Experimental
    Video text condition

    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

  • BehavioralNo video

    Weekly text messages

  • BehavioralVideo Text

    Weekly text messages including links to intervention videos

06

What researchers measure

Primary outcomes

  1. Vaccination uptake at baseline

    Did the participant vaccinate when offered?

    Time frame: baseline

  2. Vaccination uptake at follow-up

    Did the participant vaccinate when offered?

    Time frame: up to 6 weeks

  3. Vaccination series completion

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

    Time frame: up to 12 weeks

Secondary outcomes

  1. SARS-CoV-2 literacy at baseline

    Knowledge of COVID 19 as measured by correct responses to true/false questions.

    Time frame: baseline

  2. SARS-CoV-2 literacy at follow-up

    Knowledge of COVID 19 as measured by correct responses to true/false questions.

    Time frame: up to 12 weeks

  3. Secondary

    Attitudes toward vaccination and medical care at baseline

    Time frame: baseline

  4. Secondary

    Attitudes toward vaccination and medical care at follow-up

    Time frame: up to 12 weeks

07

Study locations

1 site
  • OnPoint NYC
    New York, New York 10035, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04924803
Lead sponsor
NDRI-USA, Inc.
Collaborators
New York Harm Reduction Educators, National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Jun 14, 2021
Start date
Jun 21, 2022
Primary completion
Nov 25, 2025 (estimated)
Completion
Feb 27, 2026 (estimated)
Last update
Mar 21, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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