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
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.
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.
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.
Browse COVID-19 studies →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.
Exclusion Criteria:
Participants in the no video condition will receive weekly text messages designed to increase vaccination among our sample.
Behavioral: No video
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
Weekly text messages
Weekly text messages including links to intervention videos
Vaccination uptake at baseline
Did the participant vaccinate when offered?
Time frame: baseline
Vaccination uptake at follow-up
Did the participant vaccinate when offered?
Time frame: up to 6 weeks
Vaccination series completion
Did the participant receive a second vaccine dose to complete the vaccination series?
Time frame: up to 12 weeks
SARS-CoV-2 literacy at baseline
Knowledge of COVID 19 as measured by correct responses to true/false questions.
Time frame: baseline
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
Secondary
Attitudes toward vaccination and medical care at baseline
Time frame: baseline
Secondary
Attitudes toward vaccination and medical care at follow-up
Time frame: up to 12 weeks
Plan to share: No
No publications or documents are linked to this record.
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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NDRI-USA, Inc.