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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04924803
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : October 14, 2022
Sponsor:
Collaborators:
New York Harm Reduction Educators
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid19 Behavioral: No video Behavioral: Video Text Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Community Developed Technology-Based Messaging to Increase SARS-CoV-2 Vaccine Uptake Among People Who Inject Drugs
Actual Study Start Date : June 21, 2022
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Weekly text messages
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
Weekly text messages including links to intervention videos


Outcome Measures
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Primary Outcome Measures :
  1. Vaccination uptake at baseline [ Time Frame: baseline ]
    Did the participant vaccinate when offered?

  2. Vaccination uptake at follow-up [ Time Frame: up to 6 weeks ]
    Did the participant vaccinate when offered?

  3. Vaccination series completion [ Time Frame: up to 12 weeks ]
    Did the participant receive a second vaccine dose to complete the vaccination series?


Secondary Outcome Measures :
  1. SARS-CoV-2 literacy at baseline [ Time Frame: baseline ]
    Knowledge of COVID 19 as measured by correct responses to true/false questions.

  2. SARS-CoV-2 literacy at follow-up [ Time Frame: up to 12 weeks ]
    Knowledge of COVID 19 as measured by correct responses to true/false questions.

  3. Secondary [ Time Frame: baseline ]
    Attitudes toward vaccination and medical care at baseline

  4. Secondary [ Time Frame: up to 12 weeks ]
    Attitudes toward vaccination and medical care at follow-up


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • Pregnant women will be excluded. Likewise, adults unable to consent, individuals who are not yet adults (infants, children, teenagers) and prisoners will be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04924803


Contacts
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Contact: Ian D Aronson, Ph.D. (212) 998 9014 ia14@nyu.edu

Locations
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United States, New York
OnPoint NYC Recruiting
New York, New York, United States, 10035
Contact: Brent Gibson, Ph.D.    212-828-8464    bgibson@nyhre.org   
Sponsors and Collaborators
New York University
New York Harm Reduction Educators
National Institute on Drug Abuse (NIDA)
More Information
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Responsible Party: New York University
ClinicalTrials.gov Identifier: NCT04924803    
Other Study ID Numbers: COVID Vaccination
R01DA054990 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases