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

Primary Purpose

Covid19

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No video
Video Text
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • OnPoint NYCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

No video condition

Video text condition

Arm Description

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

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

Outcomes

Primary Outcome Measures

Vaccination uptake at baseline
Did the participant vaccinate when offered?
Vaccination uptake at follow-up
Did the participant vaccinate when offered?
Vaccination series completion
Did the participant receive a second vaccine dose to complete the vaccination series?

Secondary Outcome Measures

SARS-CoV-2 literacy at baseline
Knowledge of COVID 19 as measured by correct responses to true/false questions.
SARS-CoV-2 literacy at follow-up
Knowledge of COVID 19 as measured by correct responses to true/false questions.
Secondary
Attitudes toward vaccination and medical care at baseline
Secondary
Attitudes toward vaccination and medical care at follow-up

Full Information

First Posted
June 9, 2021
Last Updated
October 11, 2022
Sponsor
New York University
Collaborators
New York Harm Reduction Educators, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04924803
Brief Title
Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs
Official Title
Community Developed Technology-Based Messaging to Increase SARS-CoV-2 Vaccine Uptake Among People Who Inject Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
New York Harm Reduction Educators, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No video condition
Arm Type
Experimental
Arm Description
Participants in the no video condition will receive weekly text messages designed to increase vaccination among our sample.
Arm Title
Video text condition
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
No video
Intervention Description
Weekly text messages
Intervention Type
Behavioral
Intervention Name(s)
Video Text
Intervention Description
Weekly text messages including links to intervention videos
Primary Outcome Measure Information:
Title
Vaccination uptake at baseline
Description
Did the participant vaccinate when offered?
Time Frame
baseline
Title
Vaccination uptake at follow-up
Description
Did the participant vaccinate when offered?
Time Frame
up to 6 weeks
Title
Vaccination series completion
Description
Did the participant receive a second vaccine dose to complete the vaccination series?
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
SARS-CoV-2 literacy at baseline
Description
Knowledge of COVID 19 as measured by correct responses to true/false questions.
Time Frame
baseline
Title
SARS-CoV-2 literacy at follow-up
Description
Knowledge of COVID 19 as measured by correct responses to true/false questions.
Time Frame
up to 12 weeks
Title
Secondary
Description
Attitudes toward vaccination and medical care at baseline
Time Frame
baseline
Title
Secondary
Description
Attitudes toward vaccination and medical care at follow-up
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian D Aronson, Ph.D.
Phone
(212) 998 9014
Email
ia14@nyu.edu
Facility Information:
Facility Name
OnPoint NYC
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brent Gibson, Ph.D.
Phone
212-828-8464
Email
bgibson@nyhre.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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