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

Community Developed Technology-Based Messaging to Increase SARS-CoV-2 Vaccine Uptake Among People Who Inject Drugs

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Behavioral: No video; Behavioral: Video Text

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 Type: Interventional
• Enrollment (Actual): 545
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10035
      • OnPoint NYC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 literacy at baseline	Knowledge of COVID 19 as measured by correct responses to true/false questions.	baseline
SARS-CoV-2 literacy at follow-up	Knowledge of COVID 19 as measured by correct responses to true/false questions.	up to 12 weeks
Secondary	Attitudes toward vaccination and medical care at baseline	baseline
Secondary	Attitudes toward vaccination and medical care at follow-up	up to 12 weeks

Collaborators and Investigators

• Sponsor: NDRI-USA, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); New York Harm Reduction Educators

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Estimated): November 25, 2025
• Study Completion (Estimated): February 27, 2026

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: COVID Vaccination; R01DA054990 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No