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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924803
• Other study ID #: COVID Vaccination
• Secondary ID: R01DA054990
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: New York University
• Contact: Ian D Aronson, Ph.D.
• Phone: (212) 998 9014
• Email: ia14[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 1, 2025
• Est. primary completion date: October 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Behavioral:
• No video
Weekly text messages
• Video Text
Weekly text messages including links to intervention videos

Locations

Country	Name	City	State
United States	OnPoint NYC	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University	National Institute on Drug Abuse (NIDA), New York Harm Reduction Educators

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccination uptake at baseline	Did the participant vaccinate when offered?	baseline
Primary	Vaccination uptake at follow-up	Did the participant vaccinate when offered?	up to 6 weeks
Primary	Vaccination series completion	Did the participant receive a second vaccine dose to complete the vaccination series?	up to 12 weeks
Secondary	SARS-CoV-2 literacy at baseline	Knowledge of COVID 19 as measured by correct responses to true/false questions.	baseline
Secondary	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	Secondary	Attitudes toward vaccination and medical care at baseline	baseline
Secondary	Secondary	Attitudes toward vaccination and medical care at follow-up	up to 12 weeks