Clinical trial NCT04924803: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Covid19
Lead sponsor: NDRI-USA, Inc.
Sponsor class: OTHER
Collaborators: name: New York Harm Reduction Educators
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-06-14
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Vaccination uptake at baseline
timeFrame: baseline
measure: Vaccination uptake at follow-up
timeFrame: up to 6 weeks
measure: Vaccination series completion
timeFrame: up to 12 weeks
Secondary outcomes:
measure: SARS-CoV-2 literacy at baseline
timeFrame: baseline
measure: SARS-CoV-2 literacy at follow-up
timeFrame: up to 12 weeks
measure: Secondary
timeFrame: baseline
measure: Secondary
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: OnPoint NYC
state: New York
Study officials:
References: