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临床试验/NCT04924803
NCT04924803进行中(未招募)不适用

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

NDRI-USA, Inc.1 个研究点 分布在 1 个国家目标入组 545 人开始时间: 2022年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
545
试验地点
1
主要终点
Vaccination uptake at follow-up

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •Pregnant women will be excluded. Likewise, adults unable to consent, individuals who are not yet adults (infants, children, teenagers) and prisoners will be excluded.

研究组 & 干预措施

Video text condition

Experimental

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

干预措施: Video Text (Behavioral)

No video condition

Experimental

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

干预措施: No video (Behavioral)

结局指标

主要结局

Vaccination uptake at follow-up

时间窗: up to 6 weeks

Did the participant vaccinate when offered?

Vaccination series completion

时间窗: up to 12 weeks

Did the participant receive a second vaccine dose to complete the vaccination series?

Vaccination uptake at baseline

时间窗: baseline

Did the participant vaccinate when offered?

次要结局

  • Secondary(up to 12 weeks)
  • SARS-CoV-2 literacy at baseline(baseline)
  • SARS-CoV-2 literacy at follow-up(up to 12 weeks)
  • Secondary(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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