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临床试验/NCT05534061
NCT05534061已完成不适用

Motivational Enhancement to Augment Contingency Management for SARS-CoV-2 Testing and Vaccination Utilization Among Syringe Exchange Clients

University of Oregon1 个研究点 分布在 1 个国家目标入组 349 人开始时间: 2022年8月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
349
试验地点
1
主要终点
SARS-CoV-2 Testing

研究概览

简要总结

People who inject drugs (PWIDs) are highly vulnerable to SARS-CoV-2 infection and to the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), however, rates of SARS-CoV-2 testing and vaccination uptake -vital to mitigating the spread of COVID-19 and achieving herd immunity - are lower among PWIDs compared to the general population. Building on our Phase I Rapid Acceleration of Diagnostics project, which found that contingency management (CM) increased testing utilization among PWIDs, the proposed project evaluates the comparative effectiveness of CM versus CM plus a brief motivational enhancement intervention on SARS-CoV-2 testing and vaccination uptake among PWIDs. This project has the potential to reduce COVID-19 health disparities among PWIDs and to decrease population level COVID-19 morbidity and mortality.

详细描述

This study uses contingency management, specifically $10 financial incentives for participation in SARS-CoV-2 testing and $10 for participating in COVID-19 vaccination. It also uses a motivational enhancement intervention which is a brief conversation with clients to improve intrinsic motivation for testing and vaccination. Thus, the clinical trials portion of this study is a randomized control trial (N = 349) in which 177 participants will be assigned to contingency management plus the Connect2Test intervention and 172 will be assigned to the contingency management alone (i.e. services as usual). There will be a per site quota to ensure there are relatively equivalent numbers of participants per site to avoid site-specific biases. The data collection software (e.g., Qualtrics, PowerBI) will randomly assign individuals to condition in real time, after a participant consents to participate in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

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

  • •18 and older, understand English

排除标准

  • 未提供

研究组 & 干预措施

Connect2Test Intervention + Contingency Management

Experimental

$10 financial incentive for vaccination and $10 financial incentive for testing plus a brief feedback-based motivational enhancement intervention.

干预措施: Connect2Test (Behavioral)

Contingency Management Alone

Active Comparator

$10 financial incentive for vaccination and $10 financial incentive for testing.

干预措施: Connect2Test (Behavioral)

结局指标

主要结局

SARS-CoV-2 Testing

时间窗: Up to 9-months after intervention

Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record

SARS-CoV-2 Testing

时间窗: Immediate post intervention (i.e., same day)

Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record

次要结局

  • COVID-19 Vaccination(Up to 9-months after intervention)
  • COVID-19 Vaccination(Immediate post intervention (i.e., same day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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