跳至主要内容
临床试验/NCT05697068
NCT05697068进行中(未招募)不适用

Tailored Behavioral Intervention to Prevent Household and Community Spread of COVID-19 Among Latinos

San Diego State University2 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2022年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
256
试验地点
2
主要终点
Number of households with SARS-CoV-2 Antibodies

研究概览

简要总结

This study will examine the effectiveness of a 6-week behavioral intervention for patients who are recently diagnosed with COVID-19. Patients and their households will be randomized to one of two groups (Standard of Care vs. Enhanced Standard of Care). Patients in the Standard-of-Care group will receive established clinical care and follow-up. Patients in the Enhanced Standard-of-Care group will receive standard-of-care plus tailored, real-time text messaging and virtual counseling delivered by promotores/as. The investigators hypothesize that households in the Enhanced Standard-of-Care group will have fewer (any new) household COVID-19 infectivity rates compared to households in the standard-of-care group post-intervention.

详细描述

The study team will develop and test a novel tailored behavioral intervention for patients of a Federally Qualified Health Center who are recently diagnosed with COVID-19. The study is a pragmatic, quality improvement randomized controlled trial (RCT). This research is looking to enroll 256 index patients and their households. Index patients and their households will be invited to participate in the COVID Prevention Program, which includes free COVID-19 testing for exposed household members. Index patients will be randomized to one of two groups: (a) the Standard-of-Care comparison group who will receive established clinical care and follow-up, or (b) the Enhanced Standard-of-Care group, who will receive standard-of-care plus tailored, real-time mobile/virtual counseling delivered by promotores/as. The intervention will use theory- and evidence-based strategies for behavior change and maximize the use of mobile phone applications and technologies to capture real-time behavioral, social, and contextual data (via Ecological Momentary Assessment). The intervention will utilize motivational interviewing techniques to tailor strategies to index patients' home environment/context and social/emotional needs. The intervention will target immediate risk of household spread, followed by risk of community spread. The primary outcome assessed will be a new positive antibody test within a household (post-baseline), as assessed by a blood draw collected by a certified phlebotomist. Secondary research outcomes will be assessed via self-report surveys. Surveys will include socioeconomic status indicators and demographics, as well as measures of mental health (e.g., depression), physical health (chronic conditions), health behaviors (social distancing, hand washing & wearing face covering), as well as comorbidities and risk factors for severe COVID-19 outcomes. Primary and secondary outcomes will be measured at 5 timepoints: baseline, 6-weeks, 6-months, 12-months, and 24-months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Adult patients of a federally qualified health center (+18yrs)
  • Test positive for COVID-19

排除标准

  • Planning to move out of state in the next year
  • Cognitive impairment that is contraindicated to receiving counseling and following behavioral strategies (e.g., schizophrenia, Down syndrome)
  • Living in a transitionary home or homeless.

结局指标

主要结局

Number of households with SARS-CoV-2 Antibodies

时间窗: Baseline & 1-, 6-, 12-, and 24-months post-baseline.

Antibodies assessed by a blood draw collected by a certified phlebotomist. SARS-CoV-2 Nucleocapsid and Spike Protein IgG, used to accurately determine prior infection and/or vaccination.

次要结局

  • Number of households with SARS-CoV-2 Active Infection(Baseline, 3-5 days post-baseline, and 7-9 days post-baseline.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noe Crespo

Associate Professor

San Diego State University

研究点 (2)

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