A Nurse-Community Health Worker-Family Partnership Model to Increase COVID19 Testing in Urban Underserved and Vulnerable Communities
试验速览
- 阶段
- 不适用
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- COVID-19 Symptoms, Diagnoses, and Testing Scale
研究概览
简要总结
Historically, health disparities in the US are concentrated among underserved communities and socially vulnerable populations. The disproportionate COVID-19 related morbidity and mortality in communities of color and socioeconomic disadvantage acutely highlight this persistent public health problem, drawing attention to the urgent need for more equitable reach of testing, prevention, and control measures. The proposed research addresses this need using a 2-arm randomized controlled trial (RCT) that will evaluate the effectiveness of the Nurse-Community Health Worker (CHW)-Family Partnership intervention in promoting COVID-19 testing uptake, adoption of COVID control measures, and mutual aid capacity at the household level in an underserved and vulnerable population disproportionately affected by COVID-19. Enrolled households will be randomly assigned to either the intervention group where families will receive the Nurse-CHW-Family Partnership intervention including the offer of in-home testing and referral to seasonal influenza vaccination services, or the treatment-as-usual control group, which will be used to measure actual testing rates among public housing residents in relation to participant and household characteristics. The study hypothesis is that the Nurse-CHW-Family Partnership intervention will improve household-level COVID-19 testing uptake, adoption of COVID control measures, and mutual aid capacity relative to the treatment-as-usual control.
详细描述
The investigators will recruit and follow a randomly-chosen sample of NYCHA public housing residents in the proposed target community who meet multiple criteria for being considered vulnerable or underserved. The current study will address knowledge gaps regarding COVID-19 testing, treatment, and household prevention strategies, and generate new knowledge related to the epidemiology of COVID-19 in these communities. Working with community partners, the investigators will create an acceptable and feasible intervention and testing infrastructure in advance of the influenza season, with a view toward designing best practices for sustainable COVID-19 testing, prevention, and preparedness for vaccination trials. The investigators will implement a 2-arm RCT that will evaluate the effectiveness of the Nurse-CHW-Family Partnership Intervention in promoting COVID testing uptake, adoption of COVID control measures, and household mutual aid capacity. The investigators will recruit members of randomly selected households in their homes using area sampling methods used with excellent results in the investigators' previous research in the target community. Participants will complete a baseline assessment and the entire household will be randomized to either the experimental or a treatment-as-usual control condition, which will be used to measure actual testing rates among public housing residents in relation to participant and household characteristics. The baseline sample will include 150 households, and 400 individual household members, randomized in a 2:1 ratio, intervention:control. Families will complete follow-up assessments at 6 and 9 months following the baseline. In-home testing and referral to seasonal influenza vaccination services will be offered to the intervention group; whereas the control group will receive treatment as usual at multiple NYC Department of Health COVID-19 testing sites that are within walking distance of each of the three housing complexes. Test acceptance will be recorded, and incentives will be paid for study visits, not for testing.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residence in one of the public housing complexes in Mott Haven, South Bronx
- •English or Spanish-speaking
- •Age 10 years or older
- •Willing and able to provide informed consent or assent
排除标准
- •Non-resident of one of the public housing complexes in Mott Haven, South Bronx
- •Neither English nor Spanish speaker
- •Younger than 10 years old, unless household index case tests antigen positive. In this instance, all members of family will be included.
- •Unwilling or unable to provide informed consent or assent
结局指标
主要结局
COVID-19 Symptoms, Diagnoses, and Testing Scale
时间窗: Delayed Follow-Up (9 Months)
An adapted version of the (PhenX Toolkit) COVID-19 Symptoms, Diagnoses, and Testing Scale will be used to measure COVID-19 symptoms, diagnoses, and testing. Participants will be asked questions regarding whether they are currently sick with an illness that might be related to COVID-19, any symptoms the participant experienced in the past three months \[Check All That Apply\], and the result of the participant's last COVID-19 test \[Positive/Negative\].
Household COVID-19 Testing Uptake
时间窗: Delayed Follow-Up (9 Months)
All medical services delivered by nurses during home-visits (such as COVID-19 test administration) will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information regarding COVID-19 testing uptake by study participants in the treatment and control groups. Respondents will be asked whether they have received COVID-19 testing in the past three months \[Yes/No\].
次要结局
- COVID-19 Improved Household & Family Mutual Aid(Immediate follow up (6 months))
- Vaccine Uptake(Immediate follow up (6 months))
- COVID-19 Household Environment Scale(Immediate follow up (6 months))
- COVID-19 Avoidant Behaviors Scale(Immediate follow up (6 months))
- Household COVID-19 Testing Uptake(Immediate follow up (6 months))
- COVID-19 Symptoms, Diagnoses, and Testing Scale(Immediate follow up (6 months))