Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04832919
Status:
UNKNOWN
Last Update Posted:
2022-12-15
First Post:
2021-04-02
Brief Title:
A Nurse-Community Health Worker-Family Partnership Model Addressing Uptake of COVID-19 Testing and Control Measures
Sponsor:
New York University
Organization:
New York University
Study Overview
Official Title:
A Nurse-Community Health Worker-Family Partnership Model to Increase COVID19 Testing in Urban Underserved and Vulnerable Communities
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 21 ratio interventioncontrol 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None