A Nurse-Community Health Worker-Family Partnership Model: Addressing Uptake of COVID-19 Testing and Control Measures
1 other identifier
interventional
392
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Jul 2021
Longer than P75 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2021
CompletedFirst Posted
Study publicly available on registry
April 6, 2021
CompletedStudy Start
First participant enrolled
July 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedDecember 15, 2022
July 1, 2022
1.7 years
April 2, 2021
December 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Household COVID-19 Testing Uptake
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 \[Yes/No\].
Delayed Follow-Up (9 Months)
COVID-19 Symptoms, Diagnoses, and Testing Scale
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 \[Positive/Negative\].
Delayed Follow-Up (9 Months)
Secondary Outcomes (10)
COVID-19 Avoidant Behaviors Scale
Delayed Follow-Up (9 Months)
Vaccine Uptake
Delayed follow up (9 months)
COVID-19 Improved Household & Family Mutual Aid
Delayed follow up (9 months)
COVID-19 Household Environment Scale
Delayed follow up (9 months)
Household COVID-19 Testing Uptake
Immediate follow up (6 months)
- +5 more secondary outcomes
Study Arms (2)
Nurse-Community Health Worker-Family Partnership
EXPERIMENTALThe experimental arm will receive the Nurse-Community Health Worker-Family Partnership intervention
Standard of Care
NO INTERVENTIONThe control arm will receive standard access to NYC Department of Health COVID-19 testing sites and standard COVID-19 public health messaging
Interventions
Nurses conduct home visits on a monthly basis for the first five months post-baseline. During visits, nurses emphasize the importance of infection control measures and, jointly with household members, develop and follow-up on the implementation of an infection control plan tailored to the unique circumstances of the household. Nurses deliver training on infection control skills necessary for optimal implementation of the plan. Nurses offer at-home SARS-CoV-2 testing to all members of the household. Nurses conduct triage, medical case management, monitoring, and follow-up of individuals identified to have COVID-19 or any other acute health emergencies. CHWs conduct visits on a bi-weekly basis for the first five months post-baseline. CHWs deliver healthcare information and medical mistrust counseling in a culturally relevant and linguistically appropriate fashion; and provide social support, navigate household members to social welfare/vocational/economic/psychosocial services.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University
New York, New York, 10003, United States
Related Publications (1)
Guilamo-Ramos V, Benzekri A, Williams D, Thimm-Kaiser M, Wizentier MM, Goodman M, Amezquita-Castro B, Hagan H. A nurse-led clinical practice model to increase healthcare reach among underserved families during public health emergencies: A randomized controlled trial. Nurs Outlook. 2025 Nov-Dec;73(6):102591. doi: 10.1016/j.outlook.2025.102591. Epub 2025 Nov 6.
PMID: 41202466DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent M Guilamo-Ramos, PhD
New York University
- PRINCIPAL INVESTIGATOR
Holly Hagan, PhD
New York University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2021
First Posted
April 6, 2021
Study Start
July 23, 2021
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
December 15, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The project team will make the data available beginning 3 months and ending 5 years following article publication.
- Access Criteria
- The project team will make the data available for investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
The project team will share all individual participant data that underlie the results reported in any future published manuscript, after deidentification (text, tables, figures, and appendices). We will make available the study protocol and statistical analysis plan. The project team will make the data available beginning 3 months and ending 5 years following article publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Investigators will be approved to conduct analyses to achieve the aims in the proposal that they submit for approval by an independent review committee. Proposals should be directed to Dr. Holly Hagan (hh50@nyu.edu). To gain access, data requesters will need to sign a data access agreement.