A Nurse-Community Health Worker-Family Partnership Model: Addressing Uptake of COVID-19 Testing and Control Measures
Primary Purpose
COVID-19
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse-Community-Family Partnership Intervention
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring SARS-CoV-2, COVID-19, COVID-19 testing, Behavioral COVID-19 Mitigation Measures
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- New York University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nurse-Community Health Worker-Family Partnership
Standard of Care
Arm Description
The experimental arm will receive the Nurse-Community Health Worker-Family Partnership intervention
The control arm will receive standard access to NYC Department of Health COVID-19 testing sites and standard COVID-19 public health messaging
Outcomes
Primary Outcome Measures
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].
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].
Secondary Outcome Measures
COVID-19 Avoidant Behaviors Scale
An adapted version of the COVID-19 Avoidant Behaviors Scale (PhenX Toolkit) will be used to measure the secondary study outcome of COVID-19 control measure uptake. Respondents will be asked questions regarding their engagement in behaviors associated with COVID-19 exposure on a 5-point scale [Almost Never, Sometimes, a Moderate Amount of the Time, Most of the Time, Always]; with greater values indicating higher frequency of uptake of COVID-19 prevention behaviors in the past three months (e.g., "Had close contact (within 6 feet) with people who do not live with you. "Gone out to a bar, club, or other place where people gather) and questions regarding their uptake of COVID-19 control (e.g., "Worn a mask or other face covering." "Washed your hands with soap or used hand sanitizer several times per day").
Vaccine Uptake
Referral to COVID-19 and seasonal influenza vaccination services by study nurses to intervention group participants will be carefully documented by the investigative team. At the time of the delayed assessment, the investigators will obtain self-reported information and documentation of COVID-19 and influenza vaccine uptake by study participants in the treatment as usual control group. For self-reported information, respondents will be asked if they received the flu shot in the past three months [Yes/No] and whether they received the COVID-19 vaccine [Yes/No], the type of vaccine, and the number of doses.
COVID-19 Improved Household & Family Mutual Aid
A set of measures will assess families' abilities to adjust to the COVID-19 pandemic, as evidenced by the reported overall impact of COVID-19 on family dynamics and relationships, psychological distress, food and housing insecurity, substance use, and sexual behavior in the past three months.
COVID-19 Household Environment Scale
An adapted version of the COVID-19 Household Environment Scale will be used to measure the secondary study outcome household/family mutual aid. The scale measures household conflict/togetherness. Participants are asked to rate, on a 5-point Likert scale, how much more or less conflict there was (as compared to before COVID-19) about 15 topics in the past three months (e.g., "Home maintenance;" "Decisions about visitors to the home"), with higher values indicating greater frequency of family conflict concerning the topic.
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 six months [Yes/No].
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 six months [Check All That Apply], and the result of the participant's last COVID-19 test [Positive/Negative].
COVID-19 Avoidant Behaviors Scale
An adapted version of the COVID-19 Avoidant Behaviors Scale (PhenX Toolkit) will be used to measure the secondary study outcome of COVID-19 control measure uptake. Respondents will be asked questions regarding their engagement in behaviors associated with COVID-19 exposure on a 5-point scale [Almost Never, Sometimes, a Moderate Amount of the Time, Most of the Time, Always]; with greater values indicating higher frequency of uptake of COVID-19 prevention behaviors in the past six months (e.g., "Had close contact (within 6 feet) with people who do not live with you. "Gone out to a bar, club, or other place where people gather) and questions regarding their uptake of COVID-19 control (e.g., "Worn a mask or other face covering." "Washed your hands with soap or used hand sanitizer several times per day").
Vaccine Uptake
Referral to COVID-19 and seasonal influenza vaccination services by study nurses to intervention group participants will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information and documentation of COVID-19 and influenza vaccine uptake by study participants in the treatment as usual control group. For self-reported information, respondents will be asked if they received the flu shot in the past six months [Yes/No] and whether they received the COVID-19 vaccine [Yes/No], the type of vaccine, and the number of doses.
COVID-19 Improved Household & Family Mutual Aid
A set of measures will assess families' abilities to adjust to the COVID-19 pandemic, as evidenced by the reported overall impact of COVID-19 on family dynamics and relationships, psychological distress, food and housing insecurity, substance use, and sexual behavior in the past six months.
COVID-19 Household Environment Scale
An adapted version of the COVID-19 Household Environment Scale will be used to measure the secondary study outcome household/family mutual aid. The scale measures household conflict/togetherness. Participants are asked to rate, on a 5-point Likert scale, how much more or less conflict there was (as compared to before COVID-19) about 15 topics in the past six months (e.g., "Home maintenance;" "Decisions about visitors to the home"), with higher values indicating greater frequency of family conflict concerning the topic.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04832919
Brief Title
A Nurse-Community Health Worker-Family Partnership Model: Addressing Uptake of COVID-19 Testing and Control Measures
Official Title
A Nurse-Community Health Worker-Family Partnership Model to Increase COVID19 Testing in Urban Underserved and Vulnerable Communities
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 23, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, COVID-19, COVID-19 testing, Behavioral COVID-19 Mitigation Measures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
392 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse-Community Health Worker-Family Partnership
Arm Type
Experimental
Arm Description
The experimental arm will receive the Nurse-Community Health Worker-Family Partnership intervention
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
The control arm will receive standard access to NYC Department of Health COVID-19 testing sites and standard COVID-19 public health messaging
Intervention Type
Behavioral
Intervention Name(s)
Nurse-Community-Family Partnership Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Household COVID-19 Testing Uptake
Description
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].
Time Frame
Delayed Follow-Up (9 Months)
Title
COVID-19 Symptoms, Diagnoses, and Testing Scale
Description
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].
Time Frame
Delayed Follow-Up (9 Months)
Secondary Outcome Measure Information:
Title
COVID-19 Avoidant Behaviors Scale
Description
An adapted version of the COVID-19 Avoidant Behaviors Scale (PhenX Toolkit) will be used to measure the secondary study outcome of COVID-19 control measure uptake. Respondents will be asked questions regarding their engagement in behaviors associated with COVID-19 exposure on a 5-point scale [Almost Never, Sometimes, a Moderate Amount of the Time, Most of the Time, Always]; with greater values indicating higher frequency of uptake of COVID-19 prevention behaviors in the past three months (e.g., "Had close contact (within 6 feet) with people who do not live with you. "Gone out to a bar, club, or other place where people gather) and questions regarding their uptake of COVID-19 control (e.g., "Worn a mask or other face covering." "Washed your hands with soap or used hand sanitizer several times per day").
Time Frame
Delayed Follow-Up (9 Months)
Title
Vaccine Uptake
Description
Referral to COVID-19 and seasonal influenza vaccination services by study nurses to intervention group participants will be carefully documented by the investigative team. At the time of the delayed assessment, the investigators will obtain self-reported information and documentation of COVID-19 and influenza vaccine uptake by study participants in the treatment as usual control group. For self-reported information, respondents will be asked if they received the flu shot in the past three months [Yes/No] and whether they received the COVID-19 vaccine [Yes/No], the type of vaccine, and the number of doses.
Time Frame
Delayed follow up (9 months)
Title
COVID-19 Improved Household & Family Mutual Aid
Description
A set of measures will assess families' abilities to adjust to the COVID-19 pandemic, as evidenced by the reported overall impact of COVID-19 on family dynamics and relationships, psychological distress, food and housing insecurity, substance use, and sexual behavior in the past three months.
Time Frame
Delayed follow up (9 months)
Title
COVID-19 Household Environment Scale
Description
An adapted version of the COVID-19 Household Environment Scale will be used to measure the secondary study outcome household/family mutual aid. The scale measures household conflict/togetherness. Participants are asked to rate, on a 5-point Likert scale, how much more or less conflict there was (as compared to before COVID-19) about 15 topics in the past three months (e.g., "Home maintenance;" "Decisions about visitors to the home"), with higher values indicating greater frequency of family conflict concerning the topic.
Time Frame
Delayed follow up (9 months)
Title
Household COVID-19 Testing Uptake
Description
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 six months [Yes/No].
Time Frame
Immediate follow up (6 months)
Title
COVID-19 Symptoms, Diagnoses, and Testing Scale
Description
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 six months [Check All That Apply], and the result of the participant's last COVID-19 test [Positive/Negative].
Time Frame
Immediate follow up (6 months)
Title
COVID-19 Avoidant Behaviors Scale
Description
An adapted version of the COVID-19 Avoidant Behaviors Scale (PhenX Toolkit) will be used to measure the secondary study outcome of COVID-19 control measure uptake. Respondents will be asked questions regarding their engagement in behaviors associated with COVID-19 exposure on a 5-point scale [Almost Never, Sometimes, a Moderate Amount of the Time, Most of the Time, Always]; with greater values indicating higher frequency of uptake of COVID-19 prevention behaviors in the past six months (e.g., "Had close contact (within 6 feet) with people who do not live with you. "Gone out to a bar, club, or other place where people gather) and questions regarding their uptake of COVID-19 control (e.g., "Worn a mask or other face covering." "Washed your hands with soap or used hand sanitizer several times per day").
Time Frame
Immediate follow up (6 months)
Title
Vaccine Uptake
Description
Referral to COVID-19 and seasonal influenza vaccination services by study nurses to intervention group participants will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information and documentation of COVID-19 and influenza vaccine uptake by study participants in the treatment as usual control group. For self-reported information, respondents will be asked if they received the flu shot in the past six months [Yes/No] and whether they received the COVID-19 vaccine [Yes/No], the type of vaccine, and the number of doses.
Time Frame
Immediate follow up (6 months)
Title
COVID-19 Improved Household & Family Mutual Aid
Description
A set of measures will assess families' abilities to adjust to the COVID-19 pandemic, as evidenced by the reported overall impact of COVID-19 on family dynamics and relationships, psychological distress, food and housing insecurity, substance use, and sexual behavior in the past six months.
Time Frame
Immediate follow up (6 months)
Title
COVID-19 Household Environment Scale
Description
An adapted version of the COVID-19 Household Environment Scale will be used to measure the secondary study outcome household/family mutual aid. The scale measures household conflict/togetherness. Participants are asked to rate, on a 5-point Likert scale, how much more or less conflict there was (as compared to before COVID-19) about 15 topics in the past six months (e.g., "Home maintenance;" "Decisions about visitors to the home"), with higher values indicating greater frequency of family conflict concerning the topic.
Time Frame
Immediate follow up (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent M Guilamo-Ramos, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Holly Hagan, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The project team will make the data available beginning 3 months and ending 5 years following article publication.
IPD Sharing 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.
Learn more about this trial
A Nurse-Community Health Worker-Family Partnership Model: Addressing Uptake of COVID-19 Testing and Control Measures
We'll reach out to this number within 24 hrs