Clinical trial NCT04832919: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: SARS-CoV-2
COVID-19
COVID-19 testing
Behavioral COVID-19 Mitigation Measures
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 392
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Household COVID-19 Testing Uptake
timeFrame: Delayed Follow-Up (9 Months)
measure: COVID-19 Symptoms, Diagnoses, and Testing Scale
timeFrame: Delayed Follow-Up (9 Months)
Secondary outcomes:
measure: COVID-19 Avoidant Behaviors Scale
timeFrame: Delayed Follow-Up (9 Months)
measure: Vaccine Uptake
timeFrame: Delayed follow up (9 months)
measure: COVID-19 Improved Household & Family Mutual Aid
timeFrame: Delayed follow up (9 months)
measure: COVID-19 Household Environment Scale
timeFrame: Delayed follow up (9 months)
measure: Household COVID-19 Testing Uptake
timeFrame: Immediate follow up (6 months)
measure: COVID-19 Symptoms, Diagnoses, and Testing Scale
timeFrame: Immediate follow up (6 months)
measure: COVID-19 Avoidant Behaviors Scale
timeFrame: Immediate follow up (6 months)
measure: Vaccine Uptake
timeFrame: Immediate follow up (6 months)
measure: COVID-19 Improved Household & Family Mutual Aid
timeFrame: Immediate follow up (6 months)
measure: COVID-19 Household Environment Scale
timeFrame: Immediate follow up (6 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: New York University
name: Vincent M Guilamo-Ramos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Holly Hagan, PhD
role: PRINCIPAL_INVESTIGATOR
References: