Trials / Unknown
UnknownNCT04832919
A Nurse-Community Health Worker-Family Partnership Model: Addressing Uptake of COVID-19 Testing and Control Measures
A Nurse-Community Health Worker-Family Partnership Model to Increase COVID19 Testing in Urban Underserved and Vulnerable Communities
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 392 (actual)
- Sponsor
- New York University · Academic / Other
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Nurse-Community-Family Partnership Intervention | 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. |
Timeline
- Start date
- 2021-07-23
- Primary completion
- 2023-04-01
- Completion
- 2023-04-01
- First posted
- 2021-04-06
- Last updated
- 2022-12-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04832919. Inclusion in this directory is not an endorsement.