Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04568889
Other study ID # IRB20-1444
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2020
Est. completion date August 31, 2022

Study information

Verified date October 2022
Source Harvard University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this project is to help the state of Minnesota understand why individuals are not getting tested and potentially identify trusted individuals or organizations that could be used in follow-up work to send messages. Investigators focus on the first two issues of unit and item nonresponse, which is not random across the population and thus could lead to nonresponse bias. To do so, investigators are deploying flyers through 10 Twin City area food shelves and potentially through public housing units with information on how to answer an online questionnaire.


Description:

In the United States, recent statistics show that African American and Latinx communities bear a disproportionate burden from COVID-19. Reaching vulnerable and underserved populations is therefore crucial to combating the disease. However, most public messaging campaigns are not targeted toward underserved communities and don't address fears of social stigma, mistrust in the healthcare system, or concerns about immigration status. The goal of this project is to help the state of Minnesota understand why individuals are not getting tested and potentially identify trusted individuals or organizations that could be used in follow-up work to send messages. To do so, investigators are deploying flyers through 10 Twin City area food shelves and potentially through public housing units with information on how to answer an online questionnaire. This provides us with an opportunity to study who answers surveys and why - and what questions are particularly sensitive. This is of general interest to academicians and policymakers alike. The quality of household surveys is in decline, for three main reasons. First, households have become increasingly less likely to answer surveys at all (unit nonresponse). Second, those that respond are less likely to answer certain questions (item nonresponse). Third, when households do provide answers, they are less likely to be accurate (measurement error). This is important since household surveys help to estimate the employment rate, healthcare needs and of course the census determines resources/representation. Investigators focus on the first two issues of unit and item nonresponse, which is not random across the population and thus could lead to nonresponse bias. Census tracts with predominantly Hispanic or Black residents had significantly lower response rates to the American Community Survey as compared to the response rates in predominantly white tracts. Similarly, response rates to the Health Information National Trends Survey (HINTS) were lower in areas with higher levels of Hispanic and minority residents. Investigators hypothesize that financial incentives may encourage unit response; conversely, a close association with the government may discourage response. To test these hypotheses, investigators plan to cross-randomize the incentive amount offered and the emphasis placed on government involvement in the study on flyers advertising the baseline survey. Individuals will see either a) a 10 dollar incentive, or b) a 20 dollar incentive; and either a) messaging that emphasizes government involvement in the study, or b) messaging that emphasizes the involvement of academic researchers. Flyers will be randomized at the foodshelf-day level. To test what affects item non-response on potentially sensitive questions, such as questions which ask for health information, investigators hypothesize that ethical framing may encourage individuals to answer questions. This takes two forms --- the deontological (or duty based) frame, and the consequential (or cost-benefit) frame. Moreover, knowing others feel the same way (regarding the obligation or benefits of providing health information) may amplify motivation. Finally, there is the possibility that emphasizing the importance of ethnic and racial disadvantage associated with COVID-19 outcomes may be important for improving item non-response on sensitive questions. Upon completion of the demographic module of the survey but prior to starting several potentially sensitive survey modules, individuals will see a message that either a) emphasizes the public health benefits of answering the survey questions (cost-benefit frame); b) emphasizes an individual's responsibility to their community (duty frame); c) emphasizes the disproportionate impact of COVID-19 on certain ethnic and racial groups; or d) provides no messaging. Messaging content will be randomized at the individual level.


Recruitment information / eligibility

Status Completed
Enrollment 561
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All participants who are aged 18 or above and speak English or Spanish Exclusion Criteria: - Children, those who do not identify as above or adults who identify as above but do not agree to participate in survey during the consent stage.

Study Design


Intervention

Behavioral:
A $10 Survey Incentive
Individuals see a 10 dollar incentive on the flyers advertising the baseline survey.
A $20 Survey Incentive
Individuals see a 10 dollar incentive on the flyers advertising the baseline survey.
Emphasis of Government Involvement
Individuals see a message emphasizing the involvement of the government in the study,
Emphasis of Academic Researchers Involvement
Individuals see a message emphasizing the involvement of academic researchers in the study,
Cost-Benefit Frame
Individuals will see messaging that emphasizes the public health benefits of answering the survey questions in the baseline survey (cost-benefit frame).
Duty Frame
Individuals will see messaging that emphasizes an individual's responsibility to their community in the baseline survey (duty frame),
Racial/Ethnic Frame
Individuals will see messaging that emphasizes the disproportionate impact of COVID-19 on certain ethnic and racial groups in the baseline survey.
No Messaging
Individuals will see no messaging in the baseline survey.

Locations

Country Name City State
United States Volunteers Enlisted to Assist People Bloomington Minnesota
United States Southern Anoka Community Assistance Columbia Heights Minnesota
United States People Reaching Out to People Food Shelf Eden Prairie Minnesota
United States Fridley Covenant Church Fridley Minnesota
United States Calvary Lutheran Church Food Shelf Minneapolis Minnesota
United States Community Emergency Assistance Programs Minneapolis Minnesota
United States NorthPoint Health and Wellness Minneapolis Minnesota
United States Intercongregation Communities Association Minnetonka Minnesota
United States Valley Outreach Stillwater Minnesota
United States White Bear Area Foodshelf White Bear Lake Minnesota

Sponsors (3)

Lead Sponsor Collaborator
Harvard University Abdul Latif Jameel Poverty Action Lab, Government of Minnesota Office of Management and Budget

Country where clinical trial is conducted

United States, 

References & Publications (3)

Griffin, DH. Measuring survey nonresponse by race and ethnicity. In Proceedings of the Annual Meetings of the American Statistical Association. 2002; 11-15.

Maitland A, Lin A, Cantor D, Jones M, Moser RP, Hesse BW, Davis T, Blake KD. A Nonresponse Bias Analysis of the Health Information National Trends Survey (HINTS). J Health Commun. 2017 Jul;22(7):545-553. doi: 10.1080/10810730.2017.1324539. Epub 2017 May 30. — View Citation

Meyer, Bruce D., Wallace KC Mok, and James X. Sullivan. Household surveys in crisis. Journal of Economic Perspectives. 2015; 29(4): 199-226.

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of monetary incentives in increasing unit response 1 Number of participants who received a flyer that mentions a $20 incentive and completed the survey This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.
Primary Effect of monetary incentives in increasing unit response 2 Number of participants who received a flyer that mentions a $10 incentive and completed the survey. This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.
Primary Effect of a government frame in reducing unit response 1 Number of participants who received a flyer that mentions a government frame and completed the survey This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.
Primary Effect of a government frame in reducing unit response 2 Number of participants who received a flyer that mentions a research frame and completed the survey. This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.
Primary Interactions between monetary incentives and a government frame 1 Number of participants who received a flyer that mentions a government frame and $20 incentive and completed the survey This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.
Primary Interactions between monetary incentives and a government frame 2 Number of participants who received a flyer that mentions a government frame and $10 incentive and completed the survey This outcome will be assessed when the individual agrees to participate in the Baseline survey, which takes approximately 20 minutes.
Primary Interactions between monetary incentives and a government frame 3 Number of participants who received a flyer that mentions a researcher frame and $20 incentive and completed the survey This outcome will be assessed during the 20-minute Baseline Survey.
Primary Interactions between monetary incentives and a government frame 4 Number of participants who received a flyer that mentions a researcher frame and $10 incentive and completed the survey This outcome will be assessed during the 20-minute Baseline Survey.
Primary Demographic characteristics of participants assigned into each treatment arm Demographic characteristics (e.g. sex, education level, income level, race/ethnicity) of participants who are assigned to each treatment arm and completed the survey. This outcome will be assessed during the 20-minute Baseline Survey.
Primary Effect of various messaging frames in increasing item non-response Number of survey participants who are randomly assigned to receive each messaging frame that: a) emphasizes the public health benefits of answering the survey questions (cost-benefit frame); b) emphasizes an individual's responsibility to their community (duty frame); c) emphasizes the disproportionate impact of COVID-19 on certain ethnic and racial groups; or d) provides no messaging. This outcome will be assessed during the 20-minute Baseline Survey.
See also
  Status Clinical Trial Phase
Completed NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Completed NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed NCT04961541 - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine Phase 1/Phase 2
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Terminated NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Terminated NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Active, not recruiting NCT06042855 - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) Phase 3