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Protecting Native Families From COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
COVID-19 Symptom Monitoring System
Motivational Interviewing and COVID-19 Symptom Monitoring System
Supportive Services
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Prevention Measures, Symptom Tracking, Testing, Navajo Nation, White Mountain Apache Tribe

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Tribal members who live within an approximately 1-hour radius of the Indian Health Service (IHS) /Tribal health facility within each of the three participating sites (Whiteriver, Arizona; Chinle, Arizona; Shiprock, New Mexico).
  • Elder participants must be ≥65 years old at the time of recruitment.
  • Young adults must be 18-34 years old with self-reported alcohol or drug use in the past 6 months.
  • Have access to a cell phone or reliable access to a family member's cell phone and be able to send/receive text messages.
  • Consent to participate in all study activities.

Exclusion Criteria:

  • History of COVID19 infection.
  • Inability to cognitively complete interventions and assessments.

Sites / Locations

  • Johns Hopkins Center for American Indian Health Whiteriver Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

MotivationaI Interviewing Group

COVID-19 Symptom Monitoring System Group

MotivationaI Interviewing and COVID-19 Symptom Monitoring System Group

Control Group

Arm Description

Participants in this study group will receive a brief, culturally appropriate, and age-tailored motivational interviewing (MI) intervention targeting facilitators and barriers to appropriate testing, isolation, and care-seeking among young adults and elders. This group will also receive supportive services. Participants will be provided with referrals to needed medical, mental, or behavioral health care and a hygiene kit containing basic hygiene supplies. Additionally, participants will be provided with information on COVID-19 and nearby testing locations. This will include basic information about COVID-19, mask-wearing, how to prevent the spread in the home and managing stress during COVID-19.

Participants in this study group will receive daily COVID-19 symptom (CS) text-based monitoring system to prompt more rapid testing at the onset of symptoms. This group will also receive supportive services. Participants will be provided with referrals to needed medical, mental or behavioral health care and a hygiene kit containing basic hygiene supplies. Additionally, participants will be provided with information on COVID-19 and nearby testing locations. This will include basic information about COVID-19, mask-wearing, how to prevent the spread in the home and managing stress during COVID-19.

Participants in this group will receive both motivational interviewing and daily COVID-19 symptom (CS) text-based monitoring system. This group will also receive supportive services. Participants will be provided with referrals to needed medical, mental or behavioral health care and a hygiene kit containing basic hygiene supplies. Additionally, participants will be provided with information on COVID-19 and nearby testing locations. This will include basic information about COVID-19, mask-wearing, how to prevent the spread in the home and managing stress during COVID-19.

Participants in this group will only receive supportive services. Participants will be provided with referrals to needed medical, mental or behavioral health care and a hygiene kit containing basic hygiene supplies. Additionally, participants will be provided with information on COVID-19 and nearby testing locations. This will include basic information about COVID-19, mask wearing, how to prevent the spread in the home and managing stress during COVID-19

Outcomes

Primary Outcome Measures

TESTING: Proportion tested for COVID-19
Testing status will be assessed using Case Manager, Twilio (CS Group), iCare and State Notifiable Disease Surveillance. This outcome will be reported as a percentage.
TESTING: Time to Test from Symptom Onset
Time to Test from Symptom Onset will be assessed by collecting information on date of testing and date of first symptom onset. The amount of time (measured in days) between testing and first symptom onset will be calculated.
CHANGE IN PROTECTIVE BEHAVIORS Over time - Recommended Practices
COVID-19 Recommended Practices (i.e. social distancing, mask wearing, etc.) will be assessed with a self-report checklist. Participants will be asked how often they have practiced recommended behaviors to prevent the spread of COVID-19 using a Likert Scale: 1 (not at all) to 5 (very often). A higher score equals a better outcome.
PROTECTIVE BEHAVIORS - Days quarantined in the past month
In the past month, days quarantined or isolated will be assessed by showing participants a calendar tool which asks them to recall over the past 30-days which days they were quarantining. If participants answer "yes" to quarantining in the past month, they will be asked to mark each day they spent quarantining or social distancing from others on a calendar tool.
PROTECTIVE BEHAVIORS - Vaccine Acceptance
Potential vaccine acceptance will be assessed with vaccine acceptance questionnaire. Participants will be asked of their opinion about the effectiveness of recommended practices to stop the spread of COVID-19. Averaging 10 items; each marked on scale of 1 (Not effective at all) to 5 (Very effective). Participants will also be asked how much they trust and use (in the last one week) a list of sources for COVID-19 information. Averaging 10 items; each marked on scale of 1 (Not at all) to 5 (Completely). Participants will also be asked a series of questions of their experiences with receiving vaccinations, perceived benefits of vaccinations and perceptions or concerns about the potential COVID-19 vaccine.

Secondary Outcome Measures

Cultural Identity and Connectedness
The Enculturation and Discrimination scale is a 27-item scale assessing self-reported cultural identity, connectedness and perceived discrimination. Items assessing cultural identity are marked on scale of 1 (Strongly Agree) to 5 (Strongly Disagree). Items assessing perceived discrimination are marked on scale of 1 (Never) to 5 (Many times).
Substance Use
The World Health Organization's (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) will be used to assess alcohol and substance use among participants. Scores range from 0 to 27+. Higher score is a worse outcome. Alcohol: Total score of 0-10 Low Risk/No intervention Total score of 11-26 Moderate Risk/Brief Intervention Total score of +27 High Risk/More intensive treatment Other Drugs: Total score of 0-3 Low Risk/No intervention Total score of 4-26 Moderate Risk/Brief Intervention Total score of +27 High Risk/More intensive treatment
Depression
The Center for Epidemiologic Studies Depression Scale (CES-D10) will be used to assess depression. The CES-D10 is a 10-item Likert scale questionnaire assessing depressive symptoms in the past week. The CES-D10 demonstrates strong validity in American Indian communities. Participants will answer "Yes" or "No" to each item on the scale. Higher score suggest greater severity of symptoms.
Anxiety
The PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress Anxiety Short Form will be used to assess symptoms of generalized anxiety disorder. Scores range from 1 to 4. Higher score connotes a worse outcome (i.e. more depression or anxiety). Averaging 10 items each scored on scale of 1 (not at all) to 4 (extremely).
Demographic
Age, gender, and household composition will be assessed with a demographics questionnaire.

Full Information

First Posted
January 29, 2021
Last Updated
July 15, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT04765475
Brief Title
Protecting Native Families From COVID-19
Official Title
Protecting Native Families From COVID-19 (PROTECT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
November 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to increase and hasten testing among those with COVID-19 symptoms and improve adherence to recommended strategies following positive test results in high-risk groups in the White Mountain Apache and Navajo Nation communities.
Detailed Description
As of late July 2020, the novel coronavirus, SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), continues to spread globally. Although knowledge about the pathogenesis, epidemiology and clinical aspects of the virus is improving every week, evidence-based interventions that promote testing, quarantine, isolation, symptom monitoring and care-seeking still elude us. Rigorously collected data about how to overcome barriers and promote testing, the cornerstone of our public health response, and the constellation of necessary preventive behaviors linked to testing is urgently needed to prevent the spread and toll of COVID-19. Study investigators will work with long-term Navajo Nation (NN) and White Mountain Apache Tribe (WMAT) partners to answer COVID-19 research questions foundational to the effectiveness of testing through evaluation of community-based evidence-informed interventions targeting enhanced symptom tracking and monitoring, uptake of rapid testing after symptom onset, care-seeking, and preventive behaviors. The first case of COVID-19 was detected on Navajo Nation on March 17, 2020. As of August 2020, over 8,500 cases and 400 deaths have occurred among a population of ~206,000 (4,126 per 100,000). On the Fort Apache Reservation (WMAT), cases have been steadily increasing since the first documented illness on April 1. More than 2,200 cases and 32 deaths have occurred among a population of ~17,000 (12,353 per 100,000) (as of August 2020). Per capita, these disease rates are among the highest in the US. These communities also suffer some of the highest rates of underlying conditions (obesity, heart disease and diabetes), putting them at increased risk for severe COVID disease, complications and mortality. Infectious diseases have been a threat to Indigenous peoples since the Europeans arrived. Historical records show that smallpox, cholera, scarlet fever, influenza and tuberculosis took more Indigenous lives than wars, enslavement, and starvation combined. Intentional germ warfare by federal officials to decrease American Indian and Alaska Native populations is a dark page in US history and a traumatizing memory for American Indian and Alaska Natives. The current pandemic is a profound reminder of endured injustice, simultaneously inciting trauma and tribal resilience to survive and thrive anew. In past respiratory viral pandemics, American Indian and Alaska Natives experienced more severe illness, with 4-5 times higher death rates vs. general US population. With COVID-19, there has been greater recognition of the social determinants that underlie these persistent health disparities. A number of factors including poverty, lack of running water, and sub-standard, overcrowded federal housing shared by multi-generational families contribute to increased risk. On Navajo Nation, between 30-40% of households lack running water. Up to one-third of Navajo Nation and White Mountain Apache Tribe homes lack reliable electricity, internet and cell phone infrastructure. Underlying conditions, driven by food and water insecurity, environmental toxins, and over a century of inadequate access to health services, exacerbate the susceptibility to and severity of COVID-19. Further, the acute psychosocial stress caused by the pandemic is leading to an increase in already disproportionate mental and behavioral health conditions, including substance abuse, depression, and anxiety, that contributes to more spread (through more sharing of substances), more avoidance or stigma related to testing positive, and ongoing cycles of greater fear and despair. Interventions designed for this project seek to address both physical and psychosocial effects of COVID-19. This study will conduct research to understand how to expand and hasten testing when a person has symptoms or exposure, and preventive behaviors, isolation and care-seeking when positive, among elders, ages >65 and young adults ages 18-34 years who have used alcohol or drugs in the past 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Prevention Measures, Symptom Tracking, Testing, Navajo Nation, White Mountain Apache Tribe

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Study investigators will employ a 2x2 factorial design to evaluate the relative merits of a brief culturally-tailored motivational interviewing (MI) intervention and an m-health intervention (COVID-19 daily symptom text messaging system-CS) among two high-risk and inter-related age groups-young adults and elders-on preventive behaviors, promoting rapid COVID-19 testing after symptom onset, and isolation and appropriate care-seeking among those who test positive.
Masking
Investigator
Masking Description
The Research Program Assistants (responsible for collecting assessments) will be blinded to participant status as they will be functioning as independent evaluators.
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MotivationaI Interviewing Group
Arm Type
Experimental
Arm Description
Participants in this study group will receive a brief, culturally appropriate, and age-tailored motivational interviewing (MI) intervention targeting facilitators and barriers to appropriate testing, isolation, and care-seeking among young adults and elders. This group will also receive supportive services. Participants will be provided with referrals to needed medical, mental, or behavioral health care and a hygiene kit containing basic hygiene supplies. Additionally, participants will be provided with information on COVID-19 and nearby testing locations. This will include basic information about COVID-19, mask-wearing, how to prevent the spread in the home and managing stress during COVID-19.
Arm Title
COVID-19 Symptom Monitoring System Group
Arm Type
Experimental
Arm Description
Participants in this study group will receive daily COVID-19 symptom (CS) text-based monitoring system to prompt more rapid testing at the onset of symptoms. This group will also receive supportive services. Participants will be provided with referrals to needed medical, mental or behavioral health care and a hygiene kit containing basic hygiene supplies. Additionally, participants will be provided with information on COVID-19 and nearby testing locations. This will include basic information about COVID-19, mask-wearing, how to prevent the spread in the home and managing stress during COVID-19.
Arm Title
MotivationaI Interviewing and COVID-19 Symptom Monitoring System Group
Arm Type
Experimental
Arm Description
Participants in this group will receive both motivational interviewing and daily COVID-19 symptom (CS) text-based monitoring system. This group will also receive supportive services. Participants will be provided with referrals to needed medical, mental or behavioral health care and a hygiene kit containing basic hygiene supplies. Additionally, participants will be provided with information on COVID-19 and nearby testing locations. This will include basic information about COVID-19, mask-wearing, how to prevent the spread in the home and managing stress during COVID-19.
Arm Title
Control Group
Arm Type
Other
Arm Description
Participants in this group will only receive supportive services. Participants will be provided with referrals to needed medical, mental or behavioral health care and a hygiene kit containing basic hygiene supplies. Additionally, participants will be provided with information on COVID-19 and nearby testing locations. This will include basic information about COVID-19, mask wearing, how to prevent the spread in the home and managing stress during COVID-19
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
A culturally-tailored brief motivational interviewing (MI) intervention to promote preventive behaviors and COVID-19 testing when experiencing symptoms, and isolation and care-seeking when positive among two important high-risk groups in American Indian and Alaska Native communities-ages 18-34 and elders (ages ≥65 years).
Intervention Type
Behavioral
Intervention Name(s)
COVID-19 Symptom Monitoring System
Intervention Description
A daily COVID-19 symptoms (CS) monitoring system with alerts, ways for participants to request home testing after first symptoms, and Geographic Information System (GIS) routing for those responding to alerts.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing and COVID-19 Symptom Monitoring System
Intervention Description
A combination of: 1) a culturally-tailored brief motivational interviewing (MI) intervention to promote preventive behaviors and COVID-19 testing when experiencing symptoms, and isolation and care-seeking when positive among two important high-risk groups in American Indian and Alaska Native communities-ages 18-34 and elders (ages ≥65 years); 2) a daily COVID-19 symptoms (CS) monitoring system with alerts, ways for participants to request home testing after first symptoms, and Geographic Information System (GIS) routing for those responding to alerts
Intervention Type
Other
Intervention Name(s)
Supportive Services
Intervention Description
Provision of supportive services such as referrals to needed medical, mental or behavioral health care and delivery of a hygiene kit containing basic hygiene supplies. Participants will also be provided information on COVID-19 and nearby testing locations and basic information about COVID-19, mask wearing, how to prevent the spread in the home and managing stress during COVID-19.
Primary Outcome Measure Information:
Title
TESTING: Proportion tested for COVID-19
Description
Testing status will be assessed using Case Manager, Twilio (CS Group), iCare and State Notifiable Disease Surveillance. This outcome will be reported as a percentage.
Time Frame
Percent of participants tested for COVID-19 after three months of study enrollment.
Title
TESTING: Time to Test from Symptom Onset
Description
Time to Test from Symptom Onset will be assessed by collecting information on date of testing and date of first symptom onset. The amount of time (measured in days) between testing and first symptom onset will be calculated.
Time Frame
The number of days between symptom onset and a COVID-19 test will be calculated for anyone who reports symptoms and or has a COVID-19 test over the course of the three-month study enrollment period
Title
CHANGE IN PROTECTIVE BEHAVIORS Over time - Recommended Practices
Description
COVID-19 Recommended Practices (i.e. social distancing, mask wearing, etc.) will be assessed with a self-report checklist. Participants will be asked how often they have practiced recommended behaviors to prevent the spread of COVID-19 using a Likert Scale: 1 (not at all) to 5 (very often). A higher score equals a better outcome.
Time Frame
Change from baseline at 3-month post enrollment. (Longitudinal data analysis will be used incorporating data collected at baseline, 1-month, 2-month and 3-month post enrollment. Analyses will examine change from baseline at each of these timepoints).
Title
PROTECTIVE BEHAVIORS - Days quarantined in the past month
Description
In the past month, days quarantined or isolated will be assessed by showing participants a calendar tool which asks them to recall over the past 30-days which days they were quarantining. If participants answer "yes" to quarantining in the past month, they will be asked to mark each day they spent quarantining or social distancing from others on a calendar tool.
Time Frame
The number of days quarantined per month (given quarantine was required/advised) over the 3-month enrollment period.
Title
PROTECTIVE BEHAVIORS - Vaccine Acceptance
Description
Potential vaccine acceptance will be assessed with vaccine acceptance questionnaire. Participants will be asked of their opinion about the effectiveness of recommended practices to stop the spread of COVID-19. Averaging 10 items; each marked on scale of 1 (Not effective at all) to 5 (Very effective). Participants will also be asked how much they trust and use (in the last one week) a list of sources for COVID-19 information. Averaging 10 items; each marked on scale of 1 (Not at all) to 5 (Completely). Participants will also be asked a series of questions of their experiences with receiving vaccinations, perceived benefits of vaccinations and perceptions or concerns about the potential COVID-19 vaccine.
Time Frame
Baseline and 3 months only
Secondary Outcome Measure Information:
Title
Cultural Identity and Connectedness
Description
The Enculturation and Discrimination scale is a 27-item scale assessing self-reported cultural identity, connectedness and perceived discrimination. Items assessing cultural identity are marked on scale of 1 (Strongly Agree) to 5 (Strongly Disagree). Items assessing perceived discrimination are marked on scale of 1 (Never) to 5 (Many times).
Time Frame
Baseline and 3 months only
Title
Substance Use
Description
The World Health Organization's (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) will be used to assess alcohol and substance use among participants. Scores range from 0 to 27+. Higher score is a worse outcome. Alcohol: Total score of 0-10 Low Risk/No intervention Total score of 11-26 Moderate Risk/Brief Intervention Total score of +27 High Risk/More intensive treatment Other Drugs: Total score of 0-3 Low Risk/No intervention Total score of 4-26 Moderate Risk/Brief Intervention Total score of +27 High Risk/More intensive treatment
Time Frame
Baseline and 3 months only
Title
Depression
Description
The Center for Epidemiologic Studies Depression Scale (CES-D10) will be used to assess depression. The CES-D10 is a 10-item Likert scale questionnaire assessing depressive symptoms in the past week. The CES-D10 demonstrates strong validity in American Indian communities. Participants will answer "Yes" or "No" to each item on the scale. Higher score suggest greater severity of symptoms.
Time Frame
Baseline and 3 months only
Title
Anxiety
Description
The PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress Anxiety Short Form will be used to assess symptoms of generalized anxiety disorder. Scores range from 1 to 4. Higher score connotes a worse outcome (i.e. more depression or anxiety). Averaging 10 items each scored on scale of 1 (not at all) to 4 (extremely).
Time Frame
Baseline and 3 months only
Title
Demographic
Description
Age, gender, and household composition will be assessed with a demographics questionnaire.
Time Frame
Baseline and 3 months only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Tribal members who live within an approximately 1-hour radius of the Indian Health Service (IHS) /Tribal health facility within each of the three participating sites (Whiteriver, Arizona; Chinle, Arizona; Shiprock, New Mexico). Elder participants must be ≥65 years old at the time of recruitment. Young adults must be 18-34 years old with self-reported alcohol or drug use in the past 6 months. Have access to a cell phone or reliable access to a family member's cell phone and be able to send/receive text messages. Consent to participate in all study activities. Exclusion Criteria: History of COVID19 infection. Inability to cognitively complete interventions and assessments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Barlow, PhD, MPH, MA
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Cwik, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Hammitt, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Center for American Indian Health Whiteriver Office
City
Whiteriver
State/Province
Arizona
ZIP/Postal Code
85491
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Investigators only plan to share de-identified participant data with approved researchers.

Learn more about this trial

Protecting Native Families From COVID-19

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