Protecting Native Families From COVID-19

NCT04765475 | Completed DMC

• 1 other identifier: IRB00014147
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; Prevention Measures; Symptom Tracking; Testing; Navajo Nation; White Mountain Apache Tribe

Outcome Measures

Primary Outcomes (5)

• 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.

  Percent of participants tested for COVID-19 after three months of study enrollment.

• 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.

  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

• 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.

  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).

• 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.

  The number of days quarantined per month (given quarantine was required/advised) over the 3-month enrollment period.

• 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.

  Baseline and 3 months only

Secondary Outcomes (5)

• Cultural Identity and Connectedness

  Baseline and 3 months only

• Substance Use

  Baseline and 3 months only

• Depression

  Baseline and 3 months only

• Anxiety

  Baseline and 3 months only

• Demographic

  Baseline and 3 months only

Study Arms (4)

MotivationaI Interviewing Group

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing; Other: Supportive Services

COVID-19 Symptom Monitoring System Group

EXPERIMENTAL

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.

Behavioral: COVID-19 Symptom Monitoring System; Other: Supportive Services

MotivationaI Interviewing and COVID-19 Symptom Monitoring System Group

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing and COVID-19 Symptom Monitoring System; Other: Supportive Services

Control Group

OTHER

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

Other: Supportive Services

Interventions

Motivational Interviewing BEHAVIORAL

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).

MotivationaI Interviewing Group

COVID-19 Symptom Monitoring System BEHAVIORAL

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.

COVID-19 Symptom Monitoring System Group

Motivational Interviewing and COVID-19 Symptom Monitoring System BEHAVIORAL

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

MotivationaI Interviewing and COVID-19 Symptom Monitoring System Group

Supportive Services OTHER

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.

COVID-19 Symptom Monitoring System Group; Control Group; MotivationaI Interviewing Group; MotivationaI Interviewing and COVID-19 Symptom Monitoring System Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Johns Hopkins Center for American Indian Health Whiteriver Office

Whiteriver, Arizona, 85491, United States

Location

Related Publications (1)

• Oguntade HA, Grubin F, Foster H, Tessay R, Neault N, Mitchell K, Masten K, Sundbo A, Rosenstock S, Sutcliffe CG, Hammitt LL, Barlow A, Cwik M. Protecting Native Families from COVID-19: Implementation and Lessons Learned from a Community-Based Approach to Collecting Evidence to Support Uptake of Health Behaviors During the COVID-19 Pandemic. J Racial Ethn Health Disparities. 2025 Aug 22. doi: 10.1007/s40615-025-02598-0. Online ahead of print.

  PMID: 40844569 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Allison Barlow, PhD, MPH, MA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Mary Cwik, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Laura Hammitt, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Research Program Assistants (responsible for collecting assessments) will be blinded to participant status as they will be functioning as independent evaluators.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 21, 2021
• Study Start: March 8, 2021
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)