Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Intervention 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.
Primary Purpose
Prevention
Masking
Single (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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MotivationaI Interviewing Group
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
    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).
  • Other: Supportive Services
    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.
Experimental
COVID-19 Symptom Monitoring System Group
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
    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.
  • Behavioral: Motivational Interviewing and COVID-19 Symptom Monitoring System
    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
  • Other: Supportive Services
    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.
Experimental
MotivationaI Interviewing and COVID-19 Symptom Monitoring System Group
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
    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
  • Other: Supportive Services
    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.
Other
Control Group
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
    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.

Recruiting Locations

More Details

NCT ID
NCT04765475
Status
Completed
Sponsor
Johns Hopkins Bloomberg School of Public Health

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.