Clinical trial NCT04765475: Protecting Native Families From COVID-19
Official title: Protecting Native Families From COVID-19 (PROTECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Prevention Measures
Symptom Tracking
Testing
Navajo Nation
White Mountain Apache Tribe
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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

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.

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.

Primary outcomes:
measure: TESTING: Proportion tested for COVID-19
timeFrame: Percent of participants tested for COVID-19 after three months of study enrollment.
measure: TESTING: Time to Test from Symptom Onset
timeFrame: 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
measure: CHANGE IN PROTECTIVE BEHAVIORS Over time - Recommended Practices
timeFrame: 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).
measure: PROTECTIVE BEHAVIORS - Days quarantined in the past month
timeFrame: The number of days quarantined per month (given quarantine was required/advised) over the 3-month enrollment period.
measure: PROTECTIVE BEHAVIORS - Vaccine Acceptance
timeFrame: Baseline and 3 months only
Secondary outcomes:
measure: Cultural Identity and Connectedness
timeFrame: Baseline and 3 months only
measure: Substance Use
timeFrame: Baseline and 3 months only
measure: Depression
timeFrame: Baseline and 3 months only
measure: Anxiety
timeFrame: Baseline and 3 months only
measure: Demographic
timeFrame: Baseline and 3 months only
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: Johns Hopkins Center for American Indian Health Whiteriver Office
state: Arizona
Study officials:
affiliation: Johns Hopkins University
name: Allison Barlow, PhD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Mary Cwik, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Laura Hammitt, MD
role: PRINCIPAL_INVESTIGATOR
References: