COVID-19NCT04765475
Protecting Native Families From COVID-19
A study testing Motivational Interviewing, COVID-19 Symptom Monitoring System and Motivational Interviewing and COVID-19 Symptom Monitoring System in people with COVID-19, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Motivational Interviewing, COVID-19 Symptom Monitoring System and Motivational Interviewing and COVID-19 Symptom Monitoring System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 18 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of COVID19 infection.
- Inability to cognitively complete interventions and assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Center for American Indian Health Whiteriver Office
Whiteriver, Arizona, 85491
About this study
Official title: Protecting Native Families From COVID-19 (PROTECT)
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Motivational Interviewing, COVID-19 Symptom Monitoring System, Motivational Interviewing and COVID-19 Symptom Monitoring System, Supportive Services
- Keywords
- COVID-19, Prevention Measures, Symptom Tracking, Testing, Navajo Nation, White Mountain Apache Tribe
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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).
COVID-19 Symptom Monitoring SystemBehavioural
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.
Motivational Interviewing and COVID-19 Symptom Monitoring SystemBehavioural
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
Supportive ServicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Other: Supportive Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months only
Secondary outcomes (5)
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).
Measured: Baseline and 3 months only
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
Measured: Baseline and 3 months only
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.
Measured: Baseline and 3 months only
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).
Measured: Baseline and 3 months only
Demographic
Age, gender, and household composition will be assessed with a demographics questionnaire.
Measured: Baseline and 3 months only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start8 Mar 2021
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Barlow, PhD, MPH, MA, Principal investigator, Johns Hopkins UniversityMary Cwik, PhD, Principal investigator, Johns Hopkins UniversityLaura Hammitt, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765475
- Sponsor's protocol ID
- IRB00014147
- Status last verified
- Jul 2022
- First submitted
- 29 Jan 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators only plan to share de-identified participant data with approved researchers.
Publications
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.
PubMed 40844569
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting Native Families From COVID-19 (PROTECT)
- ClinicalTrials.gov ID
- NCT04765475
- Acronym / sponsor ID
- IRB00014147
- Conditions
- COVID-19
- Keywords
- COVID-19, Prevention Measures, Symptom Tracking, Testing, Navajo Nation, White Mountain Apache Tribe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| MotivationaI Interviewing Group | Experimental | Behavioral: Motivational Interviewing, Other: Supportive ServicesParticipants 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. |
| COVID-19 Symptom Monitoring System Group | Experimental | Behavioral: COVID-19 Symptom Monitoring System, Other: Supportive ServicesParticipants 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. |
| MotivationaI Interviewing and COVID-19 Symptom Monitoring System Group | Experimental | Behavioral: Motivational Interviewing and COVID-19 Symptom Monitoring System, Other: Supportive ServicesParticipants 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. |
| Control Group | Other | Other: Supportive ServicesParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- History of COVID19 infection.
- Inability to cognitively complete interventions and assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingA 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). | Behavioural | MotivationaI Interviewing Group |
| COVID-19 Symptom Monitoring SystemA 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. | Behavioural | COVID-19 Symptom Monitoring System Group |
| Motivational Interviewing and COVID-19 Symptom Monitoring SystemA 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 | Behavioural | MotivationaI Interviewing and COVID-19 Symptom Monitoring System Group |
| Supportive ServicesProvision 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 | COVID-19 Symptom Monitoring System Group, Control Group, MotivationaI Interviewing Group, MotivationaI Interviewing and COVID-19 Symptom Monitoring System Group |
Primary outcome
TESTING: Proportion tested for COVID-19
Time frame: Percent of participants tested for COVID-19 after three months of study enrollment.
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 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
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
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).
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
Time frame: The number of days quarantined per month (given quarantine was required/advised) over the 3-month enrollment period.
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
Time frame: Baseline and 3 months only
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.
5 secondary outcomes
Cultural Identity and Connectedness
Time frame: Baseline and 3 months only
Substance Use
Time frame: Baseline and 3 months only
Depression
Time frame: Baseline and 3 months only
Anxiety
Time frame: Baseline and 3 months only
Demographic
Time frame: Baseline and 3 months only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Derived from this study: PubMed 40844569Oguntade 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.
- Individual participant dataSharing planned: No. Investigators only plan to share de-identified participant data with approved researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Barlow, PhD, MPH, MA principal investigator
Johns Hopkins University
Mary Cwik, PhD principal investigator
Johns Hopkins University
Laura Hammitt, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing, COVID-19 Symptom Monitoring System and Motivational Interviewing and COVID-19 Symptom Monitoring System in people with COVID-19, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TESTING: Proportion tested for COVID-19 (time frame: Percent of participants tested for COVID-19 after three months of study enrollment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.