Pilot Studies

PriSSM studies are designed with help from people in the population being studied, and the results are shared with the study participants as well as with professionals. Every PriSSM pilot study captures a set of common data elements for each participant, including physical activity with a Fitbit-like wearable accelerometer and saliva samples that are tested for DNA and other biomarkers.

Pilot Studies

Adapting a Fatigue Self-Management Intervention for Latinos Living with HIV/AIDS (2016-2019)

Principal Investigator:  Michelle Odlum, BSN, EdD

Half of the 1.1 million people living with HIV/AIDS (PLWH) in the U.S. are projected to be 50 years of age and over, mainly due to medications that have greatly extended survival in recent years.  Studies suggest that between 33 and 88 percent of this populations suffers from fatigue—a symptom that can interfere with patients' self-management (including adherence to their antiretroviral regimen) and their overall quality of life.  Because low income and unemployment are among the risk factors for fatigue, Latinos with AIDS and HIV may be especially vulnerable.

Few interventions have been developed to improve fatigue-related outcomes. Adapting the existing Energy Conservation Course (ECC) for Latino PLWH is one promising mechanism to support HIV-related fatigue self-management. To address this critical need, we propose a pilot project informed by the Assessment-Decision-Administration-Production-Topical Experts-Integration-Training-Testing (ADAPT-ITT) model that guides systematic adaptation of interventions. The aims of the pilot project are to:

  1. Adapt a fatigue self-management intervention for Latino PLWH older than 50 years of age. Focus group discussions will be used to identify cultural and population-specific symptom experiences and fatigue self-management strategies for intervention adaptation. Feedback from a mock intervention demonstration and insight from three topic experts will be used to refine the adaptation for intervention implementation.
  2. Pilot test the adapted fatigue self-management intervention, determine fidelity, and examine changes in primary and secondary outcomes. Grounded in symptom science, the adapted intervention will be pilot tested with a group of Latino PLWH older than 50 years of age. To assess the short-term intervention feasibility, variables including CDEs (actigraphy sleep patterns, fatigue biomarkers, self-management survey) will be collected (baseline and three-month follow-up) and analyzed to: 1) determine short-term intervention outcomes and 2) examine changes in fatigue intensity and fatigue-related impairment of functioning over time.

Clustering and Validation of COVID-19 Symptom Phenotypes (2020-2025)

Principal Investigator: Caitlin Dreisbach, PhD, RN

In response to the surge in COVID-19, a collaborative team at Columbia built COVIDWATCHER, an app to help inform the response to COVID-19 and better understand the personal, social, and health implications of the pandemic. COVIDWATCHER is driven by the approach of citizen science, or the public actively participates in scientific research. Medical providers during the pandemic have often needed to make a COVID-19 diagnosis based only on symptoms. Major health organizations have already established the differential impact of the COVID-19 pandemic on women and girls (United Nations, 2020) and, further, on women of color, including Latinas (Pew Research Center, 2020) and African American women (Lindsay, 2020). Latinas across their life course have already been noted to be a demographic group at high risk for testing positive for COVID-19.

In this pilot study, we focus on several aspects of precision to achieve our goal of determining the feasibility of using a citizen science-based approach enabled by the COVIDWATCHER platform to advance our understanding of women's-specific symptom phenotypes and how they vary over time. We will be utilizing the subset of female users (n=551) from COVIDWATCHER to identify symptom clusters and follow-up with representative participants for in-depth interviews focused on women's experiences during this pandemic period.

The specific aims for the study are:

  • Aim 1: To identify COVID-19 symptom phenotypes and compare them between men and women. Hypothesis: There will be symptom phenotypes based on health status, environmental factors, and access to healthcare that impact a participant’s health trajectory throughout the pandemic and that these phenotypes are different for female compared to male users.
  • Aim 2: To compare COVID-19 symptom phenotypes for Latina and non-Latina women. Hypothesis: There will be different symptom phenotypes between Latina and non-Latina women.
  • Aim 3: To explore the symptom experiences of Latina and non-Latina participants from the unique symptom phenotypes to identify themes of intensity, burden, and symptom trajectories.

Fatigue in Elderly Latino Home Health Care Patients with Chronic Disease (2016-2018)

Principal Investigator:  Jingjing Shang, PhD, RN

Informed by the National Institutes of Health Symptom Science Model, the objective of this pilot project is to explore the nature of fatigue in elderly Latinos admitted to home health care with a chronic condition. The pilot project will test the feasibility of measuring fatigue in this population and identify potential variability in expression of symptoms of fatigue, behavioral mechanisms, and self-management strategies used by elderly Latinos in a home health care setting. Study findings will be used to further develop our understanding of fatigue and its relationship to genetic, biological, and behavioral characteristics in an underserved population. This will provide a critical foundation for intervention development including those related to symptom self-management. The aims of the pilot project are to:

  1. Develop methods for quantifying the experience of fatigue among elderly Latino patients with a chronic condition in a home health care setting to identify potential phenotypes of fatigue in this population.
  2. Examine the association between phenotypic data and "omic" data to identify potential pathways to predict or prevent fatigue and its manifestations.
  3. Apply visualization strategies to explore an integrated data set that includes biomarkers and "omic" data to discover potential intervention target for future research into self-management of fatigue in elderly Latino home health care patients with chronic illness.

Sleep and Fatigue among Latino Transgender People (2018-2020)

Principal Investigator: Kasey Jackman, PhD, RN

Transgender people are estimated to make up 0.6% of the U.S. adult population, which equals approximately 1,400,000 people. Transgender individuals are those who identify as a member of a gender not congruent with their sex assigned at birth (i.e., a person assigned male at birth who identifies as a girl or woman, or a person assigned female at birth who identifies as a boy or man), as well as individuals who describe their gender identity outside of the binary conceptualizations of sex (as either male or female) and gender identity (as either boy/man or girl/woman), with such labels as bigender, nonbinary, gender fluid, or genderqueer. Studies consistently find that transgender people experience high levels of stress due to stigma associated with their transgender identity. Stigma-related stress experienced by transgender people is attributable to victimization and discrimination (enacted stigma), which lead to expectations of rejection, concealment of their transgender identity (felt stigma), and internalized stigma. Numerous studies with transgender participants have identified significant effects of stigma-related stress on depression, anxiety, suicidality, non-suicidal self-injury, and substance use, which help to explain these health disparities compared to non-transgender people. The effects of stigma-related stress on mental health have been investigated while scant attention has been paid to the mechanisms by which this stress affects physiologic functioning in the transgender population. Evidence also shows that sleep disturbance is associated with chronic health conditions and impaired quality of life among transgender people.

The specific aims of the proposed pilot study are:

  • Aim 1: Describe sleep and fatigue among a sample of Latino transgender adults (N = 48) using self-report and biomarker data.
  • Aim 2: Examine how inflammatory markers and stigma-related stress relate to sleep and fatigue in this population.
    • Hyp. 2.1: Higher levels of stress will be associated with higher levels of sleep disturbance and fatigue.
    • Hyp. 2.2: Cytokine abnormalities will be associated with higher levels of sleep disturbance and fatigue.
  • Aim 3: Explore associations between genetic variation and sleep and fatigue in this stigmatized population.
    • Hyp. 3: Variation in genes in candidate biological pathways (e.g., inflammation, oxidative stress, and circadian rhythm) will be associated with self-reported variability in levels of sleep disturbance and fatigue.

Sociocultural Influences on the Association of Posttraumatic Stress Symptoms and Cardiovascular Disease Risk in Latinas (2018-2020)

Principal Investigator: Billy Caceres, PhD, RN

Many women report exposure to traumatic experiences in their lifetime. Previous studies have found that reporting stressful symptoms after a traumatic event, called posttraumatic stress, might be associated with higher risk for cardiovascular disease. This pilot study will investigate the association between posttraumatic stress disorder (PTSD) symptoms and atherosclerotic cardiovascular disease (ASCVD) in Latinas. Several studies have documented a link between posttraumatic stress symptoms and incident cardiovascular disease (CVD). Although Latinas appear more likely to report PTSD symptoms and display higher rates of CVD compared to Non-Hispanic White women, few studies have examined the association between PTSD symptoms.

  • Aim 1: Investigate whether PTSD symptom severity is associated with psychosocial (depression, anxiety, emotional support, and social isolation), behavioral (alcohol use, physical activity, sleep quality, and diet), and biological risk factors (body mass index, inflammatory, and endothelial function markers) for ASCVD after accounting for demographic/clinical characteristics and sociocultural factors. Hypothesis 1: Higher PTSD symptom severity will be associated with higher report of psychosocial, behavioral, and biological risk factors for ASCVD after accounting for demographic/clinical characteristics and sociocultural factors.
  • Aim 2: Examine the association of PTSD symptom severity and the ACC/AHA 10-year ASCVD risk score (an established algorithm calculated from participant age, gender, race, systolic and diastolic blood pressure, hypertension treatment, total cholesterol, high-density lipoprotein, diagnosis of diabetes, and tobacco use). Hypothesis 2: Higher PTSD symptom severity will be associated with higher ACC/AHA 10-year ASCVD risk score. This pilot study focuses on: 1) promoting cardiovascular health and disease prevention and 2) examining PTSD symptom severity, as a novel ASCVD risk factor in Latinas.