Psychosocial Stress and Aging in HIV

April 14, 2022 updated by: Wake Forest University Health Sciences

The Syndemic of Stress and Aging in an HIV-infected Population

This study will begin to assess the association between perceived stress and enhanced aging in persons living with HIV (PLWH). The investigators suspect this relationship may be mediated by increased aging within the immune system and subsequent low-level inflammation that commonly leads to multiple illnesses and frailty as one ages. The findings from this study will identify potential diagnostic and therapeutic targets to improve the health of aging PLWH which could also apply to HIV-uninfected populations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

While life expectancy has increased markedly for people living with HIV (PLWH), gains in expected years of life have come at a cost - earlier onset and greater frequency of age-associated comorbid conditions, such as osteoporosis, metabolic syndrome, and cardiovascular disease. Accumulated multi-morbidity is the likely cause of much higher than age-expected rates of frailty in PLWH. Perceived stress is prevalent in PLWH and, when present, associated with worse clinical outcomes, including poor engagement in HIV care, rapid progression to AIDS, and higher AIDS-related mortality. Stress is a well-documented risk factor for many illnesses that demonstrate early onset in PLWH, and perceived stress has been hypothesized to be a cause of aging itself. Nonetheless, the role of perceived stress in early-onset aging and age-related illness in PLWH is essentially unexplored. Investigating the interrelatedness of aging, perceived stress, and HIV may elucidate mechanism(s) that underlie a phenotype of premature aging and functional decline in HIV patients with implications for understanding fundamental mechanisms of stress and aging in HIV uninfected populations. The proposed randomized controlled study will estimate correlations between perceived stress and both aging and HIV-specific outcomes and will measure feasibility of a cell phone-delivered stress reduction intervention. Participants will complete structured interviews to measure cumulative life stress, perceived stress, intimate partner violence exposure (as a traumatic stressor), functional status, frailty, and potential covariates across the age spectrum in PLWH. Stress measures will be correlated with biomarkers known to be associated with functional decline in aging, HIV-uninfected populations. The findings from this exploratory R03, led by a New Investigator, will measure feasibility of mobile technology for stress reduction interventions and estimate correlations between perceived stress and markers of aging and HIV disease. The results will be used to determine sample sizes necessary to perform definitive studies to assess the link between perceived stress and a phenotype of premature aging, as well as interventional studies of stress modification to mitigate the onset of early multi-morbidity and functional decline. These findings can be applicable to both HIV-infected and HIV-uninfected populations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV positive serostatus
  • Wake Forest ID clinic patient for at least 12 months
  • prescribed ART for at least 6 months
  • English fluency (cell phone app and some interview tools are only available in English)
  • consistent access to a smartphone

Exclusion Criteria:

  • ART-naive
  • unable to perform functional measures
  • recent (within 30 days) acute illness requiring medical therapy or hospitalization
  • immunosuppressive agents (e.g. > 20 mg/d prednisone or equivalent, chemotherapy, biologic immune-modulating agents) in the last 6 months
  • cancer requiring treatment within 3 years (except for non-melanoma skin cancer)
  • use of non-steroidal anti-inflammatory drugs more frequently than once per week within the last 30 days.

Criteria iii-vi are necessary because of their effects on biomarkers of aging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual care
Participants randomized to this arm will have no change to their usual care
Experimental: Cell phone app
Participants randomized to this arm will use a stress reduction cell phone app called "Breathe2Relax" to assess feasibility and acceptability
Behavioral: Breathe2Relax
The app teaches diaphragmatic breathing and has audiovisual coaching
Other Names:
  • cell phone app

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation of perceived stress with HIV virologic suppression
Time Frame: 12 weeks
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with HIV viral load
12 weeks
Correlation of perceived stress with immune senescence
Time Frame: 12 weeks
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with biomarkers of immune senescence, including IL-6, soluble CD-14, telomere length, and DNA methylation
12 weeks
Correlation of perceived stress with inflammation
Time Frame: 12 weeks
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with biomarkers of inflammation (C-reactive protein, salivary cortisol)
12 weeks
Correlation of perceived stress with frailty phenotype
Time Frame: 12 weeks
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with each participant's Fried Frailty Index score (comprised of 5 items, including weight loss, exhaustion, 4 meter walk time, physical activity, and grip strength).
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of a stress-reduction cell phone app
Time Frame: 12 weeks
This outcome will measure the accrual, adherence and retention of using a stress-reduction cell phone application in people aging with HIV through the randomized pilot study.
12 weeks
The effect of a cell phone app on stress-reduction
Time Frame: 12 weeks
The study will collect preliminary data on the efficacy of a cell phone-based stress reduction intervention versus usual care for improving markers of inflammation and aging, as well as HIV-specific outcomes.
12 weeks
Acceptability of a stress-reduction cell phone app
Time Frame: 12 weeks
An exit survey will measure the acceptability of using a stress-reduction cell phone application in people aging with HIV.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine R Schafer, MD, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00033537
  • 1R03AG048033-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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