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Psychosocial Stress and Aging in HIV

Primary Purpose

HIV, Aging, Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathe2Relax
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Cell phone app

Arm Description

Participants randomized to this arm will have no change to their usual care

Participants randomized to this arm will use a stress reduction cell phone app called "Breathe2Relax" to assess feasibility and acceptability

Outcomes

Primary Outcome Measures

Correlation of perceived stress with HIV virologic suppression
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with HIV viral load
Correlation of perceived stress with immune senescence
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
Correlation of perceived stress with inflammation
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with biomarkers of inflammation (C-reactive protein, salivary cortisol)
Correlation of perceived stress with frailty phenotype
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).

Secondary Outcome Measures

Feasibility of a stress-reduction cell phone app
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.
The effect of a cell phone app on stress-reduction
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.
Acceptability of a stress-reduction cell phone app
An exit survey will measure the acceptability of using a stress-reduction cell phone application in people aging with HIV.

Full Information

First Posted
November 4, 2016
Last Updated
April 14, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02965469
Brief Title
Psychosocial Stress and Aging in HIV
Official Title
The Syndemic of Stress and Aging in an HIV-infected Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Aging, Stress, Psychological, Frailty

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will have no change to their usual care
Arm Title
Cell phone app
Arm Type
Experimental
Arm Description
Participants randomized to this arm will use a stress reduction cell phone app called "Breathe2Relax" to assess feasibility and acceptability
Intervention Type
Behavioral
Intervention Name(s)
Breathe2Relax
Other Intervention Name(s)
cell phone app
Intervention Description
The app teaches diaphragmatic breathing and has audiovisual coaching
Primary Outcome Measure Information:
Title
Correlation of perceived stress with HIV virologic suppression
Description
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with HIV viral load
Time Frame
12 weeks
Title
Correlation of perceived stress with immune senescence
Description
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
Time Frame
12 weeks
Title
Correlation of perceived stress with inflammation
Description
Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with biomarkers of inflammation (C-reactive protein, salivary cortisol)
Time Frame
12 weeks
Title
Correlation of perceived stress with frailty phenotype
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Feasibility of a stress-reduction cell phone app
Description
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.
Time Frame
12 weeks
Title
The effect of a cell phone app on stress-reduction
Description
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.
Time Frame
12 weeks
Title
Acceptability of a stress-reduction cell phone app
Description
An exit survey will measure the acceptability of using a stress-reduction cell phone application in people aging with HIV.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine R Schafer, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Psychosocial Stress and Aging in HIV

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