NCT02965469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2017

Completed
Last Updated

April 15, 2022

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

November 4, 2016

Last Update Submit

April 14, 2022

Conditions

HIVAgingStress, PsychologicalFrailty

Outcome Measures

Primary Outcomes (4)

  • 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

    12 weeks

  • 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

    12 weeks

  • 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)

    12 weeks

  • 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).

    12 weeks

Secondary Outcomes (3)

  • Feasibility of a stress-reduction cell phone app

    12 weeks

  • The effect of a cell phone app on stress-reduction

    12 weeks

  • Acceptability of a stress-reduction cell phone app

    12 weeks

Study Arms (2)

Usual care

NO INTERVENTION

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

Cell phone app

EXPERIMENTAL

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

Behavioral: Breathe2Relax

Interventions

Breathe2RelaxBEHAVIORAL

The app teaches diaphragmatic breathing and has audiovisual coaching

Also known as: cell phone app
Cell phone app

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalFrailty

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katherine R Schafer, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 16, 2016

Study Start

May 1, 2016

Primary Completion

November 14, 2017

Study Completion

November 14, 2017

Last Updated

April 15, 2022

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)