Psychosocial Stress and Aging in HIV

NCT ID: NCT02965469

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-11-14

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.

Conditions

HIV; Aging; Stress, Psychological; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cell phone app

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

Group Type: EXPERIMENTAL

Breathe2Relax

Intervention Type: BEHAVIORAL

The app teaches diaphragmatic breathing and has audiovisual coaching

Interventions

Breathe2Relax

The app teaches diaphragmatic breathing and has audiovisual coaching

Intervention Type: BEHAVIORAL

Other Intervention Names

cell phone app

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine R Schafer, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

1R03AG048033-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00033537

Identifier Type: -

Identifier Source: org_study_id