N/A N=121 Randomized Supportive Care

Living Well Project for Persons With AIDS

Acquired Immunodeficiency Syndrome (AIDS)

Bottom Line

View on ClinicalTrials.gov: NCT01848483 ↗

Enrolled (actual)

121

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcome: Primary: Change in Quality of Life — 5.87; 5.17; 5.68; 5.06 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AIDS EPC Package plus MI (Behavioral); Standard of Care (SOC) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Quality of Life	5.87; 5.17; 5.68; 5.06; 5.73; 5.09	—
SECONDARY Clinical Indicator: Change in Mortality at 12 Months Post-baseline	2; 1	—
SECONDARY Clinical Indicator: Change in Self-report Hospitalizations	24; 27; 11; 12; 5; 10	—
SECONDARY Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker	13; 12; 21; 11; 22; 16	—
SECONDARY Change in Self-reported Completion of Advanced Care Planning Activities: Living Will	12; 8; 14; 8; 19; 11	—

Summary

The overall goal of this project is to implement and test the efficacy of an enhanced comprehensive multidisciplinary early palliative care (EPC) package that includes four motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance care planning in a cost effective manner and could promote engagement and retention in HIV care. If successful, it could serve as a model of early palliative care for persons with AIDS in the US.

Eligibility Criteria

Inclusion Criteria

Diagnosis of AIDS (using current Centers for Disease Control and Prevention criteria)
Detectable viral load (>1.6 log or > 40 copies per ml)
Not currently on ART
Age ≥18 years
Able to speak and write English
Able to give and understand consent
Willing to participate in study activities.

Exclusion Criteria

Participants who have a Karnofsky score of 30 or less and are impaired in 5 activities of daily living (ADL) from this list: Bathing, dressing, transferring from bed or chair, walking, eating, toilet use, or grooming
Those not HIV infected
Minors under 18 years of age
Unable to read or understand English
Cognitive impairment
Actively psychotic
Severely depressed/suicidal
Pose a risk of harm to themselves or others

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01848483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.