Living Well Project for Persons With AIDS



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2014
End Date:June 2017
Contact:Amy Lovvorn, MPH
Email:amy.lovvorn@emory.edu
Phone:404-727-8323

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The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS

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.

The overall goal of this project is to improve the health and quality of life of persons
living with HIV/AIDS (PLWH). To this end, we will implement an innovative model of enhanced
early integrative palliative care services (EPC) for persons diagnosed with AIDS. Patients
will be recruited from either the inpatient service or outpatient infectious disease program
(IDP) at the Grady Health System (GHS) in Atlanta, Georgia. The AIDS EPC Package includes
use of motivational interviewing (MI) to facilitate adjustment to disease and advance care
planning decision making. The project has three specific aims:

Aim 1. Conduct a research clinical trial (RCT) to examine the efficacy of the AIDS EPC
Package intervention vs. standard HIV care (SOC) and compare outcomes at 12 months post
baseline. Our hypothesis is that those in the AIDS EPC group will have:

i. Better clinical outcomes: a lower one year mortality, higher proportion who initiate
antiretroviral therapy (ART), higher proportion with virologic suppression, higher CD4 gain,
fewer opportunistic infections (OI), fewer hospitalizations, lower depression scores, and
better symptom management (including cognitive dysfunction).

ii. Better psychosocial outcomes: Better coping skills, higher perceived social support,
higher spirituality, higher levels of self-advocacy, lower proportion who report substance
use.

iii. Better Quality of Life (QOL) and a higher proportion who report advance care planning
activities: named a surrogate; set personal goals regarding life saving measures; and
discussed these goals with a surrogate.

SECONDARY OUTCOMES:

Aim 2. Evaluate the cost effectiveness and cost utility of the AIDS EPC Package compared to
SOC where the outcomes are valued as survival and quality-adjusted life years (QALYs)
respectively.

Aim 3. Promote engagement and retention in HIV care as evidenced by attending a greater
proportion of scheduled appointments and reporting higher satisfaction with care compared to
SOC.

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
We found this trial at
1
site
Atlanta, Georgia 30322
Principal Investigator: Marcia McDonnell Holstad, DSN
Phone: 404-727-8323
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mi
from
Atlanta, GA
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