N/A
Completed N=121
Living Well Project for Persons With AIDS
Acquired Immunodeficiency Syndrome (AIDS)
Source: ClinicalTrials.gov NCT01848483 ↗
Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Change in Quality of Life — 5.87; 5.17; 5.68; 5.06 score on a scale
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.
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 | — |
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
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. Informational only — not medical advice.