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NCT01884389 · ClinicalTrials.gov registry record · Phase 2
Randomized Trial of an HIV Navigation Program for Early Palliative Care
A Phase 2 study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- Phase 2
- Development phase
- 179
- Enrollment target
NCT01884389: Completed Phase 2 study, sponsored by Case Western Reserve University.
NCT01884389 is a Phase 2 study that has completed, run by Case Western Reserve University. The registered enrollment target is 179 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01884389, a Phase 2 study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 179 participants
- Enrollment target
Study Summary
This study is testing a navigation program for early palliative care provided in tandem with HIV primary care for persons living with HIV (PLWH) who are at high risk or mortality and morbidity related to their co-morbid chronic conditions. Participants are enrolled for a period of 36 months, with data collection at enrollment and every 9 months after, for a total of 5 data collection time points. Study participants enrolled will be randomized into one of two groups: control or intervention. Control group participants will receive control calls in between survey data collection time points. Intervention group participants will participate in a Navigation Program which includes home visits and phone calls with an advanced practice nurse (APN) and licensed social worker (LSW), as well as visits / calls by a volunteer if desired. The frequency of visits / calls will be determined based on level of need (high, medium or low). The specific aims of the study are to: 1) identify needs and preferences for palliative care and advance care planning for PLWH, in order to tailor an existing Navigation Program for this study; 2) test the effectiveness of an HIV Navigation Program intervention on outcomes of quality of life, symptom burden, coping ability, and advance care planning; and 3) determine if effectiveness of the HIV Navigation Program intervention differs by age, gender, ethnicity, education, income level, and level of palliative care service need.
Primary Outcome
Using HIV/AIDS Targeted Quality of Life (HAT\_QoL) Instrument. It has 34 items measuring 9 dimensions of quality of life on a continuous scale of 0 (worst) to 10 (best).
Interventions
- OTHER Patient Navigation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 2 |
What the finished NCT01884389 record still lists
NCT01884389 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which Patient Navigation is the first listed.
NCT01884389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01884389 about?
NCT01884389 is a clinical study titled "Randomized Trial of an HIV Navigation Program for Early Palliative Care". This study is testing a navigation program for early palliative care provided in tandem with HIV primary care for persons living with HIV (PLWH) who are at high risk or mortality and morbidity related to their co-morbid chronic conditions. Participants are enrolled for a period of 36 months, with da...
What is the current status of trial NCT01884389?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 179 participants. The study started on 2013-06. Estimated completion is 2017-07-31.
What interventions are being tested in trial NCT01884389?
The interventions under investigation include: Patient Navigation (OTHER).
Who is sponsoring clinical trial NCT01884389?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01884389's enrollment target sits among peer trials
179 391st of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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