Randomized Trial of an HIV Navigation Program for Early Palliative Care

Completed · Phase 2

Conditions studied: HIV, Chronic Disease

In brief

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.

Key facts

Study ID

NCT01884389

Run by

Case Western Reserve University

People needed

179

Starts

2013-06-01

Expected to finish

2017-07-31

Last updated by the study team

2018-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV dx for 2+ years
• English speaking
• lives within 50 miles of study headquarters
• at least one physical co-morbid condition
• receiving primary care at Institutional Review Board (IRB) approved clinic recruitment site

You may not qualify if…

• currently enrolled in hospice care

Where it is running

• Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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