Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings (HIVPASS)
The purpose of this study is to determine whether participation in the study intervention, which involves collaboration between the study interventionist and the participant's primary care physician, will reduce symptoms of pain and depression in HIV+ patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings|
- pain interference [ Time Frame: 4 months ] [ Designated as safety issue: No ]pain interference will be measured by self-report on the Brief Pain Inventory-Pain Interference Scale
- depression [ Time Frame: 4 months ] [ Designated as safety issue: No ]depression will be measured by self-report on the Quick Inventory of Depression Symptomatology scale
- antiretroviral adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]antiretroviral adherence will be measured by self-report on the AIDS Clinical Trial Group adherence measure
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Health Education
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
Active Comparator: HIVPASS Intervention
Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735708
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Michael Stein, MD||Butler Hospital|