Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care

Overview

Among HIV-infected patients, adherence to antiretroviral medications is one of the most important determinants of clinical outcomes including viral suppression, viral resistance, disease progression, and death. Unfortunately poor adherence among patients with HIV is very common, mean levels of adherence in clinical cohorts are 60-75% or less. Alcohol, drug abuse, and mental illness particularly depression symptoms are key predictors of poor adherence, common among HIV-infected individuals, and important to identify and treat among nonadherent patients. This study will examine the ability of patient reported outcomes (PROs) and a targeted care management approach to improve clinical outcomes with a randomized controlled trial (RCT) in routine clinical care of patients with HIV. The investigators will determine whether healthcare delivery team notification of PROs including antiretroviral medication adherence and barriers of adherence such as depression and substance abuse along with tailored intervention recommendations and targeted care management leads to improvement in both process and clinical outcomes including patient-reported outcomes. The investigators will examine process outcomes such as use of clinic support services, and patient outcomes such as improvement in adherence, substance use, depression, and HIV-1 RNA levels.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
  • Study Primary Completion Date: June 2015

Interventions

  • Behavioral: Care management
    • The intervention will include healthcare delivery team notification of patient reported outcomes (PROs) including medication adherence and adherence barriers such as depression symptoms along with intervention recommendations and targeted care management using a stepped care approach. Patients will receive structured calls from their care manager 2 and 6 weeks after enrollment. An assessment including depression, adherence, and substance use will be completed at the beginning of each call. After the 2nd call, a stepped care approach will be used where patients with a greater need based on adherence and depression will receive more intensive interventions based on the PEARL intervention. The components include: a) problem solving treatment, b) social and physical activation, c) pleasant events scheduling, d) patient support and education regarding medication use, and e) medical and psychiatric consultation. Patients will also receive follow-up calls at ~9 and 12 months after enrollment.

Arms, Groups and Cohorts

  • No Intervention: Usual Care
    • Patients not randomized to the intervention will receive usual care which includes a patient reported outcomes assessment every 6 months as part of routine clinical procedures and patient-initiated interactions with case managers.
  • Experimental: Care management
    • The intervention will include frequent healthcare delivery team notification of PROs including medication adherence and adherence barriers such as depression symptoms along with tailored intervention recommendations and targeted care management using a stepped care approach.

Clinical Trial Outcome Measures

Primary Measures

  • Self-reported adherence
    • Time Frame: up to 1 year after enrollment

Secondary Measures

  • HIV-1 RNA level
    • Time Frame: up to 1 year after enrollment
  • Self-reported substance use
    • Time Frame: Up to 1 year after enrollment
  • Health related quality of life
    • Time Frame: Up to 1 year after enrollment
  • Physical activity levels
    • Time Frame: up to 1 year after enrollment
  • Self-reported depression
    • Time Frame: Up to 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • HIV-infected individuals – English speaking – 18 years of age or older – Access to either a home phone or cell phone at enrollment – In care at least 6 months. – Self-reported inadequate adherence based on routine clinic assessment Exclusion Criteria:

  • Do not speak English – Not receiving antiretroviral medications

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Heidi Crane, Assistant Professor – University of Washington
  • Overall Official(s)
    • Heidi M Crane, MD, MPH, Principal Investigator, University of Washington
    • Paul K Crane, MD MPH, Principal Investigator, University of Washington
    • Donald Patrick, PhD, Principal Investigator, University of Washington

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