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Clinical Trials/NCT01505660
NCT01505660
Unknown
Not Applicable

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

University of Washington1 site in 1 country270 target enrollmentJanuary 2012
ConditionsHIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV
Sponsor
University of Washington
Enrollment
270
Locations
1
Primary Endpoint
Self-reported adherence
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
June 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heidi Crane

Assistant Professor

University of Washington

Eligibility Criteria

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

Outcomes

Primary Outcomes

Self-reported adherence

Time Frame: up to 1 year after enrollment

Secondary Outcomes

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

Study Sites (1)

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