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

Not Applicable

• Conditions: HIV
• Interventions: Behavioral: Care management

• Registration Number: NCT01505660
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-11
• Last Update Posted: 2015-04-14
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

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

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Exclusion Criteria

• Do not speak English
• Not receiving antiretroviral medications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care management	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.

Primary Outcome Measures

Name	Time	Method
Self-reported adherence	up to 1 year after enrollment

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	Up to 1 year after enrollment
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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States