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

Status unconfirmed · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT01505660

Run by

University of Washington

People needed

270

Starts

2012-01-01

Expected to finish

2015-06-01

Last updated by the study team

2015-04-14

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• Do not speak English
• Not receiving antiretroviral medications

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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