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

University of Washington

Status: Unknown

Conditions: HIV

Treatments: Behavioral: Care management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01505660

U01AR057954 (U.S. NIH Grant/Contract)

41128-K

R01MH084759 (U.S. NIH Grant/Contract)

ADH HIV001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

270 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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.

Care management

Experimental group

Description:

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.

Treatment:

Behavioral: Care management