Overview

This trial is active, not recruiting.

Condition hiv
Treatment care management
Sponsor University of Washington
Collaborator National Institutes of Health (NIH)
Start date January 2012
End date June 2015
Trial size 270 participants
Trial identifier NCT01505660, 41128-K, ADH HIV001, R01MH084759, U01AR057954

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Primary purpose supportive care
Arm
(No Intervention)
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)
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.
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.

Primary Outcomes

Measure
Self-reported adherence
time frame: up to 1 year after enrollment

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care
Principal investigator Heidi M Crane, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Washington.