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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01505660
• Other study ID #: 41128-K
• Secondary ID: R01MH084759U01AR
• Status: Active, not recruiting
• Phase: N/A
• First received: January 4, 2012
• Last updated: April 11, 2015
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported adherence		up to 1 year after enrollment	No
Secondary	HIV-1 RNA level		up to 1 year after enrollment	No
Secondary	Self-reported substance use		Up to 1 year after enrollment	No
Secondary	Health related quality of life		Up to 1 year after enrollment	No
Secondary	Physical activity levels		up to 1 year after enrollment	No
Secondary	Self-reported depression		Up to 1 year	No