Clinical trial NCT01505660: Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care
Official title: Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: Adherence
Depression
Care management
Stepped care
HIV
Patient reported outcomes
Antiretroviral medication adherence
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2012-01-06
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-reported adherence
timeFrame: up to 1 year after enrollment
Secondary outcomes:
measure: HIV-1 RNA level
timeFrame: up to 1 year after enrollment
measure: Self-reported substance use
timeFrame: Up to 1 year after enrollment
measure: Health related quality of life
timeFrame: Up to 1 year after enrollment
measure: Physical activity levels
timeFrame: up to 1 year after enrollment
measure: Self-reported depression
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Heidi M Crane, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Paul K Crane, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Donald Patrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crane HM, Fredericksen RJ, Church A, Harrington A, Ciechanowski P, Magnani J, Nasby K, Brown T, Dhanireddy S, Harrington RD, Lober WB, Simoni J, Safren SA, Edwards TC, Patrick DL, Saag MS, Crane PK, Kitahata MM. A Randomized Controlled Trial Protocol to Evaluate the Effectiveness of an Integrated Care Management Approach to Improve Adherence Among HIV-Infected Patients in Routine Clinical Care: Rationale and Design. JMIR Res Protoc. 2016 Oct 5;5(4):e156. doi: 10.2196/resprot.5492.