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Care management for HIV/AIDS

N/A
Waitlist Available
Led By Heidi M Crane, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Care managementExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Care management
2012
N/A
~30

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,241 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
493 Previous Clinical Trials
1,089,160 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,266 Total Patients Enrolled
~20 spots leftby Sep 2025