Detection of inadequate adherence prior to the development of drug resistance remains one of the most important and elusive goals for the treatment of HIV-infected patients in routine clinical care. The goal of this study is to test a brief, feasible, valid, and well-tolerated measure of computer-assisted self-administered interview (CASI) collected adherence to antiretroviral medications in routine clinical practice focusing on feasibility issues, optimal self-report strategy, and item selection. We will determine the impact of integrating routine adherence assessment and healthcare delivery team feedback with targeted care management into clinical care.
The specific aims are: 1. Integrate CASI adherence assessment into routine clinical care for all patients receiving HAART at the UW HIV clinic, a large multi-provider clinic. We will identify and address system-level, provider-level, and patient-level facilitators of and barriers to integrating CASI into clinical care. 2. Determine optimal strategies for identifying inadequate adherence in a routine clinical care setting. We will evaluate the validity of items with varying recall periods (4-, 7-, 14-, 30-, and 60-days) for number of missed doses, the 4-item Adult AIDS Clinical Trial Group assessment, a 30-day visual analogue scale item, and 30-day rating scale item in comparison with unannounced pill counts. We will examine analytic methods for self- reported adherence. In addition, we will determine the performance of adherence measures among individuals with depression and substance abuse disorders. 3. Examine the ability of self-reported adherence measurement to impact clinical outcomes with a 2x2 factorial design RCT. We will determine if healthcare delivery team notification of adherence, depression, and substance abuse scores along with tailored intervention recommendations and targeted care management leads to improvement in process and patient-level outcomes including adherence. Accurate assessment of adherence in routine clinical care is essential to target effective interventions and improve long-term clinical outcomes.

Public Health Relevance

to antiretroviral medication is the most important determinant of clinical outcomes including disease progression and death among HIV-infected patients receiving treatment. There is no widely-accepted approach to the assessment of adherence in clinical care settings. The goal of this study is to validate a novel method of adherence collection using touch-screen tablets for use in clinical care settings focusing on feasibility issues and optimal item selection. We will determine the impact of integrating routine adherence assessment and healthcare delivery team feedback with targeted care management into clinical care. Optimally and routinely assessing adherence in clinical settings is an important step toward maximizing the potential benefit of antiretroviral therapy for all patients.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH084759-05
Application #
8320281
Study Section
Special Emphasis Panel (ZRG1-AARR-F (02))
Program Officer
Stirratt, Michael J
Project Start
2008-09-17
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2014-08-31
Support Year
5
Fiscal Year
2012
Total Cost
$529,285
Indirect Cost
$183,295
Name
University of Washington
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Crane, Heidi M; Fredericksen, Rob J; Church, Anna et al. (2016) 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 5:e156
Edwards, Todd C; Fredericksen, Rob J; Crane, Heidi M et al. (2016) Content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) items in the context of HIV clinical care. Qual Life Res 25:293-302
Crane, H M; Nance, R M; Delaney, J A C et al. (2016) A Comparison of Adherence Timeframes Using Missed Dose Items and Their Associations with Viral Load in Routine Clinical Care: Is Longer Better? AIDS Behav :
Fredericksen, R J; Tufano, J; Ralston, J et al. (2016) Provider perceptions of the value of same-day, electronic patient-reported measures for use in clinical HIV care. AIDS Care 28:1428-33
Jensen, Roxanne E; Rothrock, Nan E; DeWitt, Esi M et al. (2015) The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care. Med Care 53:153-9
Mimiaga, Matthew J; Biello, Katie; Reisner, Sari L et al. (2015) Latent class profiles of internalizing and externalizing psychosocial health indicators are differentially associated with sexual transmission risk: Findings from the CFAR network of integrated clinical systems (CNICS) cohort study of HIV-infected men eng Health Psychol 34:951-9
Fredericksen, Rob J; Edwards, Todd C; Merlin, Jessica S et al. (2015) Patient and provider priorities for self-reported domains of HIV clinical care. AIDS Care 27:1255-64
Blashill, Aaron J; Mayer, Kenneth H; Crane, Heidi M et al. (2014) Body mass index, depression, and condom use among HIV-infected men who have sex with men: a longitudinal moderation analysis. Arch Sex Behav 43:729-34
Fredericksen, R; Feldman, B J; Brown, T et al. (2014) Unannounced telephone-based pill counts: a valid and feasible method for monitoring adherence. AIDS Behav 18:2265-73
Likumahuwa, Sonja; Song, Hui; Singal, Robbie et al. (2013) Building research infrastructure in community health centers: a Community Health Applied Research Network (CHARN) report. J Am Board Fam Med 26:579-87

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