144. Impact of Transitioning from HIV Clinical Trials to Routine Medical Care on Clinical Outcomes and Patient Perceptions
Session: Oral Abstract Session: HIV Primary Care and Antiretroviral Therapy, Epidemiology and Testing
Friday, October 21, 2011: 8:45 AM
Room: 157ABC

Background: Participation in antiretroviral therapy clinical trials (ART-RCTs) offers many advantages including access to new drugs, close monitoring, and cost savings. These same benefits may pose a risk to patients ending ART-RCTs and returning to routine care; as they may experience changes to their drug regimen, decreased monitoring, and new out-of-pocket costs. We aimed to evaluate this transition in care and determine its effects on viral outcomes and patient perceptions.

Methods: We identified participants in ART na´ve -RCTs at the Univ. of PA between Jan 1, 2000 and Dec 31, 2009. Data were collected for each patient in the 12 months prior to and after trial completion. Multivariable logistic regression was used to evaluate virological failure rates and to identify factors associated with failure. Qualitative interviews were held with a subset of patients. Content analysis was used to identify thematic differences between patients with viral failure and those with viral suppression.

Results: 116 patients enrolled in 5 ART-RCTs between 2000-09. Virologic failure was observed in 39 patients (34%). Non-whites, high enrollment CD4 count, and trial completion in 1999-02 were risk factors for failure. Patients transitioning from ART-RCT to routine care had a 20% increased risk of failure (AOR=1.20, 95% CI 0.37, 3.88). 9 patients with viral suppression and 3 with viral failure in the year after trial end were interviewed. Patients who maintained suppression were more eager to continue trial participation, nervous about leaving the trial, and felt prepared to return to routine care. In contrast, those with virologic failure were less concerned with the transition.

Conclusion: These findings suggest that the post-trial period may be a vulnerable time for patients. Patients without a healthy fear of transitioning from ART-RCTs to routine care are at increased risk of viral failure. Focus should be given to assisting patients during this transition.


Subject Category: H. HIV/AIDS and other retroviruses

Baligh R. Yehia, MD1, Cordelia Stearns, BA1, Judith Long, MD2, Benjamin French, PhD3, Pablo Tebas, MD1 and Ian Frank, MD1, (1)University of Pennsylvania School of Medicine, Philadelphia, PA, (2)Philadephia VA Center for Health Equity Research and Promotion, Philadelphia, PA, (3)Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, PA

Disclosures:

B. R. Yehia, None

C. Stearns, None

J. Long, None

B. French, None

P. Tebas, None

I. Frank, None

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