Placebo Practice Trials, a Tool to Assess and Improve Adherence Readiness
Published in: HIV Clinical Trials, v. 3, no. 6, Nov-Dec 2002, p. 475-481
Posted on rand.org 2002
PURPOSE: Antiretroviral therapy is being increasingly delayed until later stages of illness. Therefore, prior to prescribing HAART, providers are emphasizing the need for patients to be ready to adhere well to the treatment regimen. Unfortunately, providers are no better than chance at predicting a patient's adherence, and there are no established methods for accurately assessing a patient's adherence readiness. This pilot study assessed the utility of a series of up to five 1-week placebo practice trials accompanied by adherence counseling as a clinical tool to both assess and improve adherence readiness. METHOD: Participants were not prescribed treatment until they demonstrated readiness, which was defined as 90+% adherence during a single practice trial. Once HAART was initiated, adherence to one selected antiretroviral was monitored for 4 weeks. Electronic monitoring caps were used to measure adherence. RESULTS: Twenty men enrolled in the study at two HIV outpatient clinics in Southern California. Mean age was 33, 50% were non-White, 35% were employed, 30% had not completed high school, 15% were Spanish monolingual, and 30% had unstable housing. Nine participants achieved 90+% adherence in the first practice trial, with an additional 8 participants demonstrating readiness after two to four practice trials; two participants withdrew from the study because of intolerance of the restrictions related to the use of the caps; and one participant was removed from the study after no effort was given during two practice trials. Of the 17 participants who completed the program and demonstrated adherence readiness, 15 started on an antiretroviral regimen and 2 decided to defer treatment indefinitely. Of the 15 who started therapy, 13 (87%) achieved 90+% adherence during the first month of antiretroviral therapy. The sample's mean adherence during the first 4 weeks of treatment was 93% (SD = 13). CONCLUSION: These results suggest that once a patient is able to adhere well to a 1-week practice trial they are likely to adhere equally well to HAART. A larger controlled study is needed to further assess the effectiveness of practice trials as a clinical tool for both assessing and improving adherence readiness.