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P10 Adherence to Doxycycline in a Clinical Trial of Men with Nongonococcal Urethritis (NGU)

Wednesday, March 14, 2012
Hyatt Exhibit Hall
Christine M. Khosropour, MPH1, Lisa E. Manhart, MPH, PHD1, Danny V. Colombara, MPH1, Catherine M. Wetmore, MPH, PhD2, M. Sylvan Lowens, PA3, Noa A. Kay, MPH1, Patricia A. Totten, PhD4, Jane M. Simoni, PhD5 and Matthew R. Golden, MD, MPH6, 1Department of Epidemiology and Center for AIDS and STD, University of Washington, Seattle, WA, 2Institute for Health Metrics and Evaluation, University of Washington, Seattle, WA, 3Public Health - Seattle & King County STD Clinic, Seattle, WA, 4Department of Medicine and Center for AIDS and STD, University of Washington, Seattle, WA, 5Department of Psychology, University of Washington, Seattle, WA, 6Center for AIDS and STD, Public Health - Seattle & King County STD Clinic and Department of Medicine, University of Washington, Seattle, WA

Background: Inadequate adherence to therapy is an important contributor to poor clinical outcomes, and may be linked to high treatment failure rates recently observed in men with nongonococcal urethritis (NGU). 

Objectives: To estimate adherence to doxycycline and identify correlates among men with NGU.

Methods: From January 2007-July 2011, 598 men with NGU entered a randomized double-blind treatment trial at a Seattle STD clinic. Men were randomized to active doxycycline (100mg BID x 7d)/placebo azithromycin or placebo doxycycline/active azithromycin (1g). Self-reported doxycycline adherence was defined as taking 14 pills in 7 days reported in a daily diary or taking all medication as instructed reported in a computer assisted self interview (CASI) at the 3-week follow-up visit. In the correlates analysis, adherent men were only those reporting adherence on both measures.

Results: Of the 483 men who returned for follow-up, 88% (413/467) indicated adherence by CASI, compared to 66% (314/473) by diary (kappa=0.33).  While only two-thirds of men reported adherence by diary, 90% (435/473) actually took >12 doses in 9 days. Most missed doses occurred on the first or last day of the regimen. Men recording <12 pills in the diary were somewhat more likely (92%, 22/24) to report adherence on CASI than those recording >12 pills (88%, 358/407).  Only age >35 years was associated with higher adherence (94% vs. 82% in men <35 years, p=0.003).  Baseline clinical characteristics, medication side effects, and symptom duration were not related.

Conclusions: Although self-reported adherence was moderate, most men took the majority of their doxycycline within an acceptable timeframe. Agreement between diary and CASI was only fair, with an inverse relationship between number of pills recorded on the diary and reporting adherence by CASI. 

Implications for Programs, Policy, and Research: Factors other than adherence should be considered in cases of clinical failure in NGU patients treated with doxycycline.

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