WEPE272 - Poster Exhibition
Participant adherence in the Bangkok Tenofovir Study, an HIV pre-exposure prophylaxis trial in Bangkok
M. Martin1,2, S. Vanichseni3, P. Suntharasamai3, U. Sangkum3, M. Leethochawalit4, S. Chiamwongpaet4, S. Kittimunkong5, P.A. Mock1, L. Paxton2, K. Choopanya3, the Bangkok Tenofovir Study Group
1Thailand MOPH - U.S. CDC Collaboration, Nonthaburi, Thailand, 2US Centers for Disease Control & Prevention, Division of HIV/AIDS Prevention, Atlanta, United States, 3Bangkok Tenofovir Study Group, Bangkok, Thailand, 4Bangkok Metropolitan Administration, Bangkok, Thailand, 5Thailand Ministry of Public Health, Nonthaburi, Thailand
Background: The Bangkok Tenofovir Study is an ongoing randomized, double-blind, placebo-controlled trial to determine if daily oral tenofovir prevents HIV infection among injecting drug users (IDUs). In order to accurately assess tenofovir safety and efficacy among IDUs, it is necessary to understand participant adherence. We present adherence data collected through December 2011.
Methods: The trial is being conducted in 17 Bangkok Metropolitan Administration drug treatment clinics. Eligible IDUs are randomized (1:1) to receive daily tenofovir 300mg or placebo. Participants choose follow-up daily with directly observed taking of study drug (DOT) or monthly without DOT and may change to or from DOT at monthly visits. Adherence of all participants is assessed at monthly visits using study drug diaries and pill counts. We defined adherent as taking study drug at least 5 of 7 days/week with no more than 2 consecutive days off study drug. We assessed adherence during the most recent 12 week period that the participant provided data.
Results: From June 2005 through December 2011, 2413 IDUs were enrolled, their median age was 31 years, 80% were male, and 88% chose daily DOT visits. Overall, 1261 (53%) of participants met the adherent definition and 988 (41%) reported taking study drug every day during the 12 weeks before assessment. Among the 1818 (75%) participants who chose DOT during the entire 12 weeks, 1061 (58%) met the adherent definition and 845 (46%) took study drug every day.
Conclusions: This interim assessment of adherence shows that most participants are choosing to come to clinic daily for DOT and among these participants 58% meet or exceed the adherent definition. The Bangkok Tenofovir Study will be able to provide reliable adherence data to help determine if tenofovir prevents HIV infection among injecting drug users.
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