OA07.06 LB
Background: Pre-exposure prophylaxis (PrEP) has been shown to decrease HIV incidence in MSM, but optimal protection is dependent on medication adherence. The data presented here are from a pilot study, designed to assess whether an intervention based on Life-Steps, an effective intervention to enhance HAART adherence in HIV-infected patients, could improve PrEP adherence among men who have sex with men (MSM). who reported recent condomless anal sex.
Methods: Between 11/2012 and 12/2013, 55 Boston-area HIV- MSM who were interested in initiating PrEP were enrolled in Project PrEPARE, and randomized to Life-Steps which included 4 weekly sessions that addressed barriers and facilitators of PrEP adherence, or to a control condition that provided supportive counseling. Adherence was monitored by Wisepill, and unprotected sex was assessed via daily text messaging.
Results: Participants were primarily White (94%) and well-educated (64% had completed college), and sociodemographic factors were similar in both randomized groups. Over the 6 months' observation, 90% of the MSM in each group took at least 80% of their daily pills on a weekly basis, as measured by Wisepill and drug levels, and this did not differ by study condition. Condomless sex rates did not change significantly in either group over time. About 90% of the time during the study, the men in both groups either had drug levels consistent with taking most of their PrEP doses and/or used condoms during sex. No incident HIV infections occurred during the study.
Conclusions: Most MSM in this study demonstrated levels of PrEP adherence consistent with protective benefit, whether they received Life-Steps or supportive counseling. Given the high rates of adherence in both groups, the data suggest that MSM who elect to receive open-label PrEP can be highly adherent and self-protective. New PreP adherence interventions should focus on at risk persons who anticipate or demonstrate difficulties with routine medication adherence.