OA09.06
Background: Boston participants who enrolled in the CDC's PrEP safety study and the iPrEX PrEP efficacy trial were offered open label access to tenofovir-emtricitabine (TDF/FTC) for PrEP in the iPrEX Open Label Extension (OLE). We identified participants who enrolled and did not take TDF/FTC at the Boston study site and evaluated study records to characterize reasons for not being administered TDF/FTC.
Methods: Participants who were not dispensed TDF/FTC were identified. Visit note source documentation for each participant was analyzed to determine why participants were ineligible for drug dispensation. Reasons for drug dispensation ineligibility for each participant were then coded and sub-divided into common themes.
Results: Of 79 participants who enrolled in the CDC Safety study and 87 who enrolled in iPrEx, 56% enrolled in iPrEx OLE at the Boston site between 7/7/2011 and 3/29/2012. Median age was 44; 65% white, 23% Black, 12% other. Of 93 participants enrolled, 37% were not dispensed TDF/FTC. Median age of participants not dispensed TDF/FTC was 47; 59% white, 35% Black, 6% other. Of 34 participants, 38% did not perceive they had high enough risk for HIV to justify PrEP; 18% were concerned about side effects; 15% had active clinically significant medical problems (including cardiac disease, pulmonary disease, DM requiring hyperglycemic medication); 11% were taking contraindicated medications; 6% had seroconverted after completing the CDC Safety study, 6% felt pill-taking would be too burdensome; 6% indicated it was because of personal choice but did not provide reasons.
Conclusions: Because PrEP study participants changed clinically and behaviorally over time, these findings demonstrate that ongoing clinical examination and behavioral assessment of PrEP users is important, and PrEP delivery should not be automatic. Additional exploration into contextual factors that influence an individual's decision to take PrEP is needed as PrEP becomes one of several HIV prevention modalities.
