OA15.02
Background: During the VOICE trial, self-reports and monthly product counts were used to measure adherence. Despite high reported adherence, drug pharmacokinetic (PK) levels indicated widespread non-use. The second stage of MTN 003D, a qualitative ancillary study to VOICE, retrospectively provided participants with PK results in hopes of encouraging candid discussion of low adherence. As the first PrEP study to provide such results directly to participants, researchers and regulators in Uganda were challenged with several ethical concerns.
Methods: After weighing risks and benefits of disclosing individual PK results during in depth interviews and prior to focus group discussions, tools were developed to ensure these were presented in a clear, yet neutral manner using pictures of a teapot with varying amounts of liquid. Nonetheless, regulators were concerned about the lack of health benefit and possible victimization including blame and/or ill treatment of participants for non-use. Study teams underwent training on the meaning of results, how to provide them in a non-judgmental manner; and how to handle participants' reactions. Regulators' concerns were allayed during a face-to-face meeting with members of the study team who described how results would be provided and how participants, who might be upset by the results, would be counseled.
Results: In Uganda, 51 participants received PK results; reactions ranged from disbelief to joy. No social harms were noted. Use of the tools facilitated discussions, even after initial denial of results. Indeed, while only 3/41 “low adherers” initially accepted their results, during the course of the interview many went on to provide reasons for non-use.
Conclusions: Despite ethical concerns, provision of PK results can be done in a safe and ethical manner, which reduces the possibility of victimization. The provision of these results can provide useful insights into participants' adherence challenges and future design of trials.
