AIDS Research and Human Retroviruses, June 2021.
Analytical treatment interruptions (ATIs) have become a common feature of HIV cure-related trials but there are currently no biomarkers (or signals in the blood) that can accurately predict when HIV will return during an ATI. Co-led by Drs. Jonathan Li (Brigham and Women’s Hospital, Boston) and Davey Smith (University of California, San Diego), A5345 study was designed to identify biomarkers that could predict viral rebound. The study included a socio-behavioral research component led by Dr. Karine Dubé of UNC-Chapel Hill, in collaboration with A5345 community representatives Liz Barr and David Palm.
A5345 showed that most participants perceived societal-level benefits of advancing HIV cure research, as well as personal-level benefits, such as the opportunity to learn about the body’s response to the ATI. Further, most participants demonstrated a detailed understanding of the study. However, approximately 20 percent of A5345 study participants did not report any research risks involved despite these being presented during the informed consent process. Common concerns, in about four in five participants, were related to the ATI – including CD4+ cell count decreases, becoming detectable for HIV, and developing acute retroviral syndrome.
These results underscore the importance of considering how research risks are relayed and the perceived benefits of participation (both physical and psychological) from participants’ perspectives. Key messages pertaining to study-related risks may need to be clarified and reiterated periodically throughout follow-up in HIV cure-related studies involving ATIs. The importance of assessing participants’ perceptions and experiences over time in HIV cure-related studies is increasingly recognized (rather than one-time assessments). The investigative team will soon share results from the A5345 follow-up socio-behavioral assessments. Methods and results from the ACTG A5345 socio-behavioral component are informing the design of participant-centered measures as part of extended ATI trials in the ACTG and at UCSF.
This is a very important study confirming that informed consent is a challenging process. It emphasizes the need to continue to explain research studies to participants and obtain ongoing informed consent. Most researchers and study participants agree that consents are hard to understand and too long. The investigators highlight the need to improve our consent process so that participants understand the risks and are able to make informed decisions about study participation.
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