April 2, 2019
Monitoring the psychosocial experiences of people living with HIV is a key recommendation for conducting clinical trials where participants will have interruptions in antiretroviral therapy (ART). This new development is influenced in part by the contributions of a social scientist at the UNC-Chapel Hill Gillings School of Global Public Health.
Karine Dubé, DrPH, assistant professor in the Public Health Leadership Program at the Gillings School, is a co-author of the paper, “Recommendations for analytical antiretroviral treatment interruptions in HIV research trials — report of a consensus meeting,” which was published online March 15 in Lancet HIV.
Despite the success of ART, HIV infection remains a chronic disease that long-term ART alone cannot eliminate. While scientists search for ways to attain viral suppression without ART, clinical trial participants must often experience analytical treatment interruptions (ATI) so novel therapeutics can be tested.
On July 9, 2018, Dubé joined 40 experts in HIV research and industry from around the world at the Ragon Institute of MGH, MIT and Harvard in Cambridge, Mass., to assess the scientific value, risks, benefits and methods of ATIs, including the ethical and community perspectives of these approaches. The interdisciplinary group was charged with drafting recommendations for researchers on how to conduct ATIs in ways that maximize knowledge gained and minimize risks to trial participants.
“Our field needed consensus from experts about inclusion and exclusion criteria for HIV cure trials requiring ATIs. We also needed to better understand the possible benefits and risks of ATIs, when to reinstate ART, and how to monitor participants’ experiences and informed consent,” said Dubé, who has a growing body of research around participant perspectives in HIV cure research efforts. “As a social scientist, my contribution was to make sure we had included in our recommendations the need for monitoring the psychosocial trajectory of participating in studies involving treatment interruptions.”
Interrupting such treatment can be anxiety-inducing, Dubé explained. A participant may feel apprehensive about being removed from ART and/or about resuming treatment. Conducting studies in ways that minimize the psychosocial harm of ATIs, as well any potential for clinical harm, helps researchers consider each participant as a whole person and reflect on how a study may impact their life overall. According to Dubé, these patient perspectives are fundamental to finding a cure moving forward.
“Though a cure is a biomedical development, if we don’t pay attention to the psychosocial aspects of what an HIV cure means, it will not be as life-changing for people living with HIV,” she shared. “Having scientists agree that patient perspectives are vital to conducting these studies ethically and safely is a critical milestone for our field.”
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