In the past, this space has focused on profiles of research or clinical scientists and their individual work. While all VIDI science is by nature collaborative, many of these stories don’t touch on the magnitude of the joint effort required to perform large clinical trials such as those conducted by the HIV Vaccine Trials Network. This month, we profile Dr. Shelly Karuna, VIDI staff physician and protocol team leader for the HVTN.
The HVTN pre-dates and is an integral piece of VIDI, but also includes numerous sites, investigators and collaborators from other institutions around the world. Karuna is part of the HVTN Core Office, centered at VIDI, and is one of four protocol team leaders in the network. Three of the protocol team leaders are medical doctors, and serve as physicians for different HVTN protocols (a protocol eventually develops into a clinical trial, but also encompasses the preparatory work that precedes the trial). The job of a protocol team leader is also to help ensure collaboration and progress during the three important phases of each trial, Karuna said, namely, protocol development, protocol implementation, and post-protocol work. While she is rarely directly involved in generating the ideas that lead to HVTN trials, “the team leaders really facilitate the labor and delivery of our principal investigators’ ideas,” Karuna said.
Karuna, who joined the HVTN in March 2009, moved from California to Seattle in 2002 for a general surgery residency at Virginia Mason Medical Center, and then went on to a master’s degree program in public health at the University of Washington. Although her career took a big shift when she went from surgeon to clinical trial physician for the HVTN, Karuna has long held an interest in HIV/AIDS advocacy. She worked in HIV education in her home state of Louisiana, and continued her connection with AIDS patients and research by volunteering at a hospice for AIDS patients during her undergraduate studies at Duke University, as well as working in the infectious diseases clinic and the health policy department there. Before starting medical school at the University of California, San Diego, Karuna worked as a clinic coordinator for a study run by the AIDS Clinical Trial Group at UC San Francisco.
“From Louisiana to San Francisco, I was floored by the remarkable discrimination against people with the disease,” Karuna said, speaking of her decision to join the HVTN. “HIV is a real intellectual conundrum, and that’s inspiring as well. I was excited about the prospect of being able to combine something that was intellectually interesting with work on behalf of people who clearly could use more advocates."
Much of Karuna’s current effort is concentrated on serving as protocol team leader for the protocol called HVTN 505, an exploratory clinical trial to test whether a certain HIV vaccine regimen can reduce viral load setpoint as compared to placebo in trial participants who eventually become infected. The trial is currently enrolling participants and will use a similar (but not identical) vaccine to that used in the Step study, a trial which tested a candidate T-cell based HIV vaccine and was halted in 2007 as it did not prevent HIV acquisition. HVTN 505 is a smaller study than the Step study, enrolling 1,350 U.S. men and male-to-female transsexuals who have sex with men. Like the candidate vaccine in the Step study, one of the vaccines in HVTN 505 contains pieces of a virus called adenovirus type 5. In the Step study uncircumcised men who were Ad5 seropositive and received the vaccine had an increased incidence of HIV infection in the early months after vaccine receipt, compared to placebo recipients, so for safety reasons, HVTN 505 will only include circumcised men and MTF transgender women who are Ad5 negative.
Karuna is also protocol team leader for seven other trials and several additional concepts including: a study of a candidate vaccine regimen in South Africa; a study of the feasibility of introducing circumcision and foreskin samples to future vaccine trials; a study of the potential for vaccines to cause vaccine-induced positives on HIV tests; and two trials following participants from previous vaccine trials who became infected with HIV. “This work entails a great deal of group dynamics and interpersonal facilitation, and a lot of collaboration, and that I love,” Karuna said.
Outside of her work with the HVTN, Karuna is interested in patient advocacy, specifically in a field called “shared decision making,” which is a movement to increase patients’ participation and decision making in their own medical care in situations where a variety of preference-sensitive treatment approaches are possible. For example, a patient with early-stage breast cancer might be faced with a choice between a lumpectomy and radiation therapy or a mastectomy, two courses of treatment similar in mortality rate but very different in other respects. With shared decision making, the provider would educate the patient about her treatment choices, the patient would educate the provider about her values and preferences, and the two would come to a decision together. Karuna is a member of the Shared Decision Making Collaborative at the University of Washington, a collaboration working on shared decision making in medical centers in Washington State, which is at the forefront of this movement in the nation.
- Rachel Tompa