Kiran Grover, MPH, joined the EXTRA-CVD trial as a Senior Clinical Research Coordinator almost a year after its inception. EXTRA-CVD is a clinical trial designed to assess the efficacy of a multi-component nurse intervention to reduce cardiovascular disease risk in virally suppressed patients living with HIV who are on antiretroviral medication. The study employs multiple strategies including qualitative and quantitative methods, human-centered design, and implementation science.
People living with HIV often have untreated high cholesterol and/or hypertension and low perceived risk of cardiovascular disease, and they face challenges with primary care coordination between HIV specialists and non-HIV providers. The trial’s investigators are looking at how to address these problems. Because patients are inclined to see their infectious disease specialists to manage their HIV and their primary care physician to manage other co-morbidities, they are missing a consistent voice who advocates for the whole patient, as practitioners tend to stay in their lanes. The study is using nurses as “coaches” who educate patients on their overall cardiovascular health, and liaise between practitioners so patients can achieve lower hypertension and cholesterol goals.
Grover states that “With their vast clinical knowledge and ability to build rapport with patients, nurses are well-positioned to provide guidance and support and serve as a liaison between providers to help patients achieve their health goals. We’re hoping patients reach their cardiovascular-related goals, including a reduction in blood pressure and/or non-HDL cholesterol by the study’s conclusion.”
Participants are seen once every 4 months for a year. The first line of defense is to start or change medications, and if patients aren’t open to this, the second line of defense is education on medication adherence, exercise, and a healthy diet. All doctors involved in the patient’s care are made aware of any changes.
“This study is particularly rewarding for patients who are not aware or are not prioritizing their cardiovascular disease risk. Educating patients about their high blood pressure and cholesterol management can go a long way” said Grover.
Grover came into the picture when stakeholders, clinicians, research staff, and roughly two to three patients were starting the iterative process of designing the study’s qualitative phase. They considered the patient’s perspective and the clinicians’ day-to-day practices to make the nurse-led intervention feasible.
Duke is one of three EXTRA-CVD sites across the US that are currently recruiting, and to date, Grover is over 1/3 of the way to her goal of 100 patients. She has experienced some hurdles—first, COVID forced the Duke site to shut down recruiting for a bit. Second, her patients are considered a “vulnerable population.” Their low socioeconomic status feeds into increased life chaos—requiring the use of creative strategies to maintain engagement and follow-up.
Working on the EXTRA-CVD study is unlike Grover’s previous experiences. For example, she is the sole project coordinator and fully controls Duke’s site, whereas other studies have been more fragmented with multiple coordinators. She leads all recruitment and oversees the research assistants and specialists who screen and recruit patients on the back end. She also leads meetings, manages data entry, and keeps the other sites updated on Duke’s progress. Taking on this position has definitely taught her how to be detail-oriented and the art of multi-tasking.
Her PIs, Drs. Hayden Bosworth and Lance Okeke, along with project manager, Megan Oakes, agree that her greatest achievements have been not only ramping up recruitment after the COVID disruption but her ability to juggle a clinical trial with several moving parts that includes a vulnerable population. It’s largely due to Grover’s tremendous efforts and leadership that the Duke site has been so successful: her team is recruiting at a fast rate and is on track to achieve the study goals within projected timelines.