Battling HIV on many fronts

Today’s evolving clinical trials landscape, which has been severely impacted by the COVID-19 pandemic, provides an opportunity to challenge the HIV prevention and treatment clinical research paradigm, particularly the design of HIV vaccine efficacy trials. To do this, sponsors must start by closely examining the use of active controls, study populations, standards of prevention, primary or surrogate endpoints and biomarkers when designing such trials. More importantly, they need to take into consideration the diverse cultural, lifestyle and biological circumstances that influence individual decision-making around the use of HIV prevention strategies, which can evolve over the course of a study.

Specifically, people at risk for, or living with, HIV face the challenges of stigma and discrimination, both of which are known to negatively affect quality of life, as well as treatment outcomes. Therefore, sponsors will need to be aware of the societal stigma associated with HIV, including the possible reluctance to participate in HIV clinical trials. As such, sponsors will need to provide sensitivity training to staff and sites. For example, rather than providing smartphones for collecting patient diaries, sponsors may consider BYOD (bring your own device) to reduce stigmas, as patients may be questioned about why and how they received these new devices.

Designing patient-centric clinical trials for people at risk for, or living with, HIV

Given the unique challenges associated with HIV vaccine efficacy trials, sponsors should consider employing a decentralised, patient-centric alternative to the traditional on-site model, such as a hybrid design, which would incorporate three elements: in-home services, virtual visits and an end-to-end participant engagement platform (i.e., a study app). This option would not only enhance trial recruitment, but also promote study compliance.

Through home health care services, for example, sponsors could deploy trained nurses and teams to conduct visits in the participant’s home, which could reduce the travel burden on participants and their families. What’s more, home visits offered outside normal business hours could accommodate participants’ schedules, further facilitating better compliance.

Virtual visits using telemedicine, would allow the investigator to observe the participant, instruct them to complete assessments and record their observations, without having to travel to the patient’s home. In addition, providing a study app with notifications, reminders and surveys would allow for communication and remote data collection directly from the participant, creating better engagement. Using this strategy, the investigator and study team would not have to wait for a participant to attend an on-site visit for data collection or download, creating efficiency and saving time. Having the participant app provided via a digital tool, such as a smartphone, also would allow the participant to have one access point for recording data, thereby easing the burden on participants and study teams.

Keeping HIV clinical trials on track amid a pandemic

Ongoing clinical trials with patients at risk for, or living with HIV, have felt the disruptions caused by the COVID-19 pandemic. By implementing the new strategies outlined above, sponsors can better manage these clinical trials and reduce the risk of infection to trial participants and staff. For example, incorporating decentralised elements – such as home health care and/or other alternative site solutions – into an HIV clinical trial can ensure uninterrupted access to HIV treatments and services, while further reducing contact with clinics.

As the current pandemic has led to the increase in the use of decentralisation, sponsors are beginning to consider making these new strategies a permanent part of protocols.

For more information about infectious disease clinical research, read our latest whitepaper.

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Learn more about home health care and decentralised clinical models here: ICONplc.com/dct.