HIVR4P Co-Chair Sheena McCormack of University College London is a clinical epidemiologist specializing in HIV prevention. In addition to leading PROUD, a major U.K. study of PrEP in men who have sex with men, Sheena has served as Co-Principal Investigator of the Microbicides Development Programme, has participated in multiple HIV prevention research studies in Africa and Europe, and has a particular interest in how anthropological research can improve understanding of risk and adherence behaviours. Sheena sat down with the HIVR4P team to answer some quick questions about the research opportunities ahead and what she hopes to learn from the conference.
Your calendar is full with research, teaching and clinic duties. Why did you agree to add HIVR4P co-chair to your list of responsibilities?
My research has focused almost entirely on HIV prevention and so HIVR4P is the most important conference in the calendar for me. I previously attended most of the AIDS Vaccine conferences (I’m currently using my notebook from AIDS Vaccine 2013 in Barcelona!) and all of the Microbicide conferences. Bringing these two meetings together at the time that PrEP exploded on the scene has created a highly valuable meeting with a unique mix of scientific disciplines and community experts.
You’ve studied virtually every form of biomedical HIV prevention. What new and emerging HIV prevention approaches excite you most?
Implants and point of care diagnostics are both exciting to me. User choice is key, and we can see how successful providing choices has been in the contraceptive world, where implants are popular. I am really impressed with the expansion of contraceptive implants in countries with limited health care workers. Implants for prevention and treatment of HIV look feasible in this setting and could overcome some of the challenges associated with taking a pill every day or having to return to the clinics for more drug or another injection.
Point of care diagnostics have had an extraordinary impact in my clinical setting and community – you really put power in people’s hands with the right to test in private. At 56 Dean Street (the world’s largest sexual health clinic, located in London), we have seen how scaling up testing by offering choice and a speedy answer optimizes the effectiveness of an offer of early treatment or PrEP and has a profound impact on HIV transmission. It all starts with the test! However, there are critically important gaps…point of care affirmation that viral load is undetectable is one of these.
Where are we in the effort to combine HIV prevention and contraception in a single product? Why is it so challenging to do?
Although we have fixed dose combinations of antiretroviral drugs taken once a day, combining these with a progestin and achieving sustained release at a constant daily rate in a long-acting formulation is exponentially more challenging. Karl Malcolm (Professor of Drug Delivery at Queen’s University, Belfast) helped me to understand the issues – the potential for drug-drug interactions and vastly different mechanics required to release the thousand-fold differences in the drug dose for HIV and pregnancy prevention. That said, Bethany Young Holt of the Initiative for Multipurpose Prevention Technologies (IMPT) tells me that an oral combination of PrEP and contraception could be available 2022-24. Their database of multi-purpose products in development is impressive.
As lead investigator of the PROUD PrEP study, you’ve learned a lot about PrEP use by gay men. What are the biggest lessons from the study, and can they be applied to other populations or settings?
There are four lessons that I think translate to other populations and settings. The study was only meant to be a pilot, so the first thing I learnt was the value of a pilot phase as our assumptions about the size of trial needed derived from surveillance data were completely wrong! The second thing I learnt was that the sub-group of gay men who joined PROUD knew they were at higher risk of catching HIV than their peers, and when offered PrEP they took it really well. The third was that in spite of the shockingly high rate of HIV we observed and the high level of PrEP effectiveness (86%) in the study, it was not enough to support a national programme. Our policy makers could not commit without knowing the budget impact, and we could not be certain of the demand. The final major lesson for me was that you can change practice ahead of policy by joining forces with community organizations and clinics. Highly motivated individuals who recognized their risk and could afford it purchased drug online, and clinics provided the necessary additional kidney function test without charge.
Within every key population there will be a sub-group with a much higher rate of HIV than estimates suggest. Often they recognize this themselves, but tailored health promotion messages delivered by peers, health care providers and the media also help individuals to identify behaviours that put them at higher risk. They will want to take PrEP, but we need to make it as easy as possible because people are busy and have many other priorities. In contrast to treatment, PrEP is not something people take for life — just when they need it — so they need to know how to start and stop safely, and when to have an extra HIV test if they have not managed to follow the guidance.
The world is living through another pandemic right now, that of COVID-19. What do we know about how the novel coronavirus impacts people with HIV, and how is the epidemic playing out in the countries most affected by HIV today?
To my knowledge, there is still no evidence to suggest that people living with HIV who are on treatment are at any greater risk of catching this new coronavirus, SARS-CoV-2, or having more severe disease if they do. However, the risks for people living with HIV who also have TB, who are over age 60 or with live with other conditions such as cardiovascular disease or diabetes can be considerable. The response to COVID-19 has disrupted services everywhere, including in the countries that already bear the burden of HIV and where health service infrastructure is more vulnerable. Nonetheless, a massive effort is underway to ensure people have the drugs they need to stay well, and hopefully time will show that this has been successful.
The WHO website is a great place to go for the latest numbers, although it’s important to note that we only have tests for the virus at the moment, and the scale of testing differs substantially between countries. Once antibody testing is available we will have a much better idea of the how widespread infection is, and what the risks are for individuals.
Professor Gita Ramjee was one of the first to die of COVID-19 complications in South Africa. Gita was a good friend of mine and we worked together for over 20 years. She was passionate about HIV prevention, tenacious in her approach and always respectful of participants and communities. She ensured that they would benefit regardless of whether or not the products that were being tested worked. She remains an inspiration for us and will be sorely missed.
Finally, what are you most looking forward to learning about at HIVR4P?
I’m looking forward to hearing about the plan for broadly neutralising antibodies, the product pipeline for multi-purpose technology and vaccines, but most of all brainstorming about clinical trial design in future. We need to be efficient and deliver reliable results, but the designs have to be acceptable to the communities taking part and the ethics committees that oversee the trials.