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CROI 2024 Advocate CT
Reach for the Top: Why Meetings Like CROI 2024 Should Start With Community-Centered Research

Released: April 03, 2024

Expiration: April 02, 2025

Activity Information

Activity

Progress
1
Course Completed
Key Takeaways
  • The final session at CROI 2024 provided real-world evidence of implemented HIV prevention strategies highlighting the stories of PrEP consumers.
  • Healthcare professionals need to better engage and listen to the communities they serve to address needs and improve outcomes.
  • Policies and programs need to catch up with science and focus on innovation inside and outside the clinic when it comes to the implementation of all forms of PrEP.

Like many HIV prevention research advocates, I find myself frustrated with the glaring disconnects, delays, and dismissals we often see at the intersection of scientific research and healthcare program implementation. 

Science can declare a new intervention as “superior” to others in the context of a clinical trial, but that same intervention may be anything but in real-world practice. Large meetings such as the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) announce important new understandings on how established interventions work, yet clinical guidance and local program activities often remain stuck—following outdated recommendations that are no longer supported by current research. 

That’s why I was delighted to attend the “Promise and Pitfalls of Biomedical Prevention: Beyond Phase III” session, which was scheduled at the last timeslot on the final day of CROI 2024. Judging by participants’ comments and questions during the session, my delight was shared by many, as more than one person said that this session should have marked the beginning of the conference rather than the end. 

Real-world Evidence in HIV Prevention
I am not the only one who wants more “rubber hits the road” type of sessions at these meetings, focusing on the real-world pitfalls and promises in HIV that should compel the community to innovate, implement smarter and faster, and better prioritize the people we collectively serve. In this case, these are the people who are vulnerable to HIV acquisition. 

Punctuated by personal video testimonials from real people who shared their experiences and perspectives with using various HIV prevention strategies—a very nice touch in a scientific space that too often neglects to highlight crucial community viewpoints—the session addressed the slow rollout of long-acting (LA) cabotegravir (CAB) for pre-exposure prophylaxis (PrEP), shared updates on the trajectory of the dapivirine vaginal ring for PrEP, and  challenged the dogma of event-driven or on-demand oral PrEP.

LA PrEP
After a video testimonial from an individual using LA CAB for PrEP, the CDC’s Dr Rupa R. Patel provided a sobering and painful assessment of the first 2 years of implementation for this much-heralded PrEP modality.

Focusing on the United States, the only country with a commercial market for CAB as a PrEP option, Dr Patel illustrated the incredibly complex healthcare system from the clinical delivery standpoint—a system that takes 30 days on average to get interested individuals started with their first injection while strangling its healthcare professionals (HCPs) and clients with cumbersome structures, multiple points of friction, and repetitive, time-consuming paperwork. All the while, this under resourced system needs to deliver time-sensitive injections to those who use CAB PrEP 6 times a year—people who are HIV negative and healthy may not be inclined to jump through hoops in the same ways that people living with HIV have become accustomed to. 

A snapshot of United States pharmacy data from September 2022 shared by Dr Patel noted 186,367 PrEP users, with 50% receiving generic FTC/TDF (good news there) but only 0.5% receiving CAB.

The nonscientific term I use for this is a “hot mess,” with more pitfalls than can be described in a 20-minute session. CAB PrEP in the United States remains very much a success waiting to happen, a “game changer” that has yet to score some solid points. Thankfully, Dr Patel, while working with Whitman-Walker Health in Washington, DC, led a clinic-level program to train community health workers to give CAB injections to grow capacity and improve the client experience. The inspiration for this task shifting came from her time working in Bangladesh, pointing to the many things we in the United States can learn from the so-called “global south” to improve healthcare access and outcomes. 

Closer to home, Dr Patel pointed to legislation in Washington state, passed last month with overwhelming approval and alacrity. On March 25, the state’s governor signed into law a provision allowing medical assistants, with supervision via telehealth, to provide IM injections for syphilis treatment.

This legislation provides a template that HIV advocates and HCPs can replicate in their states and with their lawmakers, providing the policy framework needed to improve the delivery of injectable HIV PrEP. In addition, this model creates possibilities for improving a wide range of needs/services—it shows how we might synergistically bundle services for clients with myriad concerns or needs. After all, there is not a single person on the planet for whom HIV prevention is their only healthcare need. 

Monthly Vaginal Ring
Dr Leila E. Mansoor, representing the Centre for the AIDS Programme of Research in South Africa (CAPRISA), then brought us full circle via a presentation dedicated to the monthly dapivirine vaginal ring. She charted its trajectory, from phase III clinical trials held almost a decade ago that pegged the ring at about 30% efficacy to findings in 2020 that indicate 75% to 91% effectiveness if used consistently and correctly, mirroring the trajectory previously seen with oral PrEP. Products work best when they are used consistently and correctly.

Recommended by the WHO in 2021, the dapivirine vaginal ring is now approved in 9 African countries and has been shown to be safe when used before and during pregnancy. Currently, there are next-generation rings in development, including a 90-day dapivirine vaginal ring, that would reduce costs and ease adherence, as well as a 90-day multipurpose vaginal ring with both dapivirine and levonorgestrel (a hormonal contraceptive). Many people want a product that provides protection from both unwanted pregnancy and HIV infection; therefore, addressing these 2 needs with 1 option is something from which many communities would benefit.

Dr Mansoor shared that cisgender African women across all age groups were excited about having legitimate choices for HIV prevention. Furthermore, the ring has the ability to be used without negotiation, with ease, and with discretion. Dr Mansoor also spoke of a new initiative in which Kiara Health, a South African company, will be manufacturing approximately 1 million dapivirine vaginal rings per year—significantly reducing costs and increasing access to public health at the same time. A win-win!

As was noted in the question and answer portion of this presentation, the dapivirine vaginal ring was unfortunately pulled from FDA review in 2021. However, there are women in the United States who face high rates of HIV infection and want the ability to choose the dapivirine vaginal ring for their sexual health needs. American women and healthcare advocates were not engaged in the decision to take the ring out of contention for use in this country, and some people were very angry about that neglect. Thankfully, the Population Council acquired the ring in 2022 and has stated their commitment to providing vaginal ring options where they are needed most. 

Lessons Learned Thus Far

  1. Drug developers and HCPs should not make decisions without first asking the community.
  2. Listen to the community.
  3. If you mess up on lessons 1 and 2, you can always try again.
  4. We need a National PrEP Program in the United States to streamline and simplify access to all PrEP modalities.
  5. Advocates can never take their eyes off the ball (or the ring).

Challenging Our Current Understanding of PrEP
Dr Jenell Stewart from the Hennepin Healthcare Research Institute provided the final discussion, in which she challenged the dogma of event-driven oral emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) PrEP. As with the other speaker presentations, Dr Stewert’s section opened with a fantastic video testimonial from a real-world user of event-driven, also known as on-demand or 2+1+1, PrEP.

Frédérique, a transgender woman from France, shared her experience first using oral PrEP daily, saying: “Back in those days, we were having a hectic, vivid, chaotic sex life which involved lots of chemicals, and part of the whole concept was about losing control. In those days, I definitely needed to be protected, including from myself, on a permanent basis.” Then she experienced a change in her sex life. “When my life changed from big city, club chaos, and losing control to quiet, countryside, chill, and laid-back sex life, I changed to PrEP on demand just because…[there] wasn’t [a] need for me to take this medication on a daily basis.”

The flexibility of on-demand PrEP is what Frédérique finds most appealing, as she follows the 2+1+1 regimen that can be adapted as needed. “If I [would] go to a big city with a lot of action, lots of fun, lots of parties, I would rather make it…2-1-1-1-1-1-1-1 until the fun is over. And 2 days more, after the fun is over.” The point Frédérique makes here is that PrEP does not have to be used strictly on demand. If someone needs daily protection, they can always switch back to daily PrEP. “That’s how I do it,” Frédérique concluded.

Listen to the Community!
Dr Stewart, like the speakers before her, brought an advocate’s heart and passion to her presentation, emphatically challenging event-driven PrEP dogmas as most researchers and HCPs understand it today. Frédérique’s testimonial better illustrates the lived realities of those who use daily vs on-demand PrEP. Citing several studies and resources, Dr Stewart showed that event-driven PrEP is both desired and effective across various populations and pointed out that some individuals will prefer this strategy even though they may have access to long-acting options. This is because offering choices and flexibility is the very definition of patient-centered care. 

Dr Stewart highlighted the findings of a new paper by Dr Jeanne Marrazzo, finding in a pooled analysis from 11 studies of FTC/TDF PrEP in cisgender women that 4-6 pills/week provided robust protection—just as we have seen in cisgender men for years. This paper calls into question (quite loudly) that protection requires near-perfect adherence of 6 or 7 pills/week. “These data suggest that women can be just as imperfect as we’ve been allowing men to be,” Dr Stewart declared.

Dr Marrazzo’s paper also provides evidence to reconsider event-driven PrEP for women and underscores the need for more research. Event-driven PrEP for all who want it—that sounds nice, right?

It is past time for the CDC to catch up with the science. Other organizations like the WHO; International Antiviral Society‒USA; British HIV Association; European AIDS Clinical Society; Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine; California Department of Public Health; and San Francisco Department of Public Health already include event-driven PrEP in their guidelines. 

Final Thoughts and Lessons Learned
Just before this session began on that last day of CROI 2024, I was mentally and physically exhausted and more than a little numb from participating in nearly 5 days of a very intense conference. I did not know if the aging sponge that is my brain had any absorptive powers left for anything other than contemplating a nice snack and a very long nap.

But after this session I left inspired and energized to continue fighting for community-centered approaches to research and program development. I was grateful for the researchers and scientists who authentically engaged with their communities, who did not question why we (those living with and vulnerable to HIV) are the most important aspect of HIV science and human-centered research, and who asked us questions and listened— even when what we had to say was different from what they were expecting to hear, critical of their work, or smashed all the pretty little things in the proverbial China shop to smithereens.

Final lesson: Next year, CROI should include more sessions like this, and let’s have them at the top of the program, too.

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