Px Pulse Podcast: What’s next for the dapivirine ring

The newest episode of AVAC’s Px Pulse podcast is up, bringing you critical updates on the dapivirine vaginal ring.

Download the episode via iTunes or at www.avac.org/px-pulse.

In March, initial results from the two open-label trials of the dapivirine vaginal ring (HOPE and DREAM) showed that adherence and efficacy improved over the earlier Phase III trials. Open-label studies, unlike Phase III studies, do not use a placebo, and all participants know they are using an intervention with evidence of a certain level of HIV protection. The ring is also advancing along the pathway to licensure. In other words, there’s much to discuss about this female-initiated HIV prevention option.

What do these data mean? What’s important to know about how and where the ring might be approved for use? If approved, where and when could women access the ring? And what do women who use the ring say about it?

In this episode, Zeda Rosenberg of the International Partnerships for Microbicides, which developed the ring, explains the latest findings and spells out how, when, where and if the ring might become an available tool. A trial participant and community leader in Uganda, Ruth* pulls back the curtain on the ups and downs of using the ring, and a Ugandan investigator with the REACH study, Carolyne Akello of the Makere University-Johns Hopkins University Research Collaboration, explains the importance of this new trial that will explore the potential of both this monthly vaginal ring as well as daily oral PrEP for young women.

Listen for a nuanced take on the data, what questions remain—and what it means for advocacy!

*Last name withheld for confidentiality.

Now Accepting Applications for the GPP Online Training Course!

AVAC is pleased to announce the sixth offering of our global Good Participatory Practice (GPP) Online Training Course. Through online lessons, personal feedback and discussions with faculty, participants will strengthen their strategic planning skills and learn to translate GPP theory into real-world practice!

Applications are due by Wednesday, April 4. Download the application here.

Stakeholder engagement is increasingly recognized as essential for sustaining support for research and generating solutions to complex ethical and operational challenges. The question is no longer “should we engage?” but rather “who and how do we engage for greatest impact?”

The course explores the Good Participatory Practice Guidelines, a normative framework that lays out specific standards for involving stakeholders throughout the clinical trial process. The course is designed for anyone who is responsible for stakeholder engagement at a trial site or who wants to deepen their skill set related to GPP implementation.

The course will run from April 11-June 15, 2018 and learners should expect to spend approximately 2-4 hours on coursework each week.

Download the application here and submit it to GPPonlinecourse@avac.org by Wednesday, April 4. For more information or questions, please contact Jessica Salzwedel (jessica@avac.org).

CROI 2018: Highlights and what’s next for advocates

[UPDATED: slides and audio from our webinar series are now available below.]

Historically, the Conference on Retroviruses and Opportunistic Infections (more commonly known as CROI) is heavy on basic science and early-phase research. Data from these types of studies were still prominent in 2018 (see Jon Cohen’s excellent Science article on new animal data informing cure and vaccine research). This year the meeting also broadened its lens from the lab to the ways that different strategies are, or might, have an impact in the context of people’s complex lives.

Dapivirine Ring: Guess what, women use it when they know what works!

The dapivirine vaginal ring is a silicone ring containing an antiretroviral that is released slowly over time. It’s been designed to be worn by women for around a month. Two years ago, at CROI 2016, the ASPIRE and Ring Study results showed that the dapivirine vaginal ring is safe and reduces the risk of HIV infection by around 30 percent overall among women enrolled in the study. At CROI 2018, interim data from the open-label extension (OLE) trials of the ring—HOPE and DREAM—showed that the ring reduced risk by 50 percent. In the open-label studies, all participants have been given access to the dapivirine ring to use monthly for up to 12 months. There is no placebo and all participants are told about the safety and efficacy data. Presenting on behalf of the HOPE study team, Jared Baeten (MTN) remarked that the ring data are similar to the oral PrEP OLE data-in those studies too, people were more adherent once they knew the results from prior trials. Final data from HOPE and DREAM, including findings on how well it works in those who use it consistently, will be available in late 2018/early 2019.

What’s Next

The European Medicines Agency (EMA) is reviewing available data on the ring under a framework that allows it to provide regulatory guidance for developing countries. Its decision is expected in late 2018. Will the world be ready with investments, introduction plans and advocacy? Experience to date says: only if advocates work at local, regional and global levels to demand advance planning and action.

Women’s Vaginas: They’re amazing and important to HIV (duh!)

A biome is a large naturally occurring group of plants or animals in a given habitat. The vaginal microbiome is the naturally occurring group of bacteria that live in women’s vaginas and-depending on the proportion of different bacteria present at a given time-keep us healthy or may make us uncomfortable or even put us at risk. The relationship between the vaginal microbiome and HIV acquisition has been a focus at several recent conferences. It was highlighted again in a plenary presentation at CROI.

Nichole Klatt (University of Washington) presented data on what happens when there is an imbalance between good and bad bacteria, a condition known as vaginal microbiome dysbiosis. When researchers looked at vaginal bacteria and different antiretrovirals in lab studies (in vitro), they found that microbiomes with an imbalance towards bad bacteria showed some degradation of topical tenofovir and dapivirine. In other words: it could be that women with such imbalances who are adherent to a vaginal microbicide or the dapivirine ring might still have lower levels of drug in their genital tissue than what is needed for adherence.

It’s incredibly important to understand how the microbiome impacts HIV risk and vaginal health, including the presence of topically applied ARV-based prevention. It’s also incredibly important to remember that these data do not say anything about how oral tenofovir-based PrEP works for women. Oral PrEP arrives in genital tract cells in completely different ways than topical PrEP. To date, data from the human trials of both oral PrEP and dapivirine ring haven’t shown any difference in effect in women with bacterial vaginosis, which is good news. Additional data will continue to shed light on this important and continuing story. And in the meantime, the take-home is still that oral PrEP works for women and that so far there has been no difference in levels of protection in the ring studies linked to dysbiosis.

What’s Next

Advocates need to be on the frontlines of explaining what these vaginal microbiome data do and don’t tell us. We can’t afford misinformation suggesting that oral PrEP doesn’t work in women. We also can’t afford to ignore the complexities of all bodies-female, male and trans-and how they impact prevention and treatment.

Pregnant and Post-Partum Women Need HIV Prevention

A presentation from Renee Heffron (University of Washington) provided more evidence that pregnant and post-partum women are at increased risk of HIV infection. She and colleagues analyzed data from two studies of over 2,700 serodifferent couples. They found that women who were pregnant or post-partum were 3-4 times more likely to acquire HIV. Implications for care and prevention include counseling, more testing, treatment for male partners and woman-controlled prevention options like oral PrEP.

What’s Next

2018 will see many discussions of pregnancy, contraceptives and HIV risk as the many stakeholders prepare for data from the ECHO trial. ECHO is looking at three different methods (DMPA, copper IUD and Jadelle implant) to see if any have an impact on women’s HIV risk. These data are an essential reminder that HIV risk is driven by many things-including pregnancy. Advocates need to push for PrEP in the ante- and post-natal context, contraceptive choice, programs that diagnose male partners and link them to effective ART-and more. Data and global and national guidelines on the use of oral PrEP (e.g., the WHO technical brief on preventing HIV during pregnancy and breastfeeding in the context of PrEP) and the dapivirine ring for pregnant and post-partum women are essential.

PrEP Use Increases but Disparities Persist

Access to PrEP was woven throughout the CROI program, as data on PrEP programs and use continues to accumulate. Findings from San Francisco and Australia both showed a significant uptick in PrEP use and reduced infections (primarily in men who have sex with men) but across both of the studies racial and ethnic disparities in access remained largely unchanged. A new analysis from the US Centers for Disease Control and Prevention (CDC), also presented at CROI, found that two-thirds of those who could benefit from PrEP are African-American or Latino and yet prescriptions for these populations remain stubbornly low. Gaps in access were seen across racial groups but were most stark among non-white populations.

What’s Next

A continued fight for health equity as part of a broader social justice agenda in America-and around the world.


In a meeting known for a focus on basic science, conversations about the Undetectable=Untransmittable campaign and its role in reducing stigma were frequent and welcomed. And for the first time there was a plenary session on mental health at which presenter Robert Remien (HIV Center for Clinical and Behavioral Studies, Columbia University) called for stepped up mental health services to achieve the 90-90-90 goals.

What’s Next

Advocates have consistently been at the frontlines of demanding a holistic approach to prevention and treatment—here’s more data to fuel the fight.

Products in the Pipeline

While there was an increased focus on implementation work this CROI, true to form the meeting also featured plenty on data from early-stage research. Among the hundreds of posters and oral abstract presentations a couple stood out including a non-ARV vaginal insert-designed to prevent HIV, HSV-2 and HPV infection-from PopCouncil and the long-acting ARV from Merck (MK-8591) to prevent HIV. Given favorable animal data, both products are being considered for clinical development.

What’s Next

A major scientific-literacy and agenda-setting push so that advocates can join researchers and product developers to guide decisions about how these trials will be designed and when and where they will happen.

Keep the Conversation Going

Join us for a post-CROI webinar series! Dig into the data with researchers and discuss with fellow advocates how these findings can inform our advocacy work moving forward. Register today!

And stay tuned for announcements on additional webinars!

Insight to Impact: Demand Creation Challenge

The Insight to Impact: Demand Creation Challenge is dedicated to awarding innovative, disruptive, and compelling HIV prevention communications campaigns.

Campaigns may include short- and long-term communications programs and interventions, interpersonal communications, and mass media communications, including print, digital, and social media materials, developed to promote HIV prevention products, behaviors, or services.

Finalists will be showcased and winners will be announced at the AIDS 2018 pre-conference event, “Insight to Impact,” hosted by the OPTIONS Consortium on July 21, 2018.

Click here for more information.

Tracking the Fast-Changing Status of PrEP Around the World

A few weeks ago, South Korea became the latest country to introduce oral PrEP, bringing the number of countries offering PrEP to more than 50. With more people using PrEP every month, AVAC and its HIV Prevention Market Manager project has created the Global PrEP Tracker to help keep track of the fast-changing status of PrEP around the world.

The tracker, housed on the PrEP Watch online clearinghouse, is a single source offering a variety of information, including:

  • Estimated PrEP initiations compared to targets by country.
  • Specifics on PrEP programs by population, service delivery model and funder.
  • Status updates on country registration of tenofovir-based medications for prevention.
  • Up-to-date information on daily oral PrEP inclusion in national policy guidelines.

The tracker provides a global snapshot of PrEP statistics by country. PrEP Watch also houses Country Update Pages, which provide an overview of the status of daily oral PrEP in countries where PrEP is rolling out or being considered.

The numbers provided in the Global PrEP Tracker are estimates, as monitoring systems vary by country and are in early stages. Right now, the estimate is of individuals initiated on PrEP in ongoing projects. The tracker does not estimate the number of people actively taking PrEP at a given moment.

Updated quarterly, the estimates in PrEP Watch are derived by review of and outreach to implementers of oral PrEP studies, implementation initiatives and large-scale national programs. AVAC is grateful to the projects who contribute their data–these contributions make the tracker possible! If you notice data are missing, please let us know.

We hope this resource will bring some clarity to the fast-moving field of oral PrEP–and we look forward to working together to continue to improve the tracker in the future!