CROI Round-Up; Post-Conference Webinar Series

News last week from the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston was dominated by new efficacy data from two vaginal ring trials that have implications for HIV prevention for women. Our take on it is here, along with a special page with more background than we could squeeze into a blog post. But, the CROI buzz wasn’t all about vaginal rings, and this update provides some ways to hear more about what happened last week and what it all means.

Post-CROI Webinar Series

We will be convening a series of post-CROI webinars covering a range of topics over the next couple of months. The first webinar in our series explored the ring results with advocates and researchers. Slides, audio and the Flash animation of the webinar are available here. And stay tuned for details about the additional webinars in the series!

In-Depth Analysis

In addition to lots of media reports and publications, our colleagues at NAM/aidsmap, The Body and NATAP all provided in-depth coverage of the myriad studies presented in oral abstract sessions, posters and more. Check out the hyperlinks above for comprehensive coverage.

CROI Program and Webcast

CROI provides a number of ways to review what happened in Boston: check out the full program; taped playbacks of press conferences; webcasts of all sessions; and electronic posters will be available a week after the conference. There was a wealth of information on a wide range of topics, but here is a selection of sessions and presentations you might want to explore:

  • Lifetime HIV risk in the US: New data from the US Centers for Disease Control and Prevention (CDC) projected that 1 in 2 black gay men could be diagnosed with HIV in their lifetime. That number is 1 in 4 for Latino gay men and 1 in 49 for African American women. The figures for white men and women are far lower. These data highlight the ways that race impacts access to healthcare at every point in the treatment cascade. They suggest an urgent need to provide prevention including PrEP at a wider scale and with messages and programs that are community-designed and owned. They also provide another opportunity to examine the ways that alarming statistics do and do not advance a structural analysis of the problems and solutions to public health issues. As one article highlighted—individual risk calculations can lay the burden on individuals to change behavior when the drivers of risk are systemic, embedded and often out of individual control.
  • PrEP in the Real-er World: There was a lot of data on oral PrEP that, as expected, added layers to understanding of what the strategy is, and what it can and cannot do. It started with a presentation by Keith Green (University of Chicago) on Engaging Young Men of Color in Community HIV Prevention Studies and later Darrell Wheeler (SUNY Albany) presented an important PrEP study in Black MSM (HPTN 073), which showed that a culturally anchored “client-centered care coordination” model (C4) was important to getting men into and supported in a PrEP program. Other data gave some insight into additional components of PrEP programming and messaging. Presentations included findings that PrEP use can have a limited impact on renal function—as it can in people living with HIV who use TDF/FTC as part of treatment; an update from a New York City PrEP project where rates of sexually transmitted infections among PrEP users suggest that routine screening—at every clinic visit—should be the norm; and finally, a presentation of HIV infection in an adherent PrEP user who acquired TDF/FTC-resistant HIV. Each of these presentations raises concerns—and has developed an excellent resource on the HIV-resistance data—but none are insurmountable or even surprising. Piloting PrEP in the real world is the only way to find out how best do deliver, message and monitor this new strategy to all populations at risk.
  • Long-Acting Injectables for Treatment—and Prevention: Antiretrotival treatment options took a step forward with the first injectable treatment option. 91 percent of patients in a study of the 8-week long-acting injectable cabotegravir and rilpivirine combination regimen maintained virological suppression and also expressed satisfaction with this new option in a new study. Both cabotegravir and rilpivirine are also being explored separately as PrEP agents. Marty Markowitz (Aaron Diamond AIDS Research Center) presented results from the Phase IIa ÉCLAIR study that examined the safety and pharmokinetics of cabotegravir in HIV-uninfected men, setting the stage for a future Phase III efficacy trial.
  • Turning Targets into Treatment: A full abstract-driven session was devoted to Getting to 90/90/90 and included Tendani Gaolathe (Botswana Harvard AIDS Institute Partnership) presenting on how Botswana is approaching the 90-90-90 goal, getting to 83 percent (testing), 87 percent (on treatment) and 96 percent (virally suppressed) representing an overall level of viral suppression of 70 percent as compared to the 73 percent goal of the 90-90-90 goals. Factors predictive of not being virally suppressed included youth, male gender, single status and, interestingly, higher education level. At the same time, there was a presentation on how Malawi is using its Option B+ rollout to prepare for universal treatment. The challenges of Option B+ could be seen in the 25 percent drop off in post-partum adherence by women after six months. And in a separate session, Helen Ayles (London School of Hygiene & Tropical Medicine) presented Missing But in Action: Where Are the Men? raising an emerging discussion of how to reach HIV-positive men with treatment programs. Strategies suggested include taking testing outside antenatal clinics and engagement through men’s clubs and even bars. While reaching these men is important, it remains critical that treatment for all who need it remain a focus.
  • Rectal Microbicides Well Received: Ross Cranston (MTN) presented data from MTN 017, the first Phase II rectal microbicide gel study—it showed no safety risk and both adherence and acceptability were high. The open-label trial looked at a rectal formulation of tenofovir gel inserted via vaginal applicator, comparing its daily use with event-driven (used before and after sex) use. A third study regimen included the use of daily oral Truvada as PrEP. All 195 MSM and transgender women cycled through each of the three regimens for eight weeks. Adherence feedback was provided to participants through daily texts, returned applicators and real-time drug levels reporting. This contributed to high adherence across all study regimens. Overall preference favors Truvada as PrEP slightly over event-driven tenofovir gel, but the difference is not statistically significant. Daily gel application came in a close third. Cranston concluded that due to these results, rectal tenofovir gel is worthy of further study. Research is already underway to expand the pipeline of rectal microbicide products in order to find the right product to move forward into an effectiveness study, said Ian McGowan (MTN), co-author of the study.
  • New Cure Work Discussed at CROI: On the day before CROI officially opened, the AIDS Treatment Activists Coalition, AVAC, European AIDS Treatment Group, Project Inform and TAG co-sponsored a community workshop on scientific, regulatory and community engagement issues in HIV cure research, which included an update on an exciting and emerging area using bNAbs for treatment and acute infection in the FRESH (Females Rising through Education, Support, and Health) cohort in South Africa. Presentations are posted online.

Medical Distrust: The Real Reason for PrEP Misgivings in the Black Community

At this year’s National African American MSM Leadership Summit on HIV/AIDS and Other Health Disparities (#NAESM2016), a white doctor stood before a room filled with hundreds of black men at the opening plenary luncheon and talked about how many people “need” to get on PrEP.

I get it. PrEP is the one of the best biomedical prevention tools available to people at risk for HIV infection today. PrEP is safe and effective. PrEP works if you take it correctly. I get it. What I don’t get is why a white doctor would be invited to stand before a room full of black men and tell them that they need to use this medication. The message may be appropriate, but the messenger (and how the message is delivered) matters.

There are lots of barriers to PrEP uptake among black MSM, but beyond the issues of risk perception, healthcare access, provider and consumer PrEP knowledge, PrEP stigma, and homophobia, the elephant in the room is still the history of medical distrust in the African-American community. Distrust of the medical system has been a barrier to care for African Americans since long before the AIDS epidemic started. Black people in the US have the highest mortality rates due to heart disease, diabetes, and some cancers, partially because of our distrust of medical providers. There is also the lingering legacy of mistreatment by researchers—particularly during the Tuskegee Syphilis Experiment—which left black people in the US wary of medical programs and clinical trials.

Medical distrust existed decades prior to the shocking revelations over the 40-year-long Tuskegee study, wherein black men with syphilis were left untreated in order to observe the natural progression of the disease. Dangerous, involuntary and unethical experiments have been carried out on African American subjects at least since the eighteenth century. Accounts of medical and personal violation were passed down orally, from generation to generation. Medical distrust could contribute to the slow uptake of PrEP among black men.

Beyond the importance of both the message and the messenger, we have to recognize that HIV prevention has been medicalized. After 30 years of abstinence, partner reduction, and condoms, we can’t talk about ending HIV today without talking about research and pills and big pharmaceutical companies that make (and charge) ridiculous amounts of money. That looks suspicious as hell to a whole lot of black folks.

Perceptions of greed and racism in routine medical care all contribute to the distrust of physicians. What other people may see as routine medical care is often perceived by African Americans as experimentation, especially when the message is that a certain number of black men “need” to be on PrEP. (Again, how the message is delivered matters.)

And – in the spirit of Black History Month in the era of #BlackLivesMatter – we don’t trust the police (or any part of the criminal justice system). They will pull you over for driving-while-black, beat you off-camera, and say you did it to yourself. We don’t trust politicians (or any part of government). They will have you drinking water from the Flint River as if it were red Kool-Aid. People who have experienced racism or discrimination from individuals or institutions are less willing to be vulnerable and place trust in a system of unknowns such as medical care.

We’ve been beating around the bush. We’ve been picking the low-hanging fruit because issues of medical distrust are too difficult to deal with head-on.

Solutions such as the recruitment of minority healthcare administrators and executives and the presence of Community Advisory Boards that represents the the people help to change the perceptions of African American patients, but we have to do better. Short of a revolution at the polls or in the streets we need to expand support for efforts like AVAC’s PxROAR and the Black AIDS Institute’s African American HIV University, which aim to develop leadership and expertise in the communities most impacted by the epidemic.

There are all kinds of ways to frame it. The GIPA principle recognizes that personal experiences of people living with HIV and AIDS are important in shaping the response; Abraham Lincoln said that government systems should be “of the people, by the people, for the people”; and the name of 90’s American hip hop clothing company FUBU is an acronym for “For Us By Us”. If gay, black men are the group most at-risk for HIV infection in the United States, then they must be allowed to take lead roles in educating our communities about HIV prevention options.

The messenger matters. Gaining the trust of black men in the health care system is imperative if we are to reduce health disparities including incomparable rates of new HIV infections in young, gay black men.

Finally, You Can Put a Ring On It!

Anna Miti, a 2015 AVAC fellow and Zimbabwean broadcast journalist, writes in her blog about the dapivirine vaginal ring results. She talks about next steps for the ring and how there is a need now to advocate for all stakeholders to call for the expedition of the process to make the ring available to those who need it.

I have to admit that the last few weeks have been a bit stressful, waiting anxiously for the results of a microbicide ring study- meant to prove its efficacy in HIV prevention. Well, finally the results are here! This is probably one of the biggest breakthroughs we have had in HIV prevention specifically for women in a while. Significant because we know women are more vulnerable to HIV infection than their male counterparts. I am glad to say that after the disappointing results of previous microbicides trials in Africa, the world has some news to share. And it is good news- well, mostly. The results of two phase 3 trials, ASPIRE study and Ring study, showed efficacy rates ranging from 27 to 61 percent. The trials showed that a monthly vaginal ring containing the antiretroviral drug (ARV) dapivirine can safely help prevent HIV infection in women. The Ring Study showed that the monthly dapivirine ring safely reduced HIV infection overall by 31 percent compared to a placebo. Similar results were seen in ASPIRE, which found that the ring safely reduced infection by 27 percent overall. The factors leading to the differences in efficacy are by age and consistency of ring use, or adherence, where older women (aged 25 and above) and those with the best adherence having the best protection. ASPIRE showed that the ring reduced HIV risk by 61 percent in women older than age 25, and 56 percent in women older than 21 (in a post-hoc analysis), who also appeared to use the ring more consistently. The Ring Study also showed higher efficacy (37 percent) for women over 21. However, little to no protection was seen in women ages 18-21 across both studies — 15 percent in The Ring Study and no protection in ASPIRE.

The good news is that the ring has the potential to prevent new HIV infections in one out of three women at worst and one out of two women at best, if used correctly and with high adherence. Besides pre-exposure prophylaxis and the male and female condom, the ring can be used as an additional tool for women to protect themselves from HIV infection. Significantly the Ring, when available, would be the only tool that women can use overtly or covertly for HIV prevention, removing the need to negotiate for safer sex. Negotiations for safer sex are not always successful as women find themselves vulnerable due to various socio-economic issues and therefore powerless to protect themselves from HIV by insisting on condom use or refusal to have sex.

The not-so-good-news is that this trial once again proved low levels of adherence in young women and subsequently low levels of protection for adolescent girls and young women, who are the most vulnerable to HIV infection. However some schools of thought suggest that other factors, such as biological differences might have played a role in low levels of protection in younger women.

The Ring Study enrolled 1,959 HIV-negative women ages 18-45 at seven sites in South Africa and Uganda, and ASPIRE enrolled 2,629 HIV-negative women ages 18-45 at 15 sites in Malawi, South Africa, Uganda and Zimbabwe. ASPIRE began in 2012 and ended in 2015. The Ring Study also began in 2012 and is reporting results early after its independent data safety and monitoring board recommended the study proceed to final analysis.

What Now

After all has been said and done the results of these two studies are positive. The microbicide ring is an additional tool that women can use to protect themselves from HIV. It can be used as part of a basket of HIV prevention methods including Pre-Exposure prophylaxis and the condom. There is need now to advocate for all stakeholders to call for the expedition of the process to make this ring available to those who need it. If we can prevent half of potential new HIV infections as proven by the two studies, then we have the potential to halt or reverse the HIV trajectory. The impact of such an occurrence would be phenomenal. Imagine the saving to public health if we stop new infections,which put a strain on health system in terms of costs, not to mention the impact on human development. On the other hand more needs to be done to investigate how to overcome barriers to HIV prevention for the youngest women. Efforts are already underway for studies to understand how ring use, and potential biological and other factors that may have influenced the different levels of protection seen by age in these studies. There is need to study what works for young women, and how we can further make HIV prevention tools work for them. We need to investigate barriers to adherence in young women, beyond the factors we already know such as low HIV risk perception.

The Future

There are still lots of potential to increase options for women, anchored on the success of the microbicides trials. Efforts are already underway to develop multi-purpose prevention technologies, which are basically products which will not only protect a woman from HIV, but protect her from pregnancy as well.


I believe that the swift move towards starting demonstration studies for the ring and the commencing of licensure processes can make HIV prevention in women happen faster. This will expedite the progress towards ending AIDS by 2030. Finally, as I finish this blog, I cannot pen off without thanking and appreciating the work done by research participants. These women are s/heroes and their dedication to the study will be beneficial to generations of women worldwide — WELL DONE!!

Conducting Research With a Heart: The stories of CROI 2016 Award Recipients

Morenike Ukpong, Associate Professor at Obafemi Awolowo University and Coordinator of the New HIV Vaccine and Microbicide Advocacy Society in Ife, Nigeria, writes why she believes CROI 2016 made strides in taking community concerns into consideration. This blog is one in a series written by community scholars who attended CROI 2016.

One of the struggles in the field of biomedical HIV prevention research for years has been the need for research teams to truly make people and communities a central theme in their work: think less about the data, publications, conference presentations and think more of the people you work with and work for. At 2016 CROI, I sincerely felt we have made significant positive strides in that area—not token forms of community engagement, but true consideration of concerns and interests of the people and communities through whom data for change are generated.

It started with Monday’s Workshop for New Investigators and Trainees where Sharon Hillier (MTN) clearly highlighted the significant role of community in changing the landscape of HIV prevention. At the same preconference meeting, Laurel Sprague (Sero Project), Sethembiso Mthembu (ICW) and Keith Green (University of Chicago) all brilliantly highlighted how the social context of the lives of people—our history, stress, experienced trauma, stigma people living with HIV and other vulnerable communities face—impact the way we as community members respond to research implementation. They discussed how this social context impacts on the truth generated through the data collected, and how research outcomes are translated and used by all of us in the community. And then, at the Clinical Trial Design workshop, Patrick Sullivan (Emory) reiterated the need to look for the human faces behind the big data you may want to use for making heroic public health changes—look for the faces in the data and ask their permission for the use of their data.

For me, the three speakers recognized for their work and who gave opening lectures at the 2016 conference were embodiments of this message of making people central to the theme of the research. We must conduct research to address human needs. “Think, plan and conduct it with them for them” was the clear message I heard.

Bruce Walker (Ragon Institute) discussed the FRESH study ongoing in South Africa where women undertook capacity-building programs, got empowered to get employment, yet contributed to a study that enabled researchers to detect acute infection and understand more about T-cell control for HIV vaccine and cure research. Of course, all HIV-positive persons got treatment immediately following diagnosis so that they could benefit from the outcome of the START study (which showed that starting HIV treatment immediately after diagnosis reduced the risk for HIV-associated diseases). Gerald Friedland (Yale) also discussed how he identified with the epidemic of HIV and tuberculosis in Bronx, USA and Tugela Ferry, South Africa where epidemics of poverty arising from neglect of people and their basic needs—health, housing, transport. Kenneth Cole also narrated how the concern for people, their lives and the need for HIV cure was central to his work at amfAR though he is a fashion designer. Clearly, we can all do something irrespective of our profession.

As I reflected on these great people, their talks, their programs and their passion, I conclude that my years of advocacy with many, many, many other brilliant advocates, to make people and communities central to the heart of research was (and still is) a worthy cause. Helping young investigators understand how the social context of people’s life need to inform the design and implementation of HIV treatment, prevention and cure research will truly get us to the end of the HIV epidemic sooner rather than later.

DREAMS Innovation Challenge

The DREAMS Innovation Challenge seeks to award and implement solutions to reduce HIV infections by infusing new thinking and approaches to meet the urgent, complex needs of adolescent girls and young women in DREAMS countries. Partners include PEPFAR, Bill & Melinda Gates Foundation, Girl Effect, Johnson & Johnson, Gilead Sciences, and ViiV Healthcare. Expression of Interest deadline: March 28, 2016. For information, go to:

AVAC’s take on ring trial results—breaking news in HIV prevention

Big news from two trials of HIV prevention for women was released today at the 2016 Conference on Retroviruses and Opportunistic Infections. Two trials of a vaginal ring containing the antiretroviral drug dapivirine announced their results. Both ASPIRE and The Ring Study found evidence of modest protection. The data were described at a CROI press conference and will be officially presented on Wednesday, February 24.

This update contains links to resources from the trials, AVAC’s press release, and a brief summary of key facts about, and AVAC’s take on, these important data. We will be updating our website in the coming days and working with partners to prepare a fuller analysis of the advocacy agenda for the ways forward. Please join the conversation—starting with our webinar on March to discuss the latest with researchers and advocates from around the globe. (Update: Recording now available.

At a glance:

  • Should I be excited about this? Yes. The two trials, which were independently conducted, had very similar results. This is good news for the field—in the past microbicide trials of the same product have had different findings. The data are clear that the dapivirine vaginal ring can work, and this should trigger regulatory action (see below).
  • What’s the bottom line? The data show that, as with daily oral PrEP and condoms, the product works when it is used correctly and consistently. But the trials also show that in a research setting, when women are told that they might be getting a placebo and that the product might or might not protect them, some participants—especially younger women—did not use the ring as prescribed.
  • When can I get the ring? The dapivirine ring is different from daily oral PrEP in that it is an experimental product (tenofovir-based oral PrEP used an existing, widely-used drug for HIV treatment). This means quantities are limited, and that the product can only be made available through research settings until it is approved. There is no opportunity for off-label use.
  • Well, then what do we do in the meantime? Younger women in both trials had lower rates of product use and lower rates of protection than older women. This, along with incidence rates of over 4 percent, is a reminder of the urgent need to deliver tools and programs that truly address young women and adolescent girls’ prevention needs now, while developing additional methods for the future.

AVAC’s priorities for action:

Demonstrate the ring’s role in prevention

  • The trials show that the dapivirine ring can be an effective prevention option for some women. The International Partnership for Microbicides should immediately proceed to submit a regulatory dossier for product licensure. If licensed, the ring could be piloted in “real world” settings, where approaches to improve consistent use can be explored.
  • Open-label extension trials for HIV-negative participants in the trials should be launched. Funders should not turn away from the evidence. The dapivirine ring works for some women and, now that safety and effectiveness has been established, it may work for more women—including those assigned to the placebo arms in the original trials. All participants should have access to open-label extension trials as originally planned by both trial sponsors.

Deliver daily oral PrEP

  • Even if the steps above are taken, it will be years before the dapivirine ring is available in public health programs designed to meet the needs of women in all their diversities. Daily oral PrEP is available today and must be explored via ambitious and innovative programs that provide safe, sustainable and community-supported access. This can include offering daily oral PrEP in open-label extension studies for the dapivirine ring.

Develop additional tools

  • Vaginal rings are already used to deliver contraception. They are a valuable platform for potential “multipurpose prevention technologies” (MPTs) that would provide both contraception and HIV prevention in a single product. MPT research must continue—for many women, including those at substantial risk of HIV, pregnancy prevention is a top priority. A combination tool is a critical goal for the field.
  • Additional prevention options remain necessary. Funders, researchers and civil society must remain resolute in sustaining the search for prevention options that women and men will want and use, including other long-acting ARV-based prevention options, vaccines and antibody-mediated prevention.

Please join us in congratulating both trial teams, the site staff and most especially the women who participated in the trials, whose contributions of time, information and trust have once again advanced the field.

We look forward to working with all stakeholders to understand and act on these results.

New Px Wire: What to Watch in 2016

There are few, if any, quiet years in HIV prevention research and implementation. 2016 promises to be another year of big deal data, whether it’s findings from clinical trials, funding levels or readouts from PEPFAR’s first year of a geographically focused program plan. We write about this and a lot more to watch for in our new issue of Px Wire.

Click here to download the new issue.

We take a look at the bigger picture in our centerspread. Check it out for the most current version of AVAC’s classic timeline of biomedical HIV prevention research. But don’t get too attached—some of the trials mentioned in the timeline will have updates presented next week at the annual Conference on Retroviruses and Opportunistic Infections. We’ll always have an updated version in our Infographics Gallery—and save the date for a March 1 webinar to discuss the latest data and what’s next?

The full issue of Px Wire, as well as our archive of old issues and information on ordering print copies, can be found at

As always, we welcome your questions and comments at

NIAID/NIMH proposed FY2017 initiative: iKnow Projects

This proposal intends to support development of innovative strategies to identify persons unaware of their HIV infection in specific high-risk populations and examine the acceptability and feasibility of new prevention interventions in the populations and settings identified. Research projects that integrate multiple approaches to achieve these objectives are strongly encouraged.

NIAID/NIMH proposed FY2017 initiative: Methods for Prevention Packages

This Program Announcement encourages collaborations between behavioral and biomedical clinical scientists, epidemiologists, mathematical modelers, and clinical trial design specialists to develop new research strategies and methodologies that will facilitate the design and testing of combination HIV prevention interventions (prevention packages).

NIAID proposed FY2017 initiative: Sustained Release of Antivirals for Treatment or Prevention

Oral therapy sustained-release strategies must have a window of effectiveness of at least 7 days from a single dose. Other approaches must have a minimal window of 30 days from a single dose (injection) or continuous dosing regimen (implant, transdermal patch, etc.). Sustained-release strategies for HIV prevention must have a minimum window of protection of 30 days from either a single dose (injection) or continuous dosing (implant, transdermal patch, etc.).