Calling the Prevention Community: The UNAIDS targeting process needs all hands on deck

Today UNAIDS hosted a webinar to describe and discuss its proposed prevention targets. These have been developed to complement the 90-90-90 target which seeks to have 90 percent of people with HIV know their status, access antiretroviral therapy (ART) and achieve virologic suppression by 2020. 90-90-90 is, of course, a combination treatment and prevention target since virologic suppression reduces the risk of HIV transmission. But AIDS advocates have been asking for targets with similar specificity and ambition for non-ART prevention—including attention to stigma, discrimination and criminalization, since rights-based delivery of services is absolutely essential.

UNAIDS has released both a prevention target draft and a draft of non-discrimination targets. Together, these two documents are the beginning of what a comprehensive response, complementing 90-90-90 could look like. But, as we describe below, there is still a pressing need to review and clearly articulate the rationale for the specific targets being laid out—particularly in the HIV prevention target draft. This is because the prevention target draft has a narrower set of possible objective than the non-discrimination target draft, which lays out two broad approaches to setting these targets—and invites input on the overall strategy.

AVAC and partners have reviewed both draft documents; you can read the composite feedback from Stop AIDS Now and the International HIV/AIDS Alliance on the draft non-discrimination target here. In this post, we focus on the prevention target draft.

The overall prevention goal is to reduce the number of new HIV infections to below 500,000 per year by 2020. There are two population specific sub-goals:

  1. By 2020, new infections in key populations will be reduced by 75%
  2. By 2020, new infections in young women and girls will be reduced by 75%

As UNAIDS’ Karl Dehne presented on today’s webinar, the over-arching target was selected for the following reasons.

These overarching goals are ambitious, and it is both necessary and exciting to envision how they could be achieved. The prevention targets document begins to map out what Dehne calls the “programmatic targets” that could contribute to these overarching objectives. The proposed “results” framework for these programmatic targets as presented today looks like this:

AVAC and partners who have reviewed the document and the results framework feel that urgent attention and discussion is warranted to ensure that the eventual finished product has the impact that’s needed. We have submitted a letter and a mark-up of the targets document itself that articulate a range of concerns. UNAIDS has also posted shared Google documents of both the prevention and non-discrimination target drafts, and they can be viewed here:

The comment period for both documents closed yesterday (November 12, 2014). However, on today’s webinar, UNAIDS’ Chris Collins said that there was still a narrow window for weighing in—but that feedback did need to come in “as soon as possible.” The above Google Docs remain available. You may also reach out to [email protected].

We will be working with partners to amplify questions and priorities in the coming days—and welcome feedback and input on the documents, our analysis and the overall process for developing these goals. Please be in touch and watch this blog for more updates!

Guest Blog by UNAIDS’ Chris Collins — Fast Track: New AIDS targets and the urgency for action

Chris Collins is Chief of the Community Mobilization Division at UNAIDS. Thoughts expressed are his own.

All the recent scientific advances in the response to AIDS present the world with a stark choice: accelerate delivery of HIV treatment and prevention and drive down HIV infection and mortality, or settle for the status quo and accept a grave, avoidable AIDS epidemic for decades to come.

New targets from UNAIDS make this clear. They are based on a modeling exercise that asked where HIV service levels need to be in six years (by 2020) if we want to be on a path so that by 2030 HIV infection and death are down to a tenth of where they were in 2010, and HIV-related discrimination is also dramatically reduced.

We can debate the details of any analysis, but the bottom line is inescapable. Without ramped up delivery of lifesaving treatment and targeted prevention in the next five years, along with advances in non-discrimination and human rights that make these services possible, the AIDS epidemic will remain a serious global health threat as far as we can see. We have the chance to change that outcome—but will we seize it?

Ambitious targets are critical now because the health of the global AIDS response is in question. Funding has slowed; stigma and discrimination continue to magnify vulnerability and have worsened in some places. The world needs ambitious targets that will drive new resources based on the evidence and human rights.

Today’s targets need to be different than those of the past. The “3 by 5 Initiative” and “15 by 15” set our sights on reaching millions with lifesaving HIV treatment. As powerful as these initiatives were, it is time for bold targets that do not close coverage gaps alone—new targets should address the interconnection of treatment, prevention and human rights, as well as the quality of service delivery, in making accelerated progress.

In July UNAIDS announced a new HIV treatment target, “90 90 90,” that calls for, by 2020, 90% of people living with HIV to know their HIV status, 90% of them to be receiving sustained antiretroviral therapy, and 90% of them to have achieved viral suppression. Taken together, the three 90s would mean that 73% of people living with HIV have achieved viral suppression by 2020, a threefold increase from current estimates. (In September President Zuma of South Africa, U.S. Secretary of State Kerry, and others endorsed 90 90 90.)

UNAIDS is now consulting with partners to develop prevention and non-discrimination targets that will promote action alongside the new treatment targets. In September, UNAIDS announced one aspect of the prevention target: to reduce annual new HIV infections to 500,000 or lower by 2020, a 75% decrease from 2010 levels.

The targets represent a new phase in goal setting for the global AIDS response. The viral suppression treatment target puts a premium on quality healthcare outcomes for people living with HIV, in addition to the total number of people reached. In July, over 40 AIDS advocacy groups called for the opportunity for viral suppression for all treatment eligible people by 2020 (here). As they emphasized, respect for human rights must underpin this effort, with respect for personal choice and vigilance against coercion in health services.

The new targets also emphasize equity. The treatment target report (here) points out that key population groups need to realize the same levels of coverage and quality treatment outcomes as everyone else. The prevention target will also highlight the need for major reductions in HIV incidence among key populations, including people who inject drugs, sex workers, gay men and other men who have sex with men, transgender people, and young women and girls.

There is no doubt the new targets are very ambitious. They assert that countries and populations all over the world should be able, in the next six years, to achieve what model programs have achieved – or are near achieving – today. For example, it is estimated that in Latin America 70% of people living with HIV know their status; in Botswana 69% of people living with HIV (PLWH) are receiving lifesaving treatment; in Chile and Venezuela retention rates in treatment are at 90% or above; in Rwanda 83% of PLWH on ART have achieved viral suppression.

Targets are about making change: pushing for new money, strategic investments, and advances in human rights. The targets need to be used as a tool for confronting barriers like drug pricing, discrimination, failing health systems, and underfinancing. They need to be a means for dramatically advancing the response among key population groups and promoting the critical enablers that make services possible, including much greater emphasis on community-provided services and treatment and rights literacy.

The next step is to put the targets to work in financing and national planning. UNAIDS is now working on a Fast Track initiative that will analyze where countries stand in implementing bold targets and help advocates and policy makers fill the gaps.

The next five years are crucial in the trajectory of the AIDS epidemic. A decade ago the “3 by 5” target galvanized advocates, funders and policy makers and changed our conception of what was possible. Today we need that kind of ambition for dramatic advances in HIV treatment reach and quality, prevention and human rights.

HIV R4P Conference Charts Way Forward for Biomedical Prevention

Last month, nearly 1,400 researchers, advocates, policy makers and journalists gathered in Cape Town for HIV Research for Prevention (HIV R4P)—the first meeting to gather all the fields of biomedical prevention research under one roof. From broadly-neutralizing antibodies to building trust between trial participants and research teams—R4P had it all.

As part of the continuing coverage of and discussion of key issues and questions raised at HIV R4P, AVAC hosted a webinar, “The State of the HIV Prevention Union: The Road from R4P” on November 6. On it, advocates and researchers alike proposed, explored and debated some of the areas where prevention research and implementation is well coordinated—and places where more union is needed. Missed the conversation? Download the slides and recording here.

Looking to read up on the conference highlights? AVAC covered many of the sessions of interest to advocates in daily “snapshot” summaries from Cape Town.

There is also a lot of great coverage on WhatsUpHIV, a “live blog” set up to report developments from the conference. Over 50 entries were published from advocates, community journalists and researchers—check out the posts here.

These various summaries make reference to webcasts of sessions—all of which are now available on the conference website.

And save the date for HIV R4P 2016, which will take place 18-21 October, 2016 in Chicago!

Evidence for PrEP builds

Over the last few weeks the PrEP for HIV prevention field has been boosted by positive news from two ongoing research studies in Europe: PROUD and IPERGAY. In each study, use of TDF/FTC (brand name Truvada) for PrEP reduced risk of HIV acquisition. The exact numbers behind the recent announcements are not yet available (in each case the data was reviewed by the trial’s independent data safety and monitoring board and will not be available more widely until published or presented, which is expected in early 2015 for both), but daily and “on-demand” (taken before and after sex) TDF/FTC as PrEP were effective at reducing risk in gay men and other men who have sex with men.

A lot has been written about these promising advances and what the announcements mean for regulatory approvals and PrEP access in Europe, the effectiveness of “on-demand” versus daily PrEP and the mounting evidence of PrEP’s utility as an important HIV prevention option. 

Aidsmap.com editor and long-time writer and activist Gus Cairns penned a piece for Huffington Post, D-day for the Pill for HIV, noting how these two studies and their show of PrEP effectiveness together mark a turning point in HIV prevention. His cogent analysis is a must-read. 

The US Centers for Disease Control and Prevention notes that the trial announcements are “encouraging” and that they look forward to seeing trial data for more information, particularly from IPERGAY, on dosing and timing required for protection. 

From the HIV R4P conference “live blog”, Emily Bass writes on PrEP for a New Era, describing the new data and the energy around PrEP exhibited at the conference.

PROUD study team statement is available here and the ANRS’ statement on IPERGAY is here.

For the latest on PrEP, visit avac.org/prep.

Leaders in the field discuss progress towards an HIV vaccine at CSIS event

The Center for Strategic and International Studies hosted “Ending Epidemics Through Technology: Developing an HIV Vaccine,” featuring a keynote presentation by Dr. Anthony Fauci, Director of the US National Institute of Allergy and Infectious Diseases, which was followed by a discussion with Margie McGlynn, President and CEO of the International AIDS Vaccine Initiative and Mitchell Warren, Executive Director of AVAC.

A recording of the 90-minute event is available here. The keynote and discussion featured lessons from industry, how Ebola relates to AIDS, the need for an AIDS vaccine, advances presented at the recent HIV R4P conference and the current AIDS vaccine pipeline.

For more on recent advances and AIDS vaccine resources for advocates, visit AVAC’s vaccine page.

November 6 Webinar- The State of the HIV Prevention Union: The Road from R4P

Last week, nearly 1400 researchers, advocates, policy makers and journalists gathered in Cape Town for HIV Research for Prevention (R4P)—the first meeting to gather all the fields of biomedical prevention research under one roof. From broadly-neutralizing antibodies to building trust between trial participants and research teams—R4P had it all. We hope you’ll join us this Thursday to talk about “what’s next” with key issues and questions that came up at the conference (click here to register). We highlighted many of these issues in our daily summaries from Cape Town.

HIV R4P Conference Day 4 Snapshot

Greetings from the fourth and final day of the HIV R4P conference in Cape Town. As with the previous days’ summaries—all of which can be found at www.avac.org/hivr4p—this is a selective, whirlwind tour through some of the highlights of a meeting that reflected tremendous momentum, energy and excitement across the HIV prevention research spectrum. Webcasts of all the sessions are available 24 hours after they take place. The live blog, What’sUpHIV, has nearly 50 posts from advocates, African journalists and researchers. It is definitely worth taking a look. And Twitter, at #HIVR4P, has great images of many sessions describe below—and much more. 

Although the conference ended today, the work together is just beginning. We hope you’ll register now for a webinar next Thursday, November 6, that will look at key themes and action items emerging from this meeting. 

Morning Sessions
No such thing as a failed trial
This, for many years, has been a mantra in the biomedical prevention field. If the trial recruited and retained participants, and got a clear answer about a product—then it could in no way be called a failure. But what about when participants don’t use the product often enough to get a clear answer—what do you call that trial? One of the themes throughout the week has been how much the prevention research field has learned from VOICE—which had low rates of adherence across oral and gel tenofovir prevention arms. It was not the outcome anyone would have wished for. But the wealth of insight into the gaps in communication, context and motivation that can exist between women and research is incredibly rich—and might not have emerged, had VOICE not provided a “wake-up call” to look closely at difficult issues. 

Two talks in the session Challenges of Biomedical HIV Prevention Trials [SY10], reflected on lessons learned from trials that didn’t go as hoped or planned. Jeanne Marrazzo (University of Washington) [SY10.01] reviewed many of the challenges—“life is messy,” she said—and showed a really useful slide summarizing the ways that the VOICE result had changed the model for future trials. She ended her talk with a quote from Winston Churchill, “Success is not final. Failure is not fatal. It is the courage to continue that counts.” 

“The trial becomes the protagonist in a story about its life,” said Jonathan Stadler (Wits Reproductive Health & HIV Institute, South Africa) [SY10.04] in a presentation that delved into the ways that myths and rumors about the trial and its experimental products can circulate in waiting rooms and outside the clinic, impacting on womens’ decisions to use the products while in the trial. 

Meeting women’s many needs
A session on multi-purpose prevention technologies [RT05] provided a glimpse of the future, as multiple presenters discussed the pipeline, regulatory considerations and potential study designs for combination prevention tools that would provide contraception as well as protection against HIV and/or other STIs. 

Beyond basic science—antibodies enter the clinic
Differential use of Antibodies in Prevention [SY12] continued the discussion of the possible ways that broadly neutralizing antibodies could be harnessed and induced as HIV prevention tools—another key theme of the conference. Barney Graham (NIH Vaccine Research Center) [SY11.01] provided an update on clinical development of VRC01, a broadly neutralizing antibody developed by the VRC, describing two ongoing studies to establish the safety of this product. One is taking place in people with HIV, the other is enrolling HIV-negative individuals. He reviewed the slate of future trials planned to explore different doses, routes and schedules—a sequence that could eventually lead to efficacy evaluations of VRC01 as a prevention tool for HIV-negative infants and high-risk adults. Even as VRC01 moves through clinical trials, there are efforts underway to engineer the BNAb to be even more potent. Neal Padte (Aaron Diamond AIDS Research Center) [SY12.02] described work, in collaboration with David Ho, also designed to engineer potent BNAbs—including clinical trials with one candidate and several more that are in preclinical development, with the goal of selecting one to bring into human evaluations. While all of these concepts are still in their early phases, the session—and the conference as whole—gave a sense of the concrete, if incremental, steps that are moving this critical field forward. 

Closing Plenary Session 
Getting it right
Douglas Shaffer (US Office of the US Global AIDS Coordinator) continued the theme of safeguarding human rights as part of an effective HIV response in a talk that also highlighted the evidence—from models—that combination prevention incorporating ART, VMMC, condoms, PrEP and other strategies is key to achieving an end to the AIDS epidemic. Continuing with a “status quo” response won’t achieve these results. To frame its work and change the paradigm, the US PEPFAR program has adopted a “Right Things, Right Places, Right Time” approach to guide spending and program design, which he presented in a slide at the end of his talk. 

P-Values
A p-value is a statistical term used to indicate the probability that a research result is a coincidence, rather than an actual finding. There was plenty of actual truth—and an alliterative festival with the letter “P”—in the talk by Alex Coutinho (Founding Director of the Infectious Disease Institute, Uganda) about what’s needed to scale up HIV prevention science from the laboratory to the village. In the move from policy to practice, Coutinho highlighted the need for “Partnerships; planning and processes; pesa, pula, pound and pennies; push and pull approaches; providers’ perspectives; population preferences; and pressure from activities.” (This was just the one of the “P”-value laden slides…watch the webcast for more.) “We are far more credible when we combine science with activism,” he said—a refrain that has been echoing through this conference, and that will be exciting to reevaluate at HIV R4P 2016. (Wondering where it will be? Read on!) 

Walk the walk
Glenda Gray (Perinatal HIV Research Unit, South Africa) used her talk on antiretrovirals for prevention to highlight the compelling science supporting their efficacy and the considerable challenges to translating that efficacy into clinical benefit. She said that much of the billions of dollars spent on research has been wasted due to failures in dissemination. “All breakthrough and no follow-through,” in a succinct formulation that she borrowed from a colleague. This isn’t for lack of cost-effectiveness, either. PrEP, Gray showed, can be cost effective when targeted to the highest risk populations. Lest this seem improbable, consider that the early results from demonstration projects show that individuals at highest risk are selecting PrEP and using it consistently—suggesting that, when provided with the right information and unbiased access, will make the choices that are best for them. The issue of bias and stigma is another huge issue in health care settings—and a major obstacle. Gray made a strong case for how the health and legal systems have failed sex workers, citing astronomical rates of abuse, violence and discrimination reported at the hands of both the police and health providers. She cited a systematic review showing that decriminalization of sex work could avert roughly 30-45 percent of new HIV infections worldwide over the next ten years. Biomedical prevention doesn’t often engage with legislative issues—but, combining Shaffer’s, Gray’s and Coutinho’s messages, it’s clear that this community needs to find and harness its activist energy and challenge the laws that undermine public health. 

Honoring heroes lost too soon
Manju Chatani-Gada (AVAC) presented the Omololu Falobi Award, a biennial honor given in memory of a tireless activist, organizer and journalist who, “lived life in a hurry as a young visionary leader.” Falobi co-founded NHVMAS, the Nigerian HIV Vaccine Microbicide Advocacy Society, as well as helping to lead the Nigerian group Journalists Against AIDS, before his untimely death in 2006. Chatani-Gada explained that this year the award recipient was another Nigerian activist and hero who shared many similarities with Falobi, including a tragic, untimely death earlier this year. Oyelakin Taiwo Oladayo, known as “Taiwo”, was killed in a car accident just six days after his wedding. His life was remarkable for its bravery, commitment and action. Chatani-Gada said, “Taiwo was a passionate advocate for the rights of young people living with and affected by HIV and AIDS with a special focus on the rights and dignity of those who are most marginalized. He was a true son of Africa—championing other African advocates and developing a mentorship program to nurture others. While he focused his efforts in Nigeria, he was also part of the global community of activists who aspired to end the epidemic. As a young person living with HIV himself, he never let that—or anything—get in his way. He had many dreams and many aspirations for the future, as an international activist, as a photo documentarian, as a politician…. Like Omololu, he lived his life in a hurry. And like him, he left his mark on all those who met him.” 

Deliver, Demonstrate, Develop—Tools to end the epidemic 
The Honourable Minister of Health for South Africa, Aaron Motsoaledi, received a warm welcome from conference co-chair Helen Rees, and provided a galvanizing vote of confidence in the role of HIV prevention research in ending the epidemic. He highlighted South Africa’s role in HIV prevention research, including its ongoing leadership in trials of microbicide gels and rings and vaccines that build on the positive results of the RV144 trial. He also looked beyond the continent, hailing the results of the PROUD and IPERGAY trials of PrEP in MSM—both trials stopped early after overwhelming evidence of benefit—and said that South Africa needed to expand PrEP access, particularly in female sex workers, young women and MSM. He also highlighted the need to address human rights issues as part of an effective AIDS response—a key theme for the meeting, and a great issue for a South African leader to raise from the podium. Amandla! 

Optimism and obstacles
Conference co-chair Robin Shattock (Imperial College, London) gave closing remarks, on behalf of his colleagues, that summed up the key themes and great sense of shared purpose at the meeting. Shattock spoke of the optimism that the meeting had generated. “Why optimistic? Because the science is outstanding and this is a key moment of change in the field.” He spoke of the “new and achievable” goals across interventions—from broadly neutralizing antibodies to microbicides to PrEP—and of the exciting engagement of new young researchers, the “lifeblood” of the field. But, he noted, it is both the best and the worst of times, as research funding is falling (see the most recent trends from a report from the HIV Vaccines and Microbicides Resource Tracking Working Group) at the moment when significant change is possible, and breakthroughs within reach. 

From the “Mother City” to the “Windy City” 
HIV R4P 2016 will be held in Chicago, US—which is nicknamed the Windy City, just as Cape Town is known as the Mother City. Nelly Mugo (University of Nairobi) accepted the hand-over as one of the four conference co-chairs for that meeting—which will take place in a country with hot-spot epidemics among MSM that are equivalent, in incidence and prevalence, to the most severe in sub-Saharan Africa. The other co-chairs for the 2016 meeting are Thomas Hope (Northwestern University, US), Lynn Morris (National Institute for Communicable Diseases, South Africa) and Jeanne Marrazzo (University of Washington). 

All of us on the AVAC team want to thank you! It’s been energizing and exciting to work with so many partners in Cape Town, and to hear from so many more who’ve followed R4P from abroad. We will see you in Chicago in 2016 and many times before, we hope, as we continue to plan, prioritize and act for effective change. Don’t forget to register for the post-R4P webinar to continue this work. 

Institute of Medicine names new forgeign associates

Why we young women had to resort to putting up the Visible Panty Line

This was originally published on the What’sUpHIV blog that provided live coverage during HIV R4P 2014.

Wednesday was the day we were finally going to be seen and heard: the day that young women from Burundi, South Africa Uganda and Kenya were going to make it all about us. While everyone was in plenary session, we young women plotted to get the most attention when researchers, policy makers and the conference elite walked out of the plenary. Well, we did succeed in catching their collective eye with our visible panty line (VPL)—a clothes line with colourful, sexy lingerie clipped to it. This attracted scores of conference-goers to our corner. But while everyone was curious, not everyone wanted to participate in the activity—which involved writing messages and clipping them to the line. Instead, I watched as the usual suspects wrote messages about issues affecting young women and a few wrote about strategy ideas to improve the young women’s agenda. I was secretly waiting for a researcher to prove me wrong.  None did.

This was disappointing because we young women have a lot to say to researchers about the prevention options we want – if only they would listen. For instance, we know that PrEP works. We know young women between the ages 19-24 are most affected in many parts of the world. We also know this group hasn’t been a priority for demonstration projects of PrEP (pre-exposure prophylaxis).

I attended two oral poster presentations on PrEP and microbicides adherence in women. Speaker after speaker explained that they had gathered evidence about how women lie in about product use (aka adherence) trials. I wanted to say to them: “We do not lie as a choice but as a negotiation. Women lie to their partners, to their family, to their community and in trials because we prioritize other people and not themselves. Some of reasons given to explain that “the lies” were – “I did not use the gel because my partner does not like the slipperiness”, “My partner felt it and I had to remove it.” Women who didn’t use a PrEP or microbicide containing an ARV had their samples measured for detectable drug in the blood. They were told their pharmacokinetic levels that indicated no product use. “I beg you to forgive my PK levels,” was one of the responses I observed. Why do we do it?

After all these lies, I rush back to the Advocates Corner and our Visible Panty Line.

Phew, these young women, like our mothers, have submissively found their space on the floor. And then the old women came and the heterosexual man came: again they wanted to help young women. This is what they should do or shouldn’t do. But why don’t they want to listen to the women themselves?

I am livid: they are doing it again! They are gagging young women.

HIV R4P Conference Day 3 Snapshot

Welcome to Day 3 of the HIV R4P conference daily round-up! As we’ve been doing all week, this update offers a selective, whirlwind tour through some of the day’s sessions—all of which are available via webcast 24 hours after they took place. There’s lots more information and insight in the conference’s liveblog and the Twitter feed #HIVR4P.

Morning Plenaries 
This morning’s plenary session brought three presentations on mucosal immunology. Mucosa, including the linings of the vagina and the rectum, are the site of sexual transmission. But these locations—like sex itself—are simultaneously easy to talk about and difficult to describe with precision. While it’s clear HIV acquisition via sex starts at the mucosa, there are still lots of questions about how infection starts—in what cells—and how it progresses from the localized site(s) of entry to a disseminated infection in which virus is found in the blood and throughout the body. 

Jake Estes (Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research) provided a vivid look—complete with 3-D imaging—at the path of dissemination using a non-human primate model. Estes and his collaborators used viral inoculum that had been carefully selected for non-inflammatory studies. (Interesting fact for the lay person—the stuff other than the virus that is in a viral challenge can change the mucosa in an animal experiment.) His presentation maps what was found in different animals—a localized, genital tract infection that may move out into the body via the lymphatic system. 

Next, Jo-Ann Passmore (University of Cape Town, National Health Laboratory Service, and CAPRISA) presented on some of the factors in the genital tract that appear to make HIV infection more likely. Sexual transmission via vaginal sex is relatively inefficient—it doesn’t happen every time, or even most times a person is exposed. As Passmore noted, there are conditions, particularly inflammation, that can make a person more susceptible. If one thinks about local HIV exposure as a fire that either goes out—doesn’t result in infection—or spreads then, Passmore said, “Inflammatory signals are fuels that bring HIV-target cells into the genital tract. If you could block inflammation it would be a very effective way of limiting infection.” She identified several inflammatory markers or cytokines in the genital tract of women from the CAPRISA 004 microbicide trialwho acquired HIV. Her talk also touched on the different cytokine profiles found in the blood and concluded with a Venn diagram of inflammation, compartment (blood versus genital tract), inflammation and so on that is worth lingering on for what it suggests about measuring and addressing inflammation as part of HIV prevention. At the end of her talk, Passmore shifted gears from the scientific to the practical and made an important and passionate argument for policy change. “Young women have unacceptably high rates of asymptomatic STIs and bacterial vaginosis”—conditions linked to inflammation. Given the correlation between inflammation and HIV risk, and the high rates of HIV in young women, she called for “an urgent reevaluation of how appropriate our current STI surveillance and testing guidelines are for sub-Saharan Africa.” 

Finally, Omu Anzala (Kenya AIDS Vaccine Initiative) gave a thorough and accessible explanation of the importance of mucosal assays as part of HIV prevention trials—stressing the necessity of gathering information about immune responses in these tissues, as well as the feasibility of doing so in African settings. With a strong focus on Kenyan activity, he described a center of excellence for mucosal work that comprises several collaborating institutions, as well as early work to determine whether nasal sampling could provide relevant information—a potential way to address the cost and invasiveness of genital biopsies and other sampling. He concluded by raising the priority of looking for broadly neutralizing antibodies at mucosal sites—and of designing vaccines to induce such defenses.

Other Presentations We are family?: Babies, mothers, fathers and the ongoing challenges of “PMTCT”
This morning’s session [OA.23] on pregnancy intentions, safe conception and prevention of vertical transmission was, if not the first, then at least one of the early examples of a discussion that embraced both PrEP (pre-exposure prophylaxis) for the HIV-negative partner and traditional ART interventions for prevention of vertical transmission. This, in and of itself, is a thrilling development—since it moves the prevention conversation into a place of shared responsibility and choices for both the HIV-positive and -negative partners in the context of conception. Erika Aaron (Drexler University) [OA23.SY] provided a clear, comprehensive review of “PrEP-ception” decision-making as part of a discussion of the worldwide context of woman-centered PrEP implementation. (Perhaps, as PrEP enters the conversation, we will finally abandon “PMTCT”, which foregrounds the mother’s role in favor of more neutral terminology.) 

PrEP and Option B-plus (ART for life for pregnant and lactating women) are effective strategies, but they only work if they are taken as prescribed. Durban-based researcher Nzwakie Mosery (MatCH) described the role of depression, social support, stigma and structural barriers to care in adherence to ART among 200 HIV-positive women [OA23.02]. Twenty-four percent of women reported depression symptoms; and depression was correlated with adherence challenges, as measured by self report. The information on other barriers spoke volumes about the gaps in effective, accessible HIV and contraceptive services. Sixty percent of the women said that they did not want to be pregnant. One-third of the women attended the clinic on foot, and spent an average of a half an hour to get there—a barrier under any circumstances, but a tremendous consideration as pregnancy progresses. 

These and other presentations in this session complemented the Day 2 (Wednesday) roundtable “Prevention of Mother to Child Transmission Revisited” [RT2], which focused much more intensively on the strategies that could be directed towards the fetus, newborn and infant of an HIV-positive mother to help prevent infection or achieve a functional cure. In remarks from the floor at this session, Susan Allen (Rwanda-Zambia HIV Research Group—Emory University) presaged her talk at this afternoon’s session [RT04.05], which featured  an urgent call for integration of couples counseling into prevention trials and services—nicely summarized by its subtitle, “Most transmissions are in marriage, most pregnancies are not immaculate conceptions, and women aren’t just incubators.” 

Deep thoughts on viral variability
Deep sequencing is a technique that is a strategy for sensitively characterizing rapidly evolving viruses like HIV—including minor, hard-to-detect variants. Two talks at the morning session on viral transmission [OA.21] highlighted some of the subtle but potentially important distinctions in the virus that establishes infection (founder virus). Even if a person is exposed to several different genetic variants of HIV, infection usually involves a single variant. There is a bottleneck—still not understood—created by mucosal defenses that contributes to this phenomenon. Understanding the characteristics of the viruses that establish infection is key for informing vaccines and other strategies that aim to boost immunity in the genital tract. Damien Tully (Ragon Institute) described slight differences in the “genetic footprints” of founder viruses that establish infection in gay men and other men who have sex with men, compared to founder viruses in heterosexual transmission [OA21.05]. Specifically, he identified some site-specific differences in glycosolation—signature sites—that might confer some selective advantage on specific viruses that establish infection at the rectal mucosa. 

Gustavo Kijak [OA21.06LB] used deep sequencing to look closely at the genetics of founder viruses from people acutely infected with HIV in Thailand and South Africa. He focused his talk on four individuals and described how, although it looked like a single variant established infection, close analysis revealed a small population of a minor variant. This is called “cryptic multiple infection.” Soon after infection, the minor variant can very quickly become a larger proportion of the virus found in the blood. 

Understanding these fluctuations and the possibility of cryptic multiple infection is key to a working model of what happens during early infection. 

Building the best possible vaccine: More on selecting adjuvants and immunogens 
This session [OA.25] explored the critical role of adjuvants (immune boosting agents that are formulated as part of a vaccine) and immunogens (the precise elements of HIV selected to present to the immune system). This conference has included many talks related to follow-on work based on RV144, the successful Thai vaccine trial—and this session added to the conversation. Genoveffa Franchini (National Cancer Institute, USA) presented non-human primate data on a study of an RV144-like regimen formulated with the adjuvant used in the original trial in Thailand (alum) or the adjuvant planned for use in the RV144 follow-on trial (MF59) [OA25.01]. A new adjuvant has been selected in hopes of boosting immunogenicity and, therefore, protection in humans. 

Getting real about universal test and treat
Kwame Shanaube (ZAMBART Project, Zambia) presented preliminary lessons from the ongoing PopART trial that is designed to find out whether a “universal test and treat” (UTT) strategy can be delivered with high uptake and acceptability [OA28.03]. Her opening comments were a great reminder of the reasons why models can’t predict, with certainty, what the impact of this or any strategy will be. “They don’t take the complexities of real-life scale up” into account, Shanaube said. PopART is still underway so no data was presented, but Shanaube described the tremendous effort needed to recruit and train health workers to deliver home-based testing, and the discovery that in-home testing may not meet everyone’s needs. She said a “combination of community models” including work-based VCT and more should be explored—a relevant finding for ART programs, not just research projects. 

Is PrEP faster than a speeding tampon?
The discussion of what it will take to achieve real-world impact with existing and emerging strategies continued in the afternoon roundtable “Diffusion of Innovation” [RT3]. Presentations presented timelines and experiences for the introduction of various interventions—from the tampon to female condom to VMMC to PrEP. It can take decades for a product to “catch on”, and success is dependent on smart introduction and investment. The panel made clear that product introduction requires the same (and even more) commitment to strategy, resource and planning that product development receive–and questioned why invest in new product development if funders aren’t willing to commit to future product delivery. 

The work we do together
Eduard Sanders (KEMRI-Wellcome Trust Research Program, Kenya) presented on in-depth work at a coastal Kenyan research site that, over time, addressed community concerns, built trust among gay men and other MSM, as well as site staff skills and comfort in working with this population. Udom Likhitwonnawut (advocate and consultant in Thailand) presented on ongoing, community-led work to ensure implementation of the Good Participatory Practice Guidelines in a country that continues to play a key role in biomedical prevention research [RT4]. 

This is the last full day of the conference. Tomorrow, everything comes together in a final plenary–and then we return to our work in the real world. Stay tuned for a final update and don’t forget to save the date for ourpost-R4P webinar—Thursday, November 6—on the way forward!