AVAC at HIVR4P 2018, Update 2: The World is Not a Nail

Greetings from Madrid! Some meetings are a series of presentations, coffee breaks and cocktails. Others are these things plus something else—a sense of movement towards a consensus, a new commitment. As this HIV R4P conference enters its final day, we feel like it’s safe to say that this conference heralded an energized, nuanced commitment to choice.

In This Update:

As it happens, AVAC highlighted choice in our annual report, No Prevention No End, released last week ahead of the conference. We noted how politicized the world has become, and how essential it is to reclaim it in speech and more importantly in actions. HIV R4P did this in extraordinary ways. Here are a few takeaways and the sessions that brought this home:

Young women should run the world and if they did, there would be choices and much less shame about bodies and their coverings.
Throughout the conference, the Advocates Corner has been the site of vibrant, spirited engagement, much of it led by young African women attending the conference from Uganda, Tanzania, Malawi, South Africa and many other countries. Over the course of the week, they’ve engaged with researchers, challenged the audience in a powerful opening action, and articulated their needs and desires in creative ways. This included a “panty line”—a powerful, visual uncovering of the hopes, priorities and demands that women are supposed to keep hidden—like our desires. The hotel’s demand that fabric panties be removed from the line, conveyed by the conference staff, prompted strong feelings and swift action. In the closing plenary, these young women took to the stage with signs, panties and pride, to great applause and a strong statement of support from the Conference chairs.

People really do want different things; use can influence preference.
In a Tuesday session called If I Choose, Will I Use, researchers from the Quatro study and from a collaborative between RTI International and the Desmond Tutu HIV Foundation (DTHF) in Cape Town presented results from two different inquiries into what people who may someday use products want in those products. This seemingly logical step is not always taken in the context of HIV prevention—or product development writ large—so products don’t always match people’s preferences. In the next era of choice, if these presentations are any indication, they will. Here are some highlights:

  • As Elizabeth Montgomery (RTI International) explained (QA05.04), Quatro was designed to assess the acceptability, preferences, user experience and effect on sexual behavior of four different vaginal microbicide or multi-purpose technology (MPT) delivery forms, using placebo products in roughly 200 18- to 30-year-old African women. All of the women got to use four products: rapidly disintegrating vaginal insert, intravaginal ring (IVR), film and gel. In the first four months of the study, women were asked to use each of the four products in turn either once a week (for the insert, film and gel) or for a month (the ring). They were then asked to choose one preferred product to use as directed for the final month. The study found that preferences varied before and after use and by country—that there was no dominant favorite. Importantly, given the potential regulatory opinion on the dapivirine ring, the ring’s popularity increased the most—it was also the most “polarized” option, insofar as women either really liked it, or did not.
  • Quatro tested formulations of real-world products; the DTHF-RTI study (QA05.05) took on preferences at an even earlier stage, involving about 600 young South African men and women in a project that asked them to choose between hypothetical products with a range of qualities, or attributes, including duration of protection, site where the product would be delivered, mode of delivery and pain or discomfort associated with use. As Alexandra Minnis (RTI International) explained, the project was set up in such a way that people could weigh the importance of different qualities in different combinations. Again, there was evidence that people weigh trade-offs: the people in the study prioritized long-acting products with low levels of discomfort associated with use, and favored injections over implants. But every quality or attribute of the product impacted decisions.
  • A presentation of qualitative research from the Ring Study (QA05.02) was a reminder of how much can be learned from efficacy trials besides whether a product works or not. Cecilia Mitford (MatCH Research Unit, University of Witwatersrand, South Africa) explained the different factors influencing women’s use of the ring, based on in-depth interviews with trial participants across the study’s six research centers. Factors influencing use included ring efficacy and partner perceptions.

Injectables have promise, based on user preferences and trial data, but also real-world challenges, including “the tail.”

  • A leading next generation PrEP product candidate is an injectable formulation of cabotegravir given every eight weeks via an injection in the buttocks. Betsy Tolley (FHI 360) presented data on the acceptability of this approach gleaned from trial participants in HPTN 077—who by and large reported that the injections were acceptable—with embrace of the method increasing from the beginning to the end of the study. That’s the good news…
  • …a cautionary note, also from HPTN 077, was delivered by Raphy Landovitz (UCLA Center for AIDS Research and Education) who presented on the duration of drug , after the last injection in the bodies of a subset of 177 people from the trial. By 18 months after final injection, 87 percent of the men (n=60) were below the limit of quantitation (25nanongrams/ml), while 13 percent still had detectable levels of drug in the blood. In women (n=117), 58 percent were undetectable at 18 months; 42 percent of women still had detectable CAB. Sex was an important predictor of the half-life of the product; in this analysis, the half-life of the drug was 45 percent longer in women (all of whom were cis-gender) than men (ditto). BMI was also an independent predictor. The drug that’s left in the body after a final injection is known as “the tail”—and the tail matters because at some point, the drug is still in the body but not at a level that will protect against HIV. When this happens, people are at risk of both HIV and drug resistance. So injectable use will likely require a period of oral PrEP use for anyone who wishes to stop. How long would you need to be on daily oral PrEP to cover the tail? Landovitz calculated that the median time for each sex group to fall below the limit of quantitation—undetectable—for male was 42.7wks (20-134wks) and females, 66.3wks (18-182wks). Trial participants in ongoing efficacy trials of CAB-LA PrEP receive 48 weeks of oral PrEP after discontinuation. These data suggest that this might need to be revisited.
  • This same drug is being evaluated, in combination with another ARV, rilpivirine, for antiretroviral treatment. In It Only Hurts a Little Bit satellite session (SA13), Santiago Moreno reported, in moving terms, the transformative impact that injectable ART had on young people who said that, for the weeks between injections, they forgot they were ill, or felt truly healthy for the first time. Around the world, young people are less likely to be virologically suppressed and linked to treatment, so their preferences and experiences are of profound importance. Panelists noted a coming conundrum: injectable ART is only being considered for people who have taken oral ART and achieved virologic suppression for six months, yet the people who may need it the most may not be able to meet these criteria.

The choice of a vaccine in the future is key—and possible, provided funding remains.
While the field awaits results in 2021 or so from the two efficacy vaccine trials in the field, R4P included a number of presentations on experimental vaccine approaches to creating broadly neutralizing antibodies (bNAbs). The goal of this work is to develop products that teach the human immune system to create antibodies like those being given, in pre-made form, to participants in passive immunization studies, such as the AMP trial.

There are three approaches being considered for early human trials from data now mostly in mice:

  1. Lineage based vaccine design, or basically retracing the steps a known bNAb has taken to become a bNAb.
  2. Germline targeting vaccine design, which finds the scarce “precursor” B-cells that later could become bNAbs and stimulating them to become protective.
  3. Immune-focusing vaccine design which focuses all immune responses on one key part of the virus like the fusion peptide at the base of the HIV spike or the V1/2 loop linked to the immune response in RV144. Immune-focusing attempts to get around the problem that the immune system often prefers to create off-target non-protective antibodies. All of these approaches are considering new immunogens like the SOSIP trimer which is designed to look as much like the HIV spike as possible to spur greater immune responses.

On the heels of the Resource Tracking Working Group report presented at the conference declining resources for HIV vaccine research, Robin Shattock (Imperial College London) and his colleagues presented on research from the 5-year €23 million EAVI2020 project. Working with a modest budget in the HIV vaccine world, EAVI2020 plans to design, test and manufacture multiple vaccine candidates, a model perhaps for more financially constrained times.

Finally, so much is going on in vaccine research that Julie McElrath from HVTN noted we “drowning in a sea of data.”” The rise of bioinformatics has highlighted the need coordinate across networks to make data useable. Uniform assays and ultimately common criteria for down selection for clinical trials for efficacy trials are needed to conserve resources and ensure the most promising candidates move forward.

Choice has many champions—including activist scientists!

In Wednesday’s plenary presentation, Raphy Landovitz and Craig Hendrix (Johns Hopkins University) embodied activist principles of naming issues and calling on specific actors to respond to concerns. Hendrix used a toolbox metaphor to take the audience through a “thought experiment” about what they’d like to have in their bedside drawer for a safe sexual life. Did people want the equivalent of a handyperson’s special—drill, hammer, wrench, pliers and so on—or did they just want a hammer, in other words a single option. “Not everything,” Hendrix remarked, “is a nail.” The most important slide was his final one, in which he laid out core tasks for a range of stakeholders with power over the future of HIV prevention research. We find it so relevant and powerful that we have reproduced it here.

Biomedical tools must live in programs that address structural issues
In an oral abstract session (OA10) titled Key to the Response: Populations, Partners and Prevention, researchers reviewed a range of familiar and essential realities: marginalized populations carry a high HIV burden, need biomedical interventions and culturally competent care along with strengthened communities and changes in criminalization laws. Studies from Brazil, Indonesia, Kenya, South Africa, the Ukraine, the US, and Viet Nam all highlighted the degrees of violence by the state, families and societies that impact adolescent girls and young women, sex workers, transgender people, and drug users—as well as the resilience of these groups, and their essential role in designing and delivering solutions that fit into their lives.

We all need to choose our words carefully, and take actions to match
In our first update, we noted that both words and silences matter a great deal at this moment in history—in the world and in our field specifically. In that update, the quote attributed to Dr. Mike Cohen regarding PrEP in women did not include the full text as presented on the slide, which stated, “Concerns about potential limitations of TDF/FTC prevention in women have been noted, and will likely be clarified through ongoing studies (e.g. HPTN 082) and observational data.” We should have used the precise language from the slide, and we apologize for shortening the text as every individual should be heard in the words they choose.

The concerns AVAC has raised, including at length in our AVAC Report 2017: Mixed Messages and How to Untangle Them and at a range of consultations, about the ways that daily oral PrEP is described with respect to relevance for women remain. Daily oral PrEP is less forgiving in women; close to perfect adherence is likely required for protection. This is a limitation faced by many drugs that require diligent use for efficacy. We feel that it is essential that limitations related to PrEP for women be framed as problems to solve via innovative program designs, and that suggestions that a WHO-endorsed strategy may still be require research to validate its use in women can be misconstrued as reasons to delay expanded access. Cohen did not in any way suggest a delay, and we hope the full quotation clarifies this fully. However, AVAC’s advocacy partners have observed countries questioning PrEP’s utility in women and using similar framings to justify their reasoning.

We will cover the closing plenary session in more detail in our final update, and it will soon be available via webcast. It was a remarkable panel of leading researchers and advocates, including the conference co-chairs and Maureen Luba, a Malawi-based member of the AVAC team who works closely with MANET+ and CEDEP. While all the presentations were on different topics, there was a single unifying theme of collaboration, choice and voice. This is a field in which we must find ways to work together and to respectfully disagree. We look forward to working collaboratively and in community with all stakeholders dedicated to scaling up today’s tools and continuing investigation for new ones in the future.

AVAC at HIVR4P 2018, Update 1: #believewomen

Along with #metoo and many others, #believewomen is one of the social media rallying cries of the past months (and years) as women and allies have taken a stand against violence, assault and the power structures that protect perpetrators, be they an aspiring Supreme Court justice or an employee at the UN agency charged with coordinating the global AIDS response. If silence is violence, #believewomen is the response. At this week’s HIV R4P conference in Madrid, we are hearing both silence and the challenge. In this first of a series of updates from the conference, we bring you a set of session updates, and this overall observation: #believewomen has no borders. It is everywhere. Even when the discourse is polite. Here in Madrid: Skilled, esteemed speakers are saying a lot and… silence speaks volumes.

Many of the silences occur in spaces where the lives and bodies of women, girls, gay and trans people are on the line. A Monday PrEP satellite (SA16 Current State of Play: PrEP Implementation Update and Challenges) focused on experiences delivering oral PrEP in diverse countries and started with an update on implementation progress from WHO’s Michele Rodolph. She emphasized that PrEP works for men and women and that programs should be selective and permissive: targeting the strategy but also offering it to anyone who comes into a clinic asking for the strategy. She also reminded us that the primary areas of scale-up are in the US and Europe, where gay men are the predominant population accessing PrEP.

As John Brooks from the US Centers for Disease Control and Prevention noted in that session, the patterns of access do not mirror the patterns of incidence: black and brown gay men and other men who have sex with men are at the highest risk of HIV and are least likely to access PrEP. Reports from the Jilinde project in Kenya by Daniel Were and the South African National Department of Health by Hasina Subedar—some of the most well-resourced and advanced PrEP programs in sub-Saharan Africa—showed that low uptake and continuation is slowly giving way to incremental increases in use by young women and female sex workers. A presentation by Mike Cohen of the HIV Prevention Trials Network started with the statement that PrEP works in men and women, but then turned to an exploration of data on the ability to offer women a precise estimate of protection associated with daily oral PrEP, and ended with a bullet point stating that “concerns about potential limitations of TDF-FTC prevention in women have been noted, and will likely be clarified through ongoing studies (e.g. HPTN 082) and observational data.

This was a head-spinning destination compared to Rodolph’s curtain-raising talk. The silences in these sessions is deafening. No one remarked on the degree to which racism and white supremacy drive HIV risk in the US. Nor did anyone raise the possibility that it is time, now, for African women—versus American men—to use available data to decide whether PrEP works for them, and to determine whether questions about whether daily oral PrEP work in women help or hinder HIV prevention.

Unfortunately, these silences recurred in the opening ceremony where a spirited yet respectful intervention by advocates called for continued research investment in daily and monthly methods in the category of microbicides—which includes the ARV-containing dapivirine vaginal ring—by the US government and all research funders. Dr. Anthony Fauci, the head of the US National Institute of Allergy and Infectious Diseases, spoke directly after this action and did not address the demands. Instead, he stated that the ring was a non-starter and also did not use the word microbicides, to the great dismay of the African women who had helped lead the action. Dr. Fauci also identified black and brown American men as a clear “demographic hotspot” without addressing structural issues. Silence on racism, silence on women’s desires—happily and profoundly broken by Gcobisa Madlolo, the recipient of the Omololu Falobi Award, who stated that her award was for all women who do not have control over their bodies, and by Linda-Gail Bekker (Desmond Tutu HIV Foundation and President of the International AIDS Society) who, on receipt of the 2018 Desmond Tutu Award for HIV Prevention Research and Human Rights, reminded the audience that the anti-Apartheid archbishop for whom the award was named was clear on the necessity of activism to propel social change. Speak truth to power.

These themes of gaps, questions, unuttered possibilities and implications continued in a robust plenary on Tuesday morning, which included an animated (literally) tour by Tom Hope of Northwestern University regarding early events in HIV infection. This led to some evaluation of so-called topical PrEP (perhaps better known as a microbicide), specifically an intravaginal ring, compared to daily oral PrEP and its ability to reduce risk of HIV. Hope used a single high-dose challenge in non-human primates to evaluate protection provided by the ring and the pill in rhesus macaques. He noted in passing that the high-dose model was sure to raise questions, as it does not mimic actual patterns of exposure. He did not return to this potentially significant limitation as he drew the conclusion that the levels of drug were localized in the vaginal tract, leaving some areas susceptible to infection, at least in the context of the high-dose challenge. Some of the actual human women in the trials of the ring have been protected from HIV—a reality that is worth uttering, and that does not diminish the need to continue to explore markers of protection and early events of infection.

Subsequent Tuesday plenary speakers shed more light on early and local vaginal events. Thumbi Ndung’u’s presentation on the FRESH cohort in South Africa involved insights from a group of young women who visit the clinic twice a week for job skills, educational training and blood draws to identify HIV in its very earliest stages of infection. Over five years of the cohort, incidence has remained very high—at over 8 percent. Women who do acquire HIV based on sensitive tests start ART immediately and some of these women have never seroconverted—meaning infection has not been established in the blood. Ndung’u and colleagues isolated the “founder” virus from these women in early infection and found that single broadly neutralizing antibodies did not block all viral activity of all of these isolates. Right now, the bNAb in efficacy trials (VRC01) is a single monoclonal; combinations are in the pipeline but farther down the road. Based on this, Ndung’u observed that combinations will be what’s needed for efficacy. Unasked questions: what would happen if the site offered PrEP on-site along with its training programs and intensively supported adherence, versus referring out for PrEP? Given that there has been no incidence reduction, yet DREAMS and She Conquers programs (South Africa’s nationally driven version of DREAMS) in the country have shown reductions, albeit, modest, in new diagnoses, is there a standard of care that could be adapted on site to help drop incidence? Given that combo bNAbs are needed and are many years away, can the world really afford not to say the word “microbicide” and act on the ring?

“We are entering the era of the microbiome,” said Sharon Achilles from the University of Pittsburgh, the final plenary speaker, before moving into a deep exploration of the role of vaginal bacteria in HIV risk. Picking up from Ndung’u, she noted FRESH cohort findings that the presence of unhealthy vaginal bacteria associated with bacterial vaginosis was associated with HIV risk. She then looked at how different contraceptive methods impacted presence of these bacteria. Oral and hormonal contraceptives decreased presence of these unhealthy bacteria; the copper IUD increased detectable BV-associated bacteria. This information makes the upcoming results from the ECHO trial, a randomized, controlled trial of the copper IUD, DMPA and the Jadelle implant to directly measure impact on HIV risk, all the more important. Sadly, Dr. Achilles did not mention the trial at all.

Other highlights from the conference included:

Voices in the long-acting PrEP movement
Showing how the voices of possible users of long-acting prevention were and could be listened to during different stages of product design and development was the theme of a session aimed at fostering dialogue between different groups represented at the session. The speakers included people from pharmaceutical companies such as Alex Rinehart from ViiV and Mike Robertson from Merck, researchers such as Elizabeth Montgomery and Leah Johnson from RTI, Maggie Keane from IAVI and Anabel Gomez from AVAC. There was much interest in how to ensure getting feedback from people who may use the products before clinical trials, and a consensus that there is a need for better human-centric research earlier in the development process particularly to identify possible behavioral factors that could affect adherence. Participants identified a key question related to figuring out how to ensure that information about the behavior and preferences of users of today’s products is gathered in a way that is relevant to future products.

GPP a must in clinical trials: Nelson Michael
“Community engagement is not just “nice to have”; it’s essential to clinical research,” Rt Col. Dr. Nelson Michael of the US Military HIV Research Program (MHRP) said. He addressed a group of GPP implementers, advocates and other research team staff at a GPP focused session on Monday, October 22. Michael shared how lessons learned during the RV144 vaccine trial in Thailand are informing MHRP’s work in Germany today.

Cate Hankins of the Amsterdam Institute for Global Health & Development (AIGHD) and AVAC’s Stacey Hannah facilitated the satellite, which delved into 10 years of implementation of Good Participatory Practice (GPP) in biomedical research, with interactive discussion around successes, challenges, and strategic directions for the future. The meeting explored consensus on GPP as a standard in clinical trials, and its measurement. Participants received tutorials of new innovative GPP tools, such as the Engage! online platform for the GPP Community of Practice and the new Engagement in Ethics Review online course.

“If you don’t work with the community, you’ll fail,” said Michael, who served on the Obama Presidential Commission for the Study of Bioethical Issues.

What’s next for bNAbs for prevention?
A pre-conference session reviewed where we are in the next stage bNabs for prevention beyond the VRC01 antibody currently being tested in AMP. There is increasing emphasis on the likely need for more than one antibody for any prevention formulation (possibly 3 or more) to avoid existing or developed resistance seen in bNAb for treatment. bNAb combos might need to be matched regionally to provide better breadth (e.g. a clade C passive immunization), The durability of antibodies for prevention is being explored. Gene modifications of the LS region could extend half-life four times as long from the current two months but might take slightly longer to reach effectiveness after infusion.

The AMP trial testing VRC01 in two trials in Africa and the Americas is fully enrolled as of October 7 with no serious adverse events after 30,000 infusions. Larry Corey suggests that VRC01 is possibly the safest bNAbs treatment ever.

At a satellite session on HIV Prevention for Pregnant and Breastfeeding Women, Renee Heffron summarized data that pregnant women are 2- to 3-fold more at risk then women who are not pregnant, with the risk rising 4-fold in post-partum women. Yet the dearth of research and hence data on the safety of drugs for pregnant women often mean that their safety is only captured in post-marketing evaluations and off-label use. There’s a palpable tension between providing access to PrEP to pregnant women now due to the urgent need vs. ensuring there is enough safety data before use. Dr. Abednego Musau described Jhpiego’s experience in providing PrEP to pregnant and breastfeeding women in Kenya while Dr. Bonus Makanani described planned MTN trials to study PrEP and dapivirine ring use in 4 cohorts of pregnant women (MTN 042) and in breastfeeding women (MTN 043). Research in this community has traditionally had a protectionist attitude but this is changing with more and more ethicists challenging that we need to move from assumed exclusion to presumed inclusion, of women in clinical trials. Advocates are urging that US regulations be revisited so that pregnant women are able to reap the same benefits from research as other populations and have a right to safe, efficacious, appropriately dosed therapies that have been studied specifically in pregnant and breastfeeding women. All women—in all stages of their reproductive and sexual life—have the right to use safe and efficacious drugs that have been studied specifically for them.

If you want to view the sessions, visit the HIV R4P webcast portal to stream these and any other conference session. And for real-time coverage, follow the conference hashtag, #HIVR4P2018.

Stay tuned for additional updates as the week unfolds!

Ready Or Not, R4P Starts This Weekend

Last week, we talked about some sessions we are looking forward to at next week’s HIV Research for Prevention 2018 conference in Madrid. We also included information on how to follow your favorite prevention issue, whether in-person or from afar. This week, we’re sharing more details on programming and spaces for advocates!

Find continuing support for your advocacy and expand your knowledge of critical issues at the Advocates’ Corner (AC), found by the Estrasbrugo Room. The AC will be open throughout the conference, and in addition to the materials displays and opportunities for informal networking and fun games, the Advocates’ Corner will play host to a program of activities scheduled during breaks in the conference program. Don’t forget to pick up a hard copy of the new AVAC Report—No Prevention, No End—hot off the press!

You can download the full Advocates’ Corner program here—and please join us on Monday afternoon at 15:00 for a welcome reception!

To help plan the rest of your time in Madrid, download this roadmap of conference sessions and satellites, which is sortable by intervention.

And, as always, look for real-time updates from AVAC’s Twitter feed and updates from the Advocates’ Network for the latest on the research and the complex work of implementing the tools that exist today.

The entire program for R4P is available here. If you are tuning in remotely, there are webcasts from current and past conferences.

Here’s to the work ahead in Madrid and afterward!

No Prevention, No End – AVAC launches new report and call to action

Today AVAC released No Prevention, No End, our 2018 annual report on the state of the field. Starting from the title—which humbly borrows the cadence of the call for an end to state-sanctioned violence against Black Americans, “No Justice, No Peace”—through to the closing words, “This is the worst possible moment for slowing down,” the Report is a call to action and guide for addressing the HIV prevention crisis that threatens progress in curtailing epidemics worldwide.

Click here to download the Report and individual sections and graphics; click here for a new episode of the Px Pulse podcast which covers the Report’s key themes and features lead author Emily Bass, AVAC’s Director of Strategy and Content.

UNAIDS named the prevention crisis in its July 2018 report, Miles to Go. It acknowledged that the scale-up of antiretroviral treatment, while essential, is insufficient as a prevention strategy. AVAC has been warning of an imbalance in approaches and investments across approaches, and calling for ambitious targets matched with political will, financing, timelines and more since the UNAIDS targets were first launched in 2014. (Check out AVAC Report 2014/5: Prevention on the Line for a summary of this critique of targets.)

In this year’s Report, we call out three core problems with primary prevention and the global HIV response, identifying the risks they bring and the path to a solution. Specifically, we focus on:

  • Investing in demand creation: The private-sector gloss on this term cannot obscure its essential role in making primary prevention work. Strategies that might save lives are condemned as unwanted or unfeasible when they’re delivered in programs that lack integrated demand-side thinking, which is a science and not a set of slogans.
  • Making informed choice central to HIV prevention: Programs that offer more than one option, along with a supportive environment for a provider and client to discuss risks, benefits and personal preferences aren’t a luxury but a necessity. The family planning field has metrics to measure choice; HIV should pick these up, with prevention programs leading the way.
  • Unstinting radical action: Progress in the global AIDS response is tenuous; so is the state of democratic institutions and the future of the planet. These interconnected issues require more bold action, including from countries that are aid beneficiaries, and from the citizens of those countries who unite to hold truth to power. In the HIV prevention context, this means accountability for primary prevention at every level, including research for next-generation options.

AVAC is launching this Report as many stakeholders in HIV prevention research gather in Madrid for the HIV Research for Prevention (R4P) conference. Visit our special R4P page to find us on-site and follow along from afar, to see how the themes of this year’s Report resonate in a global and wide-ranging discussion of HIV prevention research and implementation at a critical time.

Science, Theory and Practice of Engaged Research: Good Participatory Practice and beyond

journal issue cover

“Science, theory and practice of engaged research: Good Participatory Practice and beyond,” a special supplement of the Journal of the International AIDS Society was published in October 2018. This issue tracks practices and articulates the value of GPP and stakeholder engagement in clinical trials across fields, research areas, geographies and populations.

This supplement was supported by AVAC with funding from the Bill and Melinda Gates Foundation and via the Coalition to Accelerate and Support Prevention Research (CASPR) through the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the US Agency for International Development (USAID).

Looking Ahead to R4P!

At AVAC we are looking ahead with anticipation to the biennial HIV Research for Prevention 2018 conference to be held in Madrid, October 21-25. Affectionately known as R4P, it’s a space where HIV prevention takes center stage. Whether you’re headed to Madrid in a couple weeks or following the action from afar, AVAC will keep you connected! Read on for information on AVAC sessions, a sortable roadmap, the Advocates’ Corner (open all week) and more!

For those joining in-person, use this roadmap of conference sessions and satellites, sortable by intervention, to find what interests you at the conference.

From updates on major trials to the complex work of implementing the tools that exist today and all the advocacy needed to get it all done, our dispatches to the Advocates’ Network keep you informed. For real-time coverage follow AVAC’s discussions on Twitter.

If you plan to be in Madrid, you won’t want to miss the satellite sessions AVAC has organized with partners (more below) including a Sunday-morning pre-conference for advocates. Register by Octoberober 17th and get an in-depth and of-the-moment view of the field and advocacy priorities to carry with you throughout the conference.

Find continuing support for your advocacy and expand your knowledge of critical issues at the Advocates’ Corner (AC), found by the Estrasbrugo Room. The AC will be open throughout the conference, and in addition to the materials displays and opportunities for informal networking, the Advocates’ Corner will play host to a program of activities scheduled during breaks in the conference program. Stay tuned for the final AC program, available next week!

The entire program for R4P is available here. If you are tuning in remotely, there are webcasts from current and past conferences.

Here’s a calendar of satellites and sessions of interest:

Sunday, 21 October

Advocates’ Pre-Conference Workshop
AVAC, IRMA, NHVMAS
Provides an overview of the field and explores cross-cutting issues, priorities and common goals. Register here.
Location: Dresden & Stuttgart

Planning for Success: Next Steps for Dapivirine Ring
OPTIONS, IPM
Stakeholders share research and experience to inform next steps for introduction.
Location: Burdeos

Social Sciences in Vaccine Trials: A Booster to Recruit Volunteers
ANRS, Vaccine Research Institute
Time: 12:30-14:30​
Location: Marsella

Monday, 22 October

Current State of Play: PrEP Implementation Update and Challenges
AVAC, WHO
A look at the status of PrEP and future products, and approaches to implementation in low and middle income countries, including challenges and controversies.
Time: 8:30-11:30
Location: Bristol

Voices in the Long-acting PrEP Movement: Fostering Dialog Between End-users and Product Developers During the Product Development Process

AVAC, RTI International, Desmond Tutu HIV Research Foundation, IAVI
Time: 8:30-11:30
Location: Burdeos

GPP@10—Setting New Standards for Clinical Trial Engagement Globally
AVAC, Amsterdam Institute for Global Health and Infectious Diseases
How Good Participatory Practice evolved over the last ten years with a look at implementation, challenges, and the status of GPP as a standard in clinical trials.
Time: 8:30-11:30
Location: Marsella

Whose Desire? Whose Choice? A Debate on the Future of HIV Prevention
AVAC, IRMA
Panelists unpack the priorities for HIV prevention research and product development and debate what it means to give people choices.
Time: 12:00-15:00
Location: Oxford

Accelerating a Labor of Love: Time to Transform HIV Prevention for Pregnant and Breastfeeding Women
AVAC, Jhpiego, MTN, PHASES
A look at the growing body of evidence and advocacy for biomedical HIV prevention options for pregnant and breastfeeding women.
Time: 12:00-15:00
Location: Estrasburgo

The Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy
African Microbicides Advocacy Group (AMAG), AVAC, IRMA, Journalists Against AIDS in Nigeria (JAAIDS), NHVMAS
This award honors individuals who have shown extraordinary leadership and commitment to HIV prevention research advocacy and inspired others to action. This year’s recipient will be announced during the opening session, 17:47-17:55.
Location: Auditorium

Tuesday, 23 October

Entry Into the PrEP Continuum (oral abstract)
Tracking Global Oral PrEP Provision: The Who, What, Where of Oral PrEP
Time: 10:30-12:00
Location: Marsella, Burdeos & Estrasburgo

ARVs for Prevention: Extrapolating from Data to Clinical Practice (symposium)
The PrEP Paradigm for Prevention, Advocacy and Implementation in sub-Saharan Africa: Strong Starts, Short Cuts, and the Use (and Abuse?) of Data
Time: 15:00-16:30
Location: Marsella, Burdeos & Estrasburgo

Wednesday, 24 October

Accelerating Product Introduction for Impact (roundtable)
Time: 15:00-16:30
Location: Bristol

Trials and Tribulations in Roll Out (poster discussion session)
Time: 16:45-17:30
Location: Oxford

Thursday, 25 October

Opinion 360: Meaningful Engagement From Research to Roll Out (oral abstract)
Time: 8:30-10:00
Location: Oxford

Putting It Together: Strategies to End the Epidemic (closing plenary)
Implementing a Multi-disciplinary Prevention Revolution
Time: 15:00-16:30
Location: Auditorium

Here’s to the work ahead in Madrid and afterward!

PrEP Messaging: Using radio to reach communities with oral PrEP messages

This story is part of a series of reports from the ongoing POWER Study, which is developing cost-effective and scalable models for PrEP delivery in Kenya and South Africa. AVAC and the University of Washington (UW) have teamed up to help answer questions from implementers rolling out PrEP in a variety of settings. Using qualitative stories from the UW PrEP projects, these blogs share lessons learned from the field and actionable insights for implementers developing strategies for delivering PrEP.

Joel Odondi must be doing something right. The former chaplain for a girls’ school has become a trusted expert on HIV prevention to radio listeners across Kenya – delivering messages that correct misinformation, counter myths, explain scientific concepts, and frame public health debates on PrEP and a host of other issues related to HIV. Keeping an ear out especially for what young women need to hear, Odondi uses a powerful combination of responsiveness, accuracy and credibility to get the job done.

Joel Odondi on the mic

It started ten years ago, when Odondi turned to a local radio station in Kisumu to get out messages about PrEP. The idea was to inform the community about research going on in their backyard on a new HIV prevention intervention, PrEP, and enroll people in the study, known as Partners PrEP, which also sponsored the show. Since that launch, the show was popular enough to continue through the open label extension study, demonstration study, and scale up program that is part of national roll out.

At the time, Odondi was part of the Partner’s PrEP team in Kisumu. It was a phase III placebo-controlled trial of daily oral TDF or TDF/FTC as PrEP for the prevention of HIV among heterosexual men and women in sero-discordant partnerships in Kenya and Uganda. Odondi saw that the providers and the scientists had developed a strong program to explain the study and how PrEP works. But that wasn’t enough.

Download a tool for radio engagement written by Odondi

“Those messages were not reaching the rural women, the village girls and that was a problem. Among other things, they needed information in their own language, Luo. I lost my sister to HIV and it was important to me to find a way to help make someone’s life better. I wanted to address issues of stigma and combat those myths with facts.”

Odondi started at two Luo speaking stations with hour-long shows where he would talk about PrEP, how it worked and who it was for. He talked about knowing your status and connecting with services. He confronted myths about the research process. He talked about why young people are vulnerable to HIV exposure. He talked about condom use, abstinence, voluntary medical male circumcision, morality and public health, and the importance of protecting young people as an investment in the future.

“Many of the participants [in PrEP demonstration projects] come from rural areas. It’s a challenge to get information to them. But they listen to the radio. And the radio gives you a kind of celebrity. It’s a kind of authority.”

Ten years later, Odondi is the Community Liaison Officer for the POWER study (Prevention Options for Women Evaluation Research) and the Lead Technical Advisor for Community Outreach for the Partners Scale-Up project operated out of KEMRI (Kenya Medical Research Institute). As part of his work on these projects, he has 18 shows a month on six different stations in three languages, Luo, English and Swahili, including stations in Nairobi that are heard across Kenya. Through all these stations his shows reach millions.

Each show starts with a 20-minute discussion between him and a station host on a prepared subject, the rest of the hour they open the phone lines and answer questions. The phone lines routinely fill up and stay full through the hour. His prepared remarks come from material he gets from the community through a couple of channels: he holds weekend workshops where he provides HIV prevention information to young women and they write down questions for him; the stations give their listeners a phone line where their questions and concerns are recorded for Odondi to review in advance of a show; and he provides a help line number over the air and promises that someone is always available to answer.

People call. A lot. Odondi is able to provide them with information about where to get PrEP in their area which has led to increased enrollments in both the POWER study and Partners Scale Up project.

“The same questions come up. The young people want to know if they are eligible to take PrEP. They want to know the side effects, if they have to take it forever, could they get an injection instead. Religious leaders ask me if PrEP will be abused, if it promotes promiscuity. One called into a show to say HIV was God’s punishment. I said ‘No. This is a health issue.’ When they bring the religious point of view, I can bring in a new point of view, a research literacy point of view.”

Sometimes he shapes his radio program based on new findings from the clinics he works with in his role in POWER and the Partners Scale Up project. “We saw a gap in HIV testing. So the station promoted my next show on the topic of testing with short spots on ‘What to do if you’re positive’ and ‘What to do if you’re negative’.”

When it comes to reminding people to take PrEP every day there are a few analogies he turns to again and again. “PrEP works if you take it. It’s the same if you want security — you have to lock your door every day. Condoms don’t work in your pocket. Wear a seatbelt every day for that one day you are in an accident.”

Odondi takes extra care in his messages to young people. He says it’s a real mistake to assume you know what they need. He attends community discussions about PrEP and listens to the voices of young women to stay up to date. But some parts of his message don’t change. “First I tell them they are special, their energy and spirit is our future. Then I tell them they [young women] are vulnerable and talk about condoms and sexual health and other risks. Finally, I tell them ‘you can be part of the solution,’ and invite their ideas. And then I listen.”

Additional Resources

  • Odondi has authored this brief outline on the benefits of radio as a tool for community engagement, complete with highlights of commonly asked questions and topics he covers.
  • Hear Joel Odondi explaining PrEP on the radio airwaves of KBC English, a Kenya-based news service.

logos for USAID, PEPFAR, and POWER

POWER (Cooperative Agreement AID-OAA-A-15-00034) is made possible by the generous support of the American people through the President’s Emergency Plan for AIDS Relief (PEPFAR) and the United States Agency for International Development (USAID). The contents do not necessarily reflect the view of USAID or the United States Government.

MPT Field Investments & Collaborations are Assets for Global Sexual Health

This post first appeared on the Initiative for MPTs’ blog.

Recently, on World Sexual Health Day, we at the IMPT reflect on how to work with partners to improve sexual health across the globe. There are many things that could be done, many different approaches, and many people we can work with towards this goal. Here, at the IMPT, we see multipurpose prevention technologies (MPTs) to be one such promising strategy with the potential to improve the sexual health – and lives – of women and their families across the globe.

Sexual and reproductive health risks, such as unintended pregnancy and sexually transmitted infections, including HIV, are intrinsically interlinked. Yet, the current mix of prevention options has fallen short in protecting the sexual health of millions of women. The innovative work being done to advance prevention science, including the development of MPTs, is essential to better meet sexual health needs and improve countless lives. The price of innovation is steep and the time horizon is long, but the end result has the potential to be game changing.

Sustained investment in prevention science is crucial for both the roll-out of existing prevention methods, as well as the development of new and effective technologies, like MPTs. The IMPT, led by the IMPT Secretariat, has partnered with the Resource Tracking for HIV Prevention R&D Working Group to monitor investments that support MPTs and the wider field of HIV prevention on an annual basis.

Since its inception in 2004, the Resource Tracking for HIV Prevention R&D Working Group, hereby referred to as the Working Group, has tracked US$17 billion of investments in biomedical HIV prevention research and analyzed funding trends across various prevention technologies, research stages, and sectors. This multi-tiered analysis of global investment flows is crucial for evaluating public policies, improving transparency, and furnishing facts for advocacy. As the HIV prevention toolbox has expanded, so has the mandate of the Working Group and the scope of our resource tracking efforts.

Substantial growth of the MPT pipeline coupled with an ever-present concern about the risk of STIs and unintended pregnancy in women, heralded the beginning of a partnership between the IMPT and the Working Group. From 2013 onwards, in a unique collaboration defined by a shared commitment to prevention science, knowledge and data-sharing, the IMPT and the Working Group have collated and analyzed close to US$142 million in funding for the advancement of MPT products. Expanding the scope of the Working Group’s original mandate, grants relevant to MPT R&D are also collected during the annual outreach to funders and implementers of HIV prevention science. This engenders a more efficient and streamlined method for data collection and the monitoring of field-wide investment trends.

Funding trends for MPT R&D reflect the rapid pace with which the field has grown – to cover two dozen new products and a 52 percent increase from 2013 levels when the resource tracking partnership began. While annual investments have averaged at US$37 million, overall funding dropped for the first time in 2016 by 14 percent to US$40 million. The US public sector remains the predominant funder of MPT research, primarily through the NIH and USAID, and accounting for 63 percent, 74 percent, and 67 percent of all overall investments in 2014, 2015, and 2016 respectively. Philanthropic investment in MPT research totaled US$4 million in 2016. Compared to the preceding year, private sector investment fell in 2016 and represented 10 percent of overall investment in MPT research.

The MPT field has seen a remarkable increase in investment in the last five years. However, the recent decrease in investment in prevention science, including MPTs, is concerning and should not be ignored. Advocates need to reinvigorate support for this important work and push for the investment needed to drive cutting edge and life changing science that will improve the sexual health of millions worldwide. The IMPT and the Working Group will continue to work together to monitor the progress of the fields and hope to see the needed resources committed to advancing prevention science and saving lives.

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Since 2000, the Resource Tracking for HIV Prevention R&D Working Group (formerly the HIV Vaccines & Microbicides Resource Tracking Working Group) has employed a comprehensive methodology to track trends in research and development (R&D) investments and expenditures for biomedical HIV prevention options. AVAC leads the secretariat of the Working Group, that also includes the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

More information about the growth and investment in the MPT field can be accessed in the 2017 IMPT Annual Report.

About the Authors
Fatima Riaz is the Program Coordinator for Research and Data Analytics at AVAC and has an MPH from Columbia University and a certification in Global Health Delivery from Harvard University. Her career started as a student health advocate in Pakistan where she founded and led a national polio advocacy campaign, and has since worked with the World Bank, the International Rescue Committee and UNICEF on diverse issues like WASH, violence prevention and maternal child health.

Kathryn Stewart is Deputy Director for CAMI/IMPT and has a Master’s in Public Policy from UC Berkeley with a special focus on maternal and child health. She also holds a BA in Politics and International Relations from Scripps College. Kathryn applies her 20-year experience in sexual and reproductive health prevention, policy, and research to coordinate a spectrum of projects aimed to advance the development and introduction of multipurpose prevention technologies (MPTs).

Check Out the Latest Episode of Px Pulse: Combination Prevention and AIDS 2018

The August episode of Px Pulse is waiting for you!

In this episode, featuring Ambassador Deborah Birx, we take a look at one area of great importance that was center stage at last month’s AIDS 2018 conference in Amsterdam: primary prevention.

Hear Brad Jones of Weill Cornell Medical College pose a basic question about T cells and what his research could teach us about the immune system. Advocate Dorothy Okatch of the NGO Young 1ove sizes up the challenges for prevention in her country Botswana, where gains in treatment have been lauded.

And you won’t want to miss our discussion with the head of PEPFAR (the US President’s Emergency Plan for AIDS Relief), Ambassador Deborah Birx, who oversees one of the biggest HIV/AIDS programs in the world. Hear how Amb. Birx defines today’s prevention priorities and find out the difference between “lumpers” and “splitters”.

For the full podcast, highlights and resources go to avac.org/px-pulse. And subscribe on iTunes to catch every episode!

What’s Right – And What’s Not – On the Road Towards Epidemic Control?

Maureen Luba is the African Regional Advocacy Advisor: COMPASS and AVAC, based in Malawi.

In 2016 when I attended the International AIDS conference in Durban for the first time, my impression from the conference was that the world was on track to achieving epidemic control. I was assured the 90-90-90 targets, if achieved by 2020, would mean we were on track to control the epidemic. I left the conference feeling hopeful, re-energized and geared to push Malawi, my home country, to increase and align its investments to the 90-90-90 targets. For me, the end to AIDS was near.

Two years later, I found myself attending the International AIDS Conference in Amsterdam. Three days before commencement of the conference, UNAIDS released its annual state of the epidemic report, this year titled Miles to Go. I was astonished to learn that we are in a prevention crisis, and that epidemic control might not be within reach as we had all anticipated.

Going through the UNAIDS report I was not sure what to expect from the conference itself. I had so many questions on my mind: What are we not doing right? When will HIV cease to be a crisis? For how long should we keep pushing? As I attended the conference I was hoping to get some answers, but sadly I left the conference with some unanswered questions. As time continues to tick and resources continue to wane, it is important that we all take a moment and reflect on this journey.

The critical issues that stood out for me included: the need to allocate more resources, the optimal use of resources currently available, recognizing and supporting the critical role of civil society organizations (CSOs), advocates and communities, the need for more prevention options for women and leaving no one behind.

One thing I liked about the 2018 conference was the tremendous recognition of community voices. I marveled at how community groups were rigorously engaged and given an opportunity to be heard. As a community representative myself, sitting on a panel with UNAIDS Executive Director, Michel Sidibe, I spoke about primary prevention and took advantage of the opportunity to remind UNAIDS and other key stakeholders in the room about the critical role that CSOs, and communities generally, continue to play in the response and why there is need to invest in it.

As a young woman, a champion and a passionate advocate for women-controlled HIV prevention options, being given a chance to make a speech at the International Partnership for Microbicides (IPM) reception was an opportunity to express gratitude to all partners present for the contribution they have made towards the development of the dapivirine vaginal ring and other products in the pipeline. It was also an opportunity to remind people of the need for continued support of women’s access to discrete tools that they can use without negotiating with anyone. Just reflecting on the conference itself, it is very clear to me that we still have a lot of work to do.

Achieving epidemic control will require pulling together strategies and engaging with the work of different stakeholders. It will also require that we reflect on past experiences; what has worked and what has not, whilst drawing on those key lessons to guide programming and implementation going forward. All this must be to put to use in the early adoption of policies that support interventions that work, addressing the social and cultural issues that have an impact on the epidemic, increased investing in research efforts focusing on women-controlled HIV prevention interventions and last but not least, greater involvement of the communities in the design and implementation of the programs.