New Issue! Px Wire: The prevention question cascade

In the new issue of Px Wire, AVAC gives our take on this year’s PEPFAR process for establishing the Country Operational Plans (COPs). These plans define what work will be done with PEPFAR money at the country level and how that work will be evaluated in each of the 63 countries that receive PEPFAR money.

The process has changed considerably since last year, allowing for deeper insights into what’s working and what’s not. In this issue, AVAC takes you through the good and bad of PEPFAR’s emphasis on index testing, analyzes crucial gaps in combination prevention, and lays out a series of questions to shape a powerful agenda for advocacy.

This issue’s centerspread takes a closer look at Zimbabwe’s data, and highlights amfAR’s detailed country factsheets that draw from PEPFAR’s giant data sets. Additional tools and information on influencing the COPs process are available from COMPASS partner Health GAP’s PEPFAR Watch.

Find the full issue Px Wire and the archive of past issues at www.avac.org/pxwire.

Px Pulse Podcast: From the trenches, advocates share their prevention priorities

Check out the April episode of Px Pulse on iTunes or at www.avac.org/px-pulse!

We bring you two different conversations, each throwing a spotlight on different aspects of HIV prevention advocacy today.

AVAC’s Manju Chatani-Gada talks with three advocates who attended AVAC’s African Advocacy Partners’ Forum in Johannesburg, where seasoned and new advocates came together to look at prevention priorities from every angle. In this discussion, you’ll hear how the forum brought key issues into focus and how these advocates are sharpening their strategies.

Then we turn to a global effort to accelerate prevention.

Christine Stegling, the head of the UK-based International HIV/AIDS Alliance joins us to talk about a new initiative led by UNAIDS and UNFPA to escalate and maximize HIV prevention in the 25 countries with the biggest number of new HIV diagnoses. Dubbed the Global HIV Prevention Coalition, we talk with Christine about how to know if it’s living up to its name.

For the full podcast, highlights and resources, visit here. Subscribe on iTunes to catch every episode!

Post-CROI Roundup and Webinar Series

[UPDATED: slides and audio from the webinars now available.]

The annual Conference on Retroviruses and Opportunistic Infections featured over 4,000 researchers, advocates, implementers—and a couple big snowstorms—along with a range of scientific findings of great interest to prevention advocates.

Join us to dig into the data with researchers and discuss with fellow advocates how these findings can inform our advocacy work moving forward.

Webinar Series

We will be adding additional webinars over the next couple of weeks, so please do stay tuned for additions to the schedule!

Conference Coverage

We’ve rounded up a selection of conference highlights, which are posted on our P-Values blog—check out it here!

For comprehensive coverage of the conference check out the excellent work from aidsmap. Resources from the UNAIDS and WHO co-organized update to staff and beyond on the Latest HIV science from CROI 2018 are now accessible.

CROI Program and Webcast

CROI provides a number of ways to review what happened in Boston: check out the full program; abstracts and e-posters; and webcasts of all sessions.

HIV R4P scholarship deadline

HIVR4P is dedicated to ensuring the participation of researchers, community activists, and civil society representatives, especially those from resource-limited settings and communities. The conference offers full scholarships as well as registration-only scholarships. Scholarships are highly competitive and will be awarded based on the availability of funds. Conference Scholarship applications are accepted until 23 April 2018. More information can be found here.

CROI 2018: Research for the Front Lines

Rob Newells is the newly appointed Executive Director of AIDS Project of the East Bay; he is minister and founder of the the HIV program at Imani Community Church in Oakland and is a PxROAR member since 2012.

The annual Conference on Retroviruses and Opportunistic Infections (CROI) brings together thousands of researchers from around the world to share the latest information on HIV, AIDS, and related infectious diseases. The 2018 meeting in Boston highlighted 114 oral abstracts and 991 posters in 23 different science categories, from Virology to Population and Cost Modeling.

The time lag from research to implementation in health can be long. One study from 2011 suggested an average 17-year delay (Morris, Wooding, and Grant, 2011). This graphic (adapted by AVAC from Dana Hovig at the Bill and Melinda Gates Foundation) shows a five year lag in the US for vaccines and drugs. As one of 26 Community Educator Scholarship Awardees at this year’s Conference on Retroviruses and Opportunistic Infections (CROI), it is my goal to help reduce that delay by focusing on research that has the potential to impact community members and frontline workers who I interact with on a daily basis in the short term.

I am sure that scientists and advocates will spend the next year talking to each other about the issues and information that came from oral abstract sessions reporting on long-acting cabotegravir (Abstract 83) and dapivirine ring studies (Abstract 143LB and Abstract 144LB). Advocates should also be engaging community members and frontline workers in conversations about these emerging tools for HIV prevention.

Almost six years after FDA approval, oral PrEP is a part of the HIV prevention landscape worldwide, but it looks different depending who you are and where you live. PrEP access still seems to be among the most relevant issues for HIV-negative black MSM in the United States, while viral suppression (which is key to improving health outcomes and eliminating the risk of onward transmission) remains a priority concern for PLHIV. Do PrEP and treatment as prevention really give us all of the tools we need to end the HIV epidemic? What follows are a few of my (US-centered, black MSM-focused) highlights from #CROI2018:

Oral Pre-Exposure Prophylaxis (PrEP)

Does PrEP drive STI rates? No! Abstract 1025 looked at condom use patterns in about 300 MSM and transgender participants in a PrEP pilot study. Reported condom use did drop, but overall rates of STI diagnosis didn’t not rise. The investigators conclude that “neither overall condom use nor change in condom use were associated with STI diagnosis.” Good predictors of STI diagnosis among PrEP users included being under 25 years old, being diagnosed with an STI in the 6 months prior to starting PrEP, and the number of sex partners. The researchers conclude that “particular attention and support is needed for younger PrEP users,” and, “although many PrEP prevention messages stress condom use, the number of partners appears to be a more important predictor of STI diagnosis among PrEP users.”

…and, in an exploration of the intersection of PrEP and STIs in the United States, Dr. Julia Schillinger said, “as researchers are looking at retention on PrEP, maybe one of the things they could also measure is, even if people aren’t retained on PrEP, are they retained in a system of testing and primary care?”

Should PrEP be prescribed for people who use meth? Yes! Starting with data from the iPrEX study and its open-label extension, it’s been clear that people at risk of HIV and unable to use condoms will use PrEP correctly and consistently. A study of these issues at CROI found more evidence of this. The study enrolled MSM who were using PrEP and reported condomless anal sex with multiple partners (CAS-MP). Some also reported stimulant use. The researchers wanted to know how stimulant use and condomless anal sex affected adherence to PrEP. They measured the presence of PrEP in blood samples from the study participants. (This can give a more accurate picture of whether people are taking PrEP than their own reports. Overall, 80 percent of participants in the study had protective levels of PrEP in their blood over the course of the 48 week study, regardless of stimulant use or frequency of condomles anal sex.) Conclusion: “Stimulant use should not be a deterrent to prescribe PrEP to high-risk individuals engaging in CAS-MP.”

Short-term PrEP as part of vacation package??? Yes! Advocates have stressed for years that oral PrEP is not forever. Rather, it should be used during a person’s “season of risk.” Sometimes those seasons aren’t very clear. Sometimes they are. Researchers investigating the feasibility of short-term, fixed interval, episodic PrEP (epi-PrEP) found in a study of 54 men who have sex with men (MSM) that most were adherent during short, high risk vacation periods. Study participants started oral PrEP 7 days prior to vacation and were instructed to adhere to daily dosing through seven days post-vacation. (They also received a single session of cognitive behavioral therapy at least two weeks before the vacation.) Nearly 94 percent of the men in the trial had protective levels of tenofovir-based PrEP in their blood at a study visit three days after their vacation was over. Epi-PrEP may be a good option for some men with episodic high risk for HIV infection, and as an added bonus, “initiating PrEP on vacation may provide a helpful way to initiate long term PrEP.”

Oral tenofovir-based PrEP is still one of the most important tools for HIV prevention available today, but it is not a magic pill. Dr. Roel Coutinho reminded CROI attendees that using PrEP to eliminate HIV would take about 80 to 120 years without including other HIV prevention strategies. This is why viral suppression for people living with HIV is still a priority.

Viral Suppression

Findings from CROI:

  • Higher HIV viral load was independently associated with the likelihood of transactional sex. Additionally, those testing positive for an STI were nearly twice as likely to report transactional sex as compared to those without STIs.
  • Decreasing alcohol use without abstinence from alcohol was associated with a lower viral load. In other words, people with HIV whose drinking interferes with adherence to medication may be better able to take their medications when they reduce their drinking-without completely stopping. This can inform counseling messages and harm reduction approaches.
  • A study of PLHIV living in the San Francisco Bay Area got nuanced about types of homelessness-which can range from living outdoors to crashing with friends or family. It looked at the relationship between different types of homelessness and virologic suppression. Although living outdoors was associated with the lowest proportion of viral suppression, other forms of unstable housing (including living in a shelter, ‘couch-surfing’, and being in an single-room occupancy) were also associated with lower levels of viral suppression compared to renting or owning. Interventions are needed to increase viral suppression among PLHIV across a spectrum of unstable housing arrangements.
  • More frequent social work visits and nurse phone calls were associated with retention in care for young adults with HIV, but improved retention did not to lead to improved viral suppression. In general, young adults have lower rates of antiretroviral use and medication adherence than older adults, so lower rates of viral suppression in this group should come as no surprise. CDC’s HIV Care Continuum by Age shows that young people living with HIV are less likely than older Americans to be diagnosed, to be in care, and to be virally suppressed. Socioeconomic challenges, depression, and lack of tailored interventions to improve adherence among young people are among the issues that must be addressed to improve viral suppression for young adults with HIV.

HIV Care Continuum, by Age, US 2014

So much information, so little time. This year’s CROI featured lots of research focused on women, hepatitis C, tuberculosis, anal cancer, and a host of other issues that will continue to be analyzed and reported over the next several months. My initial brain dump to frontline staff at APEB was intended to share information that they might find useful in their work with members of our community now. We’ll continue to develop workshops and presentations and events that attempt to keep folks armed with the latest information available and prepared for what’s coming next. Somewhere between “now” and “next,” we have a lot of work to do!

4/18 Webinar: Introducing Oral PrEP

At CROI 2018 we heard stories, saw new data, and had lots of questions about early PrEP rollout. Please join AVAC and partners from Jilinde in Kenya and PZAT in Zimbabwe for an upcoming webinar on Wednesday, April 18, 9am ET to explore valuable resources for people working to deliver oral PrEP. See below for some of the tools and resources we will explore and discuss during the webinar. Check them out and come with your questions!

Click here to register!

  • Country Updates and the Global PrEP Tracker provide the status of PrEP.
  • A Framework For Scaling Up PrEP features step-by-step guidance for introducing PrEP into new settings.
  • PrEP Resources aims to be a central repository for materials currently being used by programs—in areas such as global guidance; national policies and guidelines; M&E; training curricula; advocacy; implementation; and demand creation.

All of these materials (and many more) can be found on PrEPWatch.org, the clearinghouse for oral PrEP efforts across the globe. Questions? Reach out to us at avac@avac.org, we want to hear from you!

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

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

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

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

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

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

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

*Last name withheld for confidentiality.

Now Accepting Applications for the GPP Online Training Course!

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

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

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

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

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

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

CROI 2018: Highlights and what’s next for advocates

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

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

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

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

What’s Next

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

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

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

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

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

What’s Next

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

Pregnant and Post-Partum Women Need HIV Prevention

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

What’s Next

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

PrEP Use Increases but Disparities Persist

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

What’s Next

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

Undetectable=Untransmittable

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

What’s Next

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

Products in the Pipeline

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

What’s Next

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

Keep the Conversation Going

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

And stay tuned for announcements on additional webinars!

Insight to Impact: Demand Creation Challenge

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

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

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

Click here for more information.