Reflection on bNAbs and Broadening the Toolbox

Josh Agee is the PrEP Coordinator at My Brother’s Keeper in Mississippi where he educates individuals about PrEP, assess their risk of HIV and navigates insurance plans for PrEP users. He is currently a Fellow at the Black AIDS Institute’s African American HIV University.

#CROI2016 was truly an amazing experience for me. I had the chance to learn about new scientific advancement and new tools that could expand the prevention options for my community. The new treatment and prevention strategies are exciting and offer a level of promise that my community is looking for since the current options aren’t doing enough for us.

Sometimes I reflect on history and where this epidemic has been and where it might be going. I think about the things that we once thought were beyond our grasp but now seem within our reach. I think how we’ve progressed from AZT to PrEP to potentially using broadly neutralizing antibodies (bNAbs) for prevention. Researchers first identified an HIV bNAb in 2009 from a person living with HIV. Subsequently, bNAbs were proven to be highly effective in neutralizing HIV in vitro in the lab and were able to neutralize over 90 percent of HIV strains. Science has given us the promise that this could be a new strategy, and we now have begun moving the testing of bNAbs out of the labs and into clinical trials.

At the conference it was discussed, as is the case of HIV treatment, which uses several classes of antiretrovirals per regimen, that a combination of antibodies might also be effective. These monoclonal bNAbs might be more efficient combined with other monoclonal bNAbs to increase their coverage of known HIV strains. The more, the merrier might be the way to go in this strategy. It is time to see if it is something that shows promise and might be our next big breakthrough. The only way to know if this will be an effective strategy is to test this in a real world setting. Future studies with bNAbs will include administering them to populations that are at high risk for HIV acquisition. This particular research stood out to me. It is a different approach that sparked my curiosity to see where this research might take the field.

The call for needing another option could not have been clearer than when the CDC made its announcement about lifetime risk for individuals. With the CDC’s release that 1 in 2 black MSM are projected to acquire HIV in their lifetime, it is imperative that we broaden our prevention toolbox and make it accessible to the community. These staggering numbers have also prompted me to take more action in my community as I realize the state of our emergency. I plan to do more innovative community outreach and educate our community on HIV treatment and prevention. While keeping a close eye on options and making sure my community is aware that help is on the way. And more options to meet their needs are coming.

The Railroad: From science to delivery, freeing young black gay men from a tragic trajectory

Brandon Harrison is a New York City based HIV advocate and a graduate of 2014 class of the Black AIDS Institute’s African American HIV University. He has held positions at both Callen-Lorde and the Black Leadership Commission on AIDS, providing technical assistance and support for community engagement and new HIV prevention methods.

In February at the Conference on Retroviruses and Opportunistic Infections (CROI), the Centers for Disease Control and Prevention released new data that suggest the lifetime risk of HIV diagnoses in all Americans is one in 78. More alarming than that, the analyst estimated that one in two or 50 percent of all black gay, bisexual and other same gender loving men are projected to be diagnosed with HIV in their lifetime.

While we know this population and those of the trans-experience continue to have the highest new infection rates among all other populations, these new estimates have created a state of emergency among members and leaders of this community. This is a call for action. We must save ourselves, we can no longer sit back and watch our friends, family and community members fall victim to a new HIV diagnoses. It’s our responsibility to ensure that the black community is not without the knowledge and access to the proper prevention tools or understanding of antiretroviral medications.

Lack of education and access to healthcare, cultural trauma and stigma are all part of a vicious cycle that has caused not only HIV but other health and economic disparities to continue thriving in black communities. Researchers have worked hard to development major advances in preventing and treating HIV, but unless these discoveries are appropriately delivered and implemented among those who need them most, black communities will continue to be affected negatively, greater than our counterparts. It is ultimately our responsibility to take control of our health. As Black History Month has come to an end, I reflect on how much affliction our community has faced and overcome. HIV is just another one that we can fight.

As we continue fighting to end this epidemic among black communities, I have been honored to stand here at CROI thinking about the way the people inspire me with their breakthroughs. I reflect back on the Martin Delaney Panel Discussion, one of the early plenary sessions, that discussed the need to engage men of color in clinical research. I felt the passion and heart from this session was an answer to so many pieces about the other things that act as barriers in the lives of men of color. I look at this conference and the science coming from it and think we have to figure out how to guarantee access to this new promising research. You have to be able to engage these at-risk folks and keep them in the study because whatever strategy you develop has to work for them. I leave you with the words of Harriet Tubman, “If you hear the dogs, keep going. If you see the torches in the woods, keep going. If there’s shouting after you, keep going. Don’t ever stop. Keep going. If you want a taste of freedom, keep going.”

Testing Integration of PrEP into Prevention Services for Sex Workers in Senegal

It’s been slow and somewhat piecemeal—but around sub-Saharan Africa, countries are beginning to explore PrEP using daily oral TDF/FTC for HIV prevention for women, gay men and other men who have sex with men and other vulnerable groups. In the first of a series of visits to PrEP programs in action or soon to be underway, AVAC’s Policy Director, Kevin Fisher, visited a program underway in Senegal. Here is his update.

In October 2015, I visited a PrEP demonstration project focused on female sex workers which began earlier in the year in four suburban communities ringing Dakar. One of my hosts, Daouda Gueye, from the site explained that Senegal has a nationwide prevalence below 1 percent, but approximately one in four sex workers in Dakar are women living with HIV.

Gueye, whose serves as a project manager, said that the demonstration project will provide PrEP to female sex workers recruited through Senegalese health department clinics and hospitals. The demonstration project was fully enrolled with 273 women by November 2015. In Senegal, the official policy is that all women who exchange sex for money have to register with the Institute d’Hygiene Sociale or other government-run designated clinics where they are issued a health card and required to visit for bi-monthly checkups for STIs and HIV testing. Registered sex workers are given free condoms and, if they are positive, antiretroviral therapy. This PrEP project will include both government registered and unregistered sex workers who do not receive services.

Registered sex workers have lower HIV incidence than unregistered sex workers, according to Gueye. If the program is successful, Senegal will consider integrating PrEP into its suite of prevention services for registered sex workers, if support can be found to fund the program, said Dr. Moussa Sarr, one of the principal investigators.

Across Africa, many programs piloting PrEP for women are reaching out to sex workers. Some, especially through the PEPFAR-funded DREAMS program, are also exploring delivery to adolescent girls and young women.

These programs are happening in dialogue with policy makers, advocates and, in some cases, potential users. UNAIDS released in 2014 recommendations on community-based PrEP services for sex workers developed in consultation with sex workers from India and South Africa in November 2013 in Johannesburg. Sex workers have begun to explore the potential benefits of PrEP for HIV prevention in the US, too. One issue that is consistently raised is how to ensure that individuals at high risk get access to needed services—without stigmatizing the intervention—leading it to be seen as something that is only used by certain types of people. There are also concerns among some sex workers about PrEP not destabilizing their use of other prevention tools, such as condom negotiation.

This certainly isn’t the intention of the WHO’s Recommendation On Oral Pre- Exposure Prophylaxis Of HIV Infection released in September 2015. This document addresses both when to start antiretroviral therapy as well as the offer of PrEP to those at substantial risk. The Guideline recognizes that some people at substantial risk may fall into the categories of “key populations” (like sex workers or men who have sex with men) but that others, like young married women, may not.

This is a promising move—as long as programs for all people, including those specifically marginalized and discriminated against due to who they have sex with, are rolled out. We don’t want a world without sex work-specific PrEP programs (designed with the community as full partners), but we also don’t want a world where these are the only PrEP programs around.

By including both registered and unregistered sex workers, after consultations with both, the Senegalese demonstration project will hopefully provide insights into how to reach women who have different identities or have made different choices about formally adopting the label of “sex worker.”

The challenge in implementing PrEP will be to find those at substantial risk without sweeping in all sex workers or MSM or IDUs. The PrEP study in Senegal may provide one path.

UK NHS Punts on PrEP: Advocates call for decision reversal and wide access to PrEP

Early yesterday, long-time activist and aidsmap.com editor Gus Cairns wrote a piece in Huffington Post UK, “Where is PrEP?” highlighting the UK National Health Service’s silence around PrEP. In the piece he recapped an 18-month process by which he and myriad stakeholders worked towards a UK plan for PrEP, the impact of which could be significant in a county that is home to one of the largest HIV epidemics in western Europe. He encouraged fellow Britons to join him in a letter-writing campaign to the CEO of NHS England—#whereisprep?

Just hours later, NHS England released a statement on PrEP. Advocates were disappointed to learn that a PrEP policy would not be included in the NHS’ June decision-making process as was originally expected. The NHS statement noted that it was “not responsible for commissioning HIV prevention services” [like PrEP] but that it would work with other stakeholders on making PrEP available, including providing up to £2m over two years. These funds are expected to support PrEP for around 500 gay men at “early-implementer test sites”.

HIV groups in the UK quickly condemned the announcement and pushed for clarity on whose role it is (NHS, local authorities) to ensure that PrEP is widely available to all who need it, not a few hundred gay men.

For more on advocacy and letter-writing efforts, please visit the following:

Imagining LGBTI Youth Leadership in Africa

Stephen Chukwumah is an AVAC collaborator in Nigeria, working on biomedical HIV prevention with key populations. Here he reflects on the need for an African LGBTIQ Youth leadership movement. (This blog first appeared on Alturi).

“Imagine if we had a movement that is led by young LGBTIQ Africans addressing the issues in Africa and doing research on how homosexuality has always been in African cultures,” says Stephen Chukwumah as he addresses his frustrations with the journey towards equality. “Then, a young person would have the right to say that he or she is gay.”

Stephen Chukwumah is a regional and international human rights activist working on issues affecting lesbian, gay, bisexual, transgender, and intersex (LGBTI) youth from Nigeria, his home country, and beyond. But in terms of age, how does the international human rights community define a young person, and more specifically, a young LGBTI person? Stephen may argue that this question and the issues at stake for the community need to be primarily addressed by youth like him.

At the age of 19, Stephen began his journey as a youth activist when he moved to eastern Nigeria to help form Improved Youth Health Initiative, an organization concerned with educating key populations like LGBTI youth on issues of sexual health and rights. Stephen grew up in the city of Lagos, to the west, where he was trained as a peer educator by the Lagos state government through their National Youth AIDS Program. He quickly began to develop an understanding for the needs of LGBTI people at home and felt that LGBTI Nigerians in the eastern part of the country, particularly young people, were facing a lack of resources in support of the same type of trainings and advocacy present in Lagos and the capital city Abuja.

While Stephen got his start as an activist for sexual and reproductive health rights at the local level in Nigeria, he has used his platform and knowledge to advocate for LGBTI youth at the regional and international levels as a member of the Global Forum on Men who have Sex with Men (MSM) & HIV’s Youth Reference Group and as an International Youth Activist for Advocates for Youth. One of the most pivotal moments for youth activists in Africa happened at the 2015 Changing Faces, Changing Spaces Conference in Kenya, where Stephen was invited last-minute to sit on a panel discussing issues affecting young LGBTI people. During this panel, young LGBTI Africans decided that their community needed a formal organization that could be a collective voice on a wide-range of issues affecting their youth-centric movement.

A major discussion point during the panel was the need to “change the narrative that is happening in Africa where they are saying that young people are being influenced into homosexuality,” says Stephen. “To let them say that no, that is not the case, young people are not being influenced into homosexuality, they are just now being given the opportunities, support and the space to talk about the issues that affect them.” The African Queer Youth Initiative, the organization formed as a result of these discussions, hopes to rewrite the painful and often dangerous narrative surrounding LGBTI youth across the region.

The initiative’s advisory board members and newly engaged young activists will hold their first organizing meeting on the margins of the Pan Africa ILGA Regional Conference in May 2016. While a main goal of the meeting will be to establish an organizational structure, Stephen says that it will also act as a forum for young LGBTI Africans to express the community’s greatest adversities. “Young people are turned away from their homes because their parents reject the idea of homosexuality, or they don’t feel comfortable staying home because it affects their mental well being,” says Stephen, addressing a multitude of intersecting factors. Stephen also says that it is important to remember that these issues become magnified if a young person is largely dependent on his or her family for economic survival or is HIV positive.

In addition to issues of homelessness, Stephen expects his fellow advocates to address how LGBTI youth in Africa are dealing with a wide-spread, multi-front battle against discrimination at school and in the home, HIV/AIDS, free access to condoms and lube, and drug addiction.

An overarching challenge faced by the African Queer Youth Initiative will be to dismantle the pervasive myth within the LGBTI community that young people are not responsible and professional enough to operate successful organizations and campaigns in their home communities.

“On a regional or local level, there is a competition for the little funds that are available to LGBTIQ communities in Africa,” says Stephen. “So activists already working on these issues don’t want the youth to interfere.” Stephen believes that young people need to be supported by the rest of the LGBTI community so that the movement as a whole can work towards securing fundamental human rights in Africa.

Stephen says that there is a popular saying in Nigeria: “It’s he who wears the shoe that knows where it hurts.” The LGBTI community at large may possess the willingness to work with their younger counterparts, but they must begin to build an inclusive atmosphere that gives the up-and-coming activists the space and encouragement they need to lead their grassroots movement, he believes.

New Resources at AVAC.org and Our Webinar Series Continues

There’s lots to digest from the recent 2016 Conference on Retroviruses and Opportunistic Infections, but we’ve got you covered. Here are some new resources on our website. Also our post-CROI webinar series continues. See below for details.

Read — Advocates’ Voices from CROI
CROI was about more than the ring results. In our blog series, read perspectives directly from from advocates and activists in attendance. You won’t want to miss advocates’ frank takes on which scientists walk the walk in community engagement, why research results are just the beginning and what the ring results means to African women.

Listen — Webinar: Exploring Dapivirine Trial Results
In the first of a series, Jared Baeten of the Microbicide Trials Network and Zeda Rosenberg of the International Partnership for Microbicides spoke about the dapivirine ring trial results announced at the conference and fielded questions from webinar participants. (More post-CROI webinars to come!)

Look — Infographic: Evidence for HIV Prevention Options
Given these results, what’s the big picture of ARV-based prevention trial results? This graphic shows the levels of efficacy from each major trial with the confidence intervals around the finding. (Not sure what a confidence interval is? See our one-page Advocates' Guide to Statistical Terms.)

Read — Dapivirine Ring Results
Two trials of a vaginal ring containing the antiretroviral drug dapivirine announced their results at the conference. We compiled press releases, media reaction, provided background materials, linked to the conference webcasts with the results and more.

Post-CROI Webinars Series

Upcoming Webinars

Community Perspectives from CROI 2016
April 6 at 2:30pm EDT

The Well Project and AVAC are proud to present this webinar highlighting findings from the annual conference through community voices. We will be joined by:

  • Kate Borloglou, The Well Project
  • JD Davids, TheBody.com
  • Jessica Salzwedel, AVAC
  • Lisa Diane White, SisterLove

Please join to learn about these important clinical, research and advocacy-related updates as well as a Q&A session. Register here!

Past Webinars

Long-Acting Injectable Antiretrovirals for Treatment and Prevention
March 24, 2016

David Margolis (ViiV Healthcare) and Marty Markowitz (Aaron Diamond AIDS Research Center) spoke about long-acting injectable antiretrovirals for treatment and prevention.

At CROI, Margolis presented findings from the LATTE 2 trial, which tested a pair of long-acting injectables—cabotegravir (from ViiV Healthcare) and rilpivarine (from Janssen)—for HIV maintenance therapy, and Markowitz presented findings from the ÉCLAIR paste 2A study of cabotegravir in HIV-uninfected men.

SLIDES / AUDIO / FLASH

Harnessing Antibodies for HIV Prevention and Treatment
March 17, 2016

John Mascola of the NIH Vaccine Research Center spoke about harnessing antibodies for HIV prevention and treatment. The recording includes discussion with webinar participants. For more background, click here to view his CROI plenary session.

SLIDES / AUDIO / FLASH

Exploring Dapivirine Ring Results
March 1, 2016

In the first webinar of our post-CROI webinar series, Jared Baeten (MTN) and Zeda Rosenberg (IPM) spoke about the dapivirine ring trial results announced at the conference and fielded questions from webinar participants.

SLIDES / AUDIO / VIDEO

A FRESH Look at Basic HIV Cure Research

The Female Rising through Education, Support and Health cohort, or FRESH, located in the Umlazi Township outside of Durban, South Africa, is showing how basic science research can do more than just collect blood samples. Updates on work with FRESH are highlighted in other advocates’ reflections on CROI 2016.

The FRESH cohort—presented at CROI 2016—is a population of young women enrolled in a longitudinal study conducted by the Ragon Institute in Boston, MA and the University of KwaZulu-Natal in Durban South Africa. The purpose of the study is to identify young women (ages 18-23) in very early HIV infection—also known as “acute infection”—to study the innate, or primary, immune system and to address gaps in HIV prevention within this population.

In addition to biweekly clinic visits to draw blood, vaginal and cervical swabs, the women take part in an intensive training and education program to prepare them for jobs, entrepreneurship or reentry into the school system. The women attend two, three-hour classes per week over the course of 12 months. This intensive skills-building program was put in place to combat poverty in the population, a known driver of the epidemic, and help retain young women in the study.

The cohort began enrollment in 2013 and as of September 29, 2015, 699 women have been enrolled. Over 24 months 32 women were diagnosed soon after infection.

At the pre-CROI Community Cure Workshop, Zaza Mtime Ndhlovu (University of KwaZulu Natal) presented his research on HIV specific CD8 T cell responses in early infection. A subset of the cohort’s acutely infected women contributed to Dr. Ndhlovu’s research looking at T-cells directly before and after infection. Dr. Ndhlovu’s work shows that during the acute infection phase, HIV-specific CD8 cells develop very quickly and in high numbers. The number of HIV-specific CD8 T cells varies from person to person and contributes to the viral set point of the individual.

This means as soon as HIV enters the body, within the first few days, these HIV-specific CD8 cells can immediately begin fighting the virus. This is why the more HIV-specific CD8 responses an individual has the lower their viral set point. These HIV-specific CD8 T cells are prone to dying, so they don’t last long in the body.

This is significant because it offers a potential strategy toward HIV remission. If researchers can preserve these CD8 cells, either by preventing their death, by using a drug to enhance the immune system, or by priming the body to make more HIV-specific CD8 cells through a vaccine, they could potentially develop a “kill” component of a “kick and kill” curative strategy. The FRESH cohort is providing researchers with a new model of working with communities to prevent new HIV infections and conduct basic research toward a cure.

PEPFAR Annual Report to Congress

The 12th Annual Report to Congress is now available at http://1.usa.gov/1SvUgKN.

Move On Down the Road: The vaginal dapivirine ring will enter open-label extension trial

Over the weekend, the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), announced that it would move forward with an open-label extension (OLE) study of a vaginal ring for HIV prevention. This welcome development is the latest step in the journey of a unique, woman-controlled prevention option.

It’s been almost exactly three weeks since the world got its first look at data from the ASPIRE trial and The Ring Study, both of which found that a vaginal ring containing the antiretroviral dapivirine provided women in the trial with a modest level of protection against HIV. Both trials had similar results: among all women in the ASPIRE study, the ring reduced the risk of transmission by 27 percent; in the Ring Study, the overall reduction was 31 percent; and effectiveness varied by age—with higher levels of protection seen in older women, possibly because of more consistent use in this age group.

The trial data caused celebration and immediate conversation about what would happen next given that the trial showed both that the ring works and that there may be real challenges with adherence, particularly in younger women. These are the kinds of questions that open-label trials are meant to answer (for a description of the types of studies that follow efficacy results, click here). By definition, in an open-label extension (OLE) study, everyone knows that they are receiving the product, and they receive information learned from the previous clinical trials of the product. Women participants in the open-label extension study of ASPIRE, known as HOPE, will be told that the product reduces risk of HIV if it is used correctly and consistently—worn in the vagina for roughly a month at a time. This type of information may lead more women to use the product versus the trial, where they are told at every study visit that they may have received the placebo, and that there is no evidence that the experimental product provides protection.

NIAID reached its decision to move forward after last week’s consultation with a panel of outside experts that included physicians, scientists, advocates, ethicists and statisticians – including two AVAC Advocacy Fellows from Malawi and Zimbabwe.

NIAID announced that they will also fund additional studies to help answer additional questions that the OLE is not designed to answer. One of these is a study with adolescents and young women (ages 16-21) to look at safety, adherence and acceptability of the dapivirine ring and oral PrEP. This is an important development, and one that will help ensure that the world has the information it needs about the ring should it receive regulatory approval. This regulatory approval process, which is being pursued in tandem with the open-label extensions, involves preparation and submission of an extensive dossier of information on the product from the clinical trials. The International Partnership for Microbicides (IPM), the ring’s developer, is expected to submit for approval in about one year’s time.

Now that NIAID has agreed to fund HOPE, the extension of ASPIRE, it is essential that IPM’s donors similarly support the Ring Study’s proposed open-label extension, DREAM. AVAC and our advocacy partners will be working with urgency in the coming weeks to amplify demand for this study, as well as additional research needed to understand the potential role of the ring in women’s lives. At the same time, we continue to emphasize the urgent need to roll out daily oral PrEP as a tool that can be used right now to reduce risk for women and men and to maintain a robust prevention research pipeline of additional options that will, over time, provide a wider range of options from which women and men can choose.

CROI for the Community

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 has been an AVAC PxROAR member since 2012. This blog is one in a series written by community scholars who attended CROI 2016.

I have a love-hate relationship with the annual Conference on Retroviruses and Opportunistic Infections (CROI). The 12-hour days of high science can be overwhelming, and even after being deliberate about building down time into my schedule, I still crashed and burned before the end of Day 3. (It took the entire week to adjust to the time difference between East and West coasts, and after the daily 7 am Community Educator Breakfast Updates, I struggled to stay awake and alert for the morning plenary sessions.) But I survived!

There are always major headlines coming out of meetings like CROI. As a biomedical research advocate, my inner nerd gets super-excited about things like Phase 2 study results from MTN 017 (a rectal microbicide study), but at CROI I’m a community educator. I try my best to take off my research nerd hat for a few days and tune my ears to hear what members of my community will find useful right now. (I’ll have plenty of time and dozens of webinars to help me grasp all of the high-level science presented at CROI so that my inner nerd will be ready for additional updates during the International AIDS Conference in July.)

The week after returning to Oakland from Boston, I shared information with the staff working at AIDS Project of the East Bay (APEB) and with community members participating in a series of breakfast discussions coordinated through my ministry at the Imani Community Church in partnership with the East Bay HIV Faith Collaborative. This is what I told them:

  • Vaginal microbicide rings look like they’ll work. Don’t be frightened when you hear that the HIV infection rate was only reduced by about 30 percent. Remember that old 44 percent reduction in the HIV infection rate for pre-exposure prophylaxis (PrEP) when the first iPrEx study results were released just over five years ago? It gets better! With PrEP we saw that when people know the product actually works, they use it more and risk goes down. It works when you use it! Will the same thing hold true for the vaginal ring? There’s a need for open-label studies to see if women will use it more when they know it works.
  • There’s reason to think injectable PrEP might work, but there are questions about how to deal with the “tail” — the period of time after injectable PrEP is terminated but there still may be low (non-protective) levels of drug in the system.
  • People who use oral PrEP are generally people who are already at-risk for STIs, and they should be tested more often than every six months as is currently recommended by the CDC. (Our Medical Director at AIDS Project of the East Bay already screens PrEP clients for STIs quarterly as suggested by the research presented at CROI.)
  • We talked a little about the PrEP failure case from Canada, which occurred when the PrEP user was infected with tenofovir- and emtricitibine-resistant virus. But staff and community members alike were more interested in the HPTN-073 study results showing that, with a little client-centered care coordination (C4), it’s really not so difficult to spark black men’s interest in PrEP. This was the silver lining in the cloud hovering over the community after CDC presented lifetime risk estimates indicating that half of all gay black men in the US will test positive for HIV if we don’t do something about it now. (If my community needed a wake-up call… a new reason for a sense of urgency around this HIV epidemic… a fire lit under its collective ass… This has to be it.)

Then we spent a little time talking about things I heard at CROI that probably won’t make headlines:

  • Do you really understand how much smoking while living with HIV increases risk for opportunistic infections, cardiovascular disease, lung disease and some cancers while decreasing life expectancy? What are we saying to our clients living with HIV about smoking that’s different from what we say to clients not living with HIV? (After checking in with our Medical Director, APEB will be implementing a smoking cessation program through our primary care clinic.)
  • When researchers looked at people’s “Perception of Infectiousness,” the takeaway for me was that black people still don’t believe having an undetectable viral load prevents the transmission of HIV. (There are lots of conversations about medical distrust among African Americans begging to be had over and over and over again until someone figures out how to effectively address the issue.)

Another CROI is in the books (and on webcast). It will likely take months for my inner research advocacy nerd to wrap my head around all of the science, but now that my sleep pattern and weather conditions are closer to California-normal, the community educator in me is very happy.