CROI, For the First Time

Yvette is currently working at the Centre for Communication Impact (formerly JHHESA). She is a founding member of the new Advocacy for Prevention of HIV and AIDS (APHA) in South Africa, a former AVAC Advocacy Fellow and a leader in the country’s HIV prevention movement for young women. This blog is one in a series written by community scholars who attended CROI 2016.

My first CROI and it was not the science that was overwhelming…

When I was presented with the opportunity to apply for a scholarship to attend this very scientific meeting and conference as a community educator I was thrilled and most of all exited that I would be in the presence of all the scientists who’s work I have torn to shreds to get my communities in Mpumalanga, Limpopo and KwaZulu-Natal (KZN) to understand. As a community educator I have had to explain microbicides, PrEP, TasP, HIV vaccines and the BIG one: why we still don’t have a cure. Also, I have had to explain why it is important that we know the new research and why a lot of the HIV research happens in South Africa.

Upon my arrival I was overwhelmed by the beauty of the city; the buildings all looked old but they were a beautiful sight. When I left South Africa, the university students were burning old art and statues because it reminded them of our painful past. As I was driving from the airport upon my arrival in Boston, I saw a few homemade banners of Black Lives Matter in the city attached to these old buildings. They were not torn apart; they looked just like they belonged there. They were not threatening each other—the old building and the new feelings of we matter, black lives matter. I wish I had stopped my driver to take a picture.

I was invited to a pre-conference on cure research, on where we are. Because of my suspicions with cure and quacks, I thought I would only last 30 minutes at the most. How wrong I was. I was intrigued by how much research is happening and the amount of work that researchers were putting in trying to unlock this mystery. I was overwhelmed about how much of this research is happening in South Africa and that one study was actually happening in KZN. Research showed that even with focused interventions of counselling and empowerment skills, there were no differences in the new infection rates of young women in the program and those not in the program. Suffice it to say I was there the whole day and did not want to miss a presentation let alone a slide.

The next day was the first day of the conference and our day started at 7 am. I was jet lagged but did not want to miss anything. Not even the cold could keep me in bed. For the duration of the conference we had an opportunity to interact with the scientists, thanks to a great initiative by the BAI, AVAC and CROI Community Liaison Subcommittee. These morning meetings were a space where we as community advocates could come together and learn from each other. I realised that I knew about 30 percent of the community through our work and most of all our very vocal online presence on Facebook. I did not want to show my anxiety around the pending Ring and ASPIRE results so I would walk around meditating that it works. After all, my girls were hoping it does. The day the results were going to be announced I dressed like a winner—I wanted women to win.

When Dr Annalene Nel, lead researcher on the <Ring Study, mentioned a “significant” efficacy result, I did not know what to feel. I was overwhelmed by the word and I knew it worked. I knew our work was cut out for us as advocates. A lot of questions still remained unanswered for the young women but at least the ring works and we know that now. I was happy, very happy. I immediately announced it on my FB Page and I received so many inboxes from young women— both positive and negative—and most told me there is HOPE. Seeing Annalene made me very emotional because unlike the other researchers at CROI she did not see “subjects”— a word that made be shiver every time it was mentioned at sessions throughout the conference referring to research participants. She saw trial participants as young women, some of whom she had met throughout out the study period. I knew she was counting on support and I walked up to her and I told her what this means to the young women I worked with. Annalene received a standing ovation. I was happy—finally a woman for other women. For a feminist like me it mattered that Dr. Annalene was at the forefront. It mattered that she was OK. I was overwhelmed with pride to be South African at this conference and it mostly mattered that I was a woman at the conference too. The rectal microbicides trial results were also positive news for HIV prevention.

At this conference I learnt that there are more HIV prevention tools than there has ever been before. I was left wondering who these prevention tools are developed for. Why is it that if treatment is prevention are there not more visible TasP campaigns, despite UNAIDS’ 90-90-90 and MSF’s Getting to Undetectable? Why is it taking policy makers so long to implement early treatment when the benefits from the START study are so overwhelmingly positive? The benefits, especially for those living with HIV, are lowered risk of cancer, among other risks. This cannot be rocket science, especially seeing that women living with HIV are at such high risk of cervical cancer. Why is it that if being virally suppressed reduces the risk of passing the virus on to others, we are not including this in mass HIV communications? If PrEP works and can help defeat HIV, why are there only four countries that have approved the use of Truvada as PrEP? (Since CROI, two more countries have approved PrEP.) And why is South Africa not moving any faster with rolling out PrEP to those who need it?

I was also swayed in my initial stance against home testing, thinking pre- and post-testing might get lost in the process. However, if this is not the case and home testing will increase the number of men who test, I am now for it.

It was a week of late nights and early cold mornings, a week of appreciating the science. By including the community educators at CROI 2016 I hope the scientists will appreciate the work done by communities and most of all advocates. We will only appreciate your science if you appreciate our stories. And yes it does matter who delivers the news to whom: Male, Female Gay or Straight.

Thank you for the opportunity, the support and the guidance AVAC, BAI, CROI, Sister Love and all the other sponsors.

SBIR-TT creates opportunity for small businesses to develop NIAID technologies

NIAID is seeking applications from small businesses in support of a funding opportunity announcement focusing on moving vaccines and products developed by NIAID intramural scientists into the marketplace. Vaccine and treatment inventions eligible for this award include, but are not limited to: HIV anti-gp120 env vaccine as a therapeutic or HIV prevention vaccine; HPV virus-like particles as a vaccine delivery system and adjuvant; use of the 10E8 broadly neutralizing antibody for HIV treatment and prevention.

Push

Julie Patterson is an HIV prevention research advocate and public health professional who lives in Northeast Ohio. She is chair of the Case Western Reserve University/University Hospitals AIDS Clinical Trials Unit’s Community Advisory Board, a member of AVAC’s PxROAR program, and a member of the US Women and PrEP Working Group. This blog is one in a series written by community scholars who attended CROI 2016.

Being at CROI is like being inside a scientific tornado—data and results fly by, but they are difficult to catch. There is beauty in the force of it. Everyone is caught up, scientists and advocates alike. Once the dust settles, however, it is time to clean up and make sense of it all.

As I saw it, this year’s CROI was full of HIV prevention research victories.

It was incredibly moving to be a part of a standing ovation for the results of ASPIRE and the Ring study. A dapivirine vaginal ring used for HIV prevention has the potential to save the lives of millions of women around the globe. Also, new forms of PrEP and rectal microbicides are working their way through the research pipeline. They may eventually lead to even more options that increase pleasure during sex, are long-acting, give receptive partners control, and are designed to fit the different seasons of risk throughout one’s lifetime.

As advocates, however, these kinds of results are a beginning, not an endpoint.

Our job now—in light of the range of options noted above—is to demand further clinical research, open-label extensions, regulatory approval and rollout. For example, a ring cannot save a woman’s life if she cannot obtain it. Advocates must support the International Partnership for Microbicides (IPM) as they move forward for regulatory approval, and in the meantime, open-label studies should be funded to offer women who participated in the research the opportunity to continue to use the ring now that they know it’s safe and it works. It is unethical to do otherwise. Shall we tell women that a dapivirine vaginal ring can help to prevent HIV and then take it away? No. As the number of new HIV prevention methods expands, it’s important to keep our eyes on the prize: zero new transmissions.

Also at the conference, the US CDC released newly configured data that highlighted the situation in the US for gay/bisexual/same-gender-loving Black and Latino men who face a devastating lifetime risk for HIV. In the face of these data, we cannot rest. Systemic racism and structural violence are not predestined.

Noticeably, CDC didn’t run the numbers on trans* populations when they were calculating lifetime risk. If we don’t talk about trans* risk in these meetings, if we continue to make trans* people invisible in the data, who will act? We must continue to demand HIV prevention for transwomen, and especially transwomen of color, for whom the lifetime risk can be overwhelming. It was a step forward for the conference to host Dr. Tonia Poteat’s (Johns Hopkins University) brilliant plenary focused on Transgender Populations, but it is not enough. We must fight to keep trans* people in the forefront of prevention.

As AVAC, BAI and Community Educator Scholars, our job is to ask the hard questions, to dig deeper than the numbers, to contextualize the data. As a group, we bring history, anger, passion and wisdom to the research table. We voice the fears, the hopes, and the demands of our communities. Our strength is our presence and our collective effort.

Advocates are also tasked with translating what we’ve learned at CROI into information that people can use. We come home to our loved ones: people living with the virus; communities working to fight HIV; and vulnerable people who need this research and these results. As we share what we heard, we create consumer demand and the push that researchers need to move forward. Hope comes from this dialogue. The research to implementation cycle will continue, but only if we play our part.

Making Space for Community Educators and Activists at CROI

Ntando is the Community Engagement Coordinator at the Desmond Tutu HIV Foundation in Cape Town, South Africa, a co-convener of Advocacy for Prevention of HIV and AIDS (APHA) and an AVAC Fellow Alumni. This blog is one in a series written by community scholars who attended CROI 2016.

“So you see, there’s relevance for community educators and health advocates to be at CROI.”

This was my response to a hepatitis clinical researcher I sat next to on my flight home. Having seen his CROI (Conference on Retroviruses and Opportunistic Infections) backpack, I mentioned that we had been at the same meeting. My travel companion, a Dutch PhD student researching acute Hepatitis C infection, asked how I found the conference. When I responded with approval at the high standards and organisation at CROI, he seemed disappointed to learn why I had been there. After finding out that I am neither a scientist nor researcher, he said, “I do not think there’s space for non-scientists to attend the meeting.” I was amazed by his comment. His comment highlighted that some researchers think that conferences like CROI should be exclusive to scientists and researchers to share and discuss amongst themselves. How is it that some researchers think the problems they are trying to solve can be dealt without input from the very same communities who face these issues first-hand?

It is vital that conferences, such as CROI, continue to provide space so that communities are included in the scientific environment where the problems facing communities and possible solutions are discussed. I feel honoured to be recognized as a community representative because of my community engagement and advocacy work in the field of biomedical HIV prevention. The conference re-emphasised the role of science in seeking solutions for the health problems brought about by retroviruses and opportunistic infections in South Africa and Africa, and how these are a global concern. Updates were given on the many diseases that can devastate communities, including HIV, tuberculosis, Hepatitis B and C, other sexually transmitted infections, cancer and chronic non-communicable diseases in the context of HIV.

As a community worker in the midst of this scientific arena where there is a shared language of complex terms: antibodies, adaptive and/or humoral, other immunity or immunogenicity, gene therapies, pathogenesis and metabolism, reservoirs, relapse, remission, pharmacology and pharmacokinetics, processes from laboratory, via animals to people, I often find myself desperate to hear how this translates to real change for communities. That is a bottom line I yearn for as each passionate scientist presents his or her research as if nothing else matters in the world. And indeed, perhaps in context of wanting a solution to a health problem, nothing else does matter. Many members of my society deal with infinite challenges on a daily basis, which include illness of close family members, crime, unemployment, violence and poverty to name a few. In this context, science is only part of the solution.

At this meeting, I experienced the excitement, emotions and sense of fulfilment of successful research when the dapivirine ring study results were announced. The bottom line for me is: how difficult it is going to be to bring this, or other tools, to benefit the population groups in my society who need these tools the most, including young girls, women, gay men, sex workers and many more?

Part of doing what I do requires that I continually attempt to figure out how much of the science my non-scientifically trained mind should be stretched to understand—why and how a biomedical intervention works or doesn’t as much as expected. I seek to dissect the statistical numbers and to understand how a virus interacts with the body and how it might be stopped or suppressed. This understanding allows me to help my community reach a level of not only physical, but social, mental and emotional state of wellbeing to support all to live productive and fulfilling lives. This is my contribution against a range of social and human injustices that are brought about by diseases, harmful societal belief systems and potentially detrimental policies enacted by governments.

So in the midst of a scientific conference, there are a lot of opportunities to figure out all of this and learn, especially when my hand is held by those who have done this work before me and share my interests. The conference provides the opportunity for community members from all over the world to interact, engage in serious conversation, laugh and share amongst each other. At CROI, many scientists acknowledge the important role of community members like myself and my peers, though they may vary on how they express this acknowledgement (some being better than others at it). This helps remind me why I need to be there: to constantly find and raise my shaking and intimidated voice to be heard to elevate my communities’ interests. I was happy when my fellow traveller, the scientist on the plane, eventually understood the role I have to play in scientific research and at CROI. As we spoke, he saw our conversation as an opportunity to practice a talk he had prepared for a session two days after he got home. It showed me he has the same interest and vulnerabilities as me in the seriousness of his work.

I give thanks to organisations and the passionate people behind them who use their positions to facilitate a platform for people, like me, to have a voice and equip me to prepare a platform for a voice for those who come after me. Thanks to AVAC, Black AIDS Institute and the CROI community liaison sub-committee for this experience, and constantly facilitating in this provided space for a community of likeminded community workers, health advocates and activist who are faced with similar burdens in different parts of the world. Thanks importantly to my home organization, the Desmond Tutu HIV Foundation, where all the science collides on a daily basis with communities, as well as all who seek an end to all the devastation caused by HIV, AIDS and TB.

CROI Round-Up; Post-Conference Webinar Series

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

Post-CROI Webinar Series

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

In-Depth Analysis

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

CROI Program and Webcast

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Finally, You Can Put a Ring On It!

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

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

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

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

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

What Now

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

The Future

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

Conclusion

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

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

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

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

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

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

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

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

DREAMS Innovation Challenge

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

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

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

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

At a glance:

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

AVAC’s priorities for action:

Demonstrate the ring’s role in prevention

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

Deliver daily oral PrEP

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

Develop additional tools

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

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

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