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.

New Px Wire: What to Watch in 2016

There are few, if any, quiet years in HIV prevention research and implementation. 2016 promises to be another year of big deal data, whether it’s findings from clinical trials, funding levels or readouts from PEPFAR’s first year of a geographically focused program plan. We write about this and a lot more to watch for in our new issue of Px Wire.

Click here to download the new issue.

We take a look at the bigger picture in our centerspread. Check it out for the most current version of AVAC’s classic timeline of biomedical HIV prevention research. But don’t get too attached—some of the trials mentioned in the timeline will have updates presented next week at the annual Conference on Retroviruses and Opportunistic Infections. We’ll always have an updated version in our Infographics Gallery—and save the date for a March 1 webinar to discuss the latest data and what’s next?

The full issue of Px Wire, as well as our archive of old issues and information on ordering print copies, can be found at www.avac.org/pxwire.

As always, we welcome your questions and comments at [email protected].

NIAID/NIMH proposed FY2017 initiative: iKnow Projects

This proposal intends to support development of innovative strategies to identify persons unaware of their HIV infection in specific high-risk populations and examine the acceptability and feasibility of new prevention interventions in the populations and settings identified. Research projects that integrate multiple approaches to achieve these objectives are strongly encouraged.

NIAID/NIMH proposed FY2017 initiative: Methods for Prevention Packages

This Program Announcement encourages collaborations between behavioral and biomedical clinical scientists, epidemiologists, mathematical modelers, and clinical trial design specialists to develop new research strategies and methodologies that will facilitate the design and testing of combination HIV prevention interventions (prevention packages).

NIAID proposed FY2017 initiative: Sustained Release of Antivirals for Treatment or Prevention

Oral therapy sustained-release strategies must have a window of effectiveness of at least 7 days from a single dose. Other approaches must have a minimal window of 30 days from a single dose (injection) or continuous dosing regimen (implant, transdermal patch, etc.). Sustained-release strategies for HIV prevention must have a minimum window of protection of 30 days from either a single dose (injection) or continuous dosing (implant, transdermal patch, etc.).

GPP Online Course: Now Accepting Applications

AVAC is pleased to announce its third global offering of the GPP Online Training Course, a mixed-method web-based approach to building and sustaining capacity around stakeholder engagement! This course offering will run March 21 – July 1, 2016. Applications are now open and due by Monday, February 29. Please see below for full details on the course, past participants’ experiences and how to apply.

About the Course

The GPP Online Training Course is a practical, effective and fun way to learn about the Good Participatory Practice (GPP) Guidelines, which are a set of recommendations for trial funders, advocates and implementers on how to engage a broad set of stakeholders throughout the research process. This course helps learners understand how to use and evaluate GPP in the real world. See below for feedback from past participants!

Through online discussions, interactive modules, webinars and written assignments, all moderated by GPP experts, learners will build their knowledge and skills to effectively engage communities and stakeholders in biomedical HIV prevention research processes.

This offering will have two different tracks to accommodate a wide range of learners:

  • Track A is designed for research implementers, or individuals directly responsible for GPP or community engagement at a trial site. All learners who complete the requirements for Track A will receive a GPP Implementer Certificate.
  • Track B is designed for stakeholders not directly responsible for GPP implementation but interested in understanding GPP concepts and applications, e.g., research coordinators, civil society advocates and regulators. All learners who complete Track B requirements will receive a GPP Course Completion Certificate.

What Past Participants Are Saying

All prior participants have rated the course overall as “very good” or “excellent”; 84 percent said they would recommend the course to a colleague. See how past participants describe their experiences:

“The GPP course was the best capacity development gift that has enhanced my skills in community engagement to build a healthier nation as an advocate of HIV prevention methods in South Africa.” – Neetha Morar, engagement manager, South African Medical Research Council

“Overall GPP training is an eye opening and very fruitful course; I can advise everyone working as community outreach personnel, recruiter or educator at the research center to attend this course.” – Erica Sanga, community engagement implementer, Mbeya Medical Research Council

“This course has been very helpful for putting into perspective some of the strategies my organization currently uses to engage stakeholders—including both approaches that have worked and areas that could be improved.” –Alicia Chou, engagement coordinator, Regan Udall Foundation

Click here to download the GPP Online Application (right click and select “save as”) or visit the course page on the AVAC website.

All completed applications are due to Jessica Salzwedel no later than February 29, 2016. If you have any questions about the GPP Online Training Course, please email Jessica Salzwedel ([email protected]) or Stacey Hannah ([email protected]).

Announcing the 2016 AVAC Advocacy Fellows

AVAC is delighted to announce the 2016 AVAC Advocacy Fellows—the seventh class of Fellows! Please join us in congratulating these six talented advocates. With this new class, the AVAC Fellows family has grown to 50! We hope you’ll find ways to collaborate with the new Fellows in 2016 and beyond.

The 2016 Advocacy Fellows were selected from a pool of nearly 100 applicants from over 20 countries across the globe. We thank all of the applicants and their proposed host organizations for the time and effort put into this process, and we’re also grateful to the independent review committee of advocates, scientists and former Fellows and Hosts who guided decision-making.

The 2016 Advocacy Fellows are:

Last year brought important HIV prevention developments on a number of fronts that 2015 Fellows and alumni engaged with, in a variety of capacities. Now, 2016ers take the baton, working in a world where WHO recommends the offer of treatment for everyone living with HIV and the option of daily oral PrEP for those at substantial risk; where VMMC rollout has accelerated but flat funding looms large; where the microbicide field is readying itself for results from the two dapivirine vaginal ring trials; and the vaccine field is on track to initiate two large efficacy trials. The 2016 Fellows have bold ideas to address many of these opportunities and challenges in their Fellowship year, which begins on April 1.

The 2016 Fellows join a fantastic group of 44 Advocacy Fellow Alumni from eight sub-Saharan African countries and China who have participated in the program since its inception. Please visit the Advocacy Fellows page and follow the P-Values blog to learn more about the new Fellows’ planned work for the year and to learn about the Alumni Fellows’ ongoing work.

A Call for Applications for the 2017 Fellows Program will be announced this June with an application deadline in August. If you would like to be notified of the 2017 Call for Applications or have any questions, please email us at [email protected].