Introducing the VARG: Focusing local lens on global advocacy for HIV vaccines

It has been said that advocates haven’t played a strong enough role in the HIV vaccine field. While this could be debated, it is true that the role of a vaccine advocate is complicated. How can advocates push to support slow-paced, expensive science, that over its history can be seen as having more low points than highs?

These questions and this conundrum simply highlight the need for focused, strategic advocacy to push forward the goal of vaccine development.

Two weeks ago, a group of HIV vaccine advocates known as the Vaccine Advocacy Resource Group (VARG) came together in Johannesburg to meet this need. They discussed the field, dialogued with researchers, and aired concerns and questions about the field’s current status and key developments. The VARG is a global team of AIDS prevention research advocates—made up of 11 individuals from countries key to vaccine research and well connected in those countries to broader HIV advocacy. Since its formation in 2012, the VARG has been convened virtually, and the chance to meet face-to-face for the first time could have been one of the reasons the room buzzed with excitement as the meeting began.

Another reason for the buzz could have been the current state of the field. With vaccine (P5 and Janssen) and antibody research (VRC01-AMP study) fields at exciting junctures, VARG members had a lot to discuss. Some of their questions included:

  • What will the results of the AMP study mean for the future of passive immunization? And for vaccine development? Will people really sit for an infusion for 30 to 60 minutes?
  • Why is there so much attention around the go/no-go decision making criteria in HVTN 100? What happens if the data indicate a no-go for HVTN 702?
  • Would the Clade C vaccine to be tested in HVTN 702 be relevant to other regions? What would the implications be for other countries if the vaccine is found efficacious in South Africa, the only country where 702 would be conducted?
  • How are vaccine research groups addressing the inclusion of PrEP in efficacy trials? How will stakeholders be involved as trials are planned and PrEP rollout evolves globally?

Vaccine efficacy trial results are a few years away, but we’re now at a time where advocacy roles are becoming clearer and clearer. VARG members left the meeting together with a new sense of priorities and actions. Watch this space!

To read more about the trials and science mentioned above, please visit www.avac.org/vaccines.

Women’s Prevention Works If Women’s Realities Are Appreciated and Prioritized

Seventy-five advocates from across Africa—friends, allies, researchers—came together for a one-day meeting in Johannesburg on April 14 to discuss the recent dapivirine ring results, what they mean in the broader context of women’s HIV prevention, what comes next and key milestones to plan for.

The recently released results of the dapivirine vaginal ring for HIV prevention demonstrated, for the first time, that an ARV-containing vaginal ring could prevent HIV acquisition. 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.

With new programs, funding initiatives and research specifically targeted for women and girls, this workshop convening was an important juncture to pause, take stock, consider the next few years and plan key advocacy priorities. The discussions highlighted the exciting and complicated road ahead for rings and for prevention options for women generally.

This meeting provided an opportunity to unpack and interpret the dapivirine ring results, understand and interrogate next steps, situate the next two years for women’s HIV prevention (research, implementation and funding), and identify advocacy opportunities and areas for further engagement.

Two young women living with HIV set the stage for the day with their personal stories and perspectives on where HIV prevention sits in the context of the lives of young African women. Their stories became a frame for the day—recognizing the special needs young people have for contextualized education about HIV and sexuality, but more importantly that young women are the most powerful champions and MUST be involved in designing and delivering any interventions and decision-making processes that impact their lives.

There was rich discussion on advocacy priorities for the next year or so and what is needed to ensure that women’s prevention is prioritized. Two of the issues raised underpin the way forward for women’s HIV prevention and serve as a call to action for those attending this meeting and other communities across Africa: (1) the need to roll out PrEP now as we wait for rings; and (2) the need to revive activism in the HIV prevention movement.

One of the most important takeaways was that as we consider the exciting biomedical prevention interventions to change the trajectory of the epidemic—race, gender and the unique aspects of women’s lives will continue to affect access to care and prevention. It is critical to situate the research and access in the realities of women’s, and especially young women’s lives, and that context is always important.

Please visit www.avac.org/ring-results-and-next-steps to access meeting presentations and materials. 

Where the Rubber Hits the Road…

It’s been an exciting month at AVAC for many reasons, but one of them is because AVAC’s Advocacy Fellows Program hit a milestone: with the welcoming of its seventh class, the program now boasts 50 Fellows and Alumni. In fact, that number is closer to 100 since working alongside each Fellow is a dedicated host [organization] supervisor. AVAC’s Advocacy Fellows Program supports emerging advocates in countries with ongoing or planned HIV prevention research and/or rollout of proven interventions. Fellows, with the support of a local host organization, develop and execute a 12-month work plan to address local or national policy or research gaps.

Since the program’s launch in 2009, 31 women and 19 men from China (1), Kenya (11), Lesotho (1), Malawi (4), Nigeria (2), Rwanda (2), South Africa (11), Uganda (7), Zambia (3), Zimbabwe (8) have used this opportunity to impact their respective countries’ HIV/AIDS agendas. These fearless advocates have played and continue to play a critical role in engaging in research processes, influencing policy, watchdogging, working with media, engaging global funding mechanisms, creating local and international synergies, and amplifying community voices in delivering, demonstrating and developing new HIV prevention and treatment options.

The 50-person mark was achieved in April 2016 when a new class of Advocacy Fellows started their one-year program. As has been the custom since the program’s inception, the year kicks off with an orientation workshop—and this year was no different as Fellows past and present gathered in Johannesburg April 11-13. At the workshop, 2016 Fellows got the opportunity to present their plans for the year ahead, receive feedback from peers, mentors and supervisors, build networks with colleagues from their respective countries and regions and to start the building blocks in biomedical HIV prevention research, implementation and advocacy around it. This workshop was also an opportunity to celebrate the achievements of the 2015 Fellows who graduated from the program.

The graduating Fellows had many wins worth celebrating—influencing major research funding decisions such as a recent one involving next steps of the microbicides rings (e.g., two 2015 Fellows, Anna Miti and Maureen Luba, were invited to a high-level meeting at the National Institutes of Health to help inform the next steps after positive efficacy results of two microbicide ring trials); executing evidence-based advocacy to influence guideline development and implementation plans, (e.g., PrEP in Kenya and South Africa); building coalitions with other civil society partners to identify needs and gaps and creating joint plans to address them, (e.g., viral load testing in Uganda, and coalitions pushing for PrEP for key populations including sex workers, men who have sex with men, and adolescent girls and young women in Kenya, Malawi, Uganda, South Africa and Zimbabwe); advocating to influence funding, including with major donors such as PEPFAR and the Global Fund; building research and implementation literacy amongst civil society, policy makers and the media; and engaging key populations to ensure that HIV prevention research/rollout agenda is sensitive to their unique needs, among others.

“What an opportunity this Fellowship gives to these emerging advocates! I’ve worked in the research field for a while, but this is the first time I’ve seen a deliberate effort to seek out someone from a marginalized group like sex workers and put them at the front and center of leading an advocacy project targeted at that group. We all need to do more of this,” said Kenyan researcher Dr. Kawango Agot, a Supervisor to a 2016 Fellow after a presentation on advocacy for PrEP for sex workers by 2015 Fellow Carolyn Njoroge.

The bar for excellence has been high since the program’s inception, and from what we saw at the workshop, the 2016 Fellows are up for the challenge. The new Fellows and their Supervisors vowed to move the HIV prevention research and implementation agenda to where it needs to be to impact the agenda today.

For the most part, the issues they will be tackling are similar to past Fellows, but the environment is different. For example, in Kenya and South Africa, Truvada (TDF/FTC) is now approved for use as PrEP for HIV prevention; in most priority countries, voluntary medical male circumcision (VMMC) programs continued to rise yet funding to achieve the 80 percent coverage levels in target age groups remain elusive. The DREAMS Initiative is now underway at different levels in most of the countries where 2016 Fellows come from (Kenya, Lesotho, Malawi, South Africa and Zambia); the field recently received positive results from the microbicide dapivirine ring; and new research on vaccines, antibodies for prevention, and long acting injectable PrEP has begun or is expected to begin in some of the Fellows’ countries. These are a few of the many issues that new Fellows will be grappling with and trying to influence over the next year.

The work that these advocates and their partners do, and where they do it, is where the rubber hits the road! To follow the current and Alumni Fellows’ work, go to the Fellows page.

New Film Series Captures Activists United by Urgency for HIV Prevention in Europe

In January 2016, the European AIDS Treatment Group (EATG) and AVAC jointly convened the Second European HIV Prevention Summit in Brussels. This unique meeting brought pharmaceutical companies, public health experts, academics and leading scientists in the field of prevention research together with over 50 European community-based advocates for three days of information exchange and debate.

Participants discussed the latest scientific and policy developments in the field of HIV prevention and formulated demands for researchers, medicine manufacturers and decision makers. The community urged concerted action and clear financial and political commitment to achieve effective prevention of HIV/AIDS in Europe. Specifically, the Summit called for the accelerated approval and rollout of PrEP in countries across the region, following France’s recent example as the first and only in Europe to officially implement and fund PrEP programs for men and women at substantial risk of HIV. The meeting also concluded with a call for the continuation of research for HIV vaccines, and rectal and vaginal microbicides, along with better systems for tracking the epidemic, including where new cases occur and where and how access is happening.

The packed agenda of the European HIV Prevention Summit included detailed reports on and discussions about groups of people at highest risk of HIV across Europe, including gay men, trans people, sex workers, people who inject drugs, migrants and the African diaspora. Timely information from completed, on-going and planned PrEP implementation studies was presented along with new civil society initiatives to provide PrEP and other prevention tools to those who need it. For a rare moment, stakeholders involved in the field of HIV prevention could gather in a space to exchange scientifically sound and politically meaningful ideas about way of slowing down the HIV epidemic in Europe.

In order to make the meeting accessible to those who were unable to attend in person, EATG and AVAC commissioned a three-part video series designed to give an overview of the main topics of the meeting: PrEP, Testing & Treatment, and the Future of HIV Prevention. The first of these films, focusing on PrEP, is now available here. The meeting report is also available for download.

Advancing the development and licensure of vaginal rings and innovative systemic methods for prevention of HIV infection in women

The United States Agency for International Development (USAID) is seeking applications from qualified U.S. and Non-U.S. organizations to fund a project entitled “Advancing the development and licensure of vaginal rings and innovative systemic methods for prevention of HIV infection in women”. For more information click here.

Dapivirine Ring—Past, Present and Future

AVAC’s new issue of Px Wire is an advocate’s guide to the past, present and future of the dapivirine ring for HIV prevention. It features a timeline of key milestones that could lead to licensure, a simple comprehensive Q & A, and a closer look at where sub-Saharan African women will have access to daily oral PrEP and/or the Ring via open-label extension studies. We hope this resource will be used to spark discussion and guide plans for further engagement.

Click to download the new issue of Px Wire.

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.

Introducing Implementation and Access Resources on PrEP Watch

Daily oral PrEP is moving from an idea to an offering in more countries and communities every day. And in the places where it isn’t being offered, demand is growing!

To help advocates track implementation on the ground in detail, AVAC has developed a new section of PrEP Watch (a clearinghouse of information on PrEP science, research, cost, access and advocacy) focused specifically on implementation efforts underway.

On the Implementation Initiatives page, you can find information about some of the different initiatives funding PrEP implementation in sub-Saharan Africa, including the USAID-supported OPTIONS Consortium and the PEPFAR DREAMS Initiative. Information about funder-defined initiatives can help advocates understand who’s who and what’s planned—and to follow the money!

You can also learn about the full spectrum of work happening at country level in Kenya, South Africa and Zimbabwe. As PrEP is rolled out in additional countries, more case studies will be added.

PrEP Watch will continue to grow as PrEP introduction and rollout moves forward and as new efforts and initiatives are started.

Reach us at [email protected] if you have comments or questions.

Antibody Research Advances to Prevention Efficacy Trial(s): An Advocates’ Perspective

This week the NIH-funded HIV Vaccine Trials Network (HVTN) and HIV Prevention Trials Network (HPTN) announced the launch of the HVTN 704/HPTN 085 trial, also known as “AMP” (Antibody-Mediated Prevention). The Phase IIb trial is designed to measure the safety and effectiveness of an intravenous infusion of the broadly neutralizing antibody VRC01 for HIV prevention. The infusion will be delivered to participants every eight weeks over the course of a year and a half (participants are also followed for 20 weeks after their last infusion).

AMP consists of two parallel trials conducted collaboratively by the the HVTN and HPTN. The trial that just initiated (HVTN 704/HPTN 085) has 24 sites across Brazil, Peru and the US and plans to recruit 2,700 men and transgender people who have sex with men. The other study, HVTN 703/HPTN 081, will be initiated later this year and will enroll 1,500 women at 15 sites across Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania and Zimbabwe.

For the past several years, scientists have been working with potent antibodies that neutralize many different strains of HIV. These broadly neutralizing antibodies, or bNAbs, include VRC01. Antibodies are substances made by the immune system; these bNAbs have been isolated from people living with HIV. Researchers have purified the bNAbs and modified them to make them even more effective against HIV. The antibodies in trials like AMP are delivered via infusion—meaning intravenous administration. The approach of delivering an immune defense directly is called passive immunization, and it stands in contrast to vaccination or immunizations that teach the body how to mount an immune defense itself, via a vaccine. In the AMP trial study visits are expected to take approximately 90 minutes and participants are scheduled to come to the clinic every eight weeks.

Many scientists in the field say that the point of bNAb trials isn’t to identify a new strategy for widespread use. Instead, a positive result could lead to more focused vaccine development efforts. Other researchers say that more potent antibodies that could protect in smaller, more easily-administered doses, could perhaps make it to market one day. For this to happen, all agree that the dosage (the amount delivered to a person) would need to come down from where it is in the AMP trial, and the half-life (a measure of the time that protective levels of antibody stay in the blood) would need to go up.

The AMP trials will contribute significantly to the field’s understanding of how to fight HIV. AVAC and other advocates have urged that the trial sponsors and implementers ensure consistency in the messaging about and expectations for VRC01—especially given that other, more potent antibodies may be ready for additional testing by the time the AMP trials are over, alone or in combination. (This is a common conundrum in research: first-in-class products break new ground but may not be the optimal choices for introduction.)

Extensive and continuous stakeholder engagement is essential to ensure that passive immunization trials and product development plans are clearly articulated.

The AMP trials are among the first prevention efficacy trials to start in the “post-PrEP-approval” era, raising an issue that’s challenging prevention stakeholders everywhere: the need to define the standard of prevention in trials to include daily oral PrEP, which is now recommended by the WHO for all people at substantial risk of HIV. People who participate in efficacy trials are, by definition, at substantial risk of acquiring HIV and therefore there is an ethical imperative to include PrEP. The question is how—and how to design trials that can answer questions about new products, even as incidence may go down due to PrEP use.

The AMP trial that launched this week has this to say about its approach to PrEP:

“Volunteers in the AMP Studies will be referred to available local programs where they may obtain the oral medication Truvada [TDF/FTC] to take daily for HIV prevention, a highly effective practice called pre-exposure prophylaxis (PrEP). Volunteers’ access to PrEP will expand as more host countries approve Truvada for PrEP and develop the infrastructure to support its use.”

The prevention standard of care is defined as, “condoms and lubricant, counseling on how to reduce behaviors that increase risk for infection, and counseling and referral for antiretrovirals to take immediately following suspected exposure to HIV (post-exposure prophylaxis).”

ACT UP New York member and long-time activist Luis Santiago responded, “Should Truvada/PrEP be more than just an ‘option’? Should it be actually provided in the studies in the control arm? Are we back to the ethical discussion of the 1990s?”

These questions, which were a key part of the prevention advocacy agenda years ago, still apply today—how does the field ensure that trials are not responsive to context but help to shape it? There is precedent for this, as the HVTN ensured access to antiretroviral therapy for individuals who seroconverted in vaccine trials before ART was widely available in Africa, and subsequently ensured access to voluntary medical male circumcision (VMMC) in its vaccine trial in South Africa before there was national policy on that strategy.

The reality of HIV prevention programming is rapidly evolving. In just the past four months, three of the AMP trial host countries (Kenya, Peru, South Africa) joined the US in approved TDF/FTC for daily oral PrEP, joining the USA in this decision. This leaves six AMP countries that have not: Botswana, Brazil, Malawi, Mozambique, Tanzania and Zimbabwe. But approval doesn’t mean access, and these countries may or may not have programs set up to which AMP participants can be easily and effectively referred. In that case, it’s up to the trial site to sort out provision of this key service.

At the end of the day, everyone is after the same thing—access to new options that can prevent HIV today and in the future, whether that’s a pill in hand for a young woman at risk today or a vaccine or antibody for the generations to come.

Additional Information
John Mascola of the Vaccine Research Center (VRC) that isolated the VRC01 antibody recently presented on the use of antibodies for both prevention and treatment, which provides helpful background and context for these recent developments, Harnessing Antibodies for HIV Prevention and Treatment.

Additional study info can be found in AVAC’s prevention research and development database (PxRD) and at ampstudy.org.

WHO Writes Back…Five Months Later: An update on HC-HIV advocacy

A nearly five-month long waiting game for a response from the World Health Organization (WHO) regarding advocates’ concerns about its confusing and inaccurate statement on the relationship between some forms of hormonal contraception and HIV ended on April 5. Sadly, the response starts a new waiting game, since the long-awaited letter promised action on some, though not all, of the points raised in the original letter (sent November 12, 2015), with no timeline or process described for taking that action. (Wheels may be turning, as the link to the October 2015 statement no longer goes to the full statement.)

By way of background, in October 2015, the WHO, without warning, posted a new statement on hormonal contraception and HIV on its website. The statement claimed to be a clarification of the existing, expert-reviewed guidance on the topic. However, it contained a range of inaccurate and confusing statements that contradicted or muddied the clarity of the statement it sought to simplify.

On November 12, 2015 an international coalition of organizations wrote an urgent letter to the WHO requesting immediate action on the statement. Citing the confusion that the new statement caused in terms of the mixed evidence showing that DMPA, aka Depo-Provera, impacts women’s risk of HIV, advocates asked for the statement to be taken down so that the existing note would continue to be the main point of reference for the field. The letter was sent by the International Community of Women Living with HIV Eastern Africa (ICWEA), co-convener of a civil society working group on contraception and HIV, and AVAC. (You can read the original sign-on letter here, and see a table below that outlines the requests in that letter with the WHO response).

The letter wasn’t officially acknowledged until some months later, when ICWEA wrote requesting an update. And the response did not come in until April 5. In summary, WHO agreed to:

(1) revise the statement to correctly characterize the evidence;
(2) revise the statement to specifically reference women’s right to know about the uncertainty regarding DMPA and HIV risk.

WHO stated that it will not add reference to additional prevention methods beyond male and female condoms, even though the technical guidance refers to a range of methods. This is particularly disappointing given WHO’s strong recommendation in September for the offer of oral PrEP for “all people at substantial risk of infection”.

ICWEA and AVAC will work with partners who signed on to the original response to develop a response in the coming days. Please be in touch with ideas and reactions.

Below is what we asked for and what WHO said, in detail:

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.