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

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

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

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

Then we turn to a global effort to accelerate prevention.

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

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

New Px Wire — 2018: Countdowns and counting what matters

The first issue of AVAC’s quarterly newsletter for 2018 is here! It’s designed to help you mark your calendars and make your advocacy plans for critical events in the next 12 months. These include:

  • The upcoming country deadlines for creating roadmaps to implement the priorities laid out by the UNAIDS’ Global Prevention Coalition. This work is supposed to jump-start primary prevention and bring down the rate of new diagnoses by 75 percent by 2020. Will it? Only if you get involved!
  • In the coming weeks, PEPFAR and many stakeholders will gather to develop targets, service delivery approaches and comprehensive plans for testing, prevention, treatment and virologic suppression in PEPFAR countries. It’s a key process for civil society to track. Find out how!
  • In 2019, the ECHO trial is expected to release its results on whether three different contraceptive methods impact women’s risk of HIV—but preparation for these trial results is starting now! Get involved!
  • Seven major efficacy trials of biomedical prevention tools are currently underway—read on to find out where, what and how to learn more.

This issue of Px Wire also includes a detailed infographic showing the status of oral PrEP rollout in the countries where trial sites are located. And don’t miss the infographic explaining the demographics of Africa’s “youth bulge” and its implications for the global response.

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

The January Episode of Px Pulse is Up!

As the new year gets into full swing, we at AVAC look forward to assessing, untangling, confronting and calling on all of us to commit to HIV prevention in all its complexity. Building on the advocacy agenda we lay out in AVAC Report 2017, and a corresponding December episode of our Px Pulse podcast, our January episode expands on what we’re looking forward to in the year ahead.

Find Px Pulse on iTunes or listen at AVAC.org to hear AVAC Executive Director Mitchell Warren explore more of what’s got our attention—it’s no small list.

  • Major new vaccine and long-acting injectable PrEP trials are launching.
  • The dapivirine ring is under regulatory review, and could be the world’s next biomedical prevention option since oral PrEP.
  • Recent findings from the Rakai Community Cohort Study in Uganda confirmed what models predicted—bringing combinations of existing interventions, such as voluntary medical male circumcision and antiretroviral treatment, to scale slashes new HIV diagnoses. How can we leverage these findings to maximize prevention at the global level?
  • What will advocates need to do this year to prepare for results—anticipated in 2019—of a key trial called ECHO that’s looking at whether contraceptive methods affect HIV risk?

Hear all this and more in the January episode of Px Pulse, AVAC’s podcast on HIV prevention research today. Tell us what you think!

Setting the Standard: New prevention trials in the era of oral PrEP

There’s a lot going on in the world of HIV prevention research right now. The HIV vaccine field has launched a second efficacy trial—HVTN 705/HPX 2008—investigating a mosaic vaccine that could protect against clades of HIV from around the world. HPTN 084, a second trial comparing injectable cabotegravir to oral PrEP as prevention, this one among women, also recently launched across Southern and East Africa. These two trials join five other efficacy trials currently looking to expand the range of new prevention options.

At AVAC, we came out with our annual AVAC Report on December 1–our attempt at trying to untangle the mixed messages that have been circulating, and offer solutions to confront them head on.

The report touches upon an issue that has gained a lot of attention: how participants might access oral PrEP as part of HIV prevention trials. In the midst of all this activity, we thought it necessary to dive deeper into this issue. It may seem simple: trial participants have the right to the highest standard of HIV prevention and care as part of participation. Both the WHO/UNAIDS ethics guidance and the UNAIDS/AVAC Good Participatory Practice Guidelines for biomedical HIV prevention trials clearly outline this point. But the ethics, trial design issues and the mechanisms by which interventions are provided as standard of care are quite complex. Opinions differ and politics abound.

On November 2-3, the South African Medical Research Council (SAMRC) held a summit in Cape Town to discuss this very issue of standard of care in prevention and treatment trials in Southern Africa. Before the summit, members of the Vaccine Advocacy Resource Group (VARG) convened an Imbizo—a South African term for a gathering led by a traditional leader to discuss policy issues—to develop their position on what standard of care should be in prevention trials, and the role that communities and advocates should have in these decisions. AVAC attended both the Imbizo and summit to support the VARG and engage in the discussions.

The topic and tensions–and, for the most part, the players—are not new. Standard of care, and particularly when and how to integrate new interventions into the prevention package, has been discussed and debated for nearly as long as the research itself. What is new is stakeholders across prevention research coming together to reach consensus on not only the package, but on how it should be delivered. Traditionally, these conversations have been siloed. Ethicists made decisions based on their guidelines, statisticians based on trial design considerations, researchers on national context and available resources. Excitingly, there is a way forward from the summit that integrates the different interests of a broad range stakeholders. This is Good Participatory Practice in action!

The summit arrived at some concrete next steps. The SAMRC and the Fred Hutchinson Cancer Research Center (FHCRC and home of the HIV Vaccine Trials Network) will establish a trial-agnostic fund to cover the cost of oral PrEP and HIV testing for HIV prevention trial participants for the duration of the trial; trial sites and their communities will decide how to provide PrEP at their site—and this will likely look different at different sites; sites will be encouraged to work with implementing partners to optimize PrEP access and to support adherence; and South Africa researchers will work with the National Department of Health’s (NDOH) PrEP Technical Working Group to support establishment of demonstration projects closer to trial sites.

These are commendable and essential steps—and advocates, AVAC included, will be following them closely. As we continue to reflect, these are the questions and issues that remain at the fore for AVAC.

How ‘standard’ can standard of care be?

Decisions about provision of oral PrEP in clinical trials as standard of prevention, in particular, are happening as PrEP is being rolled out with great variability in the very countries in which the trials are happening. This creates operational and ethical complications—as well as exciting opportunities. Is there undue incentive if participants are offered PrEP in the trial, but PrEP is not available in the communities? Are researchers filling for the role of government—which is responsible for setting and improving the national standards of care? Within the same country, South Africa being an example, availability of PrEP can differ even between trial sites, potentially creating inequality in how participants in the same trials and in the same country get access.

The consensus from the summit is that rigid standardization is likely impossible; community and trial context have to be taken into account. Some sites do not have the capacity to provide PrEP on site, while some do. Some are close in proximity to demonstration projects and implementation sites and can create efficient linkages, while others cannot. The agreement is that trial sites, in collaboration with communities and local and national advocates, will work together to define a model of provision that ensures all participants who want PrEP can access it. This variability presents an exciting opportunity for sites to be innovative, and for the field to learn from different models of PrEP provision in real time.

But researchers, regulators and communities must also monitor execution of the PrEP plans to ensure that variation does not lead to inequality in access—and stakeholders at all levels must be linked and coordinated so there is constant learning and more efficient collaboration.

How should coordination look different moving forward?

As we move from discussion to action, partnerships are a must. Meaningful coordination will be especially critical among:

  • Advocates and researchers: Civil society is key to the HIV response at national levels. They can, and should, play a concrete role in how to connect prevention programs to trials. As both the ethical guidance and the GPP guidelines highlight, advocates and civil society should have voice in these decisions, and it was good to see that happen in the summit. True engagement, though, doesn’t just mean one meeting. It means a comprehensive, transparent plan for the ongoing role for advocates.
  • Trial sites and governments: Science does not happen in a vacuum; national policies have great impact on trial conduct, and as we have seen with HVTN’s proactive and progressive stance with regards to treatment in HIV prevention trials in 2003—researchers can also have an impact on national policy. SAMRC has committed to working with the South African National Department of Health to set up demonstration projects closer to trial sites.
  • Trial sites and local and national PrEP implementation and research activities: If PrEP cannot be provided onsite, mechanisms must be developed to connect participants to PrEP delivery programs and initiatives. Data and existing capacity from the research and implementation activities should also inform messaging and enhance counseling and adherence support.
  • National advocates and community advisory boards (CABs): To ensure PrEP plans are developed with meaningful and inclusive engagement, that CABs need to be linked to national advocacy agendas, and national advocates, in turn, to the clinical trial objectives and activities. VARG members are planning to follow up with CABs and community engagement personnel to ensure coordination and synergy across sites and communities in South Africa.
  • Regulators, ethics review bodies and funders: The decisions from the summit stand to impact trials happening across Southern and East Africa and those being implemented by multiple clinical trial networks. To promote equity and ensure adherence to core ethical and scientific values, regulators, funders and ethicists need to be coordinated across geographies and networks.

So, what?

AVAC’s position, as we outlined in our new report, is clear: while one research organization, product developer or funder cannot reverse global inequities in HIV prevention or care, researchers have an obligation—and an opportunity—to try to narrow the equity gap. Trialists must grapple with PrEP provision in clinical trials head-on; they should work with program implementers and communities to develop, implement and assess high-quality prevention and treatment models for participants in research programs, and can encourage the development of sustainable community access to good quality, comprehensive HIV prevention.

The summit was a good starting place. As advocates we will be following the implementation of the plans set out by MRC and HVTN—we will be making sure that stakeholders involved and affected by the decisions (from advocates to regulators to trial site staff) are engaged in a sustained manner, that trial sites are communicating with PrEP programs in their contexts, and that there is equity in access across trial sites and across countries.

As we anticipate how the next generation of PrEP products and other HIV prevention modalities will further complicate standard of care conversations, it is partnerships and transparency that will make research smoother and more relevant to the real-world context.

Further resources

What Young Women Want

This letter comes from a group of young African women and reflects their HIV prevention research priorities. It was submitted to the National Institutes of Health’s (NIH) Division of AIDS (DAIDS) during the open-comment period concerning the structure and agenda for its next funding cycle (2021-2027).

Dear Dr. Carl Dieffenbach,

We are eight young women from South Africa, Uganda and Zimbabwe who were involved in recent consultations for planned HIV prevention trials with young women. We are interested in HIV prevention research because in each of our countries, young women are at high risk for HIV and we are so excited to hear that finally the needs of protecting young women are at the forefront of studies exploring new prevention tools. We understand that you and DAIDS are considering the research priorities for the next several years and we want to make sure that our voices are heard.

We are:
Sanele Ngulube – Zimbabwe, age 20
Irene Hware – Zimbabwe, age 22
Cleopatra Makura – Zimbabwe, age 21
Shakirah Green – Uganda, age 24
Catherine Nakkide – Uganda, age 22
Charity Twikirize – Uganda, age 22
Sinazo Peter – South Africa, age 24
Anelisa Madalane – South Africa, age 18

Please accept this as our feedback to you as you consider the research agenda that affects our future.

We have arranged our suggestions to you based on the themes we discussed together as a group. Here is what we want.

1) We want choice. The feeling that young women have when we know we have choices on how to protect ourselves, gives us power within and we get confident. The power and confidence means there are less chances that we become reckless about our sexual reproductive health. Choice frees us from slavery of any type because we are able to say yes or no, or even pick from a variety without being judged.

Most of all, we, young women, love experiencing new things and we love pushing boundaries. We want fun and exciting things and we shouldn’t be scared of using other methods because they are not of equal standard. Simply put, choice makes our life better.

2) We want products that are safe for our bodies and discrete. We, young women, are delicate, and you know how sensitive our vagina is. Not only that, but we have to fight social norms and cultures in our communities. We know that social norms should not dictate how we should take care of ourselves, but we also realise that most young women are oppressed by their partners, communities and culture.

We want something that will not attract people’s eyes and judgement. We need something that doesn’t require us to close our eyes, and clench our teeth when we use it. Again, it means we need different choices.

3) We want both systemic and non-systemic options. We have different opinions on what can work for us. Some of us like the idea of having to go to the clinic only once and be protected with a long-acting product—and it would be great if that could be for 6 months. Some of us like the convenience of systemic coverage. But others of us are nervous about side effects and the interaction with our sensitive bodies. We don’t want something that requires constant check-up. We want something that doesn’t stay in our bodies for a long time.

So, if you want to prioritise long-acting systemic methods, please make sure that it is easy and has no side effects for us. But remember our first point, that we want choices—we are all different and we want different tools at the table so we can choose what suits us best. We are all from different environments and cultures.

4) We want something other than injections. Some of us are okay with injections, but for others, injections don’t work and we want something we can take without pain. Some of us think twice about even going to the hospital when we are sick because we are scared of injections. Also, injections mean going to a clinic—and we have to deal with judgmental nurses who think we are too young for sex.

A visit to the clinic is really something else. So, if you plan on only giving us injections, it is not okay with us. We are not all good with the injections—please ensure that the research gives us something else too.

5) We want the ring: We love the idea of the ring. You insert it and you are done. It is like our secret weapon, painless but protective. We would use it because it’s in and doesn’t bother us for a while, and we can watch out for ourselves. We would even love the ring more if you added a contraceptive. We understand that DAIDS is thinking not to put more research into other forms of rings like this and we don’t think that’s a good idea. We have seen it works for some women and that’s okay that it doesn’t work for all because it’s another tool, another choice.

We want to thank you for the research you and your team have done. Thank you for the time you have put in and done for us, so far. However, we want you to know that we want more and we need more from you. We want to challenge you to do more for us and we want you to involve us more. We don’t want to be terrified of the products we are using (and please, if you come up with a new product, make it smell good). We don’t want side effects. And please, don’t forget about the potentially expensive costs of these methods. Most of all, we want products that will be safe and protect us as much as possible.

We hope our views will be heard and considered because we don’t want our issues to go unnoticed. We would love if—in the future—we were asked first about our needs instead of just coming with the products researchers think will be best and then asking us if we would use them. There is a South African saying, “it’s better to hear it from the horse’s mouth.”

—Sanele, Charity, Irene, Cleo, Shakirah, Catherine, Sinazo and Anelisa

US HIV Research: A family tree

This graphics shows a family tree representing HIV research in the United States. It appears in AVAC Report 2017: Mixed messages and how to untangle them.

Durban 2016 Scorecard—How did it deliver?

Excerpted from Px Wire, this is a scorecard for the 2016 International AIDS Conference. Did it deliver?

Breaking the Cycle of Heterosexual Transmission

Excerpted from Px Wire, this is a novel look at how to use today’s tools to break the cycle of heterosexual transmission that was so clearly defined in a major AIDS 2016 presentation.

Prevention, Treatment and Human Rights

AVAC Executive Director Mitchell Warren and international gay rights activist Bisi Alimi dig into the tough realities of fighting HIV in 2016 in this interview, originally livestreamed from the AIDS 2016 conference in Durban.

Alimi asks Warren to make sense of scientific advances and new discoveries that are answering big questions and raising others. And Warren shows the imperative connection between prevention, treatment and human rights. Click to view.

Ighodaro spars with Bisi over some provocative questions about the role of Africa’s activists and an agenda for the future. View the video here.

UNAIDS 2016-2021 Strategy: What Does it Say about Prevention?

The current UNAIDS strategy calls for an end to HIV-related discrimination and fewer than 500,000 annual deaths from AIDS. Out of ten highlighted targets within the strategy, three center on prevention tools. Excerpted from AVAC Report 2016: Big Data, Real People.