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Px Wire: October-December 2017

Volume 10, Number 4

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AVAC's Take

This issue of Px Wire includes a preview of AVAC Report, our annual “state of the field”. Every report has a theme—and this year it’s “Mixed Messages”.

The theme of the Report reflects the ways various messages are playing out in the world of HIV prevention research and implementation. As readers of the full Report will see, we untangle mixed messages and deliver clear advocacy priorities related to: delivering today’s prevention in the context of a global AIDS funding gap; ensuring that daily oral PrEP has a fighting chance to take hold as a prevention strategy in sub-Saharan Africa; and the monumental task—undertaken every seven years—of reconfiguring the US National Institutes of Health HIV research networks for the future.

This last topic is why we’ve worked to get this preview into your hands before the full Report is published—this content is time-sensitive. We’re sharing our recommendations to the US National Institutes of Health’s Division of AIDS (DAIDS), which is accepting comments on the future of HIV clinical research networks through November 30. Visit to submit your comments.

These recommendations are AVAC’s clarion call in the midst of an ever-evolving proposed network structure from DAIDS. During the open-comment period, NIAID and DAIDS leadership have presented a vision for what the 2020-2027 network structure should look like. First, a streamlined two-network vision. Then a three-network vision. And two weeks before the comment period closes, a four-network structure. It’s worth noting that a microbicides-focused network is still off the table.

We hope you’ll engage with DAIDS on these important issues and that you’ll download the full AVAC Report when it’s released. And join us in the work of clarifying, loudly and without compromise, what a truly comprehensive, rights-based approach to HIV looks like. —AVAC

click for larger version of the centerspread

Future of DAIDS Trial Networks

Every seven years DAIDS reviews how it structures its funding for HIV treatment and prevention clinical trials. This funding, which comes via NIH, is allocated across different “networks”. The decision about what each network should focus on is a big one. It reflects the priorities and even the philosophy of the largest funder of HIV research worldwide. The current six-network structure will be in place through 2019; the new network structure will be in place from 2020 to 2027, so it must intentionally and explicitly look into the future. AVAC and partners have engaged in a range of discussions amongst ourselves, with researchers and product developers, and with the DAIDS leadership about what the future network structure should look like. We developed the following principles and priorities in reaction to the plans shared by DAIDS, which proposes a four-part network structure (see centerspread).

What should the DAIDS networks look like—and how should they work?

Simplification of the current prevention trials network structure has been described as a means to reduce inefficiencies in structure and operating procedures. But this move to streamline must not result in over-simplification of the issues and topics that NIH-funded HIV research must address.

Specifically, the new structure must explicitly fund mechanisms that support, cross-cutting research agendas and cross-network coordination. The networks as they currently exist have shown highly variable capacity and interest related to these topics. The existing structure does not have a way to correct for this heterogeneity, which includes different policies with respect to trial conduct and standard of prevention, community and stakeholder engagement at the site and above site level, and how behavioral and social science research is incorporated into trials.

The MTN and IMPAACT are the two networks with an explicit focus on the prevention and treatment needs of cisgender women and adolescent girls. HVTN and HPTN both have significant investments in e cacy trials in women, particularly in sub-Saharan Africa, but they have not advanced these trials under an overarching women’s prevention agenda or been guided by a set of core principles about how to talk about, implement and act on the findings of trials of products that women can use. If explicit steps are not taken to incorporate the strengths of the existing networks into the new structure, they could be lost or diminished, to the detriment of all.

Recommendations for network structure and cross-cutting issues:

  • A comprehensive, cross-network behavioral and social science research agenda that supports consistency in approaches and focus across networks, and that is reviewed on an annual basis and updated as needed.
  • Establishment of either a network core or crosscutting mechanism that guides thinking and investment related to product introduction, from the earliest stages of product development.
  • Institutionalized and consistent research engagement across networks via a funded community and stakeholder engagement division within the core of each network and/or via a cross-network mechanism. This will ensure consistent implementation of the Good Participatory Practice (GPP) Guidelines for stakeholder engagement at site level and, importantly, beyond trial communities.

Recommendations DAIDS Should Select Produtcs and Set Its Agenda

DAIDS head Dr. Carl Dieffenbach has been clear that the priority for the next generation of prevention is products that are long-acting and systemic: a shot of antiretrovirals, a vaccine, an infusion of antibodies. The rationale? Many people have multiple vulnerabilities or sites of exposure. People have vaginal and anal sex. They have penetrative sex and do not use the terms “vagina” and “anus”, but prefer “front hole” and “back hole” or other non-gendered anatomical names. People have sex and use drugs. A prevention tool that protects all holes and works in the blood too—and lasts for a long time—has a lot going for it. And that’s what Dr. Dieffenbach has argued: “We must develop prevention modalities that are safe, desired and highly effective. These tools should provide systemic protection irrespective of route of exposure.” That’s something that topical products can’t do.

But it is premature to eliminate user-initiated, on-demand methods—and important not to conflate recent clinical trial results with what people at risk for infection may actually use in their daily lives. As AVAC and many other stakeholders have said, clinical trials may offer health services, counseling or other benefits that are highly desirable and can serve as motivation for enrolling in a clinical trial. Low adherence in the context of a trial does not mean that products won’t be used in real life. Some people can and will take daily oral PrEP. Some can and would use a microbicide. It is inaccurate and potentially dangerous to say otherwise given the evidence currently available.

There is no rationale either in public health or in HIV prevention for an exclusive focus on long-acting systemic products. And there is no evidence yet from work to date on combination prevention trials, and from the broader landscape of oral PrEP introduction work, to suggest that countries will know what to do with a slew of long-acting products should they become available during the next decade.

Recommendations for scientific agenda and decision-making

  • Investment in a product portfolio supported by basic, clinical, behavioral and social science; and market research about clinical efficacy and needs; preferences and priorities of prevention users; providers; and payers.
  • A cross-network strategic collaboration mechanism with budgetary and decision-making authority that guides the overall agenda with transparency and accountability.
  • An explicit fast-track, “hand-off” approach to implementation research on interventions, with an emphasis on efficiency, engagement with national governments and integration into combination prevention packages.

How to Engage (and Learn More)