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New Research Priorities from the US National Institutes of Health (NIH) Restricts Prevention Options

By Marc-André LeBlanc, Founding member of IRMA

International Rectal Microbicide Advocates (IRMA) and our many partners and allies believe we need an array of HIV prevention options. There has been enormous progress in the field of HIV prevention research in recent years. The remarkably high efficacy of antiretroviral drugs (ARVs) for prevention has been demonstrated, both for oral pre-exposure prophylaxis (PrEP, now approved and subsidized in several countries) and through treatment leading to viral suppression or “undetectability” (U=U, Undetectable = Untransmittable).

Microbicide—products that could be used vaginally or rectally to reduce a person’s risk of HIV infection—also show tremendous promise. As of late 2018, the microbicide field is awaiting regulatory review of a vaginal ring that prevents HIV among women, has successfully completed the first-ever Phase II study of a rectal microbicide, and has several other rectal, vaginal and multipurpose products in development—which could offer protection against HIV as well as other sexually transmitted infections (STIs) and/or unplanned pregnancy.

Founded in 2005, the International Rectal Microbicide Advocates (IRMA) is a global network of over 1,200 advocates, policymakers and leading scientists from six continents working together to advance a robust rectal microbicide research and development agenda. IRMA’s goal is to support the creation of safe, effective, acceptable and accessible rectal microbicides for the women, men, and transgender individuals around the world who engage in anal intercourse.

However, microbicides are under threat.

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), presented its proposal for refining the HIV clinical research networks in early 2018. The new proposal did NOT support the research and development of user-controlled, short-acting, microbicide options (where the products are absorbed locally in the vagina and/or rectum), and focused solely on long-acting and systemic formulations (such as vaccines and injectables and implants that deliver products throughout your body). Given that the US government provides the lion’s share of global funding for rectal and vaginal microbicide research (82% of global funding to be precise), these prevention research priorities will likely mean the end of the microbicides/topical prevention field.

Report: Whose Choice Is It Anyway?

What did we do?

Concerned with the lack of transparency surrounding the NIAID request for input into its new research priorities, IRMA analyzed over 330 pages of comments submitted by advocates, researchers, academics, elected officials, research networks and industry, mostly from the US and several African countries, as well as 56 responses from NIAID. We published our findings in a report called “Whose Choice Is It Anyway?”.

We want choices—we are all different and we want different tools so we can choose what suits us best. – Young Women’s Group (East and Southern Africa)

The vast majority of submissions (79%) expressed explicit support for HIV prevention choices and/or continuing microbicides research. Many respondents mentioned both vaginal and rectal microbicides specifically, including a variety of possible topical formulations, features and delivery mechanisms they value, including:

  • The potential for multi-purpose technologies—products that could prevent not only HIV, but also unplanned pregnancies and/or STIs.
  • HIV prevention options that users—especially women, girls, and other receptive partners—can control, including in cases where discretion is desired.
  • Products that are short-acting and can be used on-demand at the time of sex, including the possibility of intermittent use during sporadic periods when the user is sexually active.
  • Products that are non-systemic (where the product’s active ingredient does not go throughout your body) and that can be used without overburdening the user or the healthcare system.
  • Products that are behaviourally congruent—meaning that they build on existing practices such as rectal douching or the use of lubricants during sex—to enhance their acceptance and uptake.

NIAID’s responses to comments were contradictory. While nominally espousing the language of choice and prevention options for women and other priority groups, they provide a list of conditions under which that would need to happen—which includes several complex, possibly scientifically unattainable criteria that by definition effectively exclude microbicides. This is disingenuous “support,” both cynical and hypocritical.

We were particularly troubled to see that the letter submitted during the input process by the leadership of the HIV Prevention Trials Network (HPTN)—which will be the strongest or only contender bidding for the entity leading non-vaccine HIV prevention research—makes absolutely no mention of the intention to continue the work or incorporate the priorities and expertise of the Microbicide Trials Network (MTN).

No single method can be expected to stop HIV. Additional methods are required to widen the choices available for more people to be protected from HIV. [Microbicide research] is making a significant contribution to make this dream a reality. – Academic (Zimbabwe)

It is not too late to change or influence the priorities proposed by the NIH. We must mobilize as a community of prevention consumers, advocates, researchers and policy-makers and continue to voice the need for research that leads to an array of prevention options for those who need them most. The current approach will not allow us to close the HIV prevention gap.

What can YOU do to close the HIV prevention gap?

  1. Share the report widely through your networks and social media, using the following link tinyurl.com/whosechoiceanyway and hashtags as appropriate: #fulltoolbox #HIVpreventionoptions#microbicides4all #usercontrolled #usercentereddesign #ourpreventionchoices #optionsforpeopleslives
  2. Write to the NIAID/NIH and HPTN leadership to express your views. Feel free to use the key messages from this blog or the full report as inspiration.
    • NIAID/NIH Leadership: Dr. Carl W. Dieffenbach, Director of the Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health (cdieffenba@niaid.nih.gov) and Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health (afauci@niaid.nih.gov)
    • NIAID’s AIDS Research Advisory Committee (ARAC): Chairperson Dr. Cara Wilson (Cara.Wilson@ucdenver.edu). Contact information for other ARAC Committee members can be found at https://www.niaid.nih.gov/about/committees-aids-research   
    • HPTN Leadership: Dr. Wafaa El-Sadr (wme1@columbia.edu) and Dr. Myron Cohen (myron_cohen@med.unc.edu), co-Principal Investigators

Marc-André LeBlanc is a founding member of International Rectal Microbicides Advocates (IRMA). He is a globally recognized leader in advocacy, capacity building and research literacy, and community mobilization, particularly as it relates to HIV prevention.

Marc-André has worked in health policy, the community-based response to HIV, Hepatitis C and other sexually transmitted and blood-borne infections (STBBIs) and gay men’s health for 25 years at local, national and international levels. His work is grounded in a gender-based perspective and a deep commitment to social justice, health equity and the meaningful engagement of individuals and communities directly affected by policy and programs.

Marc-André loves movies. He got a film studies degree while working full-time, just for the sheer fun of it. He is now leading advocacy efforts to get ice cream and popcorn recognized as new basic food groups in Canada’s updated Food Guide.