I love saying it. (It’s pronounced my-CROW-besides, by the way.) It’s a real showstopper of a term. Trust me, it’s guaranteed to command attention when uttered in “mixed company”. Just ask the gaggle of guests gawking at me incredulously at a recent fondue dinner I attended.
That’s right. I’m a guest in someone else’s home and I start talking about rectal microbicides and whether or not lubes are safe for rectal use, right there in front of men and women, gay and straight, single and coupled. No one there but me works in HIV. Heck, there was even someone there who works in a bank. A bank, people. And I said “rectal microbicides”.
The poor guy, trying to be a gracious hostess. He mostly pretended not to hear me as he passed around a plate of thinly sliced raw beef. One guy generally stayed quiet and tried to avoid eye contact, but his wife seemed interested. Oh, honey.
What are rectal microbicides?
Just so we’re all on the same page here, microbicides could be used to reduce a person’s risk of HIV infection vaginally or rectally. They could be available in a cream or gel, maybe a douche or an enema, perhaps a thin film that dissolves in the vagina or rectum, or even in a ring that stays for weeks in the vagina, slowly releasing an anti-HIV compound. But there are no vaginal or rectal microbicides available on the market yet. They are still in development.
Rectal microbicides could offer both primary protection in the absence of condoms and back-up protection if a condom breaks or slips off during anal intercourse. For those unable or unwilling to use condoms, rectal microbicides could be a safe and effective alternative means of reducing risk, especially if they were unobtrusive and/or enhanced sexual pleasure enough to motivate consistent use. Such alternatives are essential if we are to address the full spectrum of prevalent sexual practices and the basic human need for accessible, user-controlled HIV and STI prevention tools. Women, men, and transgender individuals will all need rectal microbicides.
Many products in development now use antiretroviral drugs (ARVs) as the active ingredient. But other options are being pursued as well. This is important for many reasons, including: a) more options are a good thing; b) not everyone will want to use ARV-based products; and, c) not everyone will be able to use ARV-based products. With non-ARV-based options, people living with HIV will be able to use microbicides too, without fear of developing drug resistance.
Rectal microbicides research takes a big step forward
We came one step closer to making rectal microbicides a reality in early October when the world’s first phase II expanded safety trial of a rectal microbicide trial was launched.
Hey, you can get excited over the christening of Baby George if you like (didn’t Kate look faaaabulous in that Alexander MacQueen ensemble?). I get excited over the launch of multi-site microbicide trials. No judgement.
The Microbicide Trial Network’s study, called MTN-017, will test a reduced glycerin formulation of tenofovir gel applied rectally. Volunteers consisting of gay men, other men who have sex with men, and transgender women will participate in the study at sites in the United States, Thailand, South Africa, and Peru. You can learn more about the trial here.
If all goes well with this trial, we could see a large-scale efficacy trial in the next few years. All appendages crossed!
Putting your ass on the line: Advocating for rectal microbicides
Have you ever heard of IRMA? If you work in HIV, hopefully you have. Have you wondered who she is, what she does, and why she’s so damn anal about rectal microbicides? Let me tell you a little bit about her, and why you should really join her efforts.
IRMA was founded in 2005 by 4 individuals, including yours truly! Today we have more than 1,200 members across the globe, including researchers, advocates, funders and policy-makers. Our mission is to support the development of safe, effective, acceptable, and accessible rectal microbicides for all who need them.
What do we do? We have a considerable virtual presence for starters. We have a website, blog, Facebook page, Twitter account and YouTube channel. Our website contains a host of resources, from factsheets and reports to recordings of our global teleconferences. We operate a highly active, moderated listserv that covers not only rectal microbicides, but also all HIV prevention research, and the current state of HIV prevention across the globe. Go to our website to join. Trust me, if you’re interested in HIV prevention, you need to join this listserv.
We advocate on a number of fronts, including pushing for more funding, more research, lubricant safety and access, and raising awareness about anal sex and anal health for everyone—gay, straight, men, women, transgender. We have a few projects on the go.
. Project ARM—Africa for Rectal Microbicides is an initiative through which African advocates, researchers, and global allies have developed priority actions to ensure Africa fully engages in rectal microbicide research and advocacy activities, including the integration of safer anal-sex messaging into HIV prevention programs.
. One of the cornerstones of that initiative was the creation of the GLAM Campaign, which stands for Global Lube Access Mobilization. We developed stickers with the tag line “And Lube”, meaning anytime we mention condoms, we should always say ‘and lube”. A Toolkit focussing on Africa, available in French and English, proposes a host of ways lube access can be improved, and earlier this year three small grants were provided to advocate for improved lube access in three African countries. Next year will see a new round of grants
. We also do considerable work on lubricant safety. We issued a Call to Action on Lubricant Safety, and over 500 organizations and individuals signed on. We’re working with researchers and key partners to develop a lubricant safety research agenda, and we provide regular updates on the current state of knowledge about lubricant safety.
. For the past few years, a chapter of IRMA in Latin America and the Caribbean (called IRMA-ALC) has been very active. IRMA-ALC does community education and advocacy, raising awareness of anal intercourse, rectal microbicides, but also of existing prevention options like PrEP. They are advocating for Truvada to become available in Peru, because ironically, despite Peru being the site with the most iPrEx participants, Truvada is not available in that country. IRMA-ALC will be adapting the GLAM Toolkit for the region.
. "The Rectal Revolution is Here: An introduction to rectal microbicide clinical trials" is a 14-minute video developed in collaboration with the Microbicide Trials Network and Population Council. The video is available on YouTube in English, Spanish, or Thai, and is available as an electronic file for individuals and organizations that want to use it for workshops and educational sessions. A facilitator's guide has been produced in English, Spanish, and Thai.
Advocating for rectal microbicides: seven important lessons learned
Oh sure, advocating for rectal microbicides is all fun and games until you stop getting invitations to fondue dinner parties, colleagues mock you, policy-makers stop inviting you to meetings (OK, I admit that one is a nice perk), and funders avoid you like… well, like you just used the word “rectal” in your funding application.
So what has Auntie IRMA learned about being an effective rectal microbicides advocate over the years
Lesson #1: Just the facts, ma’am. When researchers and advocates started pushing for rectal microbicides, people laughed. They said we shouldn’t. It was not considered feasible because of the considerable biological challenges. But at least as important was the underlying homophobia, the discomfort with discussing anal sex, or even acknowledging that it happens—not only between men but *gasp* between men and women.
So we had to start all discussions with the basic facts. First, we have data showing that condomless anal intercourse is the highest risk sexual activity. Secondly, we pointed out, and continue to point out, that there is significant evidence that anal intercourse is relatively common among all kinds of people, and in all parts of the world. And that even if for example, men and women have anal sex just once in a while, the high risk associated with that could be a significant driver of the epidemic, not only between men as we have always known, but also in so-called “heterosexual epidemics”. Depending on who you’re talking to, these can be important things to point out.
Lesson #2: It’s all about context. It’s also clear that if we’re going to recognize and address the role of anal sex in the epidemic, we have to address the underlying social, political, cultural and legal context in which many people live. There is often complete denial about homosexuality or about anal sex between any two humans, or they are highly stigmatized and even criminalized. How can we ever hope to promote and make available rectal microbicides in such contexts? So we’ve been working with others to address these underlying issues.
Lesson #3: Creating demand. At a really basic level, we have to raise awareness and create demand. Most people outside the HIV world (and even many within the HIV world) have never even heard of microbicides. But once the concept is explained and people think about it as a possibility, they get excited about it and they want to have it in their… uhm, hands.
Lesson #4: Show me the money. Another issue that we can’t ignore is funding. Research is a costly endeavour. And the rectal microbicide field has never been funded at high levels. In 2012, there was about US$4.4 million spent on rectal microbicides research on the entire planet. To put that into perspective, there was nearly US$850 million in funding for vaccines last year. I’m not saying vaccines should get less. I’m saying rectal microbicides research is under-funded. And nearly all the funding so far has been from the US government. Where is the funding from other sources? If all goes well with the world’s first phase II rectal microbicide trial, we may be looking at a possible phase III clinical trial in the next few years. We estimate that we will need about 10 times more funding annually than we have now—or over US$40 million per year. How will we make this happen? Who will fund this?
Lessons #5: Framing microbicides in a continuum of options. Looking to the eventual availability of rectal microbicides, we continue to frame them as part of the HIV prevention toolbox. The message is that we need a range of options to meet a range of people’s needs in a range of different contexts. For some people in some contexts, rectal microbicides could play an important role.
Lesson #6: Learning from others. We benefit greatly from learning what has happened with other new HIV prevention tools, like female condoms, non-occupational PEP and PrEP. There was likely too little work done with policy makers, funders, program implementers and community stakeholders as these new prevention options were introduced. As a result, there is a fair amount of resistance, confusion, and misinformation—to put it mildly. In some cases, it’s outright hysteria and witch-hunts, with people being called whores, data from randomized controlled trials being qualified as “big bullshit” and accusations of genocide flying around for suggesting that some of these options should be made available. We must prepare the ground now so that rectal microbicides are not seen as a surprise or an unwelcome diversion when they become available.
Lesson #7: Ac-Cent-Tchu-Ate the Positive. Finally, we always try to focus on the positive. Our work is not only about avoiding the potentially negative consequences of sex. We need HIV prevention options that people like using because it enhances their pleasure, and allows them to have the kind of sex, human connection and intimacy that they want.
Thank goodness for the passion and dogged determination of incredible researchers who have developed rectal microbicides, for the support of key sponsors, and for the work of brave advocates across the globe. They are moving us ever closer to the day when we will have rectal microbicides. Go to our website and join IRMA today, and you can proudly proclaim that you played a role, next time you’re at a fondue dinner party!
For more information on IRMA’s work on rectal microbicides and lubricant safety, check out the fancy chapter in this (admittedly expensive) new book: “Advocating for Rectal Microbicides and Safe Lubricants”, from the book L. A. Eaton, S. C. Kalichman (eds.). Biomedical Advances in HIV Prevention, 2014. For a discussion of lubricant safety, please refer to Are lubes safe?