Meet Hailey Gilmore, A Friendly Rectal Microbicide Advocate

Find out a little about Hailey Gilmore in her interesting mini-bio, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Hailey is one of five new bios we are featuring.
 

Hailey Gilmore
San Francisco, California, USA

Hailey Gilmore studied international development in college and was always interested in sexual health promotion and education. While in school she interned at a local non-profit and developed a sex-ed workshop for youth in trade school. During this time she also became a volunteer HIV test counselor. This introduction to sexual health work opened the door for her current position as the Assistant Director of HIV Prevention Intervention Studies at Bridge HIV at the San Francisco Department of Public Health. She has been with Bridge HIV, supporting and coordinating clinical trials, for over four years.

Her organization conducts HIV prevention clinical trials testing HIV vaccines and pre-exposure prophylaxis (PrEP), and soon, rectal microbicides. Bridge HIV also studies behavioral interventions.

A little over a year ago, her organization was approached by the Microbicide Trials Network about conducting MTN-017, a phase II safety and acceptability study of rectally applied tenofovir gel among gay men, men who have sex with men, and transwomen in the US, Peru, Thailand, and South Africa. Hailey and her colleagues are incredibly excited for the MTN-017 launch later this year.

Hailey is also busy with the HPTN 069 study, or NEXT-PrEP, which is looking at the safety and tolerability of four daily oral regimens of PrEP. She is also analyzing qualitative data about people's motivations to take PrEP to better address advocacy strategies.

Hailey and her group will also soon be hosting a screening of "The Rectal Revolution is Here" in July to engage the San Francisco community on the topic of rectal microbicides.


Hailey would like to encourage IRMA to continue to find additional community allies to partner with - rectal microbicides are just too exciting to not talk about!

Thank you Hailey! 

------------------- *Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content. -------------------

Meet Coco Alinsug, A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of  Coco Alinsug, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Coco is one of five new bios posted this week.

  
Coco Alinsung
Boston, Massachusettes, USA

A native of the Philippines and a resident of Lynn, Massachusetts with his partner, Coco Alinsug has made a lifelong commitment to devote his time and energy to social justice, HIV/AIDS prevention, and issues facing LGBT youth.

Coco started his career as an HIV Counselor and Tester at the Gay and Bi Men's Health Program in Beverly, MA and later was appointed as the Executive Director of the North Shore Alliance on GLBT Youth which is funded by the Massachusetts Department of Public Health to provide HIV/STI education to youth 14-24 years old - a position he has held for eight years.

Currently Coco works as the Clinical Trials Field Recruitment Manager at The Fenway Institute where he has been for nearly seven years. It was in this role that Coco first came into contact with rectal microbicide advocacy as he was tasked with recruitment for all clinical trials, including the rectal microbicide study called Project Gel.

In his role at Fenway, Coco oversees outreach and recruitment for research studies looking at everything from possible HIV vaccines to microbicides to the use of pre-exposure prophylaxis (PrEP) to prevent HIV transmission. Coco and his team travel around New England, educating people about HIV and STD transmission and safer sex practices while also recruiting potential study participants.

Coco is also Chair for Community Education and Recruitment group for both HIV Vaccine Trials Network (HVTN) and HIV Prevention Trials Network (HPTN) and sits as a member of the protocol team for two studies, HVTN505 and HPTN069. Coco also is a consultant for various HIV and STD Outreach Programs both in the North Shore and Boston, and sometimes organizes and hosts shows in several clubs.

Coco would also like to encourage IRMA to keep up the good work and always stay fabulous.

Thank you for all your work Coco, and you stay fabulous too!


------------------- *Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content. -------------------

VOICE Lesson: It's Unfair to be Non-Adherent

This post by IRMA's Jim Pickett first appeared on the blog of the HIV Prevention Justice Alliance.


The VOICE results are extremely important to the field of new prevention technology research. I hope current/future/much-needed discussions about VOICE don’t get drowned out by the HYPE (yes, all caps HYPE) surrounding the “baby cure” story which has dominated coverage out of CROI so far.

If there is one VOICE lesson to focus on, it is adherence. Or in this case, the upsetting lack thereof. It is absolutely important to fully understand why so many of the women in the trial didn’t apply the gel, or take the pill. And it is critically important for scientists to develop things people actually WANT to use, and DESIRE. Perhaps a daily gel, or a daily pill, is simply not desirable for a lot of folks. Makes sense to me.

But here’s the rub. The field can’t move forward with product development when people don’t actually test-drive the product being investigated. Products can’t be improved without data from people who actually used the product. Sure, a daily gel or a daily pill may not be everyone’s idea of a good time… but the only way those ideas get translated from the clunky Model T Ford to a slick 2013 BMW is through a long, iterative process. Which requires trial participants to APPLY THE GEL and/or TAKE THE PILL.

I get that people join trials for all kinds of reasons, and that for many; it is their only access to healthcare. So, they may have no interest in actually participating in test driving anything, but are very excited about regular HIV and STD screening, counseling, access to condoms and lube, referrals to other services, etc. Can’t be mad at them for wanting those things. Right?

It’s a crime, really, or at the very least an outrage, that clinical trials end up being the only healthcare access point for too many folks. That needs to be addressed, on its own.

But…we simply can’t afford enrolling thousands of people into complicated and costly clinical trials to have them just forgo what they SIGNED UP to do. Let’s be brutally honest here, joining a trial to get health screenings and condoms is great for the individual – but it does NADA, NOTHING, NOOTCH for the community/communities fighting HIV who are desperate for new tools to prevent HIV.

Being in a clinical trial is a commitment to following the protocol as best as possible, and being honest when unable. Clinical trial participation necessitates a strong sense of altruism, a desire to help answer big questions for whole populations. I think it is unfair to everyone, especially highly impacted communities where HIV rates are soaring, and where the crisis is anything but over, for trial participants to sign informed consents and derive individual benefits from trials without fully engaging in the study protocols that would allow for potential population benefits.

There are not unlimited resources. In fact, they are shrinking (Hello Sequester!) We can’t continue to fund expensive, resource-intensive, multi-year trials in which most people only SAY they test drove the product.

Jim Pickett is the Chair of the International Rectal Microbicide Advocates (IRMA). This blogpost is part of our ongoing coverage of the 2013 Conference on Retroviruses & Opportunistic Infections (CROI). To read more perspective and analysis on the VOICE results at CROI, click here.

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  *Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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IRMA Statement on VOICE Results

[Click here for the VOICE press release - "Daily HIV Prevention Approaches Didn’t Work for African Women in the VOICE Study" - from the Microbcide Trials Network]


IRMA, like the rest of new prevention technology researchers and advocates, is disappointed to learn that daily oral Truvada was not found to be an effective HIV intervention among the African women at risk for HIV who participated in the VOICE trial.

We applaud the efforts of the 5,029 women from South Africa, Zimbabwe, and Uganda who volunteered to participate in the VOICE trial. We also commend the Microbicide Trials Network and the National Institutes of Health for successfully executing this extraordinarily ambitious, important trial, and for contributing critical new information to the field.

Today at CROI 2013 we learned that the majority of women in the daily oral Truvada arm of VOICE were not taking their drugs regularly if at all. Rather than a biological explanation, it appears daily oral Truvada was not effective at preventing HIV among the women in the VOICE trial because the drug was not used regularly.

The results of VOICE indicate low adherence to all the drugs/regimens tested in the trial. There was also low adherence in the daily oral tenofovir and daily tenofovir gel arms. Both these arms were closed due to futility in late 2011 after separate reviews by the independent Data Safety and Monitoring Board. VOICE’s daily oral Truvada arm remained open until August 2012.

One of the biggest challenges the field faces is that of adherence. Clinical trials cannot show that a drug works to prevent HIV if trial participants do not take the drug. More must be done to accurately assess adherence during clinical trials in “real time”, and more must be done to develop HIV prevention interventions that people actually want to use, and like to use. But, we won’t be able to refine the drugs, the drug dosing strategies, and/or the drug delivery vehicles to make them more acceptable if trial participants are not adherent along the way.

Science is an iterative process. We are in the “car phone” phase of new prevention technologies - some of the drugs and dosing strategies are perhaps a little clunky. We all want to get to the “i-Phone” phase where we have interventions that are highly acceptable, and desired, but we won’t get there without going through the clunky phase first.

As the field moves forward, issues of recruitment are as important as adherence. Identifying potential trial participants who are most likely to be adherent during the trial is absolutely critical – and very challenging, as the way to achieve this is admittedly not clear.

The MTN-017 trial, a Phase II safety and acceptability study testing a reduced glycerin formulation of tenofovir gel, is getting ready to launch in the coming months. The study will enroll 186 gay men and transgender women at sites in Thailand, South Africa, Peru, and the United States, including Puerto Rico. It will be absolutely essential that MTN-017 volunteers take the study drugs as directed. If adherence is low during this trial, adequate amounts of safety data will not be collected, making it likely that efforts to develop tenofovir gel as a rectal microbicide will be halted permanently. Have no doubt, this would be a huge setback for rectal microbicide research, development, and advocacy efforts in general.

IRMA is very supportive of MTN-017’s inclusion of “real time” monitoring to assess adherence throughout the trial. This will allow investigators to understand and address challenges regarding adherence while the trial is underway, and will help participants make appropriate adjustments in “real time” to improve adherence outcomes. MTN-017 sites should also pay extra special attention to recruitment activities and work to engage and enroll individuals who are most likely to fully participate in the trial, and follow the various regimens being tested as directed.

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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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Challenges for HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men in the United States

via PLoS Medicine, by Gordon Mansergh, Beryl A. Koblin, Patrick S. Sullivan

Summary Points:

Pre-exposure prophylaxis (PrEP) with anti-retroviral (ARV) medications is partially efficacious for preventing HIV infection among men who have sex with men (MSM) and heterosexuals.

As PrEP becomes available and prescribed for use among MSM a better understanding of willingness to use PrEP and avoidance of condom use are needed so that behavioral programs and counseling may be enhanced for maximum benefit.

Targeted messaging will be needed about ARV prophylaxis for various at risk populations, but the general message should be that condoms continue to be the most effective way to prevent HIV transmission through sex and that PrEP is an additional biomedical intervention.

As new effective biomedical intervention methods, such as PrEP, become available language about “protected” and “unprotected” sex, which used to exclusively mean condom use, will need to adapt.

Read the full article here.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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The HIV Prevention Pipeline: A Future of Possibilities

via IRMA/AVAC, presented by Jim A. Turpin

Please register for this teleconference.
 
Meeting Description:

In the last two years there has been great progress in ARV-based prevention strategies - both in terms of PrEP and microbicides. Specifically, there has been enormous excitement and promise around two drugs - tenofovir and Truvada. And more recently, studies testing Dapivirine and Maraviroc have gotten underway.

But...  is that all there is?  What is happening in terms of pre-clinical work?

In this teleconference brought to you by IRMA and AVAC, the NIH's Jim Turpin will examine current and emerging prevention candidates and delivery systems beyond pills, gels and rings, giving us a fascinating peek into the HIV prevention pipeline that we don't often hear about, well before large efficacy trials are imagined, even before small Phase I safety studies are in the picture.

Jim will ask the questions on all of our minds: Is a sustainable pipeline of HIV prevention products beyond the current array of candidates possible? What does that look like? And what can advocates do to better engage in early, pre-clinical efforts years before human trials are in the picture?

Join our call to hear his answers - and provide your own.

Click here to convert the time of this call to your time zone.

When you register for the call, you will be provided a list of global toll-free dial in numbers., If you need us to dial you into the call, please let us know your number when you register. We will only dial in individuals who don't have access to toll-free numbers.

Presentation slides will be made available on the IRMA website here at least a day in advance of the call. You may download the slides and follow along that way, or simply log in to the ReadyTalk web interface on the day of the call and watch the slides there.

This call will be recorded. The recording will be made available on the IRMA website within a day or two after the call.

Questions? Email IRMA at rectalmicro@gmail.com - thanks!

Register for this meeting here.



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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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Translating clinical efficacy into public health effectiveness

via Citizen News Service, by Bobby Ramakant

At the recently concluded XIX International AIDS Conference (AIDS 2012), not only the decibels went up on ending AIDS but also sane voices were heard demanding a well-costed and thought-through strategy on how to end AIDS. One of the strategies that will complement a comprehensive HIV prevention, treatment, care and support plan to end AIDS is preventing HIV transmission. In this context, we need to look beyond the Phase III trials in HIV prevention research so that if the product being tested is proved to be effective, we have the means and well-thought plan to make it available for those people in need, without delay.

The HIV prevention research is certainly going ahead with rectal microbicides phase II efficacy clinical trials (MTN017) about to begin in four countries (US, Thailand, South Africa and Peru), US FDA's approval to use 'Truvada' as pre-exposure prophylaxis (PrEP) for HIV prevention, vaginal microbicides research and HIV vaccine science progressing ahead, treatment as prevention (TasP) getting a buy-in as never before, among other positive developments that give us hope.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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What kind of prevention do gay men need?

 via aidsmap, by Gus Cairns

How do we stop the hyperepidemic in gay men?

A number of presentations at the 19th International AIDS Conference explored the 'hyperepidemic' of HIV amongst men who have sex with men, and especially black MSM.

A paper presented by Gregorio Millet (pictured above at a White House reception honoring people working in AIDS) showed that, at least in the USA, the extremely high incidence and prevalence of HIV in this group is not driven by higher levels of unsafe sex. Instead, very high prevalence, the ease with which HIV is transmitted during anal sex, and the fact that black men (and some other subpopulations of gay men) have sex within small and multiply-connected networks have created a situation in which HIV is hard to avoid.

Given this, what prevention methods would work in gay men? The one that has been talked about most keenly and which continued to generate a great deal of data and debate at Washington was pre-exposure prophylaxis (PrEP) - taking antiretrovirals (ARVs) to prevent, rather than treat, HIV.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults

via Morbidity and Mortality Weekly Report

In the United States, an estimated 48,100 new human immunodeficiency virus (HIV) infections occurred in 2009 (1). Of these, 27% were in heterosexual men and women who did not inject drugs, and 64% were in men who have sex with men (MSM), including 3% in MSM who inject drugs. In January 2011, following publication of evidence of safety and efficacy of daily oral tenofovir disoproxil fumarate 300 mg (TDF)/emtricitabine 200 mg (FTC) (Truvada, Gilead Sciences) as antiretroviral preexposure prophylaxis (PrEP) to reduce the risk for HIV acquisition among MSM in the iPrEx trial, CDC issued interim guidance to make available information and important initial cautions on the use of PrEP in this population.

Those recommendations remain valid for MSM, including MSM who also have sex with women (2). Since January 2011, data from studies of PrEP among heterosexual men and women have become available, and on July 16, 2012, the Food and Drug Administration (FDA) approved a label indication for reduction of risk for sexual acquisition of HIV infection among adults, including both heterosexuals and MSM.* This interim guidance includes consideration of the new information and addresses pregnancy and safety issues for heterosexually active adults at very high risk for sexual HIV acquisition that were not discussed in the previous interim guidance for the use of PrEP in MSM.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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AIDS Foundation of Chicago Hails FDA Approval of the Antiretroviral Drug Truvada for HIV Prevention

[Press release from AIDS Foundation of Chicago - home to IRMA]

Historic decision makes Truvada the first drug approved to reduce the risk of HIV infection from sexual contact among HIV-negative individuals at elevated risk of infection

Today, the U.S. Food and Drug Administration approved the use of Gilead’s  antiretroviral drug Truvada for HIV prevention — known as  pre-exposure prophylaxis (PrEP).

The AIDS Foundation of Chicago lauds this historic decision.

Truvada has long been an important component of treatment regimens for people living with HIV. Multiple studies found that Truvada, when taken daily as PrEP, in combination with safer sex practices, significantly reduced the risk of sexually-acquired HIV infection among high-risk adults. For more than a year, the AIDS Foundation of Chicago (AFC) has urged the FDA’s study and approval of Truvada for PrEP.
PrEP is one piece of the puzzle to preventing the spread of HIV/AIDS, said David Ernesto Munar, AFC’s President/CEO, and it is an important tool to have in a growing array of HIV prevention strategies.

“AFC has long supported the development of new prevention technologies, including PrEP and vaginal and rectal microbicides,” Munar said. “The FDA’s decision today on Truvada is exciting. Our challenge now is to implement PrEP as strategically as possible, and to ensure the people who need it most, those who are most at risk for HIV, have access.”

AFC’s support of PrEP has been multifaceted.  Last year, AFC launched a website of video and written PrEP testimonials called My PrEP Experience. Another AFC initiative, Mapping Pathways , has investigated various HIV prevention strategies — including PrEP — in different cultural contexts around the world.

And earlier this year, AFC joined a national coalition of AIDS organizations in support of the FDA’s approval of Truvada for PrEP.
“This is an enormous turning point, a real game changer, in the fight against HIV,” said Jim Pickett, AFC’s Director of Prevention Advocacy and Gay Men’s Health. “The toolbox we have been working for decades to expand now has Truvada as PrEP.”

“We can make a huge dent in new infections if we incorporate this tool into our prevention programming, and provide people more methods to avoid HIV,” Pickett said. “We can look forward to more sex acts being protected, especially among individuals who have already chosen, for whatever reason, to not use condoms consistently.”

To read the FDA news release, click here.

To read Munar’s October 2011 Huffington Post op-ed piece on PrEP, “Don’t Delay HIV Prevention for Gay and Bi Men,” click here.

Founded in 1985 by community activists and physicians, the AIDS Foundation of Chicago is a catalyst for local, national, and international action against HIV/AIDS.



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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro. *Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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France's The Warning on Biomedical Prevention

via The Warning (France)

In France, the controversy between HIV organizations about PrEP appear in the media and social networks, from moral considerations disguised in ethical objections to classic behavioral speculations (as there was on the TasP or PEP) [4].

So, to clarify and defuse the situation, it should be noted some points :

The biomedical prevention is a revolution in terms of sexual and mental health for serodifferent couples (especially those who want to have children) and poz sex workers (under pressure from their customers to have condomless sex), removing the risk and visceral fear of contamination. It is essential for fighting the demonization of people living with HIV/Aids (PLWHA) in our poz-phobic society : they are no longer considered as « viral bombs ».

 The biomedical prevention is a need expressed by all PLWHAs and peoples concerned by HIV [5].

 The biomedical prevention is an additional argument for the battle for universal access to treatment in poor countries and in prisons.

 The biomedical prevention is an important argument against the criminalization of HIV transmission, which beyond our respective countries, is increasing in Africa (since women are the first victims).

 The biomedical prevention must be done within the strict framework of informed consent and needs (therapeutic, psychological, sexual and social) of the concerned person(s). In no circumstances it may force the initiation of treatment to anyone, even if early treatment appears to have benefits, and although some mathematical models abound for the establishment of a general strategy of Test&Treat. Warning has long been positioned on the subject [6].

These reasons alone are sufficient to promote biomedical prevention [7] in a responsible manner and combined [8] to other tools in the fight against AIDS : condoms, HIV testing [9], Counseling, and struggles against serophobia and criminalization of sexual transmission of HIV

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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The road to PrEP: trials, regulation and roll-out

via aidsmap.com, by Gus Cairns

Within the next three years, up to 33,000 people may take part in 22 different studies worldwide to demonstrate the feasibility, or otherwise, of pre-exposure prophylaxis (PrEP) to prevent HIV, the IAPAC evidence summit, Controlling the HIV epidemic with antiretrovirals, was told on 12 June.Some of these studies are underway but others are still in the design stage or in need of funding.

Dr Jim Rooney of Gilead Sciences, the manufacturer of tenofovir (Viread) and Truvada (tenofovir and FTC), the products being tested in the vast majority of these studies, told the meeting that up to 13,000 men who have sex with men (MSM) could end up being involved in 14 different studies and up to 19,500 heterosexual men and women in eight studies. These studies were particularly crucial in establishing whether PrEP might be less, or more, effective in open-label settings than in randomised placebo-controlled trials.

Some of these are ongoing or open-label extensions of studies such as Partners PrEP in 4758 sero-different couples in Kenya and Uganda, or iPrEx OLE (Open Label Extension) in 1500 MSM in six countries. 

Others are just beginning, such as the IPERGAY study of intermittent PrEP in gay men in France. While it is planned that this could eventually include 1900 men, researcher Bruno Spire told the IAPAC meeting that 300 participants had to be enrolled by February 2013 if the next phase of the study was to be funded, and that recruitment had been rather slow so far, partly because of "ideological obstacles" to there being a placebo arm.

Similarly, Dr Sheena McCormack of the UK's Medical Research Council told the meeting that, while the planned UK PROUD study of immediate versus delayed PrEP could eventually include 5000 MSM, only a pilot project in 300 MSM has so far been proposed, with a tentative start date (if the protocol is agreed) in October 2012. 

Read the rest.

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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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Meet Virginia - A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of Virginia Zalazar, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Virginia is one of six new bios just posted a few days ago, including individuals from Kenya, Thailand, the UK, India and the US.  Each will be featured on the blog, and you can read all of them here right now.


Virginia Zalazar
Buenos Aires, Argentina

Virginia is a psychologist and social researcher at Fundación Huésped, an NGO that works in response to HIV/AIDS, both as an infectious disease and as a social challenge. Since 2007, she has been performing research studies focusing on microbicide acceptability with women, gay men, and transgender populations.

Virginia also coordinates workshops for serodiscordant couples, and conducts pre and post-HIV test counseling at a public hospital in Buenos Aires.

In her spare time, Virginia enjoys reading novels and science fiction books, travelling, watching movies, listening to music, and spending time with her family and friends.

Virginia first got involved with IRMA at the 2009 IAS Conference in Cape Town, South Africa. She believes that rectal microbicides are important, as well as vaginal and other biomedical prevention methods, because sexual practices require different and suitable options for each individual separately. Virginia hopes that in the near future, drugstores, healthcare centers or hospitals will carry a variety of products that will promote sexual health and sexual pleasure.

Virginia advises IRMA to continue consolidating collaborative work, strengthening international relationships, engaging additional partners, and identifying existing and future research opportunities for the region.

Currently, Virginia is looking for funding to conduct a study focusing on the public health impact of PrEP, and the accessibility of treatment among transgender sex workers in Northern Provinces of Argentina.

Virginia was introduced to a number of partners connected with IRMA-ALC (IRMA's South American chapter based at Epicentro in Lima, Peru) at the Microbicides 2012 conference in April. Less than a month later, she participated in a two-day strategic meeting led by IRMA-ALC and AVAC in Lima - with colleagues from Peru and Paraguay - to plan for expanded and improved advocacy around rectal microbicides, PrEP, sexual health and other LGBT issues. Click here for photos (on the IRMA ALC Facebook page) from the meeting. She is very excited about the possibilities this growing initiative will bring to the future of rectal microbicides and PrEP in the Latin American region.

Virginia has been influenced by her family, friends, colleagues, patients and activists. Her appreciation extends out to everyone who is passionate about what they do, and working towards a better future.

Thank you, Virginia, for all that you do!

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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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South African Clinicians Outline Best Treatment for Prevention Practices

via mg.co.za, by Mia Malan

South African guidelines for the preventative use of HIV medication by men who have sex with men who are not infected with the virus are to be published in the peer-reviewed academic publication, Southern African Journal of HIV Medicine, this month.

The treatment, pre-exposure prophylaxis (Prep), consists of an antiretroviral (ARV) pill that is taken daily by HIV-negative people to lower their chances of becoming infected with the virus.

The guidelines were developed by a panel of microbiologists, clinicians, virologists, pharmacists and community representatives affiliated to the South African HIV Clinicians’ Society. 

Several recent studies have revealed that, if Truvada pills, which contain the ARVs tenofovir and emtricitabine, are taken regularly, they can reduce the risk of men who have sex with men of acquiring HIV by up to 72.8%.

Prep is part of a movement based on the use of ARVs to protect vulnerable groups who are consistently exposed to HIV. In “discordant” couples, where one partner is HIV positive and the other negative, the uninfected person is at a high risk of contracting HIV if condoms are not always used, particularly if the ­positive partner has a large amount of the virus in his or her blood or sexual fluids because he or she is not yet on ARVs.

HIV-infected people’s chances of infecting their sexual partners with HIV are significantly lower if they are using ARVs, as the medication reduces the amount of virus in their bodies. Men who have sex with men are particularly vulnerable, and HIV infections are on the increase in this group, despite awareness of the effectiveness of condoms

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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PrEP: time to rethink prevention, effectiveness and ethics?

via Somatosphere, by Marsha Rosengarten

One of the more controversial interventions proposed for HIV prevention in those who test HIV antibody negative and perceived to be at risk is pre-exposure prophylaxis (PrEP) – a daily pill comprising one or two antiretroviral drugs manufactured by Gilead Inc. Besides the mixed results from multi-site randomised controlled trials (RCTs) seeking to establish the efficacy of PrEP (see iPrEX versus Fem-PrEP), concerns have been raised about PrEP’s potential to undermine condom use, its cost implications in locales where treatment provision is still lacking and elsewhere, its potential to cause unwanted drug side-effects as well as possible drug resistance in those it fails to protect.

Nevertheless, continuing new infections and evidence that high adherence produces a strong protective effect are mobilising many public health authorities to devise feasible implementation models.

Most remarkable about the growing interest in PrEP is the exclusion of the social sciences from major forums where this work is taking place. One such example is a two-day forum held in the UK by IAPAC on the dual topics of treatment as prevention (TasP) and PrEP. The only non-biomedical speakers listed on the programme were a psychologist (speaking on adherence), a bioethicist, activists and public health officials linked to various national epidemics.

Indeed it won’t come as a surprise to many to know that despite the millions of dollars to support RCTs for PrEP, the Bill and Melinda Gates Foundation have so far declined to support a substantial programme of social research on PrEP. In fact if we consider the bioethical requirements imposed on the conduct of RCTs for PrEP and other biomedical interventions, there is no ethical requirement for research on the social dimensions of the intervention during or post RCTs. This applies even when RCTs demonstrate candidate efficacy.

Read the Rest.
 
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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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Characteristics Qualifying Gay Men for Intermittent PrEP

via AllAfrica.com, by Michael Carter

Older, better-educated gay men who use sexual networking sites and have sex outside the context of committed relationships may be appropriate targets for intermittent pre-exposure prophylaxis (PrEP), US research published in the online edition of the Journal of Acquired Immune Deficiency Syndromes suggests.

The investigators found that individuals with this profile were more likely to plan their sexual encounters and to have anal sex fewer than three times per week.

“Our study serves to better characterize MSM [men who have sex with men] who may most benefit from event-based intermittent PrEP,” comment the authors.

The iPrEX study involving gay and other MSM showed that PrEP significantly reduced the risk of acquiring infection with HIV.

However, adherence is a major barrier to the success of PrEP. There are also concerns about its cost and potential side-effects. Intermittent dosing has been proposed as a way of overcoming these limitations. A recently published study showed that adherence was also challenging when an intermittent dosing strategy was used.

This treatment strategy involves taking a dose of antiretroviral therapy before a risky sexual encounter, with a second dose taken shortly after.

This strategy will only be suitable for people who engage in risky sex fewer than three times per week, and who plan their sexual encounters.

Investigators in the US wished to establish a better understanding of the characteristics of gay men and other MSM who fulfilled these criteria.

HIV-negative gay men were recruited to the study using social networking sites in late 2010. All were sexually active (defined as anal sex within the previous month). The men supplied demographic data, as well as information about their sexual risk behaviour, how they planned their sexual encounters, their use of sexual networking media and their relationship status.

A total of 1013 men participated in the research. Their median age was 28 years. Most (56%) participants reported that their last anal sex was unprotected.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

 *Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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PrEP Provides New Hope for HIV Prevention in Nigeria

via Leadership, by Winifred Ogbebo
*Mentions IRMA advocate Morenike Ukpong!*

Like a breath of fresh air, the news that a combination prevention drug would soon hit the Nigerian market is definitely something to cheer about, given Nigeria’s high prevalence of HIV rate, which is said to be second only to South Africa in the African continent. WINIFRED OGBEBO reports.

It is like Sunday-Sunday malaria drugs. But in this case, you take HIV drug to prevent HIV and HIV negative people, says the Director-General, National Agency for the Control of AIDS (NACA), Prof John Idoko, explaining the new prevention treatment drug, pre- exposure Prophylaxis.

“From what we learnt from malaria for example, he explains further, “if we give the drugs to somebody who doesn’t have HIV, and the person has sexual relationship with an HIV positive partner, it can prevent transmission from the positive person to the person. That is why it’s called a pre- exposure prophylaxis because before exposure, the person has taken the drugs and because he has the drugs in him, the virus cannot infect him or her.”

Also, Idoko says, “ If you take this sero-discordant couples; one is positive and the other is negative, instead of giving the drug to the negative person before the sexual relationship, just put the positive one on drug as soon as you know. It doesn’t matter what his CD-4 count is even if it’s 500, just give him the drugs. It has shown clearly one of the best study results that we have seen, as 96 per cent chance of the person transmitting HIV is blocked. So we call that treatment as prevention. So you can now imagine that if you go to a community, and they are using this method, your chances of blocking transmission are very high. We believe that these are the two things we need to put together as part of our combination prevention method.”

The pre-exposure prophylaxis is the newest HIV prevention tool that has been developed. It involves the use of Truvada, an antiretroviral to prevent HIV infection. A few studies have shown the ability of this drug to prevent HIV infection in sero-discordant couples, MSMs, transgenders and in men and women.

Read the Rest.



------------------- *Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world. *Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro. *Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content. -------------------

FDA Hearing on Truvada as PrEP - Watch the Webcast!

On May 10, 2012 the FDA Antiviral Drug Advisory Committee strongly recommended that emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) be approved for use as pre-exposure prophylaxis (PrEP) among sexually active adult men and women – particularly gay men and other MSM, serodiscordant heterosexual couples, and other individuals at high risk. It is likely the FDA will follow the committee’s recommendations and issue a new prevention indication for the use of Truvada by mid June.

Watch the recorded webcast here.

Check out the slide presentations here.



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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world. *Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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POZ: David Evans Gets Practical About PrEP

[IRMA highly recommends this one. Brilliant, strategic, thoughtful, sober, forward-thinking - a must read]

via POZ, by David Evans

Excerpt:

Give people the facts--the whole picture--and let them decide whether PrEP is right for them

Let's tell people how effective the drug is when they actually take it as prescribed--over 90 percent effective--and stop quoting statistics from the clinical trials where they averaged all of the people together whether or not they were actually taking the drugs. People are going to need motivation to adhere well to PrEP and telling them that it will only cut their chance of becoming infected by 42 percent (the iPrEx study) or 75 percent (Partners PrEP) is not only dishonest, it could significantly undercut their willingness to take a pill every day. How would people feel if we said that condoms were only 30 or 40 percent effective and never revealed that this figure is true only because we counted all of the people who never used condoms in the first place?

Let's also stress that in the clinical studies, PrEP was used with condoms, at least some of the time by some of the participants, and that it shouldn't be seen as a complete substitute. That said, the fear that people will forgo condoms for PrEP is a reasonable one. Therefore, I believe strongly that we should be targeting PrEP to those who are struggling most with condom use, for whatever reason.

Let's also emphasize that while side effects were rare, and not immediately serious in the vast majority of PrEP-takers in trials, we honestly don't know what long-term side effects will look like. People who ultimately end up taking PrEP for more than two years are entering new territory, as are people who might have greater underlying risks for kidney or bone disease.

PrEP is not benign, but neither is HIV; let's strive for balance and accuracy in describing both. We all have a responsibility to correct inaccurate information where we find it, whether in our community publications or blogs, local planning meetings or in our groups of friends. We can never know who's in most desperate need of PrEP and who might be swayed inappropriately one way or the other by misleading or cherry-picked information.

Read the rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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Antiretroviral Prophylaxis for HIV Prevention Reaches a Key Milestone

via Lancet.com, by Salim S Abdool Karim  and Quarraisha Abdool Karim

On May 10, 2012, a US Food and Drug Administration (FDA) advisory committee voted in support of the use of tenofovir-emtricitabine for HIV prevention.1 If the FDA, which is scheduled to make its decision by June 15, adopts the committee's recommendations, tenofovir-emtricitabine will become the first antiretroviral drug to be approved as pre-exposure prophylaxis (PrEP) for the prevention of HIV, paving the way for implementation.

PrEP has a unique advantage in young women in southern Africa, who bear a disproportionate burden of the HIV epidemic. In much of this region, young women are often unable to convince their male partners to use condoms, remain faithful, or have an HIV test. To rely on her HIV- positive discordant male partner to come forward to test, to agree to take antiretroviral therapy (ART), and to take his ART with high adherence, all for her protection, puts a woman's risk of acquiring HIV back in the hands of men, thereby disempowering women and undermining their efforts to control their risk of HIV.

However, there are several criticisms and concerns about PrEP. First, that data on the effectiveness of PrEP, especially in women, are inconsistent. This concern is based on the results of two PrEP studies—the FEM-PrEP2 and VOICE3, 4 trials—which were stopped, at least partly, earlier than planned when they did not show efficacy. To some extent, this concern has been allayed by recent data from the FEM-PrEP trial5 which show that adherence to daily tenofovir-emtricitabine in the trial was too low allow assessment of efficacy. Data to explain the VOICE trial, which still has an ongoing tenofovir-emtricitabine group, are not expected until 2013.

Second, some suggest that antiretroviral drugs should be provided to HIV-negative people only when all eligible HIV-positive patients are receiving ART. Although it is a legitimate concern that eligible HIV-positive patients should be prioritised for ART for their own health and to save their lives, it is spurious to trade off treatment and prevention as if these drugs are being taken away from sick and dying patients to be given to healthy people. Treatment and prevention strategies are a continuum in their use of antiretroviral drugs—both are needed in conjunction with each other to ensure ART provision is sustainable in the long term and to realise the quest to end the HIV epidemic.

Read the Rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.
 
*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
 
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