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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Anal health is not just a gay issue: Women need rectal microbicides too

via Citizen News Service, by Bobby Ramakant

"It is high time that anal health and hygiene comes out of the closet" said Dr Ross Cranston from University of Pittsburgh, USA. Dr Cranston was referring to the multitude of anal health complications people practicing receptive anal sex are likely to be dealing with in their lives and very little quality care and products that exist to relieve them. The awareness level in people (women, men, transgender women) who reported to practice receptive anal sex was abysmally low.

Zero per cent of such respondents had knowledge related to their anal cancer risk, and just half of them knew about Herpes Simplex Virus (HSV - the virus that causes genital herpes). Awareness certainly needs to be upped in people practicing receptive anal sex.

 

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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HIV and the Law

via the Commission on HIV and the Law

The end of the global AIDS epidemic is within our reach. This will only be possible if science and action are accompanied by a tangible commitment to respecting human dignity and ending injustice.

Law prohibits or permits specific behaviours, and in so doing, it shapes politics, economics and society. The law can be a human good that makes a material diff erence in people’s lives. It is therefore not surprising that law has the power to bridge the gap between vulnerability and resilience to HIV.

We came together as a group of individuals from diverse backgrounds, experiences and continents to examine the role of the law in effective HIV responses. What we share is our abiding commitment to public health and social justice. We have listened with humility to hundreds of accounts describing the eff ects of law on HIV. In many instances, we have been overwhelmed by how archaic, insensitive laws are violating human rights, challenging rational public health responses and eroding social fabric. At other times, we have been moved by those who demonstrate courage and conviction to protect those most vulnerable in
our societies.

Many would say that the law can be complex and challenging and is best left alone. Our experience during this Commission has shown us a very diff erent perspective. We have been encouraged by how frank and constructive dialogue on controversial issues can sometimes quickly lead to progressive law reform, the eff ective defence of legislation or better enforcement of existing laws. Even in environments where formal legal change is a slow and arduous process, we have witnessed countries taking action to strengthen access to justice and challenge stigma and discrimination.

Click here for the full report.


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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 Africa: Aids Response Must Be Guided By Human Rights and Justice

via allAfrica, by Festus Mogae and Stephen Lewis

In South Africa and across Africa, HIV continues to prey on women, sex workers and men who have sex with men. It is clear that to end the HIV epidemic, we must protect and support these groups.

Archaic laws and customs make women and girls more vulnerable to HIV. Legally condoned violence and oppression-including genital mutilation, sexual violence, denial of property rights and early marriage- undermine the ability of women to protect themselves. Laws urgently need to protect women, who are often the ones left to care for the sick, tend to the family and till the fields.

Laws across the continent also criminalize homosexuality. Yet, punishing men who have sex with men force them into secrecy. They are unable to access counseling and testing, making it almost impossible for HIV prevention and treatment interventions to reach them. In 2008, when the Senegalese government jailed nine gay HIV outreach workers under a law prohibiting "acts against nature," health workers went into hiding, advocacy groups disbanded and HIV treatment sites were shut down.

The time has come for African leaders to take action against bad laws that stifle our HIV response. We must challenge societal values rooted in fear and prejudice and implement laws based on human rights and sound public health.

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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So You Want to be a Sex Writer? Tristan Taormino on Activism, Anal, and Quitting Law School

via SF Weekly, by Vanessa L. Pinto

Excerpt:

"I sent them a proposal for a book I called The Ultimate Guide to Anal Sex for Women. This was a book I wanted to have on my shelf. I'm someone who started having anal sex in college. I really loved it, and I knew I couldn't possibly be the only person out there that liked it."

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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Rosie the Riveter Can No Longer Represent the Face of Microbicide Research: Lessons from M2012

by IRMA member Morenike Ukpong

Rosie the Riveter is a cultural icon of the United States, representing the American women who worked in factories during World War II, many of whom produced munitions and war supplies. These women sometimes took entirely new jobs replacing the male workers who were in the military. Rosie the Riveter is commonly used as a symbol of feminism and women’s empowerment. Rosie’s picture came to represent the objective of microbicide research – an empowering tool that will enable women to have a HIV prevention option they could control, in their hand.

The microbicide research movement was actually initiated as a women empowerment movement. Women asked for a tool that they can control independently to help reduce their own risk of HIV infection. Women activists led by Lori Heise, started making a case for a women controlled option for HIV prevention. This movement was in response to a call made by an African woman on the need to have something to protect herself, Lori Heise often recalls. The earliest movement was focused on the development of a vagina application that could ensure women can use the product discretely if and when they choose too.

Trials in many African countries continue to suggest that discrete use of a microbicide may not be feasible – male involvement in the implementation of microbicide trials and its use by women engaged in the trials is important so as to ensure participant retention and prevent other potential social harm. However, Mitzy Gafos in her presentation titled ‘What have men got to do with it: the role of men in reproductive and sexual health in a predominantly rural are of KwaZulu-Natal, South Africa’ showed that women in South African can actually take decision about the use of the microbicide independent of their male partners. I would want to assume that this is the same in South West Nigeria where women are quite independent and are better able to negotiate the use of condom with their male sex partners.

With increasing discussion on anal sex and rectal microbicide, the objective of developing a microbicide seems to have shifted. It is less so about developing a tool that will empower women to have control over her sexual and reproductive health in a way that will enable her protect herself from HIV infection. More and more attention is being paid to public health needs that are larger than women focused issue.

Rosie the Riveter can no longer represent the face of microbicide research. Current research is looking at bioavailability of microbicide gel in the rectum and vagina and its efficacy in preventing HIV infection in both the vagina and the rectum at the best. This means a microbicide product can be used by men, women and transgenders.

The message about microbicide is no longer one of empowering women in Africa. The message is now about health and access to health product in African. Structural issues that will facilitate the uptake and use of microbicides are being discussed everyday. This includes the need to strengthen health systems so as to ensure product access, human right issues so as to ensure access by MSMs. The peculiar issues related to women, women access, women empowerment, has quietly fallen off the table. The events at the M2012 make this very clear.

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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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Researchers Stress the Importance of Screening Women for Precancerous Anal Lesions

via AIDSmeds, by Tim Horn

Results from a study conducted in the Bronx, New York, serve as an important reminder to HIV care providers: Comprehensive screening for precancerous anal lesions isn’t of importance only to HIV-positive men who have sex with men (MSM). According to the Journal of Acquired Immune Deficiency Syndromes report by researchers at Albert Einstein College of Medicine in the Bronx, precancerous lesions are also common among women living with HIV—and testing for them using anal swabs alone may not be sufficient to rule out problems requiring biopsies.

Numerous studies have noted high rates of anal cancer among MSM. According to one study cited by June Hou, MD, and her colleagues at Albert Einstein, the incidence of anal cancer among MSM is 10 to 50 times that of the general population and comparable to cervical cancer incidence rates before the implementation of now-routine screening practices.

Among HIV-positive women, some studies put the incidence of anal cancer at seven to 28 times greater than the general population. Though the incidence of anal cancer has not been nearly as well studied in HIV-positive women compared with HIV-positive MSM, the confirmed higher rates of precancerous lesions—which can occur among women living with HIV, even if they’ve never engaged in anal sexual intercourse—remain a concern.

Yet there is no consensus between national and local groups on anal cancer screening among people living with HIV, either male or female. “Since 2007,” Hou and her colleague explain, “the New York State Department of Health (NYS DOH) has recommended annual anal cytology”—Dacron swabs analyzed by a laboratory—“in HIV-infected subjects with a history of [anal warts] or with abnormal cervical/vulvar histology, along with referral for high resolution anoscopy (HRA) in those with abnormal anal cytology or abnormal findings on anal exam. In contrast, the Department of Health and Human Services guidelines discourage screening and treatment programs for [anal intraepithelial neoplasia, or AIN] due to a lack of complete understanding of the relative harms and benefits of anal cytology screening.”

In turn, to better understand the incidence of precancerous anal lesions and the value of routine anal cytology, Hou and her colleagues conducted a study among women in the Bronx, which has one of the highest HIV prevalence rates in the country, representing 3 percent of the total U.S. HIV burden.

Read the Rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Acceptability of coitally-associated versus daily use of 1% tenofovir vaginal gel among women in Pune, India

via International Health, by Sanjay Mehendale, Swapna Deshpande, Rewa Kohli, Sharon Tsui, Elizabeth Tolley

Abstract

This study reports on the acceptability of 1% tenofovir microbicide gel among participants randomised to the coitally-associated use (n=50) or daily use (n=50) arms of a Phase II clinical trial in Pune, India. In a 6-month follow-up study, information on behavioural domains was collected on a 6-point Likert scale and gel acceptability was measured on a 5-point Likert scale. Random intercept logistic modelling was performed to examine the simultaneous effects of study arm, follow-up time, sociodemographic factors and behavioural domains on gel acceptability. The mean age of female participants was 32.7 years. Women in both study arms had similar sociodemographic profiles. Women liked features such as easy use of the gel and its protective effect against HIV. Messiness was the most disliked feature. Gel acceptability increased during subsequent follow-up visits in both arms, especially in the coitally-associated use arm. Non-acceptability of the gel was almost two and a half times higher in daily users (adjusted odds ratio 2.55, 95% CI 1.18–5.51; p=0.017). Acceptability differed significantly between the two study arms at 2 months (68% vs 40%; p=0.006) and 6 months (64% vs 46%; p=0.07). Acceptability was significantly lower in those participants who reported ‘messiness’ as the most disliked feature (odds ratio 2.42, 95% CI 1.02–5.72; p=0.045). In conclusion, microbicides were more acceptable in coitally-associated users than in daily users. Leakage was a problem that requires attention. Positioning of the product in a setting such as India where the majority of decision-making is done by men would need extensive and systematic education of men.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Oral HPV More Common in Men Than Women

via The New York Times, by Anahad O'Connor


About one in 15 Americans is infected with oral human papillomavirus, a sexually transmitted virus that causes throat cancers, and the disease is especially common among men, new research shows.

The research is the first major study to document the nationwide prevalence of oral human papillomavirus, or HPV, a disease that has drawn growing attention from public health experts because it has fueled a rise in oropharyngeal cancers affecting the back of the tongue and the throat. Researchers showed last year that throat cancers caused by a particular strain of the virus, HPV Type 16, have tripled in the last 20 years. But it was unclear exactly how many people over all were carrying HPV, which exists in more than 40 forms.

By looking at thousands of people across the country, the authors of the new report found that 6.9 percent of adults and teenagers are infected with oral HPV of any kind. The virus was about three times as common in men as it was in women. And the scientists identified several behaviors that significantly raised the risk of becoming infected: increasing age, greater sexual activity and smoking cigarettes.

But the study, which was published in The Journal of the American Medical Association, also revealed some reassuring findings, said Dr. Maura L. Gillison, the chairwoman of cancer research at Ohio State University and senior author of the paper. While the overall prevalence of HPV was about 7 percent, only 1 percent, or roughly two million people, were infected with HPV 16, the strain linked to throat cancers and many cases of cervical cancer. Fewer than 10,000 cases of throat cancer caused by HPV 16 are diagnosed every year, indicating that most people with the virus do not develop cancer.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Can a Faster Condom Help Prevent the Spread of HIV?

via Good Lifestyle, by Anmanda Hess



Can't wait to get it on? Meet Pronto, a condom that claims to go from package to shaft within three seconds. Pronto is the work of South African inventor Willem van Renburg, who sought to develop a barrier method that didn't "kill the mood" with all that awkward fumbling. Seeing that South Africa is home to the world's highest population of HIV-positive people, the device could also help prevent the virus' spread in a matter of seconds.

Men refusing to wear condoms is a major factor in the global spread of HIV. “My husband never wants to use a condom, so every time I sleep with him, I get sick,” one HIV-positive Malawi woman told documentarian Martha Dodge. Both men and women have filed a host of complaints over traditional rubbers, including their smell, fit, and feel. Some do experience anxiety when they begin unrolling a condom, and some sex partners express frustration when the process drags on and on. Reducing that process to a second could go a long way in convincing some couples to stay safe.

Here's how it works: Pronto's packaging doubles as an applicator. Users just need to hold the package level over the penis, crack it in half, slip it on, and discard the applicator in one quick motion. But perfecting the Pronto technique takes some practice. Incorrect application could be "uncomfortable and embarrassing" and—like with all condoms—could potentially compromise the condom's efficacy, so users can watch a video and play a hands-on game to learn how to apply the condom correctly every time. All that study can pay off, as developers claim experienced users can apply the condom in just one second. Now, they just need men to give it a whirl: Pronto officially launched in South Africa in February, and the company is looking for distributors to make the condom available worldwide.

Read the rest.

From Tuskegee to Transparency: An Evolution in the Ethics and Accountability of Clinical Trials Involving Human Subjects

via RH Reality Check, by Anna Forbes and Kate Ryan

People who participate in clinical trials take the enormous step of volunteering to test a product that may be useful and, sometimes, life-saving if it turns out to be effective. They play an irreplaceable role in research to prevent, treat, and sometimes cure illness – as well as to find other ways to improve people’s health and lives.

Trial participants make a profoundly personal contribution and accept potential medical, social, and personal risks on behalf of others. An ethical trial is one that eliminates or minimizes participants’ risks as much as possible, invests in making sure that participants understand clearly what they are volunteering for, and protects their rights at every step.

For example, without clinical trials, we would not have seen recent advances in antiretroviral drugs to treat HIV, long-acting contraceptive choices that allow women greater control over their use, or microbicides that may be able to protect women from HIV.

The United States government has rules to protect people who participate in federally-funded biomedical and behavioral research. The rules vary depending on which agency is supporting the research, but they all share a starting point known as the Common Rule, a set of regulations for all federally-funded research involving human participants, whether it is conducted inside or outside the U.S.

But those rules have not always been in place, and there are some shameful chapters in the history of medical research supported by the United States that include violations of the most basic standards of ethical behavior. This history has left some people deeply suspicious of clinical trials and the motives of those who conduct them. Many explain their suspicion with one word: “Tuskegee.”

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

NIH researchers show how anti-HIV drug acts to block herpes virus

via Infotech

"The findings explain the results of a recent clinical trial showing that the anti-HIV drug tenofovir, when it is formulated as a vaginal gel, could reduce the risk of herpes simplex virus (HSV) infections -- as well as HIV infections -- in women.

Tenofovir taken orally had been demonstrated to inhibit reproduction of HIV, but had not been known to block the genital herpes virus.

"HIV infection is closely associated with herpes viral infection. When people with genital herpes are exposed to HIV, they are more likely to become infected than are people who do not carry the herpes virus," said Leonid Margolis, Ph.D., head of the Section on Intercellular Interactions at NICHD and one of the authors of the study. "Human tissues convert tenofovir to a form that suppresses HIV. We found that this form of tenofovir also suppresses HSV. This discovery may help to identify drugs to treat the two viruses even more effectively." Discoveries leading to new uses for previously approved drugs have the potential to save millions of dollars, Dr. Margolis said. New drugs typically undergo years of testing for safety and effectiveness before they are approved for patients. Finding new uses for an approved drug increases the value of the initial investment in testing, because most of the testing has previously been completed."

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Microbicide Trials Network Statement on Decision to Discontinue Use of Oral Tenofovir Tablets in VOICE, a Major HIV Prevention Study in Women

via Microbicide Trials Network

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women – daily use of one of two different ARV tablets or of a vaginal gel – will be dropping one of the oral tablets from the study. The decision to discontinue use of tenofovir tablets in VOICE comes after a routine review of study data concluded that the trial will not be able to demonstrate that tenofovir tablets are effective in preventing HIV in the women enrolled in the trial. VOICE will continue to test the safety and effectiveness of the other oral tablet, Truvada®, a combination of tenofovir and emtricitabine, and of the vaginal gel formulation of tenofovir.

Importantly, the review, which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID)’s independent Prevention Trials Data and Safety Monitoring Board (DSMB), identified no safety concerns with any of the products being studied in VOICE.

VOICE – Vaginal and Oral Interventions to Control the Epidemic – involves 5,029 women at 15 trial sites in Uganda, South Africa and Zimbabwe. The trial is being conducted by the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network funded by the National Institute for Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver Institute for Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.

The study was designed with five study groups: tenofovir gel, an inactive placebo gel, oral tenofovir, oral Truvada and an inactive placebo tablet. The women in each group (about 1,000) are asked to take their assigned study product daily. VOICE is the only trial evaluating the daily use of an ARV tablet – an approach called oral pre-exposure prophylaxis, or PrEP – and a vaginal gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women prefer.

On September 16, 2011, the NIAID Prevention Trials DSMB reviewed VOICE study data for the period between Sept. 9, 2009, when the study began, and July 1, 2011. Based on this interim review, the DSMB determined that it was not possible to show whether oral tenofovir tablets were any better than a placebo for preventing HIV in the women assigned to that study group. The DSMB therefore recommended that the women randomized to the oral tenofovir tablet group discontinue their use of the study product. This recommendation does not apply to the women in the groups using either the tenofovir gel or oral Truvada tablets, or the corresponding placebos; the DSMB recommended that these four study groups continue in VOICE.
 
Read the rest.
 
 
[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Calling all Women and Spanish Speakers- Please Take our Survey!

Dear Women and Spanish Speakers,

We need your help with our Rectal Douching and Enema Survey! IRMA and researchers at the University of California, Los Angeles (UCLA) School of Public Health are conducting a brief survey to help us better understand the types of products people use rectally for anal sex including lubricants and enemas or douches. We are trying to gain a better understanding of rectal practices and behaviors that may affect the risk for sexually transmitted infections among people who practice anal intercourse. It is a brief survey (takes less than fifteen minutes) and is completely anonymous.

We have been running this survey for about a month now, and the participation level has been high. However, of the hundreds of responses we have received, less than 10% have been from women! We need more feedback on these anal products from women! We are asking you, ladies, to please take our survey or forward it to anyone you know who may be interested. Women’s opinions and experiences matter in all things anal, and we desperately want to take them into consideration so that women can be better protected from sexually transmitted infections.

Also, with many thanks to IRMA's chapter based in Lima, Peru, we now have a Spanish translation of the survey available! So IRMA blog followers, please forward the survey to anyone you may know who needs the Spanish translation. Thanks IRMA-ALC Lima!

You can click here for the survey or on the "Rectal Douching & Enenma Survey" logo at the top of the page. Thanks again for all of your help!

Sexual Pleasure is Key for Successful Microbicides

via WeNews, by Amy Littlefield

Participants in Kate Morrow's [IRMA Steering Committee Member] recent study may not have felt like they were fighting the global HIV epidemic.

In fact, what they were literally feeling were gels of various consistencies inside their vaginas.

The women in Morrow's Project LINK answered questions after handling the gels, inserting them vaginally, walking around and simulating intercourse with a fake phallus. Did the gel leak out? Did it inhibit the experience . . . or did they actually enjoy it?

Morrow has developed a set of scales to show the range of sensations and experiences women reported. Her goal now is to connect those sensations to data about which gels women would use to prevent HIV. Do they prefer gels that are smooth, thin or thick like hair gel? The answers to those questions could help lead to a microbicide that women will tolerate--and perhaps even enjoy.

For decades, women's health advocates have known that women need a way to protect themselves from HIV that is not dependent on a male partner. Vaginal microbicide gels are among an array of options--including pills, rectal microbicides and vaginal rings--that may one day help. Advocates hope microbicides could even be combined with birth control and help prevent other sexually-transmitted illnesses.

Read the rest.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HPV Vaccine Protects Women Against Anal Infection

via Medpage Today

A vaccine against human papillomavirus (HPV) protects women against two strains of the virus that causes anal cancer, researchers reported.

The vaccine (Cervarix) against HPV strains 16 and 18 offered "strong protection" against anal infection in a study whose main goal was to assess the efficacy of vaccination against cervical infection and pre-cancerous lesions, according to Aimée Kreimer, PhD, of the National Cancer Institute, and colleagues.

The protection was higher in women who did not have HPV infection when they were first given the vaccine, Kreimer and colleagues reported online in The Lancet Oncology.

Anal cancer is rare in women, with an annual incidence of about 1.5 per 100,000, but rates are rising, the researchers noted. The rate is higher than for men in general, but markedly lower than for men who have sex with men or those with HIV.

Most anal cancers are caused by HPV, with strains 16 and 18 responsible for up to 80% of cases, Kreimer and colleagues noted.

They tested the vaccine against anal infection in a subgroup of young adult women, ages 18 through 25, who enrolled in a community-based randomized trial of cervical vaccine efficacy in Costa Rica.

The 6,352 participants who came for the final blinded study visit, four years after their first of three vaccine shots, were asked to give an anal sample, and 4,210 did so, with a median follow-up of 48.1 months.

The researchers analyzed anal infection in the whole cohort and also in a subgroup of women who had been negative for HPV DNA and antibodies at the start of the trial. Patient characteristics in both groups were well-balanced, the researchers reported, including the proportions who got the vaccine and those who were in the control group, given hepatitis A vaccine.

Kreimer and colleagues found...

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Why So Anal about Pleasure?

Via EmpowHer, by Hannah Cutts.

Whether you are a committed fan, a non-subscriber, or have been considering engaging in anal play, I believe it is a subject that women should make an effort to include in their sexual awareness and conversations, even if only to expand their education on the female body and become resources for friends/family members who may have questions about the behavior.

According to the Center for Disease Control and Prevention’s National Survey of Family Growth, anal sex between heterosexual partners has been on the rise over the past decade. In 1992, 20.4 percent of women reported engaging in anal sex with a male partner, while in 2005, 32.6 percent indicated they include anal in part of their heterosexual repertoire (New York Magazine, 2006). While anal sex has historically been associated with gay couples, it is clear that people who enjoy sex with the opposite gender have adopted the practice, perhaps finally realizing what they have been missing out on. It is time for women—straight, gay and anywhere in between—to get the facts on anal play and what makes it worthwhile.

The bottom line is, like your vagina, your anus is packed with sensitive nerve endings that feel great when touched or stimulated. Although experimenting with this somewhat fragile opening is not necessarily a stand-alone endeavor (it requires some foreplay and careful lubrication), gentle exploration of the anus is a tremendous complement to other pleasure-giving (think cunnilingus). By slowly introducing the stimulation of this third hole into your sexual repertoire one step (or to be more accurate, one finger) at a time, you are opening yourself up to sensations that you won’t feel with vaginal-only penetration. Many sources suggest you begin simply with a massage of the anal opening, an action that carries almost no risk and allows both partners to get comfortable with the touch.

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Laws fail to protect HIV patients, says advocate

Via The Fiji Times, by Frederica Elbourne.

PACIFIC political leaders have remained silent over the protection of the rights of people vulnerable to and affected with HIV, an organisation that champions AIDS awareness said.

The Pacific Islands AIDS Foundation said laws governing those infected with the virus failed to protect their privacy.

The existing legal frameworks condemned behaviour such as anal sex, sex between men, and sex work, the PIAF report launched by Minister for Women Doctor Jiko Luveni in Nadi last month said.

Such denunciation drives these practices underground, the PIAF said in a report that highlighted the plight of HIV positive women in Fiji and Papua New Guinea.

"Public Health Acts also reflect mentalities of the colonial periods and these acts usually provide wide powers to public health authorities, impose heavy duties on infected people and others who must notify and take precautionary measures," the report pointed out.

The acts rarely gave privacy to people who are subject to these provisions, PIAF said.

"These legal frameworks are outdated and are in many instances inappropriate for HIV. Most legal systems in the Pacific lack legislation that protects the rights of people living with HIV," PIAF said.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HIV Prevention in Women Requires a Full Toolbox

Via Medscape, by Emily Paulsen.

Women account for more than 50% of the worldwide AIDS epidemic, and a disproportionate number of those women are people of color. In the United States, black women make up a growing share of new AIDS cases; the rate for black women is nearly 20 times the rate for white women.

Although these statistics are dire, new research, presented here at the National Medical Association 2011 Annual Convention and Scientific Assembly, offers hope that the tide will turn on HIV transmission.

"This has been an amazing year for HIV research," Gina Brown, MD, told meeting attendees. Dr. Brown coordinates research on microbicides at the Office of AIDS Research, part of the National Institutes of Health in Bethesda, Maryland. She offered a "walk-through of some of the interesting things we've learned about what puts women at risk for HIV, and some of the interventions available."

The biggest news in HIV prevention, reported recently at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, has been the use of antiretroviral therapy (ART) to reduce the risk for transmission, according to Dr. Brown. The HPTN 052 study showed a 96% reduction in transmission in serodiscordant couples in which the HIV-positive partner received early ART. In another study, once-daily tenofovir/emtricitabine (Truvada, Gilead Sciences) resulted in a 44% reduction in HIV transmission in men and transgender women who have sex with men. In that study, those who adhered to their medications at least 90% of the time achieved a 73% reduction in HIV transmission.

Dr. Brown pointed out that the couples in many of these studies were in steady relationships and volunteered to participate in the study. "Does this sound like the patients you see in your practice?" she asked the audience. She also said that costs and adverse effects might affect the practicality of this solution for many patients.

"When can we give up condoms?," she asked, answering that it would not likely be any time soon.

Dr. Brown said a full HIV prevention toolbox is still needed to reduce the risk for transmission. Education, partner reduction, treatment for sexually transmitted infections, condoms, circumcision, 1% tenofovir gel, and ART all offer varying amounts of protection. All interventions offer only harm reduction at this point, she said, not full protection.

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

WSJ: Trial Halted on HIV Pill for Women

[of interest: "There is research, as yet unpublished, showing that the concentration of tenofovir, when taken orally, is higher in rectal tissue than in vaginal tissue, said Timothy Mastro, an FHI vice president who spoke on behalf of the study. If so, the men might have had more of the drug than the women at the site where they were exposed to the virus."]

via Wall Street Journal, by Mark Schoofs

A highly anticipated trial to determine whether AIDS drugs taken by mouth can ward off HIV infection in women has been stopped early, a setback that surprised researchers after a string of successes in preventing transmission of the disease.

Researchers said Monday they had called off the trial among high-risk women in Africa because they wouldn't be able to determine whether use of antiretroviral medication produced any benefit. The study tested whether taking the medication once a day could prevent uninfected women from contracting the AIDS virus, estimated to infect more than 2.5 million people each year.

Several researchers lamented the result as "disappointing" and surprising. The same prevention method was proved successful just last year in a multicountry trial among gay and bisexual men. Moreover, an AIDS drug applied to the vagina in a topical gel—rather than swallowed as a pill—demonstrated a protective effect last year among women.

Researchers speculated that participants in the most recent trial might not have adhered to the regimen as closely as the participants in the other trials. Physiological differences between men and women might also account for the differences between this trial and the one among gay and bisexual men.

But a particularly intriguing hypothesis, supported by other research, is that swallowing a pill might not lead to high enough drug concentrations at the site where HIV enters a woman: in the tissues of the vagina.

In another surprise finding, women in the study taking the antiretroviral medication were more likely to get pregnant than women taking a placebo. This was true despite the fact that 96% of women in the study were on oral or injectable contraceptives when the study began.

There is no known interaction between the antiretroviral drugs and hormone contraceptives, said researchers. They said they would analyze their data to try to tease out if there might be such an interaction.

The randomized, placebo-controlled trial, called FEM-PrEP, was carried out among 1,951 women in South Africa, Kenya, and Tanzania by FHI, a non-profit health and development organization, with about $23 million in funding from the United States Agency for International Development and about $3 million from the Bill and Melinda Gates Foundation.

Approximately half the women were given Truvada, a pill that combines two antiretroviral medications, tenofovir and emtricitabine; the other half were given a placebo. Fifty-six infections occurred overall, with half among women taking a placebo and half among women taking the active drug.

Truvada is marketed world-wide by Gilead Sciences Inc., based in Foster City, Calif. In a statement Monday, the company said, "While this development is a disappointing one, Gilead believes that antiretroviral therapies remain a promising potential HIV prevention strategy."

Clinical trials are typically reviewed at regularly scheduled intervals by an independent committee. Such a committee decided that, statistically, the FEM-PrEP trial could not answer the fundamental question of whether Truvada reduces the risk of HIV infection. So the committee recommended closing the trial. Two other studies in Africa are continuing that could resolve the issue of whether AIDS drugs taken orally can prevent HIV infection in women.

Last year, a study of Truvada among gay and bisexual men showed it reduced the chance of infection by about 44%. There is research, as yet unpublished, showing that the concentration of tenofovir, when taken orally, is higher in rectal tissue than in vaginal tissue, said Timothy Mastro, an FHI vice president who spoke on behalf of the study. If so, the men might have had more of the drug than the women at the site where they were exposed to the virus.

Last year, another trial in South Africa showed that women could be protected against HIV by applying to their vaginas before and after sex a gel containing tenofovir, one of the two medications in the pill taken by the women in the latest study.

However, research presented earlier this year at the Conference on Retroviruses and Opportunistic Infections showed tenofovir concentrations in vaginal tissue were about 100 times higher when the drug was applied in the gel form compared with when it was taken orally.

One question researchers raised is whether women in the study took the pill faithfully. Dr. Mastro said his team would address this question by examining whether stored blood samples contain the medication.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]