[HOT] New Sexual Health Articles on LifeLube

We like to share good articles on gay men's health whenever we can get our hands on them. We've just uploaded a number of great materials on the LifeLube site - check them out.  

In our Online/Offline Sex Resources section of the site, you can find gems like:

Community Perspectives on Developing a Sexual Health Agenda for Gay and Bisexual Men

Trevor Hoppe's fabulous Circuits of power, circuits of pleasure: Sexual scripting in gay men's bottom narratives  

Rectal Microbicides: Can We Make Them and Will People Use Them? by Ian McGowan

What is Sexual Health? Articulating a Sexual Health Approach to HIV Prevention for Men Who Have Sex with Men, by Eli Coleman in AIDS & Behavior.

Plus more articles, websites, presentations. Click here.

VIDEO: Doctor Ho and Andrew's Anus

via Pittsburgh's Positive OUTLook

Learn more about anal health from a hot doc and a sexy advocate.

Isn't Dr. Ho DREAMY??? Please sir, may we have another pap smear?

And of course, we LOVE our very own Mark Hubbard, the genius behind Andrew's Anus :) Make sure you check out the hole Andrew's Anus series, a first-booty perspective on anal health - there have been six installments so far, and more to come.

Tenofovir gel protects anal tissue

via Reuters

An experimental gel containing a prescription HIV drug has been shown for the first time to protect rectal tissue against the virus that causes AIDS, according to new research.
The gel, containing Gilead Sciences Inc's AIDS drug tenofovir, has previously been shown to sharply reduce HIV infections in women when applied inside the vagina.

The latest study, which involved rectal tissue biopsies taken from HIV-negative men and women who used the product daily for one week, provides the first evidence that tenofovir gel could help reduce the risk of HIV from anal sex.

The researchers, who presented the findings at a medical meeting in Boston, are reformulating the gel so that it is less harmful to the rectum than the original vaginal microbicide.

The risk of becoming infected with HIV from unprotected anal sex may be at least 20 times greater than unprotected vaginal sex, in part because the rectal lining is only one-cell thick compared to the vagina's multiple layers, making it easier for the virus to reach cells to infect, the researchers said in a statement.

Read the rest.

PODCAST: LifeLube Helps Get Your Butt Out of the Sand

via Feast of Fun (one of the exclusive places LifeLube advertises, cuz they're worth it)

Your body is a magical wonderland waiting to be explored, but proceed with caution because risks may be lurking around the backside. You can’t just stick your butt in the sand and pretend there’s nothing behind there to deal with.

Today health advocate (and LifeLube minion) Jim Pickett joins us to answer your vital questions about your butt. Yes, your derriere, your bon bon, your gluteus maximus, because overcoming our bashfulness over the booty is key to gay men’s health.(And rectal microbicides too!)

Why do gay men enjoy anal sex? How do I know if my boyfriend is good for me? Are some types of lube safer than others? How do I keep my booty fresh and fabulous?

Plus we take a closer look at the Asset Based Lifestyle- the secret every gay man needs to know about focusing on what works in your life in order to bring about the change you need to shine.

And of all the hot hot hot news... Listen.

The 10 Stories to Follow as HIV/AIDS Enters Its Fourth Decade

via Colorlines, by Ramon Johnson

Thirty years into the HIV/AIDS epidemic, and after decades of research disappointments, 2010 saw major breakthroughs that put scientific advances such as microbicides, pre-exposure prophylaxis (PrEP) and vaccines within reach and created a favorable environment for other prevention and treatment efforts. In fact, some experts predict that over the next year, some of these discoveries could change the trajectory of the AIDS epidemic.

So what comes next? Colorlines will be covering the HIV epidemic closely throughout this year, in which the epidemic plunges into its fourth decade. Here, we examine 10 major HIV stories of 2010—and how experts expect them to unfold during 2011.

1. Microbicides March Toward the Market

Could applying a gel to the vagina or rectum one day prevent HIV? Scientists hope so. Last year, South African researchers reported breakthroughs in microbicide research. They found that inserting a vaginal-gel version of an antiretroviral medicine called tenofovir (prescribed in pill form as Viread) could reduce HIV incidence in women by 39 percent—and up to 54 percent in the most careful users.

What to watch: Never have scientists been closer to identifying a viable microbicide than they are today. Next steps include confirming these results. Some experts believe that a microbicide for women could be on the market by 2014. Efforts to develop a rectal microbicide are also under way; however, vaginal and rectal tissue are very different from each other, so this research may take significantly longer***.

Read the rest.

***Note - Rectal microbicide research is indeed a bit, er, behind compared to vaginal microbicides - but it is moving forward nonetheless. There are small trials underway now with sites in Pittsburgh, Boston, San Juan and Birmingham!

Learn more about rectal microbicide research and advocacy at the home of IRMA - International Rectal Microbicide Advocates. Or visit the IRMA blog.

BIG: Trial Shows AIDS Pill Can Prevent HIV Among Gay Men

AIDS Drug Shown to Prevent HIV 
in Multinational Trial of HIV-Negative Gay Men

Data Suggests Need for Rectal Gel Option

[via our sister IRMA - International Rectal Microbicide Advocates]

Results of the world’s first efficacy trial of an HIV-prevention approach called oral pre-exposure prophylaxis, or PrEP, were released online in the New England Journal of Medicine today. Data from this trial, called iPrEx, indicated an estimated 43.8% reduction of new HIV infections among men who took an antiretroviral tablet daily to prevent HIV, compared to those who took a placebo pill.[Read the article.]

“This discovery alters the HIV prevention landscape forever. While this level of efficacy is relatively strong, PrEP is not quite ready for prime time and work remains before this strategy is rolled out. However, we are thrilled to have a new prevention option beyond male and female condoms visible on the horizon,” said Jim Pickett, Director of Advocacy at AIDS Foundation of Chicago and Chair of IRMA – International Rectal Microbicide Advocates.

The iPrEx trial evaluated the safety and efficacy of the antiretroviral (ARV) drug TDF/FTC (brand name Truvada) taken once daily for HIV prevention among HIV-negative gay men, transgender women, and other men who have sex with men (MSM).

The participants, 2,499 in all, included individuals from Peru, Ecuador, Brazil, South Africa, Thailand and the United States. Half the men were randomized into the active arm that received Truvada, and the other half were randomized into the placebo arm and received a look-alike pill with no active ingredient. The participants and the researchers did not know who was in either arm.

Enrollment for the trial began in June 2007 and was completed in December 2009. The primary analysis of the results released today includes participants who were followed until May 1, 2010, or for an average of 14 months.

Each participant was tested for HIV at monthly trial visits and given intensive pre-and-post test counseling. Additionally, they were regularly screened for sexually transmitted infections and received condoms, making up a very robust prevention package.

At the end of the trial, there were 36 infections in participants who received Truvada and 64 in recipients who took the placebo. Researchers calculated that the use of Truvada reduced new HIV infections by an estimated 43.8% overall when compared to placebo. While there appeared to be few side effects reported by the men who were taking the Truvada tablet, it is clear that much more information is needed regarding long term safety of this drug.

Other PrEP trials are ongoing. Results from studies among heterosexuals in Africa and injection drug users in Thailand are expected next year.

It is important to emphasize the factors that led to successful use of Truvada to prevent HIV in iPrEx. Taking the pill regularly was one of the most important. Efficacy appeared to be higher among those participants who took the study drugs consistently. Men who did not take the pill regularly did not see a protective benefit. Regular HIV testing and ongoing monitoring by a physician was also critical. For this strategy to work, each of these pieces, including a doctor’s prescription, need to be in place.

“The study team found that about half of the men in the active arm of the trial were in fact not taking their pills regularly, if at all,” said Pickett. “It is not clear why this happened, but it certainly suggests that alternate means of using ARVs to prevent HIV infection may be more acceptable for these men. The primary means of transmission among gay men and other MSM is through unprotected anal intercourse. If we develop an ARV as a gel or lubricant applied rectally – a rectal microbicide – it could be more acceptable for some individuals who don’t like taking pills.”

Many gay men and other MSM already use lubricants for anal intercourse, so they wouldn’t have to modify their behavior to achieve higher levels of protection with a rectal microbicide formulated as a lubricant. Adopting a new behavior—such as taking a pill every day—can be a considerable challenge for some.

Dr. Ian McGowan, one of the principal investigators of the Microbicide Trials Network and Scientific Vice Chair of IRMA agreed. "The data from the iPrEx study are encouraging but the less than ideal adherence rate to oral PrEP clearly show that we need additional prevention approaches such as rectal microbicides that could be used by men and women at risk of HIV infection through unprotected receptive anal intercourse," he said.

The world's third rectal microbicide trial is currently underway with sites in Pittsburgh, Pennsylvania; Boston, Massachusetts; and Birmingham, Alabama. Scientists are testing the rectal safety and acceptability of tenofovir gel, a microbicide developed for vaginal use that has shown promise for preventing HIV through vaginal intercourse. Depending on the outcome of this new study, tenofovir gel could be further evaluated to determine if it can reduce the risk of HIV among both men and women who engage in receptive anal intercourse.

This new Phase I rectal microbicide study, known as MTN-007, aims to determine if rectal use of tenofovir gel is safe, and in particular, does not cause cells in the rectum to become more vulnerable to HIV. Investigators will also ask trial participants questions regarding the gel's desirability. The trial is planning to recruit a total of 60 men and women.

While the rectal microbicide field has gained significant momentum, more focus and resources are needed. In 2010, U.S. $7.2 million is being spent globally on rectal microbicide research. IRMA has calculated that annual investments must increase by 40% from 2011 – 2014, to U.S. $10 million/year and must increase further to U.S. $44 million (a six-fold increase) in the years 2015 – 2020. These targets need to be met to ensure a minimum of candidate products are moving through the research pipeline into late stage testing for effectiveness.

Just as we use a combination of drugs to treat individuals living with HIV, we need a combination approach to prevention. That approach should include male and female condoms, sterile syringes, and access to treatment as well as new interventions like PrEP, topical microbicides, and vaccines. Adequate funding must continue for all of the methods we currently have, and it must continue for the new strategies that are still being developed as well.

In a global context where millions of individuals do not have access to life saving medications, it is imperative that funding provided for PrEP accessibility not compete with funding for treatment. Treatment funding has not kept pace with the need.

IRMA congratulates the trial sponsors, scientific collaborators and partners who conducted this landmark trial, with special thanks to the 2,499 participants in the study who volunteered so much of their time and energy. Their extraordinary contribution to HIV prevention science brings us another step closer to a day without AIDS, and for that we are supremely grateful.

YAY for the world's third rectal microbicide trial

This brings us another step closer to the development of safe and effective rectal microbicides for use during anal intercourse.

The world's third rectal microbicide trial launched in Pittsburgh, Pennsylvania today, with sites preparing to open in Boston, Massachusetts, and Birmingham, Alabama soon. Scientists will test the rectal safety and acceptability of tenofovir gel, a microbicide developed for vaginal use that has shown promise for preventing HIV through vaginal intercourse. Depending on the outcome of this new study, tenofovir gel could be further evaluated to determine if it can reduce the risk of HIV among both men and women who engage in receptive anal intercourse.

"International Rectal Microbicide Advocates (IRMA) congratulates the Microbicide Trials Network and its partners on the launch of this very important study – the third Phase I trial in history to look at the safety and acceptability of a microbicide gel applied rectally," said Jim Pickett, IRMA Chair and Director of Advocacy at AIDS Foundation of Chicago. "This brings us another step closer to the development of safe and effective rectal microbicides for use during anal intercourse," he said.

Condoms are considered the gold standard for the prevention of HIV and STDs during sexual intercourse, but not all receptive partners are able or willing to use condoms every time. An act of anal intercourse that is not protected by a condom is 10 to 20 times more likely to result in HIV transmission compared to an act of unprotected vaginal intercourse, due to the fragility of the rectal lining and the large presence of cells targeted by HIV. New methods to protect against the sexual transmission of HIV are urgently needed. Strategies beyond condoms – such as vaccines, oral prevention, and microbicides – will provide individuals with more prevention options.

Microbicides – substances applied topically on the inside of the rectum or vagina – could potentially help prevent the transmission of HIV. The research and development of vaginal microbicide candidates is much more advanced than research on rectal microbicides. Tenofovir gel, for example, is a candidate microbicide specifically developed to prevent vaginal transmission of HIV. In a recent study known as CAPRISA 004, tenofovir gel was found to significantly reduce the risk of HIV among at-risk women who were instructed to use the gel before and after vaginal intercourse. In an ongoing, large-scale effectiveness trial called VOICE – Vaginal and Oral Interventions to Control the Epidemic – researchers from the U.S. National Institutes of Health-funded Microbicide Trials Network (MTN) are testing daily use of tenofovir gel in African women, with results expected in 2013.

This new Phase I rectal microbicide study, known as MTN-007, aims to determine if rectal use of tenofovir gel is safe, and in particular, does not cause cells in the rectum to become more vulnerable to HIV. Investigators will also ask trial participants questions regarding the gel's desirability. MTN-007 will enroll 60 men and women at the University of Pittsburgh, the University of Alabama at Birmingham, and Fenway Health in Boston. Leading the study is Ian McGowan, M.D., Ph.D., of the University of Pittsburgh, who is also co-principal investigator of the MTN and serves as Scientific Vice-Chair of IRMA.

Little is known about tenofovir gel used rectally, but science is advancing our understanding. Laboratory and animal studies involving rectal application of tenofovir gel have suggested it's safe for testing in humans. In fact, MTN researchers have just completed the first Phase I trial with eighteen participants, called RMP-02/MTN-006, in collaboration with the Microbicide Development Program at the University of California, Los Angeles. While results of RMP-02/MTN-006 are not expected until early 2011, researchers have already recommended modifications to the gel's formulation. MTN-007 is evaluating the new formulation, which still contains the same amount of active drug – 1% percent tenofovir – but has a lower concentration of glycerin (an additive found in many types of products) to make it more amenable for rectal use.

"It is very encouraging to see the rectal microbicide field moving forward," said IRMA Community Vice-Chair Kadiri Audu, who also heads up the IRMA Nigeria chapter, "and I look forward to trials taking place in Africa as well." He continued, "Gay men and other men who have sex with men in Africa have high rates of HIV infection, and we know unprotected heterosexual anal sex is relatively common on the continent and contributes a sizable number of HIV infections. As much as we need vaginal microbicides to give women an extra prevention tool, rectal microbicides for the women, men, and transgender individuals who engage in anal intercourse are absolutely essential as well."

While the rectal microbicide field has gained significant momentum, more focus and resources are necessary. In 2010, U.S. $7.2 million is being spent globally on rectal microbicide research. IRMA has calculated that annual investments must increase by 40% from 2011 – 2014, to U.S. $10 million/year and must increase further to U.S. $44 million (a six-fold increase) in the years 2015 – 2020 to ensure a minimum of candidate products are moving through the research pipeline into advanced testing for effectiveness.

Read the press release from the MTN:
Promising HIV prevention microbicide tenofovir gel being tested for safety of rectal use

[IRMA is a global network of more than 1,000 advocates, scientists, policy makers and funders from six continents working together to advance a robust rectal microbicide research and development agenda. IRMA is based in the United States at the AIDS Foundation of Chicago – www.aidschicago.org – with chapters in Latin America and Nigeria. For further information on IRMA click here and read IRMA's new report, From Promise to Product: Advancing Rectal Microbicide Research and Advocacy. The report provides an overview of the maturing rectal microbicide field, updates the resource tracking exercise IRMA last conducted in 2006, and lays out global advocacy goals and objectives.]

Condoms Aren’t Enough! Will Pills and Lubes Define the Future Of Sex?

More than 100 of the  world's top experts on  human rights and HIV among  sexual minorities led presentations and  workshops in Vienna  on July 17 at BE HEARD,  an all-day  conference event that addressed soaring global rates of HIV  among men who  have sex with men  (MSM). The event preceded  the launch of AIDS 2010, the XVIII International AIDS  Conference (IAC) and had nearly 600 participants.

Our friend IRMA (International Rectal Microbicide Advocates) and led the very interesting session called "Condoms Aren’t Enough! Will Pills and Lubes Define the Future Of Sex? An Overview of New HIV Prevention Tools in Development."

Below are 5 of the presentations - which IRMA is lovingly sharing with LifeLube. The first - directly below - begins with Kenyan researcher Dr. Gaudensia Mutua's talk - "Basic Concepts about AIDS Vaccine Research."

 

Hosted by the Global  Forum on MSM  & HIV (MSMGF),   BE HEARD focused on challenges and  solutions to  achieving  universal  access to HIV-related prevention, care,  treatment,  and  support  services for sexual minority communities  worldwide.

Vienna AIDS 2010 - Gay Days with Vlogger Mark King

"My Fabulous Disease" - a delicious video blog by LifeLube pal Mark King,  is posting daily from AIDS 2010, and this entry takes you to the Global Forum on MSM and HIV's ("Gay Day") pre-conference in Vienna. Workshops on aging, the role of HIV+ gay men in leadership, rectal microbicides, and interviews with advocates from around the world are included.

Got Lube? Sure, but is it safe?

via Windy City Times, by Bob Roehr

Water-based lubes that scored poorly were Astroglide, Elbow Grease, ID Glide and K-Y Jelly. 

New research has found that some lubricants used in anal or vaginal sex can cause damage to those tissues that can leave people more vulnerable to sexually transmitted infections, including HIV. 

Surprisingly, this is the first time that anyone has even looked at the question of whether basic sexual lubricants can cause damage to rectal tissue. The studies were presented at the Microbicides 2010 conference in Pittsburgh at the end of May.

Read the rest.

[More lube info/discussion here, on the International Rectal Microbicide Advocates' blog.]

Understanding New Research on Lubricant Use During Anal Intercourse

[great article - a must for anal sex enthusiasts!]

via About.com's Sexuality Blog, by Cory Silverberg

Excerpt:

As usual, sexual pleasure isn't being talked about at all, and this too needs to be addressed in both the conducting and reporting of future research. The end goal of all this research is awareness of risk and behavior change. We aren't talking about dental hygiene here. We are talking about activities people engage in for a reason, and sexual pleasure is often part of that reason. To talk about anal intercourse and lubricant, particularly to talk about lube as a risk factor, outside of the context of pleasure makes sense only in the lab, only in theory. It doesn't matter how good the research is, if you want to affect change in people's lives, you have to speak to us in a way that we can connect with. If the only argument you make for behavior change is numeric, it might scare us for about three minutes, but it's not likely to help us at all.

Read the whole thing.

In the pipeline - NEW WAYS TO TAKE IT beyond condoms

*currently in development a rectal microbicide is an agent that could be formulated as a lubricant, gel, douche, or an enema and used rectally to reduce a person’s risk of HIV infection. Rectal microbicides could offer both primary protection in the absence of condoms and back-up protection if a condom breaks or slips off during anal intercourse. learn more about rectal microbicides here.

International Rectal Microbicide Advocates Release 
Update on New HIV Prevention Technology  

New Report Outlines the Growing Field of 

Rectal Microbicide Research and Development

Chicago -- International Rectal Microbicide Advocates (IRMA) will officially release its third landmark report -- "From Promise to Product: Advancing Rectal Microbicide Research and Advocacy" -- at the 2010 International Microbicides Conference in Pittsburgh, PA taking place May 22-25, 2010. The ambitious, comprehensive document reports on the growing scientific activity in the rectal microbicide field, capturing the optimism among researchers and advocates alike as the field sets its sights on the development of safe and effective rectal-specific products that will provide protection against HIV during anal intercourse.

Additionally, IRMA continues to call for a Global Rectal Microbicide Development plan by which stakeholders can coordinate efforts across the full range of scientific activities, developing strategies and setting priorities. Such a plan does not yet exist.

Dr. Ian McGowan, Scientific Vice-Chair on the IRMA Steering Committee and co-Principal Investigator of the Microbicide Trials Network says, "A detailed map such as a Global Rectal Microbicide Development Plan is absolutely necessary if we are going to make the best use of each and every research dollar in this time of global recession and constricted resources."

An updated resource tracking of funds specifically allocated to rectal microbicide research and development -- the only such exercise -- is followed by a call for escalating funding over the next 10 years and for increased diversity in the funding portfolio as well. The United States National Institutes of Health currently provides over 90% of global resources devoted to rectal microbicide activities, and nations of the European Union and global philanthropic organizations need to support this critical work as well.

"Increased funding is also needed for IRMA. We maintain an enormous global footprint and are the only advocacy group focused on rectal microbicides in the world -- and we achieve this with inadequate resources," says IRMA Chair and Director of Advocacy for the AIDS Foundation of Chicago Jim Pickett. "Our work must be valued and supported if we are to continue uniting AIDS advocates, scientists, and policy makers around the globe to bring safe and effective rectal microbicides to market as well as to confront the homophobia, gender inequities, human rights, stigma, and denial that must be addressed to make sure such products will be used."

[The full report is available online in both English and Spanish.Lear more about IRMA and help make rectal microbicides a reality for the millions of men, and women, who have anal sex around the world.]

The Advocate shows some love for booty butter researcher/advocate Leo Colemon

There is a condom fatigue within our community. Gay men like the natural feeling, and I look to a future with that being an option. That’s what rectal microbicides will do.

Leo is one of 23 LGBT people profiled regarding their "perfect" jobs in the March 2010 edition of The Advocate. Check out his blurb below.

LEONARDO COLEMON
Research manager in epidemiology
Los Angeles, 37

Gay men have long had a complicated relationship with condoms. Anyone who’s fought a losing battle with a prophylactic due to a latex allergy or loss of an erection may one day owe a debt of gratitude to Leonardo Colemon. The affable Mississippi native manages a team of researchers at the University of California, Los Angeles, and in collaboration with Pamina Gorbach and Peter Anton is developing a lubricant that would be applied to a receptive partner prior to anal sex. This lube (referred to as “booty butter” in an online educational video produced by the group) will contain microbicides designed to kill HIV and other STIs to a certain degree. “There is a condom fatigue within our community,” Colemon says. “Gay men like the natural feeling, and I look to a future with that being an option. That’s what rectal microbicides will do.” This cutting-edge infection-prevention tool is “being developed and targeted to men who have sex with men and don’t use condoms consistently,” says Colemon. “But it will also be useful to heterosexuals who want safer options for anal intercourse.” Colemon, who also volunteers as an HIV/STI counselor at the Los Angeles Gay and Lesbian Center, notes that Food and Drug Administration approval could take five to 10 years, and he readily admits that while rectal microbicides “are unlikely to be 100% effective, they will certainly reduce the potential for transmission.

Read about other folks with cool jobs.

Learn more about rectal microbicides at the International Rectal Microbicide Advocates (IRMA) website.

Attitudes towards new HIV biomedical prevention technologies among HIV- gay men

[This paper has important implications for research of new prevention technologies. It is very interesting to note the researchers found that previous  knowledge of rectal microbicides was significantly associated with unwillingness to participate.]

Abstract via HIV Medicine, December 2009

Attitudes towards new HIV biomedical prevention technologies among a cohort of HIV-negative gay men in Sydney, Australia

IM Poynten 1 , F Jin 1 , GP Prestage 1 , JM Kaldor 1 , J Imrie 2 , and AE Grulich 1

1 National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, New South Wales, Australia and 2 National Centre in HIV Social Research, University of New South Wales, Sydney, New South Wales, Australia

Correspondence: Dr Mary Poynten, National Centre in HIV Epidemiology and Clinical Research, Level 2, 376 Victoria Street, Darlinghurst, NSW 2010, Australia. Tel: +61 2 9385 0900; fax: +61 2 9385 0920; e-mail: mpoynten@nchecr.unsw.edu.au

Objectives
The aim of the study was to explore the awareness of rectal microbicides, the use of pre-exposure prophylaxis (PREP) and the willingness to participate in biomedical HIV prevention trials in a cohort of HIV-negative gay men.

Methods
In a community-based cohort study, HIV-negative homosexually active men in Sydney, Australia were questioned about awareness of rectal microbicides, use of PREP, and willingness to participate in trials of such products. Predictors of awareness and willingness to participate were analysed by logistic regression. Use of PREP was examined prospectively.

Results
Overall, 14% had heard of rectal microbicides. Older (P=0.05) and university-educated men (P=0.001) were more likely to have knowledge of rectal microbicides. Almost one-quarter (24%) of men reported that they were likely/very likely to participate in rectal microbicide trials. Among those men with definite opinions on participation, awareness of rectal microbicides was significantly associated with unwillingness to participate [odds ratio (OR) 0.78, 95% confidence interval (CI) 0.65–0.93, P=0.007]. Willingness to participate in trials using antiretroviral drugs (ARVs) to prevent HIV infection was reported by 43% of men, and was higher among those who reported unprotected anal intercourse (UAI) with HIV-positive partners (OR 1.88, 95% CI 0.99–3.56). There was no evidence of current PREP use.

Conclusions
This study demonstrates that Australian gay men have had little experience with PREP use and rectal microbicides. About half would be willing to consider participation in trials using ARVs to prevent HIV infection. Extensive community education and consultation would be required before PREP or rectal microbicides could be trialled in populations of gay Australian men.

An enema with special powers?

Why Rectal Douches May Be Acceptable Rectal-Microbicide Delivery Vehicles for Men Who Have Sex With Men

Abstract via Sexually Transmitted Diseases

Carballo-Diéguez, Alex PHD; Bauermeister, José PHD; Ventuneac, Ana PHD; Dolezal, Curtis PHD; Mayer, Kenneth MD

Rationale: To explore age of onset of rectal douching among men who have sex with men (MSM) and reasons leading to and maintaining douching behavior; and to consider whether rectal douches containing microbicidal agents might be acceptable for men at HIV risk.

Methods: In stage 1, we used qualitative methods to explore douching behavior in a sample of 20 MSM. Subsequently, we developed a structured questionnaire that was administered in stage 2 to 105 MSM.

Results: More than half of participants who completed stage 1 douched during the trial despite having been advised not to do so. Of the 105 human immunodeficiency virus uninfected participants in stage 2, 51% reported using rectal douches in the prior 6 months; 47% douched before and 25% after anal intercourse. Most participants reported douching frequently or always. On average, men reported douching about 2 hours before or 1 hour following intercourse. Average age of onset was late 20s. Most men who douched wanted to be clean or were encouraged to douche by their partners. Some men thought douching after sex could prevent sexually transmitted infections.

Conclusion: Rectal douching appears to be a popular behavior among men who have receptive anal intercourse. It is necessary to identify harmless douches. If human immunodeficiency virus or sexually transmitted infections preventive douches can be developed, rectal douching before or following sexual intercourse could become an important additional prevention tool. To reshape an existing behavior to which some men strongly adhere, like douching, by suggesting use of 1 type of douche over another may be more successful than trying to convince MSM to engage in behaviors they never practiced before or those they resist (e.g., condom use).

(C) Copyright 2009 American Sexually Transmitted Diseases Association

Showin' Us the Money - Rectal Microbicides Get a Healthy Raise

Magee-Womens Research Institute Receives $17.5 million 

for Rectal Microbicide Research

Dr. Ian McGowan* (pictured below), an investigator with the Magee-Womens Research Institute (MWRI), recently received a total of $17.5 million from the National Institutes of Health (NIH) to conduct two studies involving the development of rectal microbicides.

"This is exciting for the field of HIV prevention research, and especially important in terms of moving the research and development of rectal microbicides forward," said McGowan. "We applaud the leadership and vision of our sponsors at the NIH."

[Microbicides are topical products that can be applied to the rectal or vaginal mucosa with the intent of preventing, or at least significantly reducing the risk of HIV acquisition in either compartment.]

Recognizing the fact that women in the developed and developing world are at risk of HIV infection through anal and vaginal intercourse, the Microbicide Trials Network (MTN), based at MWRI, is currently evaluating the rectal safety of microbicides designed for vaginal use.

Dr. McGowan’s new studies focus the research towards developing microbicide products specifically designed for rectal use.

The first grant is entitled the Combination HIV Antiretroviral Rectal Microbicides or CHARM program. This is an $11 million, five year, multicenter U19 grant that brings together research groups from the University of Pittsburgh, University of North Carolina, Johns Hopkins Medical School, CONRAD, and the University of California at Los Angeles. The U19 grant is part of the NIH funded Integrated Preclinical Clinical Program and is intended to advance candidate microbicides from discovery into early clinical development.

The second grant is a $6.5 million, four year, R01 grant entitled Microbicide Safety and Acceptability in Young Men with Dr. Alex Carballo-Dieguez as the Co-Principal Investigator. The focus of this grant is to evaluate the safety and acceptability of rectal microbicides in young, ethnic minority men who have sex with men (MSM). Funding for this study comes from the National Institute of Child Health and Human Development as well as the National Institute of Mental Health and will generate critical data from a population of young African American and Latino men who are at the highest risk of HIV infection in the United States. Clinical trial sites will be in Pittsburgh, Boston, and Puerto Rico.

"We need to develop safe, effective, acceptable and accessible rectal microbicides for the millions of women and men worldwide who need options beyond condoms," said Jim Pickett, chair of the International Rectal Microbicide Advocates (IRMA) said. "Our global network of advocates, scientists, policy makers and funders is encouraged to see this work moving forward."

Together with ongoing MTN rectal safety studies and another collaborative grant with the University of Oxford, UK, these two new grants establish MWRI as a leading center for rectal microbicide translational research and will hopefully lead to the development of safe and effective products for individuals at risk of HIV infection through unprotected receptive anal sex.
 

* Dr. McGowan is also a Professor of Medicine in the Division of Gastroenterology, Hepatology, and Nutrition at the University of Pittsburgh Medical Center, with a secondary appointment in the Department of Obstetrics, Gynecology and Reproductive Science.

On the Biomedical Question - Are We Set for PrEP?

Charles Stephens wonders what oral prevention and rectal microbicides might mean for prevention and pleasure, risk and taboo.

Condom-centric HIV prevention created the “cum pig.” No one back then in the 80s, could have known that, but here we are. 

There has been a considerable amount of discussion, debate, and exploration around the scientific and ethical implications of biomedical HIV prevention. This I believe has been useful. However, moving forward, it’s imperative that we consider the implications such advances might have for our community and sexual practices for gay men.

So far, especially as it relates to PrEP (pre-exposure prophylaxis, or oral prevention), I’ve mostly heard things like “it will just mean more gay men will have sex without condoms.” And usually, I’m the one in the room that says, “maybe that’s not a bad thing.”

These discussions are important, even if they are limited and frustrating, because we have to think ahead. We have to imagine how these shifts in prevention technologies and strategies today, will influence our sexual practices, inform our identities, and shape our communities tomorrow.

Essentially, we have to question what these advances will mean for the future of gay men. How rectal microbicides, for example, might influence how we as gay men experience anal sex. How we think about anal sex. And how the potential meanings we attach to both anal sex and our anuses will evolve, along with our sexual landscapes and fantasies. The strategies we develop around prevention, can’t only be for the present, but also for the future.

Read more »

NEW Rectal Microbicide Trial is Recruiting

Official Title: “A Two-site, Phase 1, Partially-blinded, Placebo-controlled Safety, Acceptability and Pharmacokinetic Trial of Topical, Vaginally-formulated Tenofovir 1% Gel Applied Rectally Compared With Oral 300 mg Tenofovir Disoproxil Fumarate in HIV-1 Seronegative Adults”

Clinical Trial Phase: Phase 1 | Start Date: September 2009

Overall Status: Recruiting

Estimated Enrollment: 18

To date, the majority of microbicide research has focused on the assessment of the safety and effectiveness of vaginal microbicides used for the prevention of HIV transmission via the vaginal compartment. Receptive anal intercourse (RAI) is common among men who have sex with men (MSM), and there is increasing evidence that heterosexual women in the developed and developing world also practice anal sex. It can, therefore, be anticipated that once vaginal microbicides are licensed, they will be used in both the vaginal and rectal compartments. As a consequence, there is a need to evaluate both the rectal and vaginal safety profile of candidate microbicides. Therefore, the primary objective of this study is to evaluate the systemic safety of 1% vaginally formulated tenofovir gel applied rectally.

In addition, this study will evaluate the immunotoxicity of the gel and evaluate its acceptability; it will also use the oral tenofovir disoproxil fumarate tablets (TDF), rectally-applied tenofovir gel,and a placebo gel to compare their systemic and compartmental pharmacokinetic (pK) profiles.

Read the rest of the info on this study here.

POZ Flashback - Beyond Condoms: Life After Latex

[See how far we've come - or not - in the last 10 years.]

Yet amidst this growing pro-microbicide chorus, one omission goes unnoticed by all but a handful of angry critics who ask,

“What about microbicides for the rectum?”

Published June 1999

Beyond Condoms: Life After Latex

by Michael Scarce, for POZ

Microbicides weren’t our dad’s safe sex. But for us, they’re just a shout away

Countdown Y2K: Part 6 of a 12-Part Series

Imagine a world without condoms. I’m talking not about the cure, a widespread conversion to barebacking or mandatory castration, but a future in which rubbers are obsolete relics, replaced by an inexpensive, easy-to-use, anti-STD gel applied internally to the vagina or the rectum before sex. These “chemical condoms,” known as microbicides, would ideally inactivate a range of harmful bacteria, viruses and other bugs, revolutionizing safer sex as we know it. Contraceptive microbicides such as spermicidal films, foams and jellies have been available over the counter and by prescription for more than two decades. More recently, scientists have begun struggling to develop a similar technology to prevent infection with HIV and other STDs. By 2000, however, the Clinton administration’s $100 million, four- year initiative to develop such “topical agents” will barely even be slouching toward its goal.

As infection rates climb among women, especially in developing countries, the need for a low-cost, female-controlled form of protection has become urgent. Gender inequity within heterosexual relationships has long been a driving force for technology to balance the scales of sexual decision-making, and two organizations have formed in the United States to carry out this advocacy—Microbicides as an Alternative Solution (MAS), in Berkeley, California, and the Alliance for Microbicide Development, in Takoma Park, Maryland. “Because condoms are controlled by the man, both partners must agree to use them,” says MAS’s Bethany Holt, explaining her group’s quest for products that can be used exclusively by the receptive partner. AIDS service organizations worldwide have reported commonplace episodes of domestic violence triggered by disputes over condom use. Even in the absence of intimidation or force, many women have learned to defer their own pleasure and safety in favor of men’s desires. Yet amidst this growing pro-microbicide chorus, one omission goes unnoticed by all but a handful of angry critics who ask, “What about microbicides for the rectum?”

The most astonishing and reprehensible thing is, why, when the gay male community has so much to gain with this scientific development and so much to lose without it, we raise no voice to advocate for it.

Scientists and public health experts have long approached anal sex with a mix of anxiety, scorn and denial. Take, for example, the often-unacknowledged fact that the FDA has never approved a single condom or other device for anal sex. As the scientific agenda of safer sex seems to be guided more by morality than epidemiology, people who practice anal sex have been technologically abandoned.

Read the rest on the IRMA (International Rectal Microbicide Advocates) blog here.

He put his ass on the line for research - literally!

There I was naked, cold, wet from lube, asshole hurting, with three people I barely knew.

Scott Wilfong describes his experience in rectal microbicide studies at Johns Hopkins
via IRMA - International Rectal Microbicide Advocates

Let me begin by saying, if you are looking for a really good conversation topic, especially on a first date, get yourself involved in the rectal microbicide studies at Johns Hopkins.

It is a quick and easy way to gage one’s comfort level in talking about anal sex and more importantly, research development that may, in fact, save the lives of others someday in the future.

What’s not to be excited about!?

If only I had a snapshot photo of everyone’s first expression upon telling them the in’s and out’s (no pun intended) of my experience with rectal microbicide research. Some people laugh immediately, some cringe, some have a shocked look, and others stare at me with total disbelief, inquiring about actual proof to something that seems so out of the box for them. For many, it is the first time they have ever heard the word microbicide, let alone microbicide research. Believe me my knowledge is somewhat limited when specifically talking about the medical component of this particular research. So, I try to explain it the best I can with a lean towards the importance of this type of research, the extraordinary doctors that are the so passionate about this research, and the extremely important benefits of microbicide development for the lives of many people in the future.

Read the rest on the IRMA blog.