IRMA - Rectal Microbicide Advocacy

Concerns about Gilead's Truvada used as HIV Prevention

2012-01-26T09:30:00.000-06:00

via Financial Times, by Christine Livoti

Gilead Sciences’ (NASDAQ: GILD) once-daily Truvada pill has seen only tepid interest for adoption in the HIV prevention setting, despite treatment guidelines by the Centers for Disease Control (CDC), experts told Biopharm Insight. This is largely related to issues around feasibility, cost and historical evidence for other prevention strategies, which may not be remedied even with the FDA label Gilead is seeking, infectious disease experts said.

Last December, the company announced a supplemental NDA (sNDA) regulatory application for its currently marketed HIV drug Truvada, a potential therapy to reduce the risk of acquiring HIV, commonly described as pre-exposure prophylaxis (PrEP). Truvada has been approved since 2004 for use in combination with other antiretroviral drugs to treat HIV infection.

Truvada has not been approved yet as a preventative therapy in HIV.

Results from the Phase III iPrEx study reported in the New England Journal Of Medicine in December 2010 showed prophylactic effect from Truvada given orally among men who have sex with men (MSM). In January 2011, the CDC issued interim guidance on the use of PrEP in this population.
While HIV therapy is much more manageable than previously, with fewer pills and side-effects, experts in recent years have begun to initiate therapy in earlier stages of the viral infection, and most recently in uninfected individuals to prevent infection. While multiple PrEP studies have reported encouraging data, multiple hurdles to adoption still remain.

Slow uptake thus far

This news service reported in December 2010 that uptake of Truvada as an HIV prophylaxis therapy would likely be slow, as non-HIV specialists would largely be responsible for prescriptions. Infectious disease specialists reported few, if any, prescriptions in this indication, when interviewed by this news service.

The University of North Carolina division of infectious disease has not been prescribing PrEP, said Dr Christopher Hurt, clinical assistant professor. He added there has been some talk in the medical community that primary care providers and potentially ob-gyns would be responsible for PrEP prescription, similar to how they are responsible for oral contraceptives.

He noted in some urban areas, particularly San Francisco, Boston, New York and Washington, DC, with stronger healthcare settings for MSM, have probably been prescribing PrEP more frequently as they regularly see those individuals at risk of HIV infection. He noted his clinic had some discussion about offering PrEP to partners of current patients, but no decision was finalized. Those partners need to be in care somewhere, where potential side effects can be monitored, he added.

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.]

Open Letter to FDA Urging Immediate PrEP Review

2012-01-25T15:07:00.000-06:00

via AIDS Foundation of Chicago

This is an open letter to the Food and Drug Administration, urging the priority review of the drug Truvada for use in PrEP (pre-exposure prophylaxis). The AIDS Foundation of Chicago and 25 other organizations signed this letter to counter the AIDS Healthcare Foundation's protest of the FDA regarding this review. To read the PDF of the letter, with footnotes, click here.

Dear Commissioner Hamburg:

We write as a coalition of 25 leading HIV/AIDS and health organizations to request that FDA grant priority review of a supplemental New Drug Application1 (sNDA) for the approval of emtricitabine/tenofovir disoproxil fumarate (Truvada®) fixed dose combination for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among adults as part of a comprehensive prevention package including risk reduction counseling and condoms.

The rigorous priority review process applicable to efficacy supplements is the best means to promote public health by recognizing the potential of PrEP to offer a major advance in HIV prevention and deserving this priority “where no adequate alternate therapy exists or as a significant improvement compared to marketed products … including nondrug products or
therapies.”

Our organizations understand that granting priority review is not tantamount to a final approval. Nevertheless, we are hopeful that the full dossier of data on emtricitabine/tenofovir disoproxil fumarate fixed dose combination of PrEP from multiple clinical trials in different populations can lead to a responsible regulatory and marketing plan that allows safe use in the populations that may benefit from this innovative development.

The need for significantly improved safe and effective HIV prevention tools is clear. Despite many years of efforts to reduce HIV incidence using available counseling methods, some 50,000 new infections occur annually. Disparities persist so that incidence continues to concentrate among African Americans and Latinos, men who have sex with men (including transgender individuals), and the poor. These grim and stubborn facts led to the creation of the White House-directed National HIV/AIDS Strategy for the United States (NHAS), which lists enhanced prevention efforts as a primary objective. If emtricitabine/tenofovir disoproxil fumarate for PrEP satisfies FDA approval criteria, health programs and individuals will have improved choices to address a domestic priority and save lives.

The PrEP sNDA for Truvada® meets criteria set out in FDA’s Manual of Policies and Procedures for priority review. As organizations committed to ending the AIDS epidemic, we appreciate how the history of FDA’s regulatory tools for fast track approval or for accelerated and priority review introduced the current suite of HIV therapeutic drugs to treat active infection. In the present case, there is a clear unmet need for new effective methods for preventing HIV infection, a need that is as urgent today as was the need for HIV therapeutics over the past two and more decades.

HIV advocacy organizations made it possible to launch such regulatory procedures for the benefit of all patient disease groups when those tools were not yet available. We are not aware of any legitimate reason to thwart the faster introduction of medicines FDA determines to be safe and effective to stop HIV, nor should anyone turn back the pages of history and act against the interests of patients to do so now. Unfortunately, recent actions by the AIDS Healthcare Foundation regarding PrEP would introduce unwarranted roadblocks in the FDA process of making responsible decisions about potentially useful medicines and public health. Those actions also foster misunderstandings of the careful balancing of risk and benefits that informs a mature marketing permission based on all available data. Those actions would also set an unhelpful precedent as PrEP research evolves in the future and the FDA is asked to review non-tenofovir-based regimens (e.g. maraviroc), microbicide gels, and intermittent PrEP. We urge that FDA continue its public health promotion goals now in the service of the critical need to prevent, as well as treat, HIV and grant this priority review.

We would be happy to discuss the priority review process as applied to HIV prevention further at your convenience. Mitchell Warren, Executive Director of AVAC, acts as the contact person for the organizations signing this letter and can be contacted at 1-212-796-6423 and mitchell@avac.org.

Yours sincerely,

AIDS Foundation of Chicago
AIDS Legal Referral Panel
AIDS Resource Center Ohio
AIDS Research Consortium of Atlanta
AIDS United
amfAR, The Foundation for AIDS
Research
Asian & Pacific Islander Wellness Center
AVAC: Global Advocacy for HIV Prevention
Black AIDS Institute
Caracole, Inc.
Chicago Black Gay Men’s Caucus
Fenway Health
HIV Prevention Justice Alliance
International Rectal Microbicide Advocates
Justice Resource Institute
LA Gay and Lesbian Center
National Alliance of State and Territorial
AIDS Directors
National Black Gay Men's Advocacy
Coalition
National Latino AIDS Action Network
National Minority AIDS Council
Ohio AIDS Coalition
Project Inform
San Francisco AIDS Foundation
SisterLove, Inc.
Ursuline Sisters of Youngstown HIV/AIDS Ministry
Us Helping Us

Read the PDF of the letter (with footnotes) 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.]

PrEP: Attitudes and Acceptance Among Potential User Groups

2012-01-25T12:55:00.002-06:00

via PLoS One, by Andreas B. Eisingerich, Ana Wheelock, Gabriela B. Gomez, Geoffrey P. Garnett, Mark R. Dybul, Peter K. Piot

Background

The use of antiviral medications by HIV negative people to prevent acquisition of HIV or pre-exposure prophylaxis (PrEP) has shown promising results in recent trials. To understand the potential impact of PrEP for HIV prevention, in addition to efficacy data, we need to understand both the acceptability of PrEP among members of potential user groups and the factors likely to determine uptake.

Methods and findings

Surveys of willingness to use PrEP products were conducted with 1,790 members of potential user groups (FSWs, MSM, IDUs, SDCs and young women) in seven countries: Peru, Ukraine, India, Kenya, Botswana, Uganda and South Africa. Analyses of variance were used to assess levels of acceptance across different user groups and countries. Conjoint analysis was used to examine the attitudes and preferences towards hypothetical and known attributes of PrEP programs and medications. Overall, members of potential user groups were willing to consider taking PrEP (61% reported that they would definitely use PrEP). Current results demonstrate that key user groups in different countries perceived PrEP as giving them new possibilities in their lives and would consider using it as soon as it becomes available. These results were maintained when subjects were reminded of potential side effects, the need to combine condom use with PrEP, and for regular HIV testing. Across populations, route of administration was considered the most important attribute of the presented alternatives.

Conclusions

Despite multiple conceivable barriers, there was a general willingness to adopt PrEP in key populations, which suggests that if efficacious and affordable, it could be a useful tool in HIV prevention. There would be a willingness to experience inconvenience and expense at the levels included in the survey. The results suggest that delivery in a long lasting injection would be a good target in drug development

Read the full study 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.]

MSMGF's Top 10 Policy Developments for Gay Men and Other MSM in 2011

2012-01-24T08:43:00.000-06:00

via MSMGF, by George Ayala, Jack Beck, Krista Lauer, Mohan Sundararaj

Dear all,

The year 2011 saw a number of events that changed the global landscape for advocates working on issues concerning HIV among men who have sex with men (MSM). From groundbreaking epidemiological research to the collapse of Global Fund Round 11, the past 12 months have brought valuable opportunities and daunting challenges. Taking stock of these developments is essential for strengthening our response to the epidemic and enhancing our advocacy for MSM health and human rights worldwide.

With this in mind, the MSMGF has released a new report highlighting the top ten policy developments of 2011. Entitled, “Top 10 in 2011: Key Global Policy Developments Concerning MSM & HIV,” the document details the successes and failures of the past year in an effort to help chart a course forward.
The document can be found on the MSMGF’s website at: http://www.msmgf.org/files/msmgf//Publications/TopTen_2011.pdf

We hope you find this document useful. We look forward to working together with you over the coming year to build the new victories of 2012, achieving a higher standard of health and human rights for MSM.

Sincerely,
The Global Forum on MSM & HIV (MSMGF)

Read the full report 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.]

Reasons behind high risk behaviors in Chinese MSM

2012-01-23T09:37:00.000-06:00

via BMC Public Health, by Guanzhi Chen, Yang Li, Beichuan Zhang, Zengzhao Yu, Xiufang Li, Lixin Wang, Ziming Yu

Background

Men who have sex with men (MSM) have become a high-risk group of HIV infection in China. To date, little is known regarding the behavioral, social and psychological characteristics in Chinese MSM, which makes the implementation of preventive and therapeutic strategies for this high-risk subpopulation of people extremely difficult.

Methods

A total of 714 questionnaires were retrieved from the database of a Chinese government-sponsored National Key Research Project titled "Risk Analysis and Strategic Prevention of HIV Transmission from MSM to the General Population in China". The respondents were categorized into a high-risk group and a control group. Their behavioral, social and psychological characteristics were comparatively analyzed.

Results

Of the 714 MSM analyzed, 59 (8.26%) had high-risk homosexual behaviors. This sub-group of MSM had a higher in-marriage rate, a higher monthly income, heavier alcohol consumption and more serious problems with sexual abuse in childhood, intentional suicide attempts and mistaken assumption on condom's role in protecting HIV infection, as compared with the control group (P < 0.05). In contrast, the two groups did not differ significantly the sexual orientation, level of education, types of profession, drug use, condom use and experience of social stigma and discrimination (P > 0.05). A vast majority of the individuals in both behavior categories expressed support of legally protected gay clubs as well as gay marriage legislation in China. There was a strong correlation between high-risk behaviors and sexual abuse in childhood, alcohol drinking, income level and a mistaken belief in perfect HIV protection through the use of condoms.

Conclusions

MSM with and without high-risk homosexual behaviors have different social and psychological characteristics, which should be taken into account when implementing behavioral and therapeutic interventions aimed at preventing HIV/AIDS transmission among MSM as well as from MSM to the general population in China.

Read the full study 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.]

Critical to fight stigma and discrimination faced by MSM

2012-01-20T08:44:00.002-06:00

via Inside Story, by Gregory Trotter

The dream of the AIDS-free generation will never be realized as long as there remain countries in the world that kill and imprison people for being gay.

Same goes for countries that won’t even acknowledge homosexuality exists within their national boundaries and therefore fail to provide targeted HIV prevention and treatment services. Such are the realities underscored by a new report, “Achieving an AIDS-free Generation for Gay Men and Other MSM,” released by amfAR and Johns Hopkins University on Wednesday.

The report studied the funding and implementation of HIV services targeted for MSM (men who have sex with men) in eight countries where same-sex intercourse is criminalized or heavily stigmatized: China, Vietnam, Ethiopia, Guyana, Mozambique, India, Nigeria and Ukraine. Among other findings, the study concluded that MSM are “deprioritized and marginalized by national HIV programs.”

In the report’s own words: “It will be impossible to achieve an ‘AIDS-Free Generation’ if MSM are left behind.”

(For those who may not know, the phrase “AIDS-free generation” has been a sort of battle cry for people and organizations involved in the ongoing efforts to stop the 30-year-old AIDS epidemic, gaining momentum since Secretary of State Hillary Clinton used it in her historic November 2011 speech.)

The report rings true for Jim Pickett, director of prevention advocacy and gay men’s health for the AIDS Foundation of Chicago (AFC). Pickett is also chair of the International Rectal Microbicides Advocates, a group that does what its name suggests. His work takes him all over the world to advocate for microbicide research and other HIV prevention strategies.

“Sadly, it’s not new. It’s what we know. But … it’s really important for us to continue to put that message out there. It’s another way to have this discussion, to shine a light on these disparities and to move forward in the right direction,” Pickett said. “(This report) is a really important document.”
Pickett was in Addis Ababa, Ethiopia, just last month for a meeting with advocates for the launch of Project ARM (stands for Africa for Rectal Microbicides). Project ARM is an IRMA initiative. The conference coincided with the 2011 International Conference on AIDS and STDs in Africa.

It was wrought with tension from the get-go, as anti-gay religious groups caught wind of an African gay men’s health pre-conference satellite and began mounting a protest. Eventually, they were silenced by the Ethiopian government, Pickett said. But it was an uncomfortable learning experience: IRMA and Project ARM kept their own agendas low-profile and encountered no problems.

At the Project ARM meeting, advocates from Malawi, Uganda and other countries talked about the fear of being discovered gay after receiving threats of bodily harm and death.

“We acknowledge that in our quest for developing these new HIV prevention strategies like rectal microbicides, they are for naught if people aren’t safe, if they can’t be who they are wherever they are,” Pickett said. “If you are so deeply stigmatized or demonized that you have to be hidden, you’re not going to come up and go to the counter and get a rectal microbicide. You’re not going to get any services.”

As an example, Pickett pointed to the arrests of nine gay men in Senegal following the 2008 ICASA. Word quickly rippled through the gay community in Senegal.

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.]

Rectal Sexually Transmitted Infections and Lubricant Use

2012-01-17T11:06:00.000-06:00

via Sexually Transmitted Diseases, by Pamina M. Gorbach, DrPH, Robert E. Weiss, PhD, Edward Fuchs, PA-C, Robin A. Jeffries, MS, Marjan Hezerah, PhD, Stephen Brown, MD, Alen Voskanian, MD, Edward Robbie, MPH, Peter Anton, MD, and Ross D. Cranston, MD

Background

Use of lubricant products is extremely common during receptive anal intercourse (RAI) yet has not been assessed as a risk for acquisition of sexually transmitted infections (STIs).

Methods

Between 2006 and 2008, a rectal health and behavior study was conducted in Baltimore and Los Angeles as part of the University of California, Los Angeles Microbicide Development Program (NIAID IPCP# #0606414). Participants completed questionnaires, and rectal swabs were tested for Neisseria gonorrhoeae and Chlamydia trachomatis with the Aptima Combo 2 assay, and blood was tested for syphilis (for RPR and TPHA with titer) and HIV. Of those reporting lubricant use and RAI, STI results were available for 380 participants. Univariate and multivariate regressions assessed associations of lubricant use in the past month during RAI with prevalent STIs.

Results

Consistent lubricant use during RAI in the past month was reported by 36% (137/380) of participants. Consistent past month lubricant users had a higher prevalence of STI than inconsistent users (9.5% vs. 2.9%; P 0.006). In a multivariable logistic regression model, testing positive for STI was associated with consistent use of lubricant during RAI in the past month (adjusted odds ratio: 2.98 95% confidence interval: 1.09, 8.15) after controlling for age, gender, study location, HIV status, and numbers of RAI partners in the past month.

Conclusions

Findings suggest some lubricant products may increase vulnerability to STIs. Because of wide use of lubricants and their potential as carrier vehicles for microbicides, further research is essential to clarify if lubricant use poses a public health risk.

Read the full study 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.]

Microbicides 2012 Conference Now Open for Registration!

2012-01-13T12:44:00.000-06:00

M2012 Registration is Open!

"To share in the latest developments in HIV prevention through microbicides and other technologies, this is the conference to attend. The conference is the key event in the microbicides world, where cutting edge research will be presented by world experts, and you will have a chance to interact with people involved at every level of microbicides development "

-Professor John Kaldor, The Kirby Institute and Conference co-Chair

Come to Sydney in April for the 2012 International Microbicides Conference - 'From Discovery to Delivery', with state of the art plenary lectures on microbicides and other aspects of HIV prevention research, cross-disciplinary symposia, oral abstracts, and poster sessions.

M2012 will be a global forum for the presentation and discussion of the latest information on microbicides and oral pre-exposure prophylaxis for HIV prevention and their interface with other prevention strategies. There will be a strong emphasis on the role of community in both research and implementation of scientific findings. The conference is interdisciplinary, and will include basic science, pharmacokinetics, formulation and delivery, clinical research, public health, prevention science, and social and behavioural research.

WHY SHOULD YOU COME?
1. LEARN... From experts from around the world who will speak on key issues in HIV prevention technologies.
2. NETWORK... with a cross-disciplinary group of researchers, community representatives and policy makers, to support you in applying new approaches and perspectives in your work.
3. PARTICIPATE... in sessions that will range from state of the art lectures, to debates on hot topics in microbicides development.

Click here to learn more.

[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 and Anal Sex Practices Among High Schoolers in Addis Ababa, Ethiopia

2012-01-12T09:00:00.001-06:00

via BMC Public Health, by Amsale Cherie and Yemane Berhane

Background

Understanding the full range of sexual behaviors of young people is crucial in developing appropriate interventions to prevent and control sexually transmitted infections including HIV. However, such information is meager in developing countries. The objective of this study was to describe oral and anal sex practices and identify associated factors among high school youth.

Methods

A cross-sectional study was conducted among high school youth in Addis Ababa, Ethiopia. A multi-stage sampling procedure was followed to select a representative sample of school youth. The total sample size for this study was 3840. Data were collected using a self-administered questionnaire. Data analysis was guided by the ecological framework.

Results

The overall proportion of people who reported ever having oral sex was 5.4% (190) and that of anal sex was 4.3% (154). Of these 51.6% (98) had oral sex and 57.1% (87) had anal sex in the past 12 months. Multiple partnerships were reported by 61.2% of the respondents who had oral sex and 51.1% of students practicing anal sex. Consistent condom use was reported by 12.2% of those practicing oral sex and 26.1% of anal sex. Reasons for oral and anal sex included prevention of pregnancy, preserving virginity, and reduction of HIV and STIs transmission. Oral sex practice was strongly and significantly associated with perception of best friends engagement in oral sex (AOR = 5.7; 95% CI 3.6-11.2) and having illiterate mothers (AOR = 11.5; 95%CI 6.4-18.5). Similarly, anal sex practice was strongly and significantly associated with favorable attitude towards anal sex (AOR = 6.2; 95%CI 3.8-12.4), and perceived best friends engagement in anal sex (AOR = 9.7; 95%CI 5.4-17.7).

Conclusion

Considerable proportion of adolescents had engaged in oral and anal sex practices. Multiple sexual partnerships were common while consistent condom use was low. Sexual health education and behavior change communication strategies need to cover a full range of sexual practices.

Read the full study 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.]

ANRS launches first PrEP trial for gay men in Europe

2012-01-11T10:25:00.000-06:00

via iPrEx NEws

The ANRS (French National Agency for Research on AIDS and Viral Hepatitis) is about to launch in Europe the first pre-HIV exposure prevention trial in men who have sex with men.

This phase III trial—ANRS IPERGAY—will start at the end of January 2012, in Paris (Hôpital Saint-Louis, Professor Jean-Michel Molina and Hôpital Tenon, Professor Gilles Pialoux) and Lyon (Hôpital de la Croix-Rousse, Dr Laurent Cotte), and later in Montreal in Quebec (CHUM Hôpital Hôtel Dieu, Dr Cécile Tremblay). The trial will include 300 volunteers in the pilot phase and ultimately 1900 in total.

ANRS IPERGAY will involve men who have sex with men and seronegative trans men who have anal sex with men without routine use of condoms, with at least two different sexual partners in the six months prior to trial participation. Participation will last for between 12 (minimum) and 48 (maximum) months.

The trial will compare two groups of participants, one given Truvada®, the other a placebo, taken in both cases during the period of sexual activity, starting before sexual relations and ending afterwards.

All participants, irrespective of group, will be offered various means of prevention: free condoms, regular HIV screening, regular screening for and treatment of sexually transmitted diseases, vaccination against hepatitis A and B. Participants can ask for personalized prevention advice, if they wish.

An important part of the trial will involve a social sciences study of the profiles of participants and analysis of their sexual behavior, in particular regarding condom use, and will determine whether or not they take the medication as intended.

Participants will be invited to the hospital every two months or so for an interview and for clinical examinations, including screening tests.
The ANRS will sponsor and fund the trial, and Gilead will supply the medication.

The HIV community-based association Aides helped draw up the protocol, is a scientific and operations partner in the trial, and is a member of the scientific board. It will coordinate recruitment in the field and provide volunteers with prevention support.

ANRS press contact:
Marie-Christine Simon – Tel : +33 (0) 1 53 94 60 30 marie-christine.simon@anrs.fr

[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.]

IRMA in Thailand to Prep for MTN 017

2012-01-10T11:03:00.003-06:00

IRMA, the Microbicide Trials Network (MTN), AVAC, and local partners participated in two community consultations in Thailand last week on the upcoming Phase II rectal microbicide trial called MTN 17.

Community stakeholders in Chiang Mai and Bangkok were provided updates on the field and were asked to provide feedback to the MTN about the draft MTN 017 protocol. In October, a similar consultation was held in Cape Town. Pittsburgh held another one of these sessions recently, and more community input sessions are planned for Boston and Lima as well.

Check out some pictures of the consults...

More pictures of Chiang Mai consult on MTN 017 here.

More pictures of Bangkok consult on MTN 017 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.]

Age as a Risk "Marker" for MSM

2012-01-09T10:34:00.000-06:00

via JAIDS, by Potterat, John J BA; Brewer, Devon D PhD

Hurt and colleagues observed that primary HIV infection (PHI) in men who have sex with men (MSM) was associated with selecting older sex partners. Specifically, MSM with PHI (median age, 24.5 years) tended to choose partners 5 years older (median, 29.8 years) compared with uninfected MSM who were much closer in age (22.5 years; partners, 23.9 years). This result is not surprising, because older MSM are more likely to be infected. In Colorado Springs, for example, rigorously sought, community-wide sexually transmitted disease/HIV surveillance data show that whereas chlamydia is an infection of the late teens and early 20s, and gonorrhea of the early to mid-20s, the average age for HIV seroconversion is late 20s (median, 27 years; mean, 27.8 years), an average age approaching that of older partners of men with PHI in Hurt and colleagues' study.

What is remarkable is Hurt and colleagues' and Coburn and Blower's interpretation of the observed association between partner age disparity and PHI. They mislabel sex with an older man as a risk factor for HIV and correspondingly call for prevention messages to be refocused on this behavior. Sex with an older MSM cannot be a risk factor for HIV infection, although it is a risk marker. The fact that the age of sex partners remained an independent correlate of recent HIV infection in Hurt and colleagues' multivariate model reflects mismeasurement of exposure to HIV. It appears objective data on partners' HIV statuses were unavailable for 90% (18 of 20) of men with PHI and 46% (25 of 54) of uninfected men. It is unclear whether all such partners were classified as “serostatus unknown” (and thus regarded as having exposed participants to HIV) or their serostatuses were estimated from participants' perceptions (the authors did not describe such procedures). In the former scenario, uninfected men's exposure to HIV may be overestimated. In the latter scenario, men with PHI may have incorrectly perceived infected partners as uninfected or not reported partners during the period when they acquired infection because the authors collected data on the three most recent partners only.

Other characteristics of partners can also serve as markers of HIV risk in MSM such as race and injection drug use. The social contexts in which MSM form sexual partnerships may be even better indicators of HIV risk. Although local data on risk markers might inform ancillary prevention messages, the educational focus in MSM should remain on avoiding the most direct risk factors-anal (especially receptive) intercourse without a condom and sex between serodiscordant men-as their own data clearly show.

[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.]

USAID Technical Brief: Human Rights Considerations in Addressing HIV Among MSM

2012-01-04T12:42:00.000-06:00

via USAID, by AIDSTAR-One Project

Just as I was very proud to say the obvious more than 15 years ago in Beijing—that human rights are women’s rights and women’s rights are human rights—let me say today that human rights are gay rights and gay rights are human rights.

–Hillary Clinton, U.S. Secretary of State (U.S. Department of State 2010)

Introduction
Men who have sex with men (MSM) face a disproportionate share of the HIV epidemic throughout the world (Baral et al. 2007; Cáceres et al. 2008), and in low- and middle-income countries bear a greater burden of the epidemic relative to the general population. In many countries, the HIV risk to MSM is exacerbated by social, cultural, and political factors. These include cultural biases against MSM, limited access to information and services, low national investments in health, and legal, institutional, or social barriers, including negative bias among providers, that make it difficult for MSM to negotiate safe sex or obtain adequate services for preventing and treating HIV and other sexually transmitted infections (STIs). This situation is compounded by adverse human rights environments— for example, in settings where same-gender sexual relationships are illegal—where MSM may fail to seek treatment because doing so may lead to harassment, refusal of services, arrest, or violence.

Yet international consensus and recommendations— including the 2011 United Nations (UN) Political Declaration on HIV/AIDS, to which the United States was a signatory—recognize the vulnerability of MSM to HIV and endorse national and international efforts to include MSM in HIV programming and address discriminatory laws and practices that keep this group from obtaining services. In keeping with this consensus,the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) has issued guidance on developing comprehensive programming to reduce HIV among MSM.

This AIDSTAR-One technical brief provides a systematic global review and synthesis of practical approaches, program examples, and resources to support human rights as a core element of HIV programming for MSM. The brief complements and is aligned with other global and regional publications that have relevance to human rights, health programming, HIV, and MSM.(1) This document gives an overview of U.S. policies on and commitments to MSM and human rights, and outlines recommended approaches, including program examples in various countries, for linking health and human rights to address HIV among MSM. It also offers a synthesis of questions for developing and monitoring HIV programs for MSM, and a list of program resources.

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.]

Treatment outcomes among different ethnic groups similar for UK gay men

2012-01-03T12:52:00.000-06:00

via Aidsmap, by Michael Carter

HIV treatment outcomes among gay men in the UK are similar across ethnic groups, investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

The study showed that gay men from black and minority ethnic (BME) populations were approximately 17% less likely to initiate antiretroviral therapy than white gay men. However, after starting treatment there were no differences by ethnicity in treatment outcomes.

“The provision through the NHS [National Health Service] of publicly funded HIV care with universal access has resulted in equitable utilisation and outcomes of HIV care across different ethnic MSM [men who have sex with men] groups,” comment the investigators. “Nevertheless we have shown that there are disparities in the uptake of cART [combination antiretroviral therapy] and the reasons for this warrant further study.”

Gay men remain one of the groups most affected by HIV in the UK. Prevalence of the infection differs significantly according to ethnicity and is higher among BME gay men compared to white gay men.

US research showed that differences in health insurance status meant that MSM from minority racial populations were less likely to access healthcare compared to white MSM.

In the UK, however, the NHS provides universal and equitable access to healthcare. Despite this, there is some evidence suggesting that BME patients are more likely to report dissatisfaction with their care and longer waiting times for appointments.

Investigators from the UK Collaborative HIV Cohort (UK CHIC) therefore analysed differences in retention in HIV care, uptake of antiretroviral therapy and HIV treatment outcomes between MSM according to ethnicity.

The study involved 16406 gay male patients who received care between 1996 and 2008. The analysis of HIV treatment utilisation was restricted to individuals who were seen after 2000. Examination of treatment outcomes was restricted to the subgroups of individuals who received care after 2007.

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.]

Gratitude, Love, and XOXO from IRMA

2011-12-30T11:19:00.001-06:00

Dearest IRMA members -

Just a quick note to say THANK YOU for everything you have done this year to advance the research and development of safe, effective, acceptable, and accessible rectal microbicides for the human beings who need them.

I think IRMA has had a banner year - and the reason it was so incredible is YOU.

Here are some highlights. Feel free to chime in with your own - this list is by no means exhaustive of all the fabulous things IRMA, and the field as a whole, have been up to...

- With thanks to AVAC, in 2011 IRMA greatly expanded our advocacy footprint in South America with a strengthened IRMA-ALC (America Latina y el Caribe). Based at the gay men's health organization Epicentro in Lima, Peru, IRMA ALC has been invigorating rectal microbicide and PrEP advocacy throughout the region, and is now perfectly poised to engage with the upcoming Phase II rectal microbicide trial MTN 017 that will include a site in Lima. Pictured above is Tia IRMA (Auntie IRMA) - a character created by IRMA-ALC to help share information on rectal microbicides, anal sex, lubricants, etc - and make it fun/funny :)

- In 2011, IRMA secured funding from MAC AIDS Foundation, the Microbicide Trials Network, and the Population Council to develop a short, fun video about rectal microbicide science and clinical trial involvement. We actually JUST HIRED a production company (based in Cape Town, South Africa), and will begin work on the project in earnest as soon as the clock switches to 2012. The video will be something that all our advocates can use, and will be especially helpful for folks in cities where advanced rectal microbicide trials are planned as the video will be designed to support site recruitment activities. We plan to have this baby ready to go by the time MTN 017 launches in mid-year.

- IRMA successfully launched a new initiative called Project ARM - Africa for Rectal Microbicides. With support from the National Institutes of Health Office of AIDS Research, the New Venture Fund, and AVAC - we held a fantastic kick-off meeting with 40 individuals in Addis Ababa in early December, and came up with a whole set of advocacy and scientific activities designed to fully engage Africa in rectal microbicide research and advocacy. A report from the meeting - a road map of sorts - will be released at Microbicides 2012. But not content to wait, the group that met in Addis is already busy getting started on Project ARM goals and objectives - and will be reaching out to our broader IRMA membership in 2012 to help move us all forward.

None of this would have happened without our amazing membership - so much love and gratitude to you all. You make me so happy and proud :)

I am excited to say that I am headed to Thailand tomorrow. IRMA is helping conduct civil society consultations in Bangkok and Chiang Mai in conjunction with MTN 017 - similar to the ones that were held in Cape Town and Pittsburgh already (and are being planned for Boston and Lima.) This will be a great opportunity for IRMA to expand it's membership in Thailand. And I must say, my slides that have been translated into the Thai language look STUNNING - the Thai script is so lovely.

Actually, the announcement of MTN 017 was another HUGE highlight in 2011. It will be the field's very first Phase II rectal microbicide trial - how cool is that?! We will be sure to tell you more about it once the protocol is finalized in the new year - including a global teleconference which will explain all the details.

If you have other highlights to share regarding our field - please feel free.

In the meantime, best wishes to each of you, and happy, happy, happy New Year.

Jim Pickett
IRMA Chair

[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.]

Anal sex increasingly popular among heterosexuals

2011-12-29T07:44:00.000-06:00

via NY Mag, by Em and Lo

Every couple of years, another once-scandalous sex taboo starts making its way toward the commonplace. A decade ago, blow jobs were what people whispered about; then three-ways became the naughty bedroom act. Now, it’s anal sex—but according to the Centers for Disease Control’s National Survey of Family Growth, it’s rapidly becoming a regular feature of hetero couples’ horizontal activities.

The survey, released last year, showed that 38.2 percent of men between 20 and 39 and 32.6 percent of women ages 18 to 44 engage in heterosexual anal sex. Compare that with the CDC’s 1992 National Health and Social Life survey, which found that only 25.6 percent of men 18 to 59 and 20.4 percent of women 18 to 59 indulged in it.

Anecdotal research also demonstrates curiosity is on the rise. Babeland’s anal-sex workshops are now held three or four times a year, instead of once, and they’re filled with straight couples. “More and more, people are devoting themselves to learning about anal pleasure,” says Carolyn Riccardi, education coordinator for Babeland’s New York retail stores. “Male-to-female anal sex has been happening since the dawn of time,” she says. “What’s different now is that women are actively learning how to enjoy it and have fun with it.”

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.]

Ongoing risk behaviour likely cause of high HIV incidence rate among gay men treated with PEP

2011-12-21T09:00:00.001-06:00

via Aidsmap, by Michael Carter

HIV incidence is high among gay men who use post-exposure prophylaxis (PEP), investigators from Amsterdam report in the online edition of AIDS.

Overall, users of PEP were almost four times more likely to become infected with HIV than gay men who did not use the therapy.

There was no evidence that PEP failure was the cause. The investigators believe this is because PEP users continued to put themselves risk of HIV after completing their treatment.

“Our study showed a high incidence of HIV among MSM [men who have sex with men] who used PEP, an indication of ongoing risk behaviour,” write the investigators. “This implies that PEP alone for this group is not sufficient to prevent HIV infection, and a combination of other more comprehensive preventative strategies is needed.”

HIV post-exposure prophylaxis is a four-week course of combination antiretroviral therapy, prescribed after an encounter with body fluids possibly infected with HIV.

It is estimated that the treatment can reduce the risk of infection by up to 81%.

Gay men are the group most likely to request PEP after a possible sexual exposure to HIV. Australian research has shown that gay men who used PEP continued to be at risk of HIV after completing their treatment.

Therefore, Dutch investigators compared HIV incidence among gay men prescribed PEP in Amsterdam between 2000 and 2009, and compared this to the rate of new infections seen over the same period among gay men enrolled in the Amsterdam Cohort Study.

A total of 355 men who received 395 PEP prescriptions were included in study. The majority of individuals took one course of PEP, but approximately 10% of men were provided with multiple prescriptions (two to four).

Adherence rates were high, with 94% of men completing their therapy. HIV status was monitored three and six months after baseline.

Eleven PEP users seroconverted. Two men tested HIV-positive at their three-month follow-up appointment; one individual who did not attend for his three month appointment was diagnosed at month six; and the remaining eight men were HIV-negative at month three, but were HIV-positive at month six.

This provided an HIV incidence of 6.4 per 100 person years among the individuals treatment with PEP.

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.]

Beliefs associated with unprotected sex are changing among gay men in Australia

2011-12-20T09:00:00.000-06:00

via Aidsmap, by Roger Pebody

A study of Australian gay men examining unprotected sex and the beliefs that are associated with it has found that the concept of ‘treatments optimism’ needs to be unpacked. While some men do think that having HIV is less serious than it used to be, there is more of an association between unprotected sex and men believing that treatments have made HIV-positive people less infectious.

But writing in the journal Sexually Transmitted Diseases, the researchers warn that the relationships between information, beliefs and behaviour are not straightforward, with individuals managing risk, desire and pleasure in complex ways.

Soon after the advent of combination therapy, commentators began to explain unprotected sex in gay and bisexual men in terms of ‘treatments optimism’ – the theory that reductions in illness and death had caused men to be less concerned about HIV infection, and so more willing to have unprotected sex. While a number of studies have confirmed an association between beliefs characteristic of treatments optimism and risk behaviour, it is unlikely that such beliefs – held by a minority of men – are sufficient to explain rising infection rates in gay men.

Moreover, there has always been controversy over whether treatment optimism leads to unprotected anal sex, or whether it is a way in which men rationalise their sexual behaviour, after the event.

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.]

HIV Among MSM in China

2011-12-19T11:16:00.000-06:00

via China Daily, by Xu Lin

**IRMA's Rectal Hygiene Survey is now available in Chinese (as well as English, Thai, Russian, Spanish, French and Portuguese). Click here to take the brief, anonymous survey.

Beijinger Zhang Lei was surprised to see posters in her neighborhood that showed two shirtless men each holding a condom.

She snapped three photos of the posters in her community in Beijing's Xicheng district and posted them on her Sina Weibo micro blog on Nov 29. Her post stirred fierce debate.

Some doubt the government approved the posters. Others believe it shows progress in China's HIV/AIDS prevention and mindset.

"I never thought government offices would print such posters, as homosexuality seems taboo in China," Zhang, who works in a real estate finance company, says.

"I think the posters are good but wonder if the elderly can understand them."

The posters were created in 2009 by the Chinese Center for Disease Control and Prevention (CDC) and Chengdu Tongle Health Consulting Center, a Chengdu, Sichuan province-based NGO that promotes homosexual culture, HIV/AIDS prevention and treatment.

In December 2010, the CDC printed the posters and mailed them to its branches throughout the country.

The center also posted the downloadable electronic versions on its website.

"The posters have been used for some time, but the public didn't know that until recently, because the posters are mostly displayed in gay bars and public bathhouses that are frequented by homosexuals," Xu Jie, of the CDC's National Center for AIDS/STD Control and Prevention, says.
"Conventional AIDS posters can't capture the attention of special groups, such as intravenous drug users and homosexuals. It's necessary to design different posters for them, to better promote HIV/AIDS prevention and treatment."

He says the center has also designed posters for drug users and sex workers.

There are about 780,000 people living with HIV/AIDS in China. About 48,000 people were diagnosed as HIV-positive in 2011. Among them, 29.4 percent are men who have sex with men (MSM).

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.]

Electrocautery ablation safe and effective to treat anal lesions

2011-12-16T14:00:00.000-06:00

via aidsmap, by Michael Carter

A clinic-based intervention offers safe and effective treatment for high-grade pre-cancerous anal lesions, US investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

Doctors at the Mount Sinai School of Medicine, New York, used a technique called electrocautery ablation to treat pre-cancerous anal lesions in 232 gay men, 132 of whom were HIV-positive.

Eighteen months after treatment, 83% of HIV-negative men and 69% of those with HIV were free of high-grade pre-cancerous anal lesions.

“Electrocautery ablation of high-grade anal squamous intraepithelial lesions is a safe and effective office-based procedure comparable to other available treatments,” comment the investigators.

Incidence of anal cancer has increased dramatically among gay men in recent years. HIV-positive gay men appear to be especially vulnerable to the disease, and its incidence is five-times higher in these patients compared to HIV-negative men.

Infection with high certain high-risk strains of human papillomavirus can cause cell changes in the anus, resulting in the formation of lesions. The severity of these changes is graded, and between 9% and 13% of high-grade lesions progress to anal cancer.

There are a number of treatments for these pre-cancerous lesions including infrared coagulation and topical creams such as imiquimod.

Another therapy is electrocautery ablation. The investigators described the procedure thus: “Using a gentle brushing technique the lesion was ablated [worn down] by moving [a] blade lightly across the surface like a paint-brush.” The therapy has a number of advantages and can be performed in clinics without the need for anaesthetic or sedation.

Investigators wished to assess the safety and effectiveness of this procedure. They therefore retrospectively analysed the notes of gay men who had the treatment between 2006 and 2010. The patients received an initial treatment and were then followed at intervals of three to six months and were provided with additional treatment if necessary.

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.]