Do you use rectal douches? Or don't you?

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Wednesday, November 30, 2011

"The End?" AVAC's 2011 Science-Based Agenda to End the Epidemic

via AVAC

This AVAC report presents a three-part agenda for ending the AIDS epidemic. It is intended as a vision and a challenge to the field, and a first step in holding all of us—civil society, researchers, governments, and funders—accountable for progress.

Each of the major priorities below demands action now—but the dividends will come in the short, medium, and long terms.

1. DELIVER today’s proven strategies at scale for immediate impact
•Model combination prevention programs to identify the parameters that are essential for scale-up to have a major impact on infections

•Mobilize demand for new tools among people who could benefit, through social marketing and other efforts

•Reprogram existing resources when evidence shows they could be used to greater effect

•Fund evidence-based scale-up today—and save money in the future—through substantial increases in commitments from U.S., European and developing country funders.

2. DEMONSTRATE and roll out newly available HIV prevention tools, including PrEP and microbicides, for even greater impact in 5 to 10 years

•Plan for the introduction of PrEP and microbicides in the next several years, and for follow-on research needed to address questions that remain unresolved in trials to date

•Pilot these interventions through demonstration projects that help define their optimal use and real-world impact

•Prioritize the use of these interventions in populations, and in combinations, where the potential benefits are greatest

3. DEVELOP long-term solutions—including an effective vaccine and a cure—that will enable us to close the door on AIDS

•Sustain funding for research, to capitalize on recent scientific insights that have begun to revitalize the search for a vaccine, while pursuing new leads that may eventually result in a functional cure for HIV infection.

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.]

When Condoms Ain't Enuf

via The Body, by Allen Kwabena Frimpong and Michael Terry Everett

"I also want to mention that we are increasingly becoming better at incorporating conversations about 'harm reduction' into the realms of substance use (needle exchanges, safe injection sites, pill testing, etc.), but we often fail to adequately translate this model when speaking of communicating risk reduction in sex (strategic positioning, sero-sorting, viral load suppression, etc.). My question back to the group then is, how do we more effectively communicate to young people the abstract concept of 'harm reduction' for sex within the context of a sex phobic society?"

This was a question posed by Jamie Forrest of Vancouver, Canada in the North America, Western Europe, and Caribbean CrowdOutAIDS Open Forum on Facebook. CrowdOutAIDS is UNAIDS new collaborative online youth-led project. He posed this question to the group after people were discussing what they considered to be the main reasons for HIV infection among young people.

Reading the responses on Facebook gave us one of those jolted reactions. The dominant message about sexual health in relation to HIV prevention has been focusing on condom usage. Jamie's question was one that I saw as challenging; given the propaganda that the HIV/AIDS field has been pushing around what it means to have safer sex. My colleague at the Harm Reduction Coalition, Michael T. Everett, was also raising this same question especially among young men who have sex with men (YMSM) of color given that their rates of infection have been steadily increasing while rates of infection among injection drug users has been on the decline.

The question for us became what (besides the exchange of needles) was accounting for the decrease in transmission of HIV among injection drug users, and how could we use what works in harm reduction messaging and education when it comes to drug use (if anything) for other high-risk populations greatly affected by the epidemic through sexual transmission. We considered this in light of the following:
a. We cannot exchange condoms like we do syringes.

b. We know people are not using condoms all the time, and the possibilities of HIV and other STI's has not scared enough people into doing so, and so ...

c. If people have been harboring condom use as the dominant end all be all harm reduction response- well then something is terribly wrong with this picture.

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.]

Tuesday, November 29, 2011

Registration for the XIX International AIDS Conference (AIDS 2012) Opens December 1!

Registration, abstract and programme activity submissions for the XIX International AIDS Conference (AIDS 2012), to be held from 22 to 27 July 2012 in Washington, D.C., open December 1 online at www.aids2012.org.

More than 25,000 participants and 2,000 journalists from approximately 200 countries are expected to convene at the conference, which is predicted to be a landmark event in the history of HIV and AIDS both in the United States and globally.
“Turning the Tide Together”, the theme of the conference, emphasises that we have reached a pivotal moment in time and that seizing this potential and actually turning the tide on HIV and AIDS will require commitment and action on many levels. The conference will be an important and high profile opportunity to reflect on the tension between recent scientific advances which could theoretically end the epidemic, and the current global economic crisis which threatens the funding necessary to implement this scientific knowledge.

“In the last couple of years we have seen some incredibly important breakthroughs in science,” said. Elly Katabira, International Chair of AIDS 2012 and President of the International AIDS Society (IAS). “The results of the CAPRISA trial presented at AIDS 2010 and the data from IAS 2011 proving beyond a doubt that treatment is prevention have shown us that we now have the real potential to change the direction of HIV. Science has provided us with the tools, what we need now is a global political and economic commitment to action. A turbulent economic climate must not halt funding for research and implementation”.

The return of the International AIDS Conference to the United States after more than 20 years represents a victory for public health and human rights and it is the result of dedicated advocacy to end the nation’s misguided entry restrictions on people living with HIV.

“Hosting AIDS 2012 in the U.S will be an occasion to highlight the disparities in access to treatment and care which exist in the country.” said Diane Havlir, Local Co-Chair of AIDS 2012. “We hope for a broad and active participation from all of those affected by the HIV epidemic, particularly people living with HIV and AIDS, policy-makers and key affected populations”.

Together with delegate and media registration, 1 December is the opening day for online abstract submissions. Over half of all conference sessions will be abstract-driven and all of the submissions will go through an extensive peer-reviewed process in order to guarantee the highest caliber of state-of-the-art science. The online abstract submission closes on 15 February 2012 and reopens on 19 April 2012 for late breaker abstract submissions.

In addition to the conference sessions, AIDS 2012 will feature a set of workshops open to delegates. Workshops will fall under professional development, community skills and leadership skills. Online submissions for workshops open on 1 December 2011 and close on 15 February 2012.

AIDS 2012 will host a Global Village, open to conference delegates and the general public, aimed at intensifying the involvement of key affected populations and other stakeholders in the conference. The conference also presents a Youth Programme with the goal of strengthening the participation of young people and youth issues in the conference through activities such as youth-driven sessions. From today it is possible to submit applications for both the Global Village and the Youth Programme. Both the submissions close on 15 February 2012.

With over 7,000 square metres of prime exhibition space AIDS 2012 offers both commercial and non-commercial organizations the opportunity to showcase their products and services to a wide public. Exhibitor applications open on December 1 and close on 25 May 2012. Exhibition space is limited so early bookings are strongly encouraged.

Various satellite meetings will take place in the conference centre during AIDS 2012. These satellite meetings are fully organized and coordinated by the organization hosting the satellite. The satellite slots are available for a fee and the applications open on 1 December and close on 31 March 2012.


From 8 December online applications for scholarships will be open. The International and Media Scholarship Programme is open to everyone around the world and is aimed at making the conference accessible to people from resource-limited settings and communities. Priority is given to those whose participation will help enhance their work in their own communities. A limited number of scholarships will be also available for media representatives.

More information on registration process and registration fees is available here: http://www.aids2012.org/Default.aspx?pageId=368


[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.]

Monday, November 28, 2011

The Future Role of Rectal and Vaginal Microbicides in Heterosexual Couples


via STI British Medical Journal, by Marie-Claude Boily, Dobromir Dimitrov, Salim S Abdool Karim, Benoît Mâsse

Objectives

To compare the potential impact of rectal (RMB), vaginal (VMB) and bi-compartment (RVMB) (applied vaginally and protective during vaginal and anal intercourse) microbicides to prevent HIV in various heterosexual populations. To understand when a RMB is as useful than a VMB for women practicing anal intercourse (AI).

Methods

Mathematical model was used to assess the population-level impact (cumulative fraction of new HIV infections prevented (CFP)) of the three different microbicides in various intervention scenarios and prevalence settings. We derived the break-even RMB efficacy required to reduce a female's cumulative risk of HIV infection by the same amount than a VMB.

Results

Under optimistic coverage (fast roll-out, 100% uptake), a 50% efficacious VMB used in 75% of sex acts in population without AI may prevent ~33% (27, 42%) new total (men and women combined) HIV infections over 25 years. The 25-year CFP reduces to ~25% (20, 32%) and 17% (13, 23%) if uptake decreases to 75% and 50%, respectively. Similar loss of impact (by 25%–50%) is observed if the same VMB is introduced in populations with 5%–10% AI and for RRRAI=4–20. A RMB is as useful as a VMB (ie, break-even) in populations with 5% AI if RRRAI=20 and in populations with 15%–20% AI if RRRAI=4, independently of adherence as long as it is the same with both products. The 10-year CFP with a RVMB is twofold larger than for a VMB or RMB when AI=10% and RRRAI=10.

Conclusions

Even low AI frequency can compromise the impact of VMB interventions. RMB and RVMB will be important prevention tools for heterosexual populations.

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.]

Friday, November 25, 2011

IRMA Statement on Discontinuation of Gel Arm in VOICE Prevention Trial


25 November, 2011
IRMA Expresses Disappointment; Calls for MTN 017 to Move Forward

International Rectal Microbicide Advocates (IRMA) expresses disappointment regarding today’s announcement that the vaginal tenofovir gel arm in the Microbicide Trial Network’s (MTN) VOICE trial is being discontinued. VOICE has been exploring two ARV-based HIV prevention approaches since it began enrolling women in high incidence areas in South Africa, Uganda and Zimbabwe in 2009.

The MTN announced that the VOICE arm studying daily vaginal application of tenofovir gel was stopping after a regular review of study data conducted by the independent Data Safety Monitoring Board revealed that the gel, while safe, was not effective at preventing HIV infection in women . Less than two months ago, VOICE announced the discontinuation of its study arm testing tenofovir tablets because they also were shown to not be effective at preventing HIV in the trial. VOICE will continue to study the safety and efficacy of Truvada tablets.

“This is tough news to hear, so soon after the tenofovir tablet arm stopped, and we are certainly disappointed,” said Jim Pickett, IRMA chair. “The field has placed a great deal of hope – and resources – in the development of vaginal tenofovir gel and no one is happy about such an outcome.”

The scientific path is a long, challenging and often confounding one. While this wasn’t information anyone wanted to hear, we will learn much about why tenofovir gel did not work in this well-conducted trial. At the moment we do not know whether this was a matter of adherence, biology, or sexual behaviors – or a combination of all three.

“Too often heterosexual transmission is presumed, by default, to be through unprotected vaginal intercourse. It will be interesting to learn how much anal intercourse was being reported in the trial. Unprotected anal intercourse is 10 to 20 times more likely to result in HIV transmission compared to unprotected vaginal intercourse. If even a small portion of VOIC E participants were practicing unprotected anal intercourse, this may have confounded the efficacy of the vaginal gel being tested,” said Pickett.

It is critical that the planned MTN 017 Phase II rectal microbicide trial moves forward. MTN 017 will study a modified formulation of tenofovir gel, to be applied rectally among gay men and other men who have sex with men (MSM) in Thailand, South Africa, Peru and the United States with a proposed launch in mid-2012. While moving forward with MTN 017 is dependent on the MTN 007 study which tested rectal safety and acceptability of this gel, we expect results soon. If the results indicate this modified formulation of tenofovir gel is both safe and acceptable when used rectally, MTN 017 must happen.

“Gay men and other MSM suffer very high prevalence rates in every part of the world, and their primary exposure is from unprotected anal intercourse. It is therefore an imperative we study products for rectal use. The rectum is a more fragile environment than the vagina and has other characteristics that increase the chances for HIV infection to take hold,” said Pickett. “As anal intercourse is a human behavior not confined to gay men and other MSM – we all have rectums after all– developing safe, effective, acceptable and accessible rectal microbicides will be important to the health and well-being of millions of women and men in Africa and throughout the world.”

IRMA is pleased the FACTS 001 study, a Phase III trial in South Africa testing the same regimen of tenofovir gel used in CAPRISA 004, plans to continue. IRMA is also excited about the upcoming Phase III trial testing a vaginal ring containing the ARV dapivirine. Delivery methods such as vaginal rings may improve adherence and drug availability.

# # # #

IRMA (www.rectalmicrobicides.org), a project of AIDS Foundation of Chicago (www.aidschicago.org) is a global network of advocates, researchers, policy makers and funders committed to the research and development of safe, effective, acceptable and accessible rectal microbicides for all that need them.





[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.]

Tuesday, November 22, 2011

MSM living in hostile social environments more likely to have negative feelings about sexuality, less likely to test for HIV

via aidsmap, by Roger Pebody

The largest ever international study of the sexual health of men who have sex with men (MSM), which recruited men from across the European continent, has found clear links between the social environment men live in and their own internal acceptance of their sexuality. Furthermore, men with 'internalised homonegativity' were much less likely to test for HIV.

These European results are to some extent confirmed by a study from the United States, which found that men living in states that are hostile to gay issues were more likely to have internalised homonegativity than men living in more tolerant states. However the American researchers found that the relationship between men's feelings about their sexuality and unprotected sex was quite weak.

Preliminary results from both studies were presented to the Future of European Prevention among MSM (FEMP) conference in Stockholm last week.

While the term 'homophobia' is probably better known than 'homonegativity', a number of researchers prefer the latter as it does not suggest that negative attitudes to homosexuality and homosexuals are fundamentally driven by fear. Public expressions of homonegativity may include discriminatory laws, personal rejection by family and friends, violent attacks in public spaces, disapproval from religious authorities and hostile newspaper articles.

When gay, bisexual and other men who have sex with men have negative or ambivalent feelings about their own sexuality, this is termed 'internalised homonegativity'. It has been defined as "the gay person's direction of negative social attitudes toward the self, leading to a devaluation of the self and poor self-regard".

While it may seem obvious that negative social environments can create negative psychological states, the link between social factors at a country level and men's internalised homonegativity has not been clearly demonstrated before.

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.]

Monday, November 21, 2011

Nigeria Stifling Gay Rights

via IRIN Africa

Rights groups in Nigeria fear a same-sex marriage bill being discussed in parliament could boost already prevalent discrimination against homosexuals. The bill goes much further than banning same-sex marriage; it threatens to ban the formation of groups supporting homosexuality, with imprisonment for anyone who “witnesses, abet[s] or aids” same-gender relationships, and could lead to any discussion or activities related to gay rights being banned.

Under a colonial-era law, sodomy is punishable by a 14-year jail sentence; and in the country’s mainly Muslim northern states, where a version of Shar’ia law applies, the penalty is death by stoning, although this has never officially been carried out.

The National Assembly began debating the latest version of the Same Sex Marriage (Prohibition) Bill in November. Most high-ranking officials have voiced their approval of the bill, signalling it is likely to pass.

Intolerance prevails

Analysts see the bill, which has been shelved twice in five years, as a potential boost to the popularity of a government whose approval ratings have stalled since elections in April this year. Most Nigerians strongly disapprove of homosexuality, with many seeing it as a foreign import at odds with a deeply religious society.

A 2008 survey by non-profit, Nigeria’s Information for Sexual and Reproductive Rights, of 6,000 Nigerians on their attitudes to homosexuality, found that only 1.4 percent of respondents said they felt “tolerant” towards sexual minorities.

A university student in the northern state of Jigawa was killed in 2002 when classmates set upon him after rumours that he was gay.

In September 2008, several national newspapers published the names, addresses and photographs of the pastor and congregation of a church in the port city of Lagos that ministered to sexual minorities. A few days later a mob that included policemen attacked the church. Members of the congregation lost jobs and homes and had to go into hiding; others are still harassed and threatened with physical harm, Human Rights Watch said in a statement.

“Homosexual and lesbian practices are considered offensive to public morality in Nigeria. The… bill is crucial to our national development because it seeks to protect the traditional family, which is the fundamental unit of society, especially in our country,” said the influential newspaper, This Day, in its editorial on 10 November. “It will be difficult to import practices and lifestyles which are alien to our country and the majority of our people.”
Homosexual rights are narrowing across Africa. In Uganda, gay rights activist David Kato was killed in January 2011 after opposing the Anti-Homosexuality Bill in 2009.

In Malawi a gay couple was imprisoned for “gross indecency”. The United States and British governments have threatened to cut off aid money to African countries seeking to curb gay rights.

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.]

Friday, November 18, 2011

Pros and Cons of Treatment as Prevention

via a&u, by Jeannie Gibbs

Post-exposure prophylaxis (PrEP) is the provision of antiretrovirals (ARVs) to HIV-negative people in order to prevent HIV infection. In light of recently released data, a heated debate is raging in the HIV community on how and if PrEP should be implemented. A vast array of ethical, financial, and medical concerns have been expressed, in fact too many to address in one article. However, most agree that PrEP (with more research), although not a single solution to preventing the continued spread of HIV, should be added to the arsenal of HIV prevention strategies where it is needed most.

Many contend that PrEP cannot be justified at the present time in all populations while millions already living with HIV are in desperate need of treatment. At the same time, the need for additional effective prevention methods, particularly among serodiscordant couples, men who have sex with men who practice unsafe sex, and disenfranchised women is immense, leading most to agree that PrEP should be explored for these groups.

Despite the concerns regarding PrEP, many in the HIV community view the recent PrEP data as a dramatic step and a valuable tool in reducing HIV transmission. “We’re excited about PrEP,” states Frank Oldham, president and CEO, National Association of People with AIDS. “Not because it will end HIV in America. It won’t and can’t. The epidemic is caused as much by poverty, homophobia, and an unfair healthcare system as it is by a virus, and no prevention tool, however promising, is going to end it until we do something about those problems. But PrEP has real promise for people for whom other prevention tools aren’t working—like sex workers, homeless youths, and women who aren’t in a position to negotiate safer sex with their partners. PrEP isn’t for everyone. We need to know more about its safety for women and adolescents. We need safeguards to make sure it isn’t given to people who already have HIV. But used wisely PrEP will save lives.”

Michael Ruppal, executive director of The AIDS Institute, echoes NAPWA’s concerns for caution and more data as well as their enthusiasm for PrEP’s potential. “The study data about PrEP offers some of the most exciting hope for stopping the transmission of HIV. With that comes a responsibility to be diligent to do more to answer long-term questions such as drug safety, efficacy, cost, access and ensuring additional studies. We all have a responsibility to educate ourselves and others about the truths surrounding PrEP and not let myths and fear drive our actions.”

Perhaps the greatest concern voiced by those both supportive and critical of PrEP is the high cost of this prevention modality. Close monitoring is essential for those on PrEP, adding to the cost of its use. Frequent HIV testing is necessary to prevent drug resistance from occurring from the use of suboptimal therapy if a person unknowingly seroconverts. Routine monitoring for ARV-related toxicities and adverse events, particularly kidney damage, loss of bone density, and changes in fat metabolism, which have been observed in clinical trials, must be conducted, as well as additional research to measure the long-term effects of ARVs on HIV-negative individuals.

Read the rest.


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

Can a Faster Condom Help Prevent the Spread of HIV?

via Good Lifestyle, by Anmanda Hess



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

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

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

Read the rest.

Thursday, November 17, 2011

Behavioral or Biomedical... Or both?!

via gaycitynews.com, by Perry N. Halkitis, Ph.D., M.S

"But is this radical shift from the behavioral to the biomedical the right course of action for all of us?
 
For me there are two bigger issues — one which I will fully address here, and the other to which I will allude."

Despite our best attempts over the last 30 years, the HIV epidemic continues unabated. There are 1.2 million identified infections in the United States, with another several hundred thousand likely undiagnosed. The impact of this ongoing health challenge is noted most dramatically and definitively evidenced among gay men, who represent somewhere in the vicinity of two to five percent of the population — but constitute 50 percent of all AIDS-related deaths, over 50 percent of all infections and over 50 percent of newly diagnosed infections.

With millions and millions of dollars spent on HIV prevention and research — and despite the best attempts of behavioral researchers and leading AIDS service organizations to modify our risk behaviors — the epidemic continues. Initial campaigns focusing on using a condom have, over time, morphed into programs underscoring the importance of efficacy, temptation and motivation to help shape behavior. But the infections continue to spread. So what has gone wrong?

Some, including myself at times, have pointed the finger at behavioral change programs that are overly simplistic, focusing on sex as an act free of emotion or passion (and in many cases, drugs). But sex is more than simple logic, or rational decision-making. Many behavioral programs have oversimplified a very complex behavior — and the programs we have developed or the research we have enacted has ultimately failed to translate to real lives. I often wonder if the folks developing these programs actually have sex themselves.
Some may argue that we have contained the disease. But how true is that when young gay men, especially Blacks and Latinos, are seroconverting at such high rates? Even among White men, there is an uptick in the incidence of new infections as this group navigates its 30s. We simply haven’t gotten it right.

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.]

Wednesday, November 16, 2011

Global Coalition for MSM Health and Human Rights Announces Five-Year Strategy


The Global Forum on MSM and HIVA global coalition of concerned stakeholders has come together to develop a collaborative strategy to promote the health and human rights of men who have sex with men (MSM). The group of more than 40 participants from over 25 countries, half of whom are people living with HIV, convened as part of a community-led process to create a five-year strategic plan for the Global Forum on MSM & HIV (MSMGF).

“There are very few venues for different sectors of the global MSM response to come together from around the world to strategize on a collective way forward,” said Dr. George Ayala, Executive Officer of the Global Forum on MSM & HIV (MSMGF). “This was an opportunity for grassroots advocates, service providers, researchers, regional MSM networks, multilaterals and major funders to talk face to face about where we need to go as a global movement and the most effective way to get there. The results are quite significant.”

The strategic plan, released earlier today, lays out five priority areas to maximize impact in MSM communities across the globe: promoting health; advancing human rights; improving information and research; increasing investment; and facilitating partnership and engagement with local advocates. Each of these priority areas is to be addressed using three primary strategies: monitoring community-level experience; initiating and supporting advocacy; and strengthening community systems.

“This meeting has come at a crucial juncture in the course of the global epidemic,” said Othman Mellouk, a member of the MSMGF’s Executive Committee. “HIV rates are still unacceptably high among MSM in every world region, yet the response is extremely under-resourced and program coverage is abysmally low. The full spectrum of the global MSM response must work together to meet these challenges with a coordinated strategy. This plan is a rally call for that kind of action.”

MSM bear a disproportionate burden of the HIV epidemic around the world, with infection rates among MSM passing 20% in countries as diverse as Thailand, Mexico and Senegal. Despite the clear need for programs and resources, less than 2% of international funding for HIV prevention is targeted at MSM and fewer than 40 out of 184 countries report to UNAIDS that they have national targets for HIV program coverage for MSM. Current data indicates that fewer than one in ten MSM are reached by HIV prevention programs worldwide.

The new document will guide the MSMGF’s work to respond to this crisis over the next five years in coordination with MSM movements that have emerged at the country and regional level. Building on significant recent developments in research and policy, the plan aims to ensure that the MSMGF is investing time and resources in programs that are highly effective, align with the needs of regional networks, and support the work of grassroots implementers across diverse global contexts.

“In the coming years, the MSMGF will be engaged in a number of collaborations and in-country technical support initiatives across Asia, Africa, Eastern Europe, Latin America and the Middle East,” said Dr. Ayala. “This plan provides our organization with a comprehensive blueprint for effective action, a strategy that has use beyond the MSMGF for all sectors of the global MSM response. The completion of the document is not the end of a process, but rather the beginning of a continuing global dialogue on how we can work together for the health and human rights of MSM around the world.”

Read the full Strategic Plan 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.]

First combination ARV vaginal ring for HIV prevention being tested in Phase I safety trial

via EurekAlert

In the first clinical trial of a vaginal ring combining two antiretroviral (ARV) drugs, researchers from the Microbicide Trials Network (MTN) are collaborating with the International Partnership for Microbicides (IPM) to evaluate whether the ring is safe for use in women. If the ring does prove to be safe, it could be considered for further testing, and eventually be evaluated for its effectiveness as a microbicide for protecting women against HIV infection through vaginal sex.

The trial, which is funded by U.S. National Institutes of Health and goes by the name MTN-013/IPM 026, is evaluating a ring that contains the ARVs dapivirine and maraviroc. Each of these drugs works against HIV in a different way. Dapivirine belongs to a class of ARVs called non-nucleoside reverse transcriptase inhibitors (NNRTIs) that prevent HIV from making copies of itself. Maraviroc, on the other hand, is an entry inhibitor that blocks HIV from getting inside target cells.

The dapivirine-maraviroc ring is the first combination microbicide to enter clinical trials. It is also the first vaginal microbicide containing an entry inhibitor.

The ring was developed by IPM, a non-profit product development partnership headquartered in Silver Spring, Maryland, in collaboration with Queens University Belfast (Belfast, Northern Ireland). The belief is that combining the two drugs, which act at different points in the HIV "life cycle," may provide greater protection against HIV than a single drug alone.

Globally, women comprise half of the 34 million people living with HIV. In sub-Saharan Africa, women represent nearly 60 percent of adults with the virus. In most cases women – especially young women – acquire HIV through unprotected heterosexual sex with an infected partner. Because the use of condoms is often not an option, there is an urgent need for effective prevention strategies that women can control themselves. Toward this end, vaginal microbicides in the form of a gel or a ring, for example, are being developed to provide women with new tools to protect themselves against HIV.

Vaginal rings provide slow, continuous delivery of a drug or multiple drugs to cells inside the vagina over a period of weeks or months. Marketed vaginal ring products include those used for contraceptive delivery and hormone replacement. However, vaginal rings can also be used as a vehicle for delivering potent ARV drugs into the vagina to prevent HIV infection. Because they could be used for one month at a time, vaginal rings may offer a long-acting and convenient prevention option for women.

MTN-013/IPM 026, which is now screening potential participants, will enroll 48 healthy, HIV-negative women ages 18-40 at the University of Pittsburgh, Fenway Institute in Boston and the University of Alabama at Birmingham. Researchers will evaluate the ring's safety and how well women like or are willing to use the ring. In addition, different tests will be performed to help determine how much of each drug is taken up by the cells usually targeted by HIV and whether drug levels are sustained throughout the four weeks the ring is worn.

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.]

Tuesday, November 15, 2011

Getting to the Bottom of It

via Positively Aware, by Gary Bucher, MD, FAAFP

Getting to the bottom of it. Be proactive about anal health, by Doctor Gary Bucher, MD, FAAFR.I have witnessed and taken part in the many changes in HIV care over the past 25 years. At the beginning of the epidemic, silence and fear was the name of the game. It took HIV activists taking control of their health care destiny to force the medical community to treat the disease and the patient.

HIV is now a chronic treatable disease, but it has a whole new set of issues regarding conditions related to prematu cian should feel for any tender areas, thickened lesions, shallow indentations, firm masses, or other abnormalities. I also ask the patient if they have performed an anal self-exam by using their finger to feel around for any lumps or bumps inside their anus. This can help guide me when I perform the digital anorectal exam.

Anal Pap smears are performed in a similar fashion to cervical Pap smears, with the area being swabbed to collect cells, which are then examined under a microscope. They can detect abnormal cells (anal dysplasia), but the anal Pap smear may be less likely to correlate with the degree of anal dysplasia that can be seen on a biopsy of an anal lesion revealed by high resolution anoscopy (HRA). Because such specificity is lacking, and there haven’t been any evidence-based clinical trials to evaluate anal cancer screening methods in preventing anal cancer, many clinicians feel that anal Pap smears should not be done at this time. However, I agree with other experts in the field who have proposed yearly anal Pap smears for all HIV-positive individuals. If the anal Pap is normal, continued annual screening is suggested. Experts also recommend anal Pap smears every one to two years for other high-risk groups and if normal, continued screening every two or three years. If any abnormal cells are detected, HRA with biopsy is recommended. However, these guidelines may be limited by the need to train a greater number of clinicians in performing HRAs and biopsies. It is also important for these screening tests to be administered in a non-hospital setting, to maximize patient compliance with screening and follow-up.

High-risk HPV subtypes, especially 16 and 18, are associated with cervical, anal, penile, vulvar, vaginal, and oral cancers. Cervical cancer is an AIDS-defining malignancy and its incidence has been decreasing with aggressive screening and treatment of pre-cancerous lesions or higher grade cervical dysplasia. Cervical cancer affected 35-40 per 100,000 women in the general population prior to cervical cancer screening and treatment and has now decreased to about 8-10 per 100,000.

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.]

Monday, November 14, 2011

Key Issues Overlooked in Hillary Clinton's "AIDS Free Generation" Speech

via AIDS Foundation of Chicago, by Gregory Trotter

The "big news" of Secretary of State Hillary Clinton's remarks today at the National Institutes of Health, in Bethesda, Md., might be that she appointed Ellen DeGeneres to be the Special Envoy for Global AIDS Awareness.

We'll get to that in a minute. What's perhaps even more interesting, though, is what was not said in Clinton's remarks, titled "Creating an AIDS-free Generation." Clinton focused on three modes of intervention in her speech: prevention of mother-to-child transmission, voluntary medical male circumcision and treatment as prevention.There was no mention of pre-exposure prophylaxis (PrEP) or rectal microbicides -- two promising new areas of HIV prevention.

"Overall, it was a good speech but it was missing some things we're interested in, like PrEP and rectal microbicides," said Jim Pickett, director of prevention advocacy and gay men's health for the AIDS Foundation of Chicago,who also serves as chair of the International Rectal Microbicide Advocates.

The omissions were disappointing but not surprising, Pickett said. Clinton's audience was a global one, he pointed out, so it made sense that she would shy away from PrEP, which has been shown in multiple trials to be effective for gay/bi men but less successful for heterosexual couples.

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! Rectal! Read all About It!

via AIDS Foundation of Chicago, by Gregory Trotter

The word elicits a certain reaction from people.

“People say the word ‘rectal’ and they -- ,” said Jim Pickett, going into a simulated full body shudder of disgust.

Pickett, chair of the International Rectal Microbicide Advocates (affectionately dubbed IRMA), would know. He’s an outspoken advocate for more research and funding in the relatively new field searching for an effective rectal microbicide, an antiretroviral gel that could be a valuable tool in saving lives by preventing HIV/AIDS.

Along with his co-panelists, Pickett was at the United States Conference on AIDS on Friday afternoon to talk about microbicides and other promising new prevention tools, such as pre-exposure prophylaxis (PrEP) and female condoms.

“If condoms work, why do even need this?” Pickett, direction of prevention policy and gay men’s health for the AIDS Foundation of Chicago, asked the group of 30 or so people gathered for the discussion.

Mumbled answers from various people essentially spoke the same truth: Often, people do not use condoms because they’re uncomfortable, and because they can inhibit pleasure and intimacy.

A vaginal microbicide is much closer to being a reality than the rectal variety, mostly because research into the latter has been slowed by years of stigma and political heel-dragging, Pickett said in a separate conversation. Whereas a vaginal microbicide is perhaps a few years away, it could be another 10 years before a rectal product is fully vetted and ready for use.

But both are essential for preventing HIV in men and women, Pickett said. Globally, women are seven times more likely to have unprotected anal sex than men, a conservative projection based on the limited data on anal sex among heterosexuals, he said.

And this biological fact speaks to the need for a rectal-specific microbicide: The rectal wall is only one cell layer of protection from viruses, as opposed to the vaginal wall, which is 20-40 cell layers thick.

But perhaps the most controversial new prevention method is PrEP.

Recent trials have proven PrEP to be effective among gay/bi men who adhere to a regimen of Truvada, the drug made by Gilead Sciences, Inc. The results have been more mixed in trials involving heterosexuals.

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.]

Friday, November 11, 2011

Microbicides 2012 - Abstract and Scholarships Deadline EXTENDED TO FRIDAY 25 NOVEMBER 2011

IMPORTANT UPDATE:

Due to popular demand the deadline for the 2012 International Microbicides Conference abstract submissions and scholarship applications has been extended until Friday 25 November 2011!

Keep in mind that the date is actually November 24 for much of the world.



[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-ALC Promotes Rectal Microbicides in Lima with Humor and Tia Irma

Report from IRMA-ALC - our South American chapter. Don't you just love Tia Irma??? Check out the cute video below...




The Sexual Diversity Festival took place on Miraflores, a district of Lima on  Saturday, Cctober 8th. Epicentro was one of the hosting organizations

IRMA ALC participated with Epicentro in our stand.. We had a roulette wheel with sexual health questions and categories, and one of the categories was "Pregúntale a la tia Irma" or ask aunt Irma… And basically it was 5 simple questions about rectal microbicides to better understand what people know about them.

Also we had the video promoting Tia Irma (the idea is to promote IRMA as a character), and to inform people about rectal microbicides but in an informal and funny way.





[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.]

Wednesday, November 9, 2011

Microbicides 2012 Abstract and Scholarship Deadlines - November 17 (Aussie time)


Heads up IRMA, you have little more than a week to submit abstracts and apply for scholarships for the Microbicides 2012 conference scheduled for April 15 - 18, 2012 in Sydney, Australia.

Please take special note of the time - as Nov 17 in Australia could very well be Nov 16 where you are.

Here is the website: http://microbicides2012.org/

Here are key dates:

Abstract Submission

Thursday 17 November 2011 (Authors should submit abstracts no later than 5pm AEST time on Thursday 17 November 2011. TAKE NOTE OF THIS TIME and figure out what it means in your time zone - it will likely be much earlier, or even the day before.)

Scholarship Application

Thursday 17 November 2011 (Scholarship applications must be submitted online no later than 5:00 p.m Australian Eastern Standard Time - again, TAKE NOTE OF THIS TIME and figure out what that means in your time zone).
Successful applicants will be informed by e-mail after 16 January 2012.

Early Bird Registration
Tuesday 31 January 2012

Late Breaker Abstracts
Sunday 13 February 2012

Accommodation Booking
Friday 9 March 2012

Standard Registration
Thursday 15 March 2012

Conference Registration
Friday 30 March 2012

Conference
15 - 18 April 2012



[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.]

Tuesday, November 8, 2011

Early trial suggests rectal microbicide is safe and could significantly reduce HIV transmission!

via University of California Los Angeles, by Enrique Rivero

A topically applied microbicide gel containing a potent anti-HIV drug has been found to significantly reduce infection when applied to rectal tissue that was subsequently exposed to HIV in the laboratory, according to a new study by the UCLA AIDS Institute. The gel was also found to be safe and acceptable to users.

The first-ever phase 1 clinical trial of the rectal HIV-prevention drug known as UC781, a non-nucleoside reverse transcriptase inhibitor, is described in the current edition of the online journal PLoS ONE.

The trial represents the first use of this novel approach to obtain early insights into the drug's potential to prevent real-life infections during sexual exposure. In addition, it represents an important contribution to efforts aimed at strategically preventing HIV transmission during receptive anal intercourse.

While anal-receptive intercourse is known to be the main route for new HIV infections in men who have sex with men, far more women than men worldwide practice anal intercourse. The risk of HIV infection, per sex act, is anywhere from 20 to 2,000 times greater with receptive anal sex than receptive vaginal sex - particularly if there are other infections present, such as herpes, gonorrhea or chlamydia, according to the study's lead author, Dr. Peter Anton, a professor of medicine in the division of digestive diseases at the David Geffen School of Medicine at UCLA.

The significant reduction in the ability of HIV to infect tissues treated with the drug was surprising, Anton said, as this was a new index in clinical trials. Typically, phase 1 clinical trials focus primarily on safety.
"While the main goal of this trial was also to evaluate safety, these new tests enabled us to evaluate, indirectly, whether this drug and route of delivery might potentially reduce new HIV infections," said Anton, who is also a member of the UCLA AIDS Institute. "Of course, it is very gratifying that the results were so impressive. This approach reflects the kind of intensive analyses these dedicated participants in these early trials are willing to tolerate to help us evaluate a drug's potential earlier in the pipeline of drug development."

Anton also noted that although this is the first time this infectibility analysis has been used in a human clinical trial, the results were quite significant.

Until now, microbicide clinical trials have focused on vaginal transmission. These trials, fortunately, have had successful results in the past year, after nearly a decade of disappointment. But the development of a microbicide prevention gel for rectal application has only been under way for the past five to six years.

In the current trial, researchers tested a formulation of the gel that was created for vaginal use in human trials and that contained two concentrations of UC781. They enrolled 36 male and female subjects at UCLA who were not infected with HIV, and they collected blood and rectal tissue samples at baseline, before participants were randomized to either a placebo group or to receive one of two concentrations of UC781. All participants were given the placebo or active drug as a single exposure by the team's clinicians, with research samples collected 30 minutes later for analysis.

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.]

Monday, November 7, 2011

PrEP Preferences of Gay Men in the UK

via aidsmap, by Roger Pebody

"Prior awareness of PrEP was low. Only 17% of respondents said that they had already heard of the idea of taking a pill before sex in order to prevent HIV infection."

"Fifty five per cent would prefer a daily pill, 28% before and after sex, and 18% were not sure."

While few gay men in England are currently aware of pre-exposure prophylaxis (PrEP), most men who are introduced to the idea support PrEP being made available. Half would consider taking it themselves, but most would prefer to take it on a daily basis, rather than before and after each time they have sex. These findings come from a snapshot survey of gay men in England, published by Sigma Research this week.

Pre-exposure prophylaxis (PrEP) involves HIV-negative people taking anti-HIV drugs in order to reduce their risk of infection. Results of the iPrEX study into the safety and effectiveness of PrEP in gay and other men who have sex with men showed that, overall, it reduced infections by 43%. Much higher levels of efficacy were seen in men with good adherence to PrEP.

Recent studies with American gay men have shown that while only a minority of men is aware of PrEP, a majority would consider using it. Most men say PrEP would not affect their own use of condoms, particularly if it is only partially effective.

To investigate the views of gay men in England, researchers put a series of questions to members of the Sigma Panel in June 2011. The panel is made up of approximately 1500 gay men, bisexual men and other men that have sex with men (MSM) who respond to monthly cross-sectional online surveys about HIV and sexual health. The surveys have a short turnaround for analysis and reporting to health workers.

Only men who do not have diagnosed HIV were asked about PrEP; 1259 responded.

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.]

Kenyan ex-pat (and IRMA Steering Committee Member) aims to help gay countrymen

[We are so proud of IRMA Steering Committee Larry Misedah - shown on the left in the pic below. His compelling story is a must-read. Of note, Larry will be joining a group of IRMA members in Addis Ababa this December for Project ARM - Africa for Rectal Microbicides organizing and strategizing activities taking place in advance of the ICASA 2011 conference.]


via Bay Area Reporter, by Heather Cassell

Excerpt:

Until recently, Kenyan LGBT individuals were isolated, believing they were the only ones in their community; some expressed the desire to take their own lives, said Misedah. Older gay and lesbian individuals were forced to marry people of the opposite sex. Younger queer Kenyans felt comfort from their problems with alcohol, said Misedah, who also felt the cold hand of isolation until he came out.

Coming out liberated Misedah, he no longer suffered from the isolation and instead became a beacon for others.

"I felt sort of obliged in order to speak for those who did not have a voice," said Misedah. "I just felt that we needed to speak more and let the society know the challenges that LGBTI people were facing."

He worked first with Ishtar MSM, one of Kenya's first organizations to provide health services to men who have sex with men. He served as the spokesman for Sexual Minorities Uganda's first media campaign. Misedah, in collaboration with IGLHRC, drafted the first Declaration on Transgender Rights for Central and East Africa in 2007 and continued to work on capacity building in Africa with IGLHRC. He spoke at the African AIDS conference in 2009.

Misedah, among others, risked the threat of up to 14 years of imprisonment under Kenya's penal codes sections 162 and 165 for attempted or homosexual behavior under "carnal knowledge against the order of nature."

Misedah, who came from a well-to-do family, found himself banished from his family and cut off from his educational support at the university, where he eventually obtained his bachelor's degree in environmental planning and management, he said.

Usually, families look the other way in regards to their LGBT family members who have financial resources and contribute to their families. Poor queer Kenyans, however, often find themselves in "deep trouble," said Misedah.
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.]

Sunday, November 6, 2011

Has anal sex gone out of vogue? What does this mean for HIV prevention?

via the HIV MSM blog

So the Advocate recently reported the findings of a large-scale survey on sexual behaviors.  Apparently, only 37.2% of over 24,000 gay and bisexually identified men indicated that their last sexual encounter consisted of anal sex.   The most practiced activities were kissing (almost 75%) and mutual masturbation (73%).

The survey, entitled  ‘The Gay and Bisexual Men’s National Sex Survey’ was sponsored by Manhunt,  its sexual health affiliate Manhunt Cares (see my past post here about them) and  its research partners, present the findings in a cutesy interactive graphical form which can be accessed from clicking on the picture on the left (i.e. I found out that 80.8 % of surveyed men have eaten cum at some point in their lives!) The abstract of the study, which appears in the Journal of Sexual Medicine can be found here.

Now before we give up our lube and condoms and other devices we find makes our anal sex experience more comfortable, there a few things to keep in mind.  For some reason, the majority of respondents in this latest conducted by researchers from Indiana University and George Mason University were Caucasian males.  Perhaps results would be changed if there was some diversity in the subject pool.  Also, one should note that the respondents were “self identified” gay or bisexual.  Perhaps if behaviors of non-identified men who have sex with men, (i.e. heterosexual identifying men) were recorded the results would also show a higher indication of anal sex.  However, I like the point that one of the commentators made:   Anal sex does require a lot of effort (much like vaginal penile sex as well) and perhaps people don’t want to go through such effort simply to get off.

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.]

Thursday, November 3, 2011

The European MSM Internet Survey (EMIS) - See What They Learned!

via EMIS

This is the second community report written especially for you - members of Europe’s diverse LGBT communities. We hope that you find this information interesting and helpful! The first community report covered testing for HIV, knowledge about testing, being ‘out’, sexual happiness and the ‘sexiest man on the planet’. All EMIS community reports are available in 25 languages at www.emis-project.eu.

In this second report we will focus on a range of topics dealing with sex and the number and type of sexual partners, as well as testing for STIs other than HIV. Please be aware that this information is only preliminary, and that we are in the process of preparing a more detailed report for publication later in 2011. Similar to the previous community report, we have included an overview of the data discussed in this report on page three. When reading the table, if you compare the numbers of EMIS respondents in the left column with the first report, you will notice that they have slightly decreased. This is due to changes in the criteria used to exclude respondents’ data from the study if responses were not consistent. We do our best not to report on data from men who hastily clicked through the survey and who did not provide answers that actually corresponded to their knowledge and experiences.

Who You Had Sex With

In each country a significant number of you, who completed the EMIS questionnaire, did not identify as ‘gay or homosexual’. This means we clearly reached a wide range of men who have sex with men. Indeed, around 15% of all respondents reported having had sex with a woman in the twelve months prior to completing the survey. As the table on page three shows, this went from a low of nearly ‘one in ten’ of you in Belgium (.be), the Netherlands (.nl), Poland (.pl) and France (.fr) to over a quarter of you in Slovenia (.si), Bulgaria (.bg) Romania (.ro) and Bosnia & Herzegovina (.ba).

How Many Men You Had Sex With

In the table on page three you can see in which countries partner numbers were particularly high or low. Many of you (43% to 59%) had between two and ten partners, while having more than ten partners went from 10% to over 25% across the 38 countries. The number of sexual partners tells us a few things, such as, how easy or difficult it is to find partners (because they might not be ‘out’ or there might be no places or venues for you to meet). This may also tell us about how hard it might be for many of you to build steady relationships, particularly in societies where same sex couples are not officially recognised or allowed. Of course many men choose to have multiple sex partners. It is advised that the more partners you have, the more often you need to have a sexual health check-up.

Where You Met Men to Have Sex

We asked you where you met your last non-steady male sex partner (of those who had a non-steady partner in the last twelve months). The most common response was “on the Internet”, followed by various sex venues including gay saunas and backrooms of bars and clubs.

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.]

Wednesday, November 2, 2011

ARV gel almost ready to roll out

via the Daily News, by Liz Clarke

quraishaIn the time it takes parents to see their children grow from birth to adulthood, the vaginal gel containing the antiretroviral tenofovir has been under close and intense scrutiny.

Now nobody is more keen to see the fast-track roll-out of the life-saving microbicide than Professor Quarraisha Abdool Karim.

Research initiated 20 years ago at the Medical Research Council and in the past ten years at Caprisa finally culminated in a definitive proof that a microbicide, namely tenofovir gel, reduces the risk of women contracting HIV.

“Twenty years might sound a long time,” she said this week, “but this sort of science requires painstaking input from every member of the research team. We have had to ensure that every avenue – from concept to proof – has been covered. Now that we can prove that tenofovir gel works, we are looking forward to implementing the next step.”

That next step, awaiting approval from the Medicines Control Council, will test the feasibility of integrating tenofovir gel provision into family planning services.

As a principal researcher in the Caprisa 004 scientific research programme, Abdool Karim demonstrated that the gel prevented both HIV and Herpes Simplex Virus (HSV) Type 2 infection.

It’s a finding that has been lauded as one of the most significant scientific breakthroughs in the fight against Aids by WHO, UNaids and several leading organisations

“But there is no time to rest on these laurels,” she says. “There is much work still to do.”

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.]

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

via RH Reality Check, by Anna Forbes and Kate Ryan

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

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

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

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

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

Read the rest.


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