What HIV-Positive MSM Want from Sexual Risk Reduction Interventions: Findings from a Qualitative Study

via pubmed.gov, by Vanable PA, Carey MP, Brown JL, Littlewood RA, Bostwick R, Blair D

Abstract

To facilitate the development of a tailored intervention that meets the needs of HIV-positive men who have sex with men (HIV-positive MSM), we conducted formative research with 52 HIV-positive MSM. We sought to (a) identify major barriers to consistent condom use, (b) characterize their interest in sexual risk reduction interventions, and (c) elicit feedback regarding optimal intervention format. Men identified several key barriers to consistent condom use, including treatment optimism, lessened support for safer sex in the broader gay community, challenges communicating with partners, and concerns about stigmatization following serostatus disclosure. Many men expressed an interest in health promotion programming, but did not want to participate in an intervention focusing exclusively on safer sex. Instead, they preferred a supportive group intervention that addresses other coping challenges as well as sexual risk reduction. Study results reveal important considerations for the development of appealing and efficacious risk reduction interventions for HIV-positive MSM.



[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.]

Announcing the 2012 Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy

Five years ago on October 5 2006, we lost our brother and colleague Omololu Falobi. Those who knew Omololu professionally will remember him, among many other things - as a talented journalist on HIV, as an activist for social justice, as an advocate for prevention research and as a son of Africa in his zeal to ensure Africans were taking ownership of their own HIV care and prevention.

Omololu founded the Journalists Against AIDS in Nigeria (JAAIDS), was an instrumental pioneer member of the Nigerian Treatment Access Movement (TAM), and co-founded the New HIV Vaccine & Microbicide Advocacy Society (NHMAS). He was tragically killed in 2006 in Lagos, Nigeria.

In 2008, in honour of Omololu’s memory and commitment to the field, The Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy was established by the African Microbicides Advocacy Group (AMAG) and partners. The Award is presented to an individual nominated by their peers at the biennial International Microbicides Conferences. Lori Heise (USA) and Aylur Srikrishnan (India) were the 2008 recipients and Charles Shagi (Tanzania) the recipient in 2010.

In continuation of this tradition and to mark the fifth anniversary of Omololu’s death, we proudly announce the call for nominations of The Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy 2012 to be awarded to a community advocate in recognition of their contribution to the HIV prevention research field through community advocacy.

The 2012 Award Planning Committee includes representatives from the African AIDS Vaccine Program (AAVP), AMAG, AVAC: Global Advocacy for HIV Prevention, the Global Campaign for Microbicides (GCM), International Rectal Microbicides Advocates (IRMA), JAAIDS, NHVMAS and TAM, with acknowledgment from the Omololu Falobi Foundation.

Nominations will be reviewed by a committee of stakeholders in the prevention research field and the selected individual will then be recognized and awarded at the Closing Ceremony of the International Microbicides 2012 Conference in Sydney, Australia in April 2012. We are pleased to work with the Microbicides 2012 Conference Planning Committee to present the Award next year.
A call for nominations and information on the selection process will be circulated later this month.

On behalf of the planning committee:
AAVP, AMAG, AVAC, GCM, IRMA, JAAIDS, NHVMAS, TAM

For more information:
Website: http://www.avac.org/ht/d/sp/i/4345/pid/4345
Email: amag_info@yahoo.com


[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 and Prevention: Interview w/Uganda's Dr. Patrick Ndase

via The Observer, by Shifa Mwesigye

Excerpt:

"Uganda has participated just like several other African countries; [in research] you must go where infection is happening. The majority of HIV research in the early stages happened in Uganda because Uganda was heavily infested with the virus. As you remember we had prevalence rates of above 20% and then we had the so called Uganda success story after the zero grazing campaign.

"At the time, the countries in southern Africa which largely [depend on] tourism were silent on HIV infection. Now the countries that are laden with infection are Swaziland, Botswana, Zimbabwe, Zambia and South Africa. So majority of HIV prevention research is not happening in Uganda anymore. In fact it is difficult to get someone who wants to do HIV research to come to Uganda."

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.]

Investment in HIV Prevention Research

A report released yesterday by HIV Vaccines and Microbicides Resource Tracking Working Group at the IAS conference in Rome "found that overall investment in HIV prevention R&D had actually increased, with the modest exception of a one percent decline in vaccine R&D. The report documented a total US$1.19 billion investment in research and development (R&D) for four key HIV prevention options: preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) using antiretroviral drugs, and operations research related to medical male circumcision.":

"2010 has been a year of retrospection, a time for looking back over the 30 years since the first published report of the mysterious illness that would come to be known as AIDS. As sobering as this anniversary has been, it has also been a time for some optimism and calls to end the epidemic. These calls may not be simply wishful thinking, fueled as they have been by promising research results over the past two years in vaccines, microbicides, pre-exposure prophylaxis using antiretrovirals (PrEP), and antiretroviral treatment as prevention—results that have energized the entire HIV prevention field.

The first good news came at the end of 2009, when researchers in the RV 144 Thai vaccine trial reported that a vaccine combination had reduced risk of infection by 31 percent—the first clinical evidence that a preventive AIDS vaccine would be possible. Then, in July 2010, the CAPRISA 004 trial team announced its findings–that use of 1% tenofovir (TDF, also known as Viread®) vaginal gel reduced women’s risk of HIV infection by 39 percent—providing the first proof that a microbicide would be possible. This news was followed in November 2010 by the announcement from the iPrEx trial team that daily oral tenofovir/emtricitabine (TDF/FTC, also known as Truvada®) had reduced risk of HIV infection by an estimated 44 percent overall in men who have sex with men (MSM) and transgender women, and proved for the first time that HIV prevention using PrEP would be possible. And finally, in early 2011, the HIV Prevention Trials Network (HPTN) 052 trial established that use of antiretroviral therapy (ART) by HIV-positive individuals reduced transmission to their partners"

Source: HIV Vaccines and Microbicides Resource Tracking Working Group

[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.]

IAS 2011: Day 3

Today is Day 3 of the exciting conference happening in Rome, and IRMA has a lot of interesting information to report. Here is the press release for Day 3, and below it are links to important and fascinating presentations from and articles about the conference.

Via IAS.

OFFICIAL PRESS RELEASE – DAY 3

                                                         EMBARGOED UNTIL 11.00 (CET), TUESDAY JULY 19

Plenary speakers address challenges in the delivery of sustained antiretroviral therapy in developing countries, call for social scientists to take their place at the HIV/AIDS policy- making table, and stress the need for a long-term response to AIDS

Tuesday, 19 July, 2011 (Rome, Italy) -- Researchers speaking in the second plenary session of the 6^th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) have today provided insights into the future direction of HIV/AIDS policy making and alerted delegates to the challenges that developing countries continue to face in the delivery of large- scale antiretroviral therapy (ART) coverage.

The presentations reflect the breadth of expertise among the more than 5,000 researchers, clinicians and community leaders attending the conference, which runs from 17-20 July in Rome.

“The AIDS response up until now has led to unprecedented mobilization of populations and significant progress in terms of prevention and treatment,” said IAS 2011 International Chair and IAS President Elly Katabira. “However, given the projections we have made of infections over the next decade, together with the growing number of people living longer with HIV, it makes perfect sense to discuss whether a remodeling or fine-tuning of that response might more effectively meet the new challenges that lie ahead.”

“Discussion around the future direction of HIV/AIDS policy must begin to give a far greater voice to the social sciences,” said Stefano Vella, IAS 2011 Local Co-Chair and Research Director at the Istituto Superiore di Sanità (ISS).  “The social and political sciences are a vital element in helping us to improve prevention efforts, especially in developing countries where major challenges remain in the effective roll-out of ART.”

The Social Barriers to Effective HIV Prevention

In her plenary remarks, Susan Kippax (Australia), Emeritus Professor at the Social Policy Research Centre, University of New South Wales, Sydney, suggested that in understanding HIV prevention efforts, people’s behaviours cannot be separated from their social, cultural and political structures, and the biomedical cannot be distinguished from the non-biomedical. Kippax argued that there is a need for social scientists to be at the table when it comes to discussing what many experts currently consider to be the greatest challenge to HIV/AIDS policy making - prevention.

Irrespective of whether prevention programmes or interventions advocate the use of condoms, clean needles and syringes, microbicides, pre- or post-exposure prophylaxis, or treatment as prevention - all prevention requires that people change their social practices: changes which cannot be effectively sustained unless they are supported by broader social transformation.

Challenges of Antiretroviral Therapy (ART) in Developing Countries

Serge Eholié (Ivory Coast) Professor of Tropical and Infectious Diseases at the Medical School of the University of Abidjan, focused on the challenges of sustaining antiretroviral therapy initiatives in developing countries.

A decade after the first antiretroviral therapy initiatives were initiated in developing countries, the number of HIV-infected individuals receiving ART has significantly increased. Recent data estimate that six million HIV-infected patients started ART and four and a half million of them (75 per cent) live in sub-Saharan Africa, and significant results have been obtained in decreasing mortality and morbidity.

Seven areas were identified as challenging in the ongoing delivery of ART in developing countries:

• financing the sustainability of ART-programmes, particularly in the context of the current adverse economic climate and with insufficient contributions from national governments;
• the high incidence of mortality and severe mortality during the first year following ART-initiation;
• the adaptation of programmes, physicians, countries and partners to the WHO 2010 revised guidelines for adults and adolescents;
• an increasing number of HIV-infected patients failing first-line treatment: the cost of second line treatment is four to five times higher than first line regimes. It is challenging for countries and partners to afford second line treatment, and difficult for physicians to detect first-line failure early enough;
• detectingfirst-line treatment failure earlier and prescribing an effective and safe second line regimen in light of the expense of the latter;
• management, diagnosis and treatment of side effects; 
• retention of patients: data for cohorts studies show that 25%-30% of HIV patients starting treatment are lost to follow up after 12-24 months;
• socio-political instability and humanitarian crisis and natural disasters

 AIDS: The Need for a Long-term Response

Peter Piot (Belgium), Director of the London School of Hygiene & Tropical Medicine, London, concluded the plenary session by reflecting that given the enormous mortality and human suffering caused by the AIDS epidemic, the nature of the global response to the AIDS epidemic has been framed as an emergency. Yet the ultimate duration of the emergency has rarely been discussed.

In spite of a recent decline in interest and funding for AIDS, UN member states recently adopted a "Political Declaration on HIV/AIDS: intensifying our efforts to eliminate HIV/AIDS" with ambitious goals for the next five years. Projections from aids2031 and UNAIDS estimate that over the coming two decades,  there may still be one to one and a half million new infections and one million deaths annually, with resources required to curb infections well in excess of currently available funds.

The combination of these developments, as well as the longer life expectancy of many people infected with HIV, provides a compelling argument for the need for a long term view on the AIDS response. In addition, resource constraints dictate that effective investments leading to the best possible outcomes in both the short and long term are necessary, and right now.

 ---

 Session abstracts and presentations for "Novel Approaches to Prevention Interventions and Measurement" can be found here. Especially of note for rectal microbicide advocates is this presentation.

Also of interest is this abstract of work done by IRMA - Nigeria: "Mobilizing MSM community in Nigeria to support rectal microbicides development", and the abstracts/powerpoints in this session: "Treatment Is Prevention: The Proof Is 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.]

IAS 2011: Day 1 Press Release

The 6^th IAS Conference on HIV Pathogenesis, Treatment and Prevention began yesterday in Rome, Italy. Here is the press release from yesterday's events:

OFFICIAL PRESS RELEASE – DAY 1

17.00 (CET), SUNDAY JULY 17

AIDS is at a scientific watershed, says IAS 2011 International Chair Elly Katabira at the opening of the world’s largest open scientific conference on HIV and AIDS

Michel Sidibé, UNAIDS Head, adds that history will judge us not by our scientific breakthroughs on AIDS, but how we apply them

Sunday, 17 July, 2011 (Rome, Italy) - More than 5,000 AIDS researchers, scientists, clinicians, community leaders and policy experts gathered in Rome for the opening of the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2011) have welcomed the growing momentum in biomedical research, but have warned that the benefits of these advances need to be evenly shared between the global North and South. Opening Session speakers also used this occasion to call on the Italian government to re-commit to the Global Fund to Fight AIDS, Tuberculosis and Malaria.

“We are at a scientific watershed in the global AIDS response,” said IAS 2011 International Chair and International AIDS Society President Elly Katabira. “We have witnessed two years of significant biomedical advances, the likes of which we have not seen since the antiretroviral breakthroughs of the mid 1990s. The excitement around these advances in research - whether they be the CAPRISA 004 vaginal gel, the HPTN 052 study on treatment as prevention, talk around the path towards a cure, or the encouraging signs on PrEP and vaccines – is very much driving the debates and discussions that we are going to see in Rome over the next few days.”

“IAS 2011 delegates, like many professionals working in the international response to HIV, are understandably excited about recent scientific breakthroughs. However, we need to ensure that the advances we are making in research such as the now proven concept of antiretroviral treatment as a means of HIV prevention – is translated into action for people in developing countries,” said IAS 2011 Local Co-Chair Stefano Vella, Research Director at the Istituto Superiore di Sanità (ISS). “Advances in science need to be matched by advances in resourcing. I call on the Italian government to recommit itself as a donor nation to the Global Fund to Fight AIDS, Tuberculosis and Malaria.”

In an Opening Session keynote speech, UNAIDS Executive Director Michel Sidibé said that gaps in access to HIV treatment within and between countries and key populations were an affront to humanity that can and must be closed by innovations in developing, pricing and delivering treatments and commodities for HIV, TB, malaria, reproductive health and other health issues.

“We have to remember that history will judge us not by our scientific breakthroughs, but how we apply them,” said Sidibé.

The IAS Conference series focuses on the translation of research into practice, particularly in low- and middle-income countries.


Opening Session

The emphasis on the real-world application of science was also reflected in today’s Opening Session, which began with welcoming remarks by IAS 2011 Co-Chairs, a message from Giorgio Napolitano, President of the Republic of Italy, an address from Giovanni Alemanno, Mayor of Rome, followed by a community welcome by Filippo von Schloesser, President of Fondazione Nadir Onlus. Mr von Schloesser said the Italian government‘s waning commitment to HIV/AIDS was a major concern to people living with HIV.

IAS 2011 will reveal promising new data across all four scientific tracks – particularly in the areas of HIV treatment as prevention, HIV cure efforts, new drugs and new antiretroviral combinations, and the scale up of effective prevention and treatment interventions in resource-limited settings. From a scientific perspective, this is a time of optimism which was last seen in the mid 1990s, when the promise of combination antiretroviral therapy (ART) first became real. IAS 2011, while urging governments and donors to commit to continued and increased commitment to HIV and AIDS across all programme areas, will stress the necessity to respect the Sydney declaration – the declaration released during the 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention, which stated that 10 per cent of all HIV funding should go on research.


[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.]

Infection-resistant monkeys could be crucial in the fight against HIV

Via Io9, by Alasdair Wilkins.

Sooty mangabeys are a monkey species found on the western coast of central Africa. Their unique immunity to SIV, a relative of HIV, has intrigued medical researchers for decades. Now we know just how their immunity works.

SIV and HIV function in much the same way - the viruses find two molecules on the surface of the cell, which are known as co-receptors. These molecules function much like gates. One of these molecules is CD4, which is found on immune cells known as T cells. The immune response triggered by the appearance of the virus stimulates these T cells, which boost the level of the other co-receptor, CCR5, which in turn facilitates the deadly infection.

But sooty mangabeys are able to avoid that chain of events, thanks to a unique type of T cell called a central memory T cell. When this particular type of T cell responds to the virus, it does so without activating CCR5. This helps the T cells survive the SIV infection, and it's a crucial reason why these monkeys are able to avoid the onset of AIDS. Best of all, central memory T cells are long-lived in the body, and their positioning in the lymph nodes makes them particularly effective in stopping the spread of SIV.

Emory University researcher Mirko Paiardini explains what this means:

Read the rest here.

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

POZ love for IRMA - The Anal Dialogues

The July/August 2011 issue of POZ Magazine belongs to IRMA and rectal microbicides. Check it out for a nice history of our work and a snapshot of the science, including important information on lubricant safety.

via POZ.com, by Trenton Straub

Excerpt:

Perhaps IRMA’s most visible work is three game-changing reports it published in conjunction with the biennial International Microbicides Conference. The first, Rectal Microbicides: Investments & Advocacy in 2006, compiled what research was being done and where—a tricky task. “A lot of researchers were concerned that if ‘anal’ or ‘rectal’ appeared in research proposals or reports, they wouldn’t get funded, so they’d scrub their papers so those words wouldn’t show up,” LeBlanc says. “Instead, they would refer to ‘topical use of products’ or other language.” And because of the dangers surrounding the subject—male-to-male sex is illegal in many countries, including 31 in sub-Saharan Africa—IRMA first had to gain researchers’ trust, proving they were not raging advocates who would alienate and antagonize. Their professionalism paid off, and the report was a hit. “It showed we were serious,” Pickett says, “and we got hundreds of new members.” 


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.]

Self-Perceived Risk of HIV Infection and Attitudes About PrEP Among STD Clinic Attendees

Via Liebert Online, by Y. Omar Whiteside, Tammy Harris, Christopher Scanlon, Stephen Clarkson, and Wayne Duffus

Background

Despite the advances in the prevention of and treatment for HIV infection, the estimated rates of HIV infections remained constant from 2005 to 2008. More importantly, during this period the estimated number of newly diagnosed HIV/AIDS cases increased 8%. In 2008, blacks accounted for more than half (52%) of all new HIV cases diagnosed. The South, where the majority of black/African Americans live, continues to suffer disproportionately from the HIV/AIDS epidemic. The Centers for Disease Control and Prevention's (CDC) 2008 HIV Surveillance Report documented that the death rate among persons with AIDS increased in both the South and the Midwest and that the South has the highest number of AIDS diagnoses of any region in the country. Because of this region's epidemiology, the need to prevent new HIV infections is of paramount importance.

South Carolina, a southern state, has one of the highest AIDS rates in the United States (2008 AIDS rate: 15.5 per 100,000 population in South Carolina; 12.2 per 100,000 population in the United States) In 2008, Columbia, South Carolina, ranked seventh in its AIDS case rate (25.6 per 100,000 population) among metropolitan statistical areas. Of increasing concern to South Carolina public health officials is the high prevalence of HIV-infected residents and the potential for unabated transmission.

Methods

This was an exploratory study on self-perceived risk of HIV infection and attitudes about using PrEP among sexually transmitted diseases (STD) clinic attendees. It was designed as a cross-sectional study and was conducted from January 2009 to May 2009 and October 2010 to December 2010 in an STD clinic in South Carolina. An STD clinic was chosen as the location from which to draw participants because individuals with an STD have an increased risk for both HIV infection and transmission. The inclusion criteria were that participants be at least 16 years of age; have had oral, anal, or vaginal sex within the past 6 months; be seeking STD clinic services, self-report being HIV-negative, and not have previously completed the survey. Participants were given a 20-min, self-administered, paper-based, anonymous survey that measured demographic information; sexual exposure history; self-perceived risk perception for HIV infection; and attitudes about PrEP.

Results

Compared to heterosexual participants, homosexual participants were significantly more likely to have knowledge of PrEP (odds ratio [OR]=6.7, 95% confidence interval [CI]: 1.70–26.1). Compared to those participants who had 1 sexual partner in the past 3 months, individuals who had 2 to 4 sexual partners in the past 3 months were approximately 2.35 times as likely to have a lower level of agreement with the statement “I believe I am at risk of getting HIV” (p=0.0003). Compared to female participants, respondents who were male were approximately 2.8 times as likely to have a lower level of agreement with the statement “If I had to it would be very difficult for me (or my partner) to both use condoms and take daily pills to prevent HIV infection” (p<0.0001). These results suggest the need for the creation of PrEP implementation programs that are tailored to self-perceived risk perception, age, and gender.

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.]

NEWS ROUNDUP: Early HIV Treatment Can Reduce Transmission Risk By 96%, Study Results Show

via Kaiser Family Foundation


Results from a multicountry clinical trial, sponsored by the National Institute for Allergy and Infectious Diseases (NIAID), show that HIV-positive people who take combination antiretroviral therapy (ART) can reduce the risk of transmitting the virus to their HIV-negative partners by 96 percent, U.S. researchers announced on Thursday "[i]n what is being hailed as a breakthrough in HIV prevention," the Los Angeles Times reports (Maugh, 5/13).

The randomized controlled trial, run by the HIV Prevention Trials Network and named HPTN 052, was meant to run another four years, but an interim analysis by an independent monitoring group prompted NIAID to halt the trial and release the results, ScienceInsider writes. The study, conducted since 2005 at 13 sites in nine countries, recruited 1,763 couples, 97 percent of whom were heterosexual, in which one partner was HIV-positive at enrollment. None of the HIV-positive partners had taken ART, and their CD4 cell counts, a measure of the immune system's health, were between 350 to 550. "Half the participants received immediate treatment, and the other half did not start [therapy] until their CD4 count dropped to 250 or they developed an AIDS-related symptom, according to ScienceInsider (Cohen, 5/12).

Analysis "identified 39 new cases of HIV among the previously uninfected partners. In 28 of these cases, genetic analysis confirmed that one partner had infected the other. Of these 28 infections, 27 – or 96 percent – occurred among couples in which the HIV-infected partner did not start antiretroviral therapy immediately," HealthDay/U.S. News reports (Reinberg, 5/12). The couples were all counseled on safe sex practices, given free condoms and provided treatment for sexually transmitted infections, BBC News adds (Gallagher, 5/12).

"This new finding convincingly demonstrates that treating the infected individual – and doing so sooner rather than later – can have a major impact on reducing HIV transmission," NIAID Director Anthony Fauci said in a statement (5/12).

The New York Times notes that though the trial was "relatively large," there are limitations to interpreting the results for other populations, like men who have sex with men, because nearly all "of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual" (McNeil, 5/12).

Treating HIV-positive participants early also improved other health outcomes, the Los Angeles Times reports, noting that the results showed 17 cases of disseminated tuberculosis (TB) among those whose treatment was deferred compared with three cases among the treatment group (5/13). According to Bloomberg News, researchers will continue to monitor study participants to determine whether treatment benefits persist (Cortez/Bennett, 5/13).

Treatment As Prevention

"Until now, antiretroviral therapy was known to improve the health of people infected with human immunodeficiency virus, but this is the first study to show a solid impact on preventing transmission to an HIV-negative partner," Agence France-Presse reports (Sheridan, 5/12).

Though the preliminary results "are likely to end, or at least diminish, a bitter feud within the AIDS world over how much funding should go to treatment versus prevention," funding "will be a major obstacle," the Wall Street Journal writes. With more than five million HIV-positive people on treatment at the end of 2009, and another 10 million in need of the drugs based on international treatment guidelines, UNAIDS has estimated a treatment funding shortfall of more than $7.5 billion, the Wall Street Journal notes (Schoofs/McKay, 5/12).

Observational studies have shown a benefit to early HIV treatment, leading UNAIDS last year to adopt "as its goal" a "test and treat" policy that "encourages doctors to start people on treatment as soon as they test positive for HIV," the New York Times states. Still, "[f]or lack of money, clinics in Africa are turning away patients who are not just infected but close to death. And in some American states where money provided by the Ryan White Care Act has run out, poor uninsured people are on waiting lists," the newspaper adds (5/12).

UNAIDS Executive Director Michel Sidibe said, "This breakthrough is a serious game changer and will drive the prevention revolution forward. It makes HIV treatment a new priority prevention option," adding, "Now we need to make sure that couples have the option to choose treatment for prevention and have access to it," according to Reuters (Steenhuysen, 5/12). Sidibe said "he hopes the new results will compel pharmaceutical companies to lower the price of ARVs as the demand for the drugs expands," that "new partnerships will form to advocate for increased funding and that the findings will be prominently discussed next month at the United Nations High Level Meeting on AIDS in New York City," ScienceInsider reports (5/12).


[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.]

Belief in AIDS origin conspiracy theory and willingness to participate in biomedical research studies: findings in whites, blacks, and Hispanics

HIV Clin Trials. 2011 Jan-Feb;12(1):37-47.

Belief in AIDS origin conspiracy theory and willingness to participate in biomedical research studies: findings in whites, blacks, and Hispanics in seven cities across two surveys.

Russell SL, Katz RV, Wang MQ, Lee R, Green BL, Kressin NR, Claudio C.

Department of Epidemiology and Health Promotion, New York University, New York, NY, USA. stefanie.russell@nyu.edu

Abstract

PURPOSE: The purpose of this study was to determine whether a belief in the AIDS origin conspiracy theory is related to likelihood or fear of participation in research studies.

METHODS: The Tuskegee Legacy Project Questionnaire was administered via random-digit-dialed telephone interview to black, white, and Hispanic participants in 4 cities in 1999 and 2000 (n = 1,133) and in 3 cities in 2003 (n = 1,162).

RESULTS: In 1999, 27.8% of blacks, 23.6% of Hispanics, and 8% of whites (P ≤ .001) reported that it was "very or somewhat likely" that AIDS is "the result of a government plan to intentionally kill a certain group of people by genocide." In 2003, 34.1% of blacks, 21.9% of Hispanics, and 8.4% of whites (P ≤ .001) reported the same.

CONCLUSIONS: Whereas blacks and Hispanics were more than 3 times more likely than whites to believe in this AIDS origin conspiracy theory, holding this belief was not associated with a decreased likelihood of participation in, or increased fear of participation in, biomedical research.

[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.]

2011 Spending Deal Spares NIH Major Cuts

via ScienceInsider

Just as White House officials promised over the weekend, the 2011 funding bill agreed to by Congress and the White House last Friday spares biomedical research from major cuts.

Details released today indicate that the National Institutes of Health (NIH) would receive $30.7 billion, or $260 million below the 2010 level. The 0.8% cut includes $210 million spread across all 27 NIH institutes and centers and the director's office, and $50 million from a buildings account. (Adding a 0.2% across-the-board cut in all non-defense agencies, the total cut will be about $300 million, says David Moore of the Association of American Medical Colleges.)

By contrast, an earlier House bill, H.R. 1, would have slashed NIH's budget by $1.6 billion to $29.5 billion.

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.]

Is Africa ready for PrEP?

Via Incidence0.org, by Adebisi Ademola Alimi

One of the biggest breakthrough in HIV clinical research, since the outbreak of the epidemic 30 years ago, is the recent success in a clinical trial of a new HIV prevention approach based on the daily use of the antiretroviral drug Truvada by HIV negative person to prevent HIV transmission (Called PrEP, for Pre-Exposure Prophylaxis).

The results of the iPrEX trial raised hope but also many questions and concerns as showed by the ensuing debate about what the next step should be. Divergences culminated with the Aids Health Foundation (AHF) petitioning the FDA not to consider Gilead’s request for a licence to use Truvada for the prevention of HIV infection and a joint counter response by a number of HIV advocacy organisations.

But for me as an advocate and an African living in Europe, the most important thing on my mind is “Will Africa be able to access PrEP?” Providing ARV to HIV negative people in Africa needs to be considered in light of the challenge of accessing treatment in Africa, where more than 50% of HIV positive people in the world live (UNAIDS report).

Even if PrEP drugs become available, what are the mechanisms in place to ensure that it will not be tribalized in a continent where there are some indications that access to ARVs is based on political and ethnical loyalty and where there are evidences of bribery at the delivery point, misused of funds and a non-negligible ARVs black market leading to ARVs being dispensed to increasing numbers of patients at the periphery of the health system. One has to be skeptical about the PrEP implementation process in this context.

Read the full article

[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.]

Pittsburgh's Dynamic Rectal Duo

IRMA Scientific Vice Chair Ian McGowan and his research/life partner, Ross Cranston (also a member of the IRMA Steering Committee) are featured in CUE Pittsburgh this month. They talk about our favorite topic - rectal microbicides - and a trial taking place right in Pittsburgh that gay men can get involved in.

The article, below, starts on Page 17. Use the arrows on both sides of the magazine to "flip" pages forward and back.

[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.]

PRESS RELEASE: Researchers Reformulate Tenofovir Vaginal Gel for Rectal Use

via Microbicide Trials Network

[The abstract, Tenofovir Gel Reformulation Results in Improved Product Safety for Rectal Application, was presented at a poster session from 2-4 p.m., Monday, Feb. 28. The results of RMP-02/MTN-006 were discussed at a CROI press conference from 7:30-8:30 a.m., Monday, Feb. 28]

‘New’ gel safe in laboratory studies




BOSTON, Feb. 28, 2011 – A change in the formulation of tenofovir gel, an anti-HIV gel developed for vaginal use, may make it safer to use in the rectum, suggests research presented today at the 18th Conference on Retroviruses and Opportunistic Infections (CROI). In laboratory tests of rectal tissue, researchers from the Microbicide Trials Network (MTN) found the reformulated gel was less harmful to the lining of the rectum than the original vaginal formulation, and just as effective in protecting cells against HIV.

Researchers are now testing the reformulated gel in an early-phase clinical trial with men and women. Results from these and future studies will have important implications for the development of a rectal microbicide that could help protect against HIV or other sexually transmitted infections during anal sex.

Tenofovir gel has shown significant promise in reducing HIV risk in women through vaginal sex. But because the rectal epithelium – the lining of the rectum that serves as the first line of defense against HIV – is much thinner than the vaginal lining, the gel may not be safe or effective to use rectally. By its nature, tenofovir gel is hyperosmolar – contains a higher concentration of sugars and salts relative to cells. This quality could have a harmful effect on the rectal lining by causing epithelial cells to shrink as they purge water to achieve balance. Weakened in this manner, the rectal epithelium may be less able to protect against HIV.

To make tenofovir gel safe and more amenable to rectal use, researchers from CONRAD, a research organization which holds the rights to develop the gel, reformulated it with a reduced amount of glycerin, a common additive found in many gel-like products. In laboratory tests conducted by MTN researchers, the reformulated gel was three times less likely to cause cells in rectal tissue to release water, and equally effective against HIV as the vaginal formulation.

“The lining of the rectum is much more fragile than the vaginal epithelium, so we can’t be certain a product like tenofovir gel that is safe for vaginal use will be completely safe to use in the rectum,” said Charlene Dezzutti, Ph.D., associate professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine and principal investigator of the MTN Network Laboratory. “We are very encouraged by our laboratory data that suggest the reformulated gel could be safer for rectal use. These results provide an important bridge to clinical studies, and we have already begun testing it with men and women.”

The new formulation of tenofovir gel is being tested for safety and acceptability in a clinical trial called MTN-007, currently underway at three MTN-affiliated sites at the University of Pittsburgh,

RMP-02/MTN-006, the first-ever clinical study to test the safety of vaginal tenofovir gel in the rectum. These results, which were also presented at CROI, found the gel significantly inhibited HIV in tissue samples, but that men and women in the study did not particularly like it and some experienced uncomfortable gastrointestinal side effects. Researchers are hopeful the reformulated gel now being tested in MTN-007 will address these concerns.

In addition to Dr. Dezzutti, other authors of the study are Lisa Rohan, Ph.D., University of Pittsburgh; J.D. Lynam, Magee-Womens Research Institute; Lin Wang, M.D., Ph.D., Magee-Womens Research Institute; and David Friend, Ph.D., CONRAD, Arlington, Va.

Tenofovir gel contains the antiretroviral tenofovir, which is commonly used in the treatment of HIV. Both the oral and vaginal formulations of tenofovir were developed by Gilead Sciences, Inc., of Foster City, Calif. In 2006, Gilead Sciences assigned the rights for tenofovir gel to the International Partnership for Microbicides of Silver Spring, Md., and CONRAD, of Arlington, Va.

The study was conducted through the MTN, which is funded by the National Institute of Allergy and Infectious Diseases Division of AIDS with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

# # #

The abstract, Tenofovir Gel Reformulation Results in Improved Product Safety for Rectal Application, was presented at a poster session from 2-4 p.m., Monday, Feb. 28. The results of RMP-02/MTN-006 were discussed at a CROI press conference from 7:30-8:30 a.m., Monday, Feb. 28.

About the Microbicide Trials Network

The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners who are devoted to preventing or reducing the sexual transmission of HIV through the development and evaluation of products applied topically to mucosal surfaces or administered orally.


[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.]

CHAARM Program Newsletter - Issue Number 1, 2011

This newsletter contains information about the CHAARM project, main activities executed and results achieved in these 12 months activity as well as researchers’ interviews to give a deeper overview of single laboratories tasks.

CHAARM - Combined Highly Active Anti-Retroviral Microbicides project is large scale collaborative project co-funded by the European Commission under the 7th Framework Programme (FP7). The main objective of this project is to develop combinations of new and existing microbicides that will be designed to be specifically targeted agents, which can be applied topically to reduce transmission of HIV during sexual intercourse.

The content of the newsletter is the result of all CHAARM project partners’ efforts under the coordination of the communication partner together with the project coordinator. This newsletter is published once per year and is sent out via email to a number of interested stakeholders but it is also available on the website.



[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.]

Study Authors Call for More Testing of Personal Lubricant Safety

via About.com, by Cory Silverberg

Last May two studies were released that got a lot of attention for pointing out the potential role personal lubricants might play in STD transmission during anal intercourse. Specifically, lab studies raised the possibility that lubricant could actually make transmission easier by irritating the rectal lining.

The work was supported by the interdisciplinary group, International Rectal Microbicide Advocates, who have been doing their best to help researchers and health care providers contextualize the findings so they are neither blown out of proportion, nor cast aside as irrelevant.

This week more findings were published in the journal AIDS Research and Human Retroviruses. Researchers studied forty-one brands of lubricants (taken from the IRMA list of most frequently used lubricants), looking for any anti-HIV-1 activity, toxicity, and essentially the salt content of lubricants that could contribute to damage at the cellular level.
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.]

The Role of Public-Sector Research in the Discovery of Drugs and Vaccines

via New England Journal of Medicine

Ashley J. Stevens, D.Phil., Jonathan J. Jensen, M.B.A., Katrine Wyller, M.B.E., Patrick C. Kilgore, B.S., Sabarni Chatterjee, M.B.A., Ph.D., and Mark L. Rohrbaugh, Ph.D., J.D.

Historically, there has been a clear distinction between the roles of public-sector research and corporate research in the discovery of new drugs and vaccines to solve unmet medical needs. Public-sector research institutions (PSRIs) have performed the upstream, basic research to elucidate the underlying mechanisms and pathways of disease and identify promising points of intervention, whereas corporate researchers have performed the downstream, applied research to discover drugs that can be used to treat diseases and have then carried out the development activities to bring the drugs to market. The intellectual property that protects the investment in developing these drugs is created in the applied-research phase.

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.]

AIDS 2010 Conference Report Now Online

Read about the important developments presented during AIDS 2010 in the recently released AIDS 2010 Conference Report.

[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.]

Don't Miss It! Recent Trends in Microbicide Formulations

via ScienceDirect, edited by David R. Friend

The most recent edition of Antiviral Research includes a series of review articles that cover every facet of microbicide development, evaluation and dissemination.


Editorial Board

Trends in microbicide formulations workshop

Preventing mucosal HIV transmission with topical microbicides: Challenges and opportunities

Preclinical evaluation of anti-HIV microbicide products: New models and biomarkers

Advances in development, scale-up and manufacturing of microbicide gels, films, and tablets

Advances in microbicide vaginal rings

Clinical evaluation of microbicide formulations

Combining prevention of HIV-1, other sexually transmitted infections and unintended pregnancies: Development of dual-protection technologies

Novel Approaches to Vaginal Delivery and Safety of Microbicides: Biopharmaceuticals, Nanoparticles, and Vaccines

Notes to Authors

[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.]