3 FEBRUARY 2012, VOLUME 13, ISSUE 5

The publication of a paper denying the link between HIV and AIDS in an Italian anatomy journal has prompted a member of its editorial board to resign in protest. Klaudia Brix, a cell biologist at Jacobs University in Bremen, Germany, says that she tendered her resignation from the board of the Italian Journal of Anatomy and Embryology (IJAE) because she felt that it was important for a journal to function within its scientific "scope". Others on the 13-member board have also raised concerns. Hanne Mikkelsen, associate professor of molecular medicine at the University of Copenhagen, Denmark, says that she too is considering resigning her position. Another board member, Laurentiu Popescu, a professor of cellular and molecular medicine at the Carol Davila University of Medicine and Pharmacy in Bucharest, Romania, says that he would have handled the paper differently, but that he will not be resigning. The IJAE - the official publication of the Italian Society of Anatomy and Histology - published the controversial paper in December after examination by just two peer reviewers, one of them the journal's editor-in-chief, Paolo Romagnoli, an expert in cell anatomy at the University of Florence, Italy. Popescu says he personally would have used more reviewers. "Only one [external] reviewer in my mind is not enough for manuscripts of a sensitive nature," he says...

The paper's lead author, Peter Duesberg of the University of California, Berkeley, is well known for denying the link between HIV and AIDS, and six of the paper's nine authors, including Duesberg, are on the board of Rethinking AIDS, a voluntary group campaigning for "scientific reappraisal of the HIV-AIDS hypothesis". The paper is a reworked version of one published in the journal Medical Hypotheses in 2009, which at that time did not use peer review... This version, like the original, attempts to challenge estimates of HIV-AIDS death-tolls in South Africa put forward in a study led by AIDS epidemiologist Max Essex of the Harvard School of Public Health in Boston, Massachusetts, and questions the effectiveness of antiretroviral (ARV) drugs... But AIDS researchers consulted by Nature say that the new paper uses the same arguments and data as the original version. Both papers, in their view, use flawed methods and selective evidence, they say... One problem that remains unaddressed in the new paper, says [Ian] Timaeus, [professor of demography at the London School of Hygiene and Tropical Medicine], is the use of estimates of AIDS deaths in South Africa based on cause-of-death data, which are notoriously unreliable. Another is the claim that South Africa's population is increasing, so large numbers of people cannot be dying of HIV-AIDS, an argument a previous reviewer described as "completely fatuous"... The paper's authors also completely ignore a raft of data demonstrating the effectiveness of ARVs, says Luis Montaner, an expert in immune-system dysfunction associated with HIV at the Wistar Institute in Philadelphia, Pennsylvania.

...Different surveys around the world have found that between one and ten out of one hundred people are sexually or romantically attracted to members of the same sex. Using the lower end of this range, we find that a minimum of 15 lakh (1.5m) people in Bangladesh are homosexual or bisexual. Despite this large number -- which is roughly equivalent to the entire population of Qatar and could actually be up to ten times as high -- LGB people are an invisible minority. Many face discrimination at school, university and their workplace, are denied access to health care and justice and, being torn between fear, confusion and guilt, find little support from family members and friends. Section 377 of the Bangladesh Penal Code makes same-sex intercourse a crime punishable by imprisonment for life. Consequently, only few are open about their sexual orientation, while most are forced to live a life of secrecy and lies, conformed to bigotry, misguided notions of honor and caricatures of justice and morality. With heterosexual marriage still being considered a woman's nirvana, the level of tolerance for lesbian women is particularly low -- they are doubly marginalized... A report published by the Bangladesh Ministry of Law, Justice and Parliamentary Affairs states that Section 377 "violates [the] constitutionally protected right to privacy under the expanded definition of right to life and personal liberty..." Supreme Court Advocate Sara Hossain further sees Section 377 in conflict with the anti-discrimination clause and the right to equality before the law guaranteed by the Constitution of Bangladesh... Repealing Section 377 is an integral step in the development of Bangladesh as a free and democratic nation...

Informing clinical-trial participants of the risks they face is a cornerstone of modern medical research, and it is enshrined as a human right in international codes of ethics. But an influential group of ethicists and medical researchers warned at a meeting in Brussels last week that the process has become a box-ticking exercise focused more on offering legal protection to a trial's organizer than actually protecting patients... [D]elegates at the meeting detailed a host of ways in which the system fails to meet those criteria. Denis Lacombe, director of the Brussels headquarters of the European Organisation for Research and Treatment of Cancer, presented data showing that the median length of consent forms used in the organization's trials tripled between 1995 and 2009... Other speakers showed that warnings of possible side effects are often vague, and jumble potentially serious problems among minor concerns. Details of the prognosis of the disease and the likely outcome of the treatment are often scarce. Long, jargony forms mean that many patients have little idea what they are actually signing up to, says Dominique Sprumont, a health lawyer at the University of Neuchatel in Switzerland...

One solution presented at the meeting was to base forms on those used in Norway, where a short summary of the main aspects of a trial precedes more detailed information. And many delegates advocated a greater use of graphics and charts... Some ethicists advocate digital consent forms, delivered by computer or smart phone. Interactive forms could lead participants through the consent process, and keep them more informed during the trial. They could also make it easier for researchers to obtain new consent if they need to change a study once it is under way.

Armed with a five-year, $13.3 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), [Deborah Anderson, Boston University... professor of obstetrics and gynecology and microbiology, is developing an innovative approach to AIDS prevention, supplementing the body's own immune system with novel antibodies grown in tobacco plants. If it works, her system will offer not only a cheap and powerful new weapon against AIDS, but also insights into stopping the spread of viruses from the common cold to the deadly Ebola virus... Anderson is creating a microbicide that a woman can insert in her genital tract via an easy-to-use ring, gel, or film. The microbicide will contain two antibodies that attack different parts of the HIV virus and a third antibody that neutralizes HSV. If the technology works, in the future it could include antibodies that protect against other STDs as well. "We could keep adding antibodies because the body makes a whole host of them," says Anderson, pointing out that human secretions are already brimming with antibodies...

To develop the particular antibodies to be used in the microbicide, Anderson is working with biophysicist Kevin Whaley, a longtime collaborator and founder of Mapp Biopharmaceuticals, in San Diego. Mapp is a leader in the production of "plantibodies," antibodies (in this case, HIV-specific antibodies) grown in plants. Plantibodies can be manufactured in huge amounts quickly and cheaply compared to growing similar antibodies in animals or cell cultures... Anderson's grant comes from the NIH's Integrated Preclinical/Clinical Program for HIV Topical Microbicides, created to foster collaboration between industry and academia. Anderson will oversee 6 projects at 10 institutions that will test new antibody formulations, grow the plants, harvest the antibodies, and build and test the application devices... Anderson's first goal over the grant's five years is to determine which configuration of antibodies works best when mixed with mucus or applied to mucosal skin cells... "Our dream is to put plantibodies on the map for preventing transmission of STDs," says Anderson. If the technology works, it could have far broader implications...

The day of the assembly-line circumcision is drawing closer... The goal is to circumcise 20 million African men by 2015, but only about 600,000 have had the operation thus far. Even a skilled surgeon takes about 15 minutes, most African countries are desperately short of surgeons, and there is no Mohels Without Borders. So donors are pinning their hopes on several devices now being tested to speed things up. Dr. Stefano Bertozzi, director of H.I.V. for the Bill and Melinda Gates Foundation, said it had its eyes on two, named PrePex and the Shang Ring, and was supporting efforts by the World Health Organization to evaluate them...

PrePex, invented in 2009 by three Israelis after one of them, a urologist, heard an appeal for doctors to do circumcisions in Africa, was approved by the Food and Drug Administration three weeks ago. The WHO will make a decision on it soon, said Mitchell Warren, an AIDS-prevention expert who closely follows the process. From the initial safety studies done so far, PrePex is clearly faster, less painful and more bloodless than any of its current rivals. And it relies on the simplest and least-threatening technology -- a rubber band. The band compresses the foreskin against a plastic ring slipped inside it; the foreskin dies within hours for lack of blood and, after a week, falls off or can be clipped off "like a fingernail," said Tzameret Fuerst, the company's chief executive officer, who compared the process to the stump of an umbilical cord's shriveling up and dropping off a few days after it is clamped. It is done with topical anesthetic cream, and there is usually no bleeding. And PrePex can be put in place and removed by nurses with about three days' training... The WHO, Mr. Warren said, is also evaluating the Shang Ring, a plastic two-ring clamp developed in China to treat conditions in which the foreskin becomes so tight that it cuts off urination. However, it requires cutting off the excess foreskin beyond the clamp, which means the circumciser must inject anesthetics directly into the penis and groin, wait for them to take effect, create a sterile surgical field and be trained in minor surgery. "The Shang is not as fast, but it's faster than full-fledged surgery," Mr. Warren said.

President Barack Obama hit upon some familiar themes in his fourth State of the Union (SOTU) address last night. Perhaps the theme most relevant to biopharma was his call for more basic research spending, which he linked not only to past science and tech triumphs but to the promise of a cure for a deadly disease as well as another science victory over other nations... "Innovation also demands basic research. Today, the discoveries taking place in our federally financed labs and universities could lead to new treatments that kill cancer cells but leave healthy ones untouched," President Obama told a joint session of Congress. "Don't gut these investments in our budget... Obama also used basic research spending to buttress the us-versus-the-rich theme he wove throughout this year's SOTU address: "Do we want to keep these tax cuts for the wealthiest Americans? Or do we want to keep our investments in everything else-like education and medical research?"... Notwithstanding his injections of urgency into his annual pitch, even the President knows that boosting basic research spending will be much easier said than done... For proof that SOTU speeches don't usually yield bigger NIH budgets, just turn the clock back a year ago. Addressing Congress on January 25, 2011, Obama tried to make the case for more basic research spending... The outcome: A FY 2012 budget that kept spending for NIH fairly flat, with just a 1% increase, to $30.6 billion. The previous fiscal year, NIH saw its budget shrink by 1%, under an April 2011 agreement with Congressional leaders that came after his 2010 and 2009 SOTU addresses...

African leaders should respect the rights of LGBT people, UN Secretary General Ban Ki-moon said Sunday at the 18th African Union summit in Addis Ababa, Ethiopia. "One form of discrimination ignored or even sanctioned by many states for too long has been discrimination based on sexual orientation or gender identity," Ban told the summit. "It prompted governments to treat people as second-class citizens or even criminals." Homosexual acts are outlawed in most African countries, and LGBT-related discrimination is rife. Previous criticisms from outside the continent have been met by angry responses from African leaders, who claim that homosexuality is alien to their culture. A bill reintroduced in Uganda's Parliament late last year would provide stiffer punishments, up the death penalty, for various LGBT-related offenses, including gay sex involving a person who has HIV. "Confronting these discriminations is a challenge, but we must not give up on the ideas of the universal declaration" of human rights, Ban said. "For as long as they are human beings we respect them but in terms of their practices and orientation we strongly condemn it," said Simon Lokodo, Uganda's Ethics and Integrity. "We condemn in all strongest forms anyone who promotes or propagates these practices."

Rather than remain dependent on donor money, African leaders must look for alternative ways to fund a sustained response to the HIV/AIDS epidemic, the executive director of UNAIDS said Saturday in Addis Ababa. Michel Sidibe, who is in Ethiopia for the 18th African Union summit, warned that the continuing global economic downturn likely will reduce further the money available to fight the disease. "Africa is too dependent on external resources, especially for the AIDS response," said Sidibe, who identified this dependence as "a source of great risk and potential instability. The status quo cannot be sustained. It is time for a new development paradigm that is developed and owned by the leaders of Africa." UNAIDS estimates that two-thirds of the money spent to fight AIDS in Africa comes from international funding sources. The vast majority of antiretrovirals used to treat HIV in Africa are imported from generic manufacturers. The agency also estimates that Africa will need $11 billion-$12 billion to combat AIDS by 2015, that is $3 billion-$4 billion more than is being spent currently. In addition to leveraging public-private partnerships, UNAIDS suggested taxes on tobacco, alcohol, and cell phones as ways to raise the money needed.

Last week, Michel Kazatchkine tendered his resignation as executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria. Regardless of whether you've heard of the French AIDS scientist, or even of the fund, you should keep reading. This is a crucial, dangerous moment for global health. Kazatchkine made clear the political struggle that forced his resignation. "Within the area of global health, the emergency approaches of the past decade are giving way to concerns about how to ensure long-term sustainability, while at the same time, efficiency is becoming a dominant measure of success," he wrote [in his resignation letter]. It is almost possible to hear Kazatchkine spitting out the words 'sustainability' and 'efficiency'. Since the financial crisis of November 2008, a storm has been brewing over these concepts, one that affects everything from humanitarian responses to projects that distribute malaria bed nets. It is a fight, and on one side are those who believe that crises in general, and the AIDS pandemic and allied diseases in particular, constitute global 'emergencies' that must be tackled with full force, mistakes be damned. On the other are those who feel that AIDS is now a chronic disease that can be managed with medication and therefore requires investment in permanent infrastructure of care and treatment that can eventually be operated and funded by the countries themselves. It is a classic battle of titans, pitting urgency against long-term sustainability. In his resignation letter, Kazatchkine essentially conceded victory to the forces for sustainability. Charitable urgency didn't stand a chance once the donor states started cinching their domestic budget belts so tightly that they had to punch new buckle holes... But Global-Fund cash has spawned dependency and expectation among its recipients. Should it disappear, or radically diminish, countries would be hard-pressed to finance malaria and tuberculosis efforts... Should the fund collapse, the consequences will be severe. Progress against tuberculosis and malaria will stall, and more than a million people living with HIV could be left without treatment.

The new chief of the Global Fund to Fight AIDS, Tuberculosis and Malaria plans a major overhaul of operations following an assessment urging improved management... "There is nothing broken that can't be fixed, but there's a lot of fixing to do," Gabriel Jaramillo, the fund's new general manager, said in a telephone interview from his native Colombia... Mr. Jaramillo, 62 years old, is a retired chairman and chief executive officer of Sovereign Bank, a Boston-based wholly owned subsidiary of Spain's Banco Santander SA, and a specialist in corporate turnarounds. He served on an expert panel last year that recommended multiple changes to the fund's operations to improve risk and grant management, visiting many programs that receive Global Fund money. He will take the helm on Feb. 1 from Dr. Kazatchkine and hold the job for one year, implementing the panel's recommendations and accepting a $1 salary... Mr. Jaramillo said he will focus on "establishing a disciplined private-sector governance process" for managing grants, improve risk management from country to country, and try to raise new money, [and] said he will strengthen the fund's forecasting... He said he hopes to hold a fund-raising conference "later in the year" as global health organizations are calling for an emergency fund-raising effort... Bill Gates said the fund's problems shouldn't discourage donors... "We detest the fact that some of the already small amount of aid money earmarked for the poor is misused, but it would be deplorable if relatively rare events of corruption were to get more attention than the millions of lives the Global Fund has saved," Mr. Gates, co-chair of the Bill & Melinda Gates Foundation, said in an emailed statement. "The Global Fund is one of the most effective ways we invest our money every year."

Last week, Oxfam and Save the Children released a report saying that emergency relief in the Horn of Africa came months late, costing thousands of lives and millions of dollars. Oxfam and Save the Children conclude that humanitarian assistance should be done differently. The anti-foreign aid establishment is using the report to argue that aid doesn't work and should be cut across the board. The very fact that $2.1 billion has been donated to help the victims of the famine is a testament to human beings' generosity. But that fact of our generosity also explains why I am so frustrated by the increasing opposition in many rich countries to foreign aid. We know people care about the suffering of others. Not only that. They are willing to express their caring by making significant donations, even in very hard times. So what keeps them from supporting government investments to alleviate extreme suffering? According to public opinion research, many people believe aid is either stolen by corrupt leaders or wasted on ineffective programs. Naturally, no one is eager to make investments they're convinced won't pay off. There is also the argument that aid doesn't work even when it gets to its intended recipients. This claim is not convincing either. In the past 50 years, the number of children who die every year has gone down from 20 million to fewer than 8 million. Meanwhile, the proportion of people living in extreme poverty has declined by more than half. These massive improvements are due in large part to aid-funded programs to buy vaccines and boost farmers' productivity.

I am confident that we can get the price of AIDS drugs down to $300 per person per year in the very near future. That will mean that every $300 a country gives to the Global Fund to Fight AIDS, TB and Malaria represents a person who will stay alive for another year. Every $300 that's not forthcoming represents a human being who will almost certainly die. That is a stark but realistic way to think about the choices we're making when we debate aid budgets... I am proud to live in a world where a stranger's suffering matters. Yet foreign aid, the best way to address that suffering, has a growing legion of critics. That is a contradiction we must remedy, and the best way to do it is to tell the truth about aid.

A pharmaceutical company has applied to the federal Food and Drug Administration to market its HIV treatment medication Truvada as a HIV prevention pill. Gilead wants to be able to market Truvada, which is currently used as an HIV treatment, as a preventative pill to uninfected individuals, reports California Watch. If approved, it would be the first of its kind. But the move has sparked debate among public health advocates who argue that the wide availability of the drug would discourage safe sex and would, in fact, increase the incidence of HIV. 'I believe that this could be catastrophic in terms of HIV prevention,' said Michael Weinstein, president of the AIDS Healthcare Foundation, based in Los Angeles... Weinstein said he's not yet convinced by the research, and he wouldn't want to see future mass marketing of the drug discourage gay men - the risk group most seriously affected by HIV, according to the Centers for Disease Control and Prevention - from using condoms based on 'the false belief that they are protected by this, when there's a possibility that those taking the medication still could contract the disease. Some HIV and AIDS awareness organizations say that while they wouldn't want to see Truvada trump other forms of prevention, they are hopeful that the drug will help reach high-risk individuals. 'It comes down to choices,' said David Evans, director of research advocacy at Project Inform, a San Francisco organization focused on improving the health of people with HIV. 'For those who are high at risk, we want them to know that there is new and a better option available to them.' Nevertheless, Evans said he shares some of the drug critics' concerns. 'We don't want to see people give up safe sex practices,' he said... Other drug companies, including ViiV Healthcare, also are planning studies to sell similar prevention drugs, but given the number of clinical trials performed or under way on Truvada, Gilead's product is likely to be the first to make it to market. Gilead did not respond to requests for comment from California Watch.

The American Academy of Pediatrics today released a new recommendation calling for pre-teen and adolescent boys to be vaccinated against human papillomavirus, part of AAP's revised standard immunization schedule for youths. The HPV vaccine already is recommended for girls in the same age range. Giving it to boys will protect them from HPV-linked oral and anal cancers and help prevent further transmission of the STD. AAP's call follows a similar one made by CDC's Advisory Committee on Immunization Practices in October. The three-shot HPV series is given over six months, with costs totaling around $360. Female vaccinations are covered by many private insurers due to inclusion on the routine vaccine schedule. Adding boys to the schedule likely will result in coverage as well. Because HPV is linked to sexual activity, some critics worry that the vaccine against it could promote promiscuity. However, a CDC study on that issue showed no such effect, said Dr. Michael Brady, chair of AAP's Committee on Infectious Diseases and chair of pediatrics at Nationwide Children's Hospital in Columbus, Ohio. "Given the amount of cancer in both genders, most people recognize the rationale," said Brady. "Adding males from a cost-perspective was the right thing to do. Boys who grow up to be men who have sex with men are at particular risk for HPV infection," Brady added. "If you immunize only girls, you wouldn't improve protection of that population."

South Africa should have a population of 55 million citizens in 2012, but the toll of HIV/AIDS makes the figure closer to 50.6 million people, according to a new study by the South African Institute for Race Relations (SAIRR). The research organization's analysis used data from the Actuarial Society of South Africa and the South African Institute for Futures Research. It found almost one-third of all deaths in 2011 were AIDS-related. By 2025, the proportion of AIDS deaths is expected to rise 121 percent from the level in 2000, SAIRR said. "The decrease of population growth has a negative impact on South Africa, because the group most affected by HIV and AIDS is aged between 15 and 49 years, which is the most productive part of the population," said SAIRR researcher Thuthukani Ndebele. "If this age group continues to die early, we will see an acute social and economic impact throughout the country." SAIRR predicts the total number of South Africans living with HIV/AIDS will reach 6 million in 2015 - double the number recorded in 2000. In addition to reduced life expectancy and increased mortality, HIV/AIDS causes broader social ills such as orphanhood and child-headed households. UNICEF figures show that in 2009, 2 million South African children had lost one or both parents to the disease. SAIRR is especially worried about the burden HIV/AIDS will have on the country's public health system. In 2009, South Africa spent nearly 9 percent of its GDP on health, according to World Bank data. This percentage could increase in the near future. "Health budgets might have to increase even further, if government wants to prevent HIV/AIDS having an even more negative impact on the economy than it already has," said Ndebele.

Industrial technology transfers should be used to help Africa fight HIV/AIDS, the head of UNAIDS said Saturday on the sidelines of the 18th African Union (AU) summit in Addis Ababa, Ethiopia. The New Agenda for Africa's Development (NEPAD) and UNAIDS are among agencies partnering for such transfers to enable Africa to produce its own AIDS drugs, Michel Sidibe said. With an economic growth rate of over 6 percent on the continent, what matters now is "not only a development of infrastructure, but also a better life with good health for the African people," Sidibe said. AIDS can be one platform for the transfer of drug-making technologies used in emerging markets such as China and Brazil, he said, suggesting that an AU summit address these opportunities. The private sector can be tapped for such social development. "You cannot put someone under treatment for 30 years while believing that all relevant resources will come from outside," Sidibe said. "I can say that pharmaceutical companies now are the first to seek a dialogue with the African continent." The period since the UN General Assembly High Level Meeting on AIDS in June last year has provided a window of opportunity to talk about the sustainability of programs, Sidibe said. He also noted progress on the adoption of comprehensive mother-to-child HIV prevention programs in Africa, which most countries have plans to accelerate.

A new study comparing needle disposal practices in Miami and San Francisco illustrates how legislative support for harm-reduction strategies like needle exchange can impact transmission rates of diseases like HIV and hepatitis. Hansel Tookes and colleagues at the University of Miami interviewed 448 injection drug users in the city's downtown area who admitted throwing away a total of 9,845 syringes during a one-month period. The IDUs either shared or sold some 700 needles. In all, 95 percent of the used needles were disposed of improperly - in public trash cans, on sidewalks, in parks, into sewers and down toilets. By contrast, just 13 percent of used needles in San Francisco were improperly disposed of. In 2009, IDUs accounted for 9 percent of new HIV infections in the United States, 15 percent of new hepatitis B cases and 44 percent of new hepatitis C infections... San Francisco has had needle-exchange programs since 1988. Florida law bans NEPs, so it is not among the 32 states in which 220 such programs are distributing 30 million clean needles, according to the North American Syringe Exchange Network. A 2009 study in the Journal of Urban Health reported that 12 percent of San Francisco IDUs were HIV-positive, compared to 23 percent of IDUs in Miami-Dade. Tom Liberti, chief of the Florida Department of Health HIV/AIDS Bureau, said he would support NEPs on the grounds they reduce disease; however, no legislation is in process to repeal the ban, which has been on the books for more than a decade. The study, "A comparison of syringe disposal practices among injection drug users in a city with versus a city without needle and syringe programs," was published in Drug and Alcohol Dependence (2011).

Just 15 percent of people with AIDS in the Democratic Republic of Congo have access to antiretroviral therapy (ARVs), according to a new MSF report. MSF said donor nations reneging on pledges to the Global Fund to Fight AIDS, TB and Malaria - the country's leading supplier of ARVs - has led the fund to sharply reduce support. In addition, DRC's government has not made free ARVs a priority, the report said. MSF was the first organization to provide free ARVs in Congo, in 2003, and today treats more than 10 percent of DRC patients on ARVs, including 20 percent of those on therapy in Kinshasa. However, only 44,000 of the estimated 350,000 people in DRC with AIDS who need ARVs receive them. Some 15,000 people waiting for ARVs likely will die in the next three years, MSF said. The pullback of donor support for the Global Fund "is directly threatening the lives of thousands of people in DRC," MSF said. Only 1 percent of HIV-positive pregnant women have access to ARVs to protect their babies from the virus; as a result, about one-third of those infants exposed to HIV will be infected, the report said. "What I'm seeing in DRC has not existed elsewhere for years," said Anja De Weggheleire, the MSF medical coordinator for the nation. "The situation here reminds me of the time before any antiretroviral treatment was available."

The Medical College of Wisconsin (MCW) will use a four-year, $2.1 million grant from the National Institutes of Health's National Institute on Drug Abuse to study HIV risks among teen gang members. The knowledge gained will be used to tailor HIV prevention interventions specific to this population. More than 450 Milwaukee gang members ages 14-19 will be interviewed. These high-risk youths will be identified and recruited by peers and through community-based groups. Eligible participants will spend about 1.5 hours completing an in-depth interview and receive $30. Researchers and health care providers have become increasingly concerned about HIV-related risk behaviors among youths, especially African-American and Latino teens, said Julia B. Dickson-Gomez, the study's principal investigator and a professor and faculty member at MCW's Center for AIDS Intervention Research. While most prevention is focused at the school or community level, little has been developed for those high-risk teens, like gang members, who are less likely to attend school and receive targeted HIV education, she said. "Part of the research will question the level of gang organization, and how that affects HIV risk," said Dickson-Gomez. "One risk behavior may compound another." According to Dickson-Gomez, Milwaukee has a "perfect storm" of conditions for encouraging youth gangs: poverty, "alarmingly high rates of risky sex," low high school graduation rates, and a high teen birth rate. Gangs vary in size and structure, from neighborhood-based groups to highly organized, corporate-style gangs that tend to have female members, formal rules, and initiation rites. Girls will comprise at least 20 percent-40 percent of the interviews.

The number of college-age students getting STDs is rising, with about 36,000 Floridians in their early 20s having contracted chlamydia, gonorrhea or syphilis in 2010. That amounted to about 3 percent of the age group. New HIV case numbers also have risen over the past decade, though not as much as STDs. Plenty of young couples are in steady, monogamous relationships, college students interviewed said, but many acknowledged the prevalence of casual sex among peers, with the Internet and social media increasing the choice of partners. "You often see hookups in media representations, but it's rare that you hear the characters talk about safe sex," said Courtney Weaver, a sexual-health educator at Florida Atlantic University. In South Florida, clubbing is a large part of the culture, and alcohol use and underage drinking have grown among college-age students in recent years, studies show. Safe sex is even less likely when alcohol is involved, educators noted. "We know when kids drink, their judgment goes out the window," said Sande Gracia Jones, a professor in Florida International University's (FIU) College of Nursing and Health Sciences. Students hook up "to get what they need without being emotionally involved," Weaver said. There is no shame about it in many cases, students said, and hooking up can blur into dating relationships. "There's a lot of serial monogamy," said Albert Garcia, an FIU senior who educates students about sexual health. "They're monogamous every couple of months and end up having four, five or six monogamous relationships in a year." Smartphone applications such as Skout and Streetspark are popular among young adults looking for casual sex. Through such apps, which use GPS technology to locate people, people can exchange messages and photos and arrange to meet.

The appointment of a new general manager, Gabriel Jaramillo, at the Global Fund to fight AIDS, Malaria and Tuberculosis could be a "turning point" for the troubled organization, which has suffered from a funding crisis and allegations of corruption. Jaramillo, a former CEO of Spain's Sovereign Bank and special adviser to the Office of the Special Envoy for Malaria of the UN Secretary-General, was a member of an independent panel set up in March 2011 to investigate the Global Fund's fiduciary controls and oversight mechanisms after allegations of grant fraud in several recipient countries. Among other things, the panel recommended the Fund strengthen its internal governance, improve its risk management and "get serious about results"...

"When problems pile up and the buzz and press get so bad, it is inevitable that leadership will be held responsible. I suppose the Global Fund board decided that the costs associated with a leadership transition during a crisis are lower than the benefits from a fresh face and new strategy," Amanda Glassman, director of global health policy and research at the Centre for Global Development, told IRIN/PlusNews... Glassman believes that current features of the Global Fund's structure probably exacerbated the crisis. "The Fund's performance-based funding model relies on self-reports and a non-transparent decision-making process on disbursements... I am very worried about the current emphasis on audit and fiduciary oversight as the 'solution' to the misuse and corruption issues in low-income countries. I would rather see the Fund tie money to measurable improvements in performance and forget about checking the receipts for every condom," she added. This has been backed up by the High-Level Independent Review Panel, which found that "the culture of the Global Fund has become one driven by the measurement of documentation, and not by health impact". But for Asia Russell, director of international policy for activist group HealthGap, it all comes down to money - or lack of it... The issue was not the credibility of the Global Fund, which has some of the most open and transparent mechanisms for identifying and responding to corruption and fraud - "much stronger than other bilateral funders, for example", Russell told IRIN/PlusNews by email.

A movement to boycott scientific publishing giant Elsevier because of the high price of its journals is rapidly gathering steam. Nine days after it started, more than 2600 scientists - including several Field Medalists - have signed a petition at thecostofknowledge.com in which they pledge not to publish papers in Elsevier's journals, nor referee other researchers' studies, or do other types of editorial work for the company. The petition, which has created a buzz on researchers' blogs and Twitter, isn't just an attack on Elsevier, its organizers say, but also an attempt to show the scientific community that it can help change the publishing business themselves to increase access to their studies... The petition mentions three main gripes: the "exorbitantly high prices" for the journals, the fact that many are sold as part of 'bundles' that include titles that libraries don't care for, and Elsevier's support of measures such as the Research Works Act, a controversial bill that would undo the National Institutes of Health's "public access" policy.

A spokesperson for Elsevier declined to answer questions, but the company sent Science Insider a written statement yesterday saying that its price increases "have been among the industry's lowest for the past ten years," and that Elsevier has made several other efforts to increase access to its information, such as the introduction of optional packages and a large contribution to the PubMed Central database... Heather Joseph, the executive director of the Scholarly Publishing and Academic Resources Coalition (SPARC), an international alliance of academic and research libraries based in Washington, D.C., says she's "surprised and pleased" to see the scientific community organize itself so quickly... Although the petition singles out Elsevier, both Gowers and Joseph emphasize that other big publishers - such as Springer and Wiley - apply similar business models. The focus is on Elsevier mainly due to its strong support to the Research Works Act, says Gowers.

Only one in three Mozambicans, Tanzanians and Zimbabweans who need antiretroviral medicine are getting it, according to new research. The biggest barriers to effective HIV treatment were centralised service provision, which meant many primary health centres did not stock ARVs, and a shortage of health workers, according to the report from the Community Based Systems in HIV treatment (CoBaSys) programme. Some health workers were also charging patients to have their CD4 counts taken or to get ARVs in some rural facilities although these were supposed to be free. The programme conducted research at 12 sites in Zimbabwe, Namibia, Mozambique, Malawi, Botswana and Tanzania. "There are shortfalls in essential medicines, staffing; equipment and other supplies, undermining coverage," according to the report. "Where services for AIDS were integrated with services for maternal and child health and treatment of common illnesses and were close to communities, they were more accessible and supportive of responses for reducing both HIV risk and vulnerability top AIDS," concluded the report. However, all services were found to be "crowded, stressed by rising demand, with poor facilities for privacy, shortfalls in supplies and frustrated and non-communicative health workers undermining uptake... Of these factors the presence of trained health workers living in the community was found to be the most critical... Faced with poor pay, poor occupational protection, shortfalls in medicines and equipment in primary care services, limited space for services, poor supervision and mentoring, some health workers were reported to leave primary care services, to raise informal charges for rationed services like ART or CD4 testing, or to have stressed and sometimes hostile communication with clients."

In 2007, WHO/UNAIDS recommended male circumcision as an HIV preventive measure based on three sub-Saharan African randomised clinical trials (RCTs) into female-to-male sexual transmission. A related RCT investigated male-to-female transmission. However, the trials were compromised by inadequate equipoise; selection bias; inadequate blinding; problematic randomisation; trials stopped early with exaggerated treatment effects; and not investigating non-sexual transmission. Several questions remain unanswered. Why were the trials carried out in countries where more intact men were HIV-positive than in those where more circumcised men were HIV-positive? Why were men sampled from specific ethnic subgroups? Why were so many participants lost to follow-up? Why did men in the male circumcision groups receive additional counselling on safe sex practices? While the absolute reduction in HIV transmission associated with male circumcision across the three female-to-male trials was only about 1.3%, relative reduction was reported as 60%, but, after correction for lead-time bias, averaged 49%. In the Kenyan trial, male circumcision appears to have been associated with four new incident infections. In the Ugandan male-to-female trial, there appears to have been a 61% relative increase in HIV infection among female partners of HIV-positive circumcised men. Since male circumcision diverts resources from known preventive measures and increases risk-taking behaviours, any long-term benefit in reducing HIV transmission remains uncertain.

According to the authors of recent research from Norwich, United Kingdom, "Information on the burden of tuberculosis (TB)-HIV co-infection is critical for the planning and evaluation of TB-HIV control and treatment strategies. This study assessed current practices in countries of the European Union (EU) and European Economic Area (EEA) for monitoring HIV co-infection in TB surveillance systems, countries' current co-infection burden and associated clinical practice. An online survey was distributed to all national TB surveillance nominated European Centre for Disease Prevention and Control contact points in the EU/EEA. We received 25 responses from 30 countries (83% response rate). Patients' HIV status was collected in 18 out of the 25 TB surveillance systems, usually via clinician reporting (16 out of 18 surveillance systems). Although most countries recommended routine testing of TB patients for HIV, the proportion actually tested varied from 5% to 90%. The burden of HIV co-infection was found to be elevated in countries with higher levels of HIV testing and higher prevalence of HIV. We suggest that TB-HIV co-infection be monitored in all EU/EEA countries to facilitate the planning and evaluation of TB-HIV control strategies. Strengthening collaboration between TB and HIV clinicians and surveillance departments, and consideration of patient confidentiality restraints would be advantageous," wrote M.E. Kruijshaar and colleagues, University of East Anglia.

Abstract
Context: Human papillomavirus (HPV) infection is the principal cause of a distinct form of oropharyngeal squamous cell carcinoma that is increasing in incidence among men in the United States. However, little is known about the epidemiology of oral HPV infection.

Objective: To determine the prevalence of oral HPV infection in the United States.

Design, Setting, and Participants: A cross-sectional study was conducted as part of the National Health and Nutrition Examination Survey (NHANES) 2009-2010, a statistically representative sample of the civilian noninstitutionalized US population. Men and women aged 14 to 69 years examined at mobile examination centers were eligible. Participants (N = 5579) provided a 30-second oral rinse and gargle with mouthwash. For detection of HPV types, DNA purified from oral exfoliated cells was evaluated by polymerase chain reaction and type-specific hybridization. Demographic and behavioral data were obtained by standardized interview. Statistical analyses used NHANES sample weights to provide weighted prevalence estimates for the US population.

Main Outcome Measures: Prevalence of oral HPV infection.

Results: The prevalence of oral HPV infection among men and women aged 14 to 69 years was 6.9% (95% CI, 5.7%-8.3%) and of HPV type 16 was 1.0% (95% CI, 0.7%-1.3%). Oral HPV infection followed a bimodal pattern with respect to age, with peak prevalence among individuals aged 30 to 34 years (7.3%; 95% CI, 4.6%-11.4%) and 60 to 64 years (11.4%; 95% CI, 8.5%-15.1%). Men had a significantly higher prevalence than women for any oral HPV infection (10.1% [95% CI, 8.3%-12.3%] vs 3.6% [95% CI, 2.6%-5.0%], P < .001; unadjusted prevalence ratio [PR], 2.80 [95% CI, 2.02-3.88]). Infection was less common among those without vs those with a history of any type of sexual contact (0.9% [95% CI, 0.4%-1.8%] vs 7.5% [95% CI, 6.1%-9.1%], P < .001; PR, 8.69 [95% CI, 3.91-19.31]) and increased with number of sexual partners (P < .001 for trend) and cigarettes smoked per day (P < .001 for trend). Associations with age, sex, number of sexual partners, and current number of cigarettes smoked per day were independently associated with oral HPV infection in multivariable models.

Conclusion: Among men and women aged 14 to 69 years in the United States, the overall prevalence of oral HPV infection was 6.9%, and the prevalence was higher among men than among women.

About one in 15 Americans is infected with oral human papillomavirus, a sexually transmitted virus that causes throat cancers, and the disease is especially common among men, new research shows. The research is the first major study to document the nationwide prevalence of oral human papillomavirus, or HPV, a disease that has drawn growing attention from public health experts because it has fueled a rise in oropharyngeal cancers affecting the back of the tongue and the throat... By looking at thousands of people across the country, the authors of the new report found that 6.9 percent of adults and teenagers are infected with oral HPV of any kind. The virus was about three times as common in men as it was in women... The reason for the higher rate among men was unclear. The men in the study tended to have higher numbers of sexual partners than the women, but statistical analyses showed that this accounted for 16 percent of the difference in virus prevalence. One line of speculation was that hormonal differences in women might play a protective role, or that oral sex on women for some reason causes a greater likelihood of transmission. But either way, the finding that men had triple the rate of infection dovetailed with earlier research on HPV-related throat cancers, which are about three times as common in men as they are in women, a difference that until now had not been explained. Some experts suspected that HPV rates for men and women were similar, but that HPV was simply more virulent in men. By looking at the effects of various behaviors on infection rates, the study showed that a greater number of lifetime sexual partners as well as sexual activity of any kind - vaginal, anal or oral sex - heightened the risk. The disease also becomes more common with increasing age.

Abstract (provisional)
Background: Continued efforts are being directed toward the development of microbicides that will be used to reduce or eliminate the risk of HIV-1 sexual transmission. Unfortunately, clinical trials involving polyanion-containing microbicide formulations, including Carraguard (lambda-carrageenan [LC]) and Ushercell (cellulose sulfate [CS]) demonstrated that these products were ineffective and may have, in some circumstances, increased the risk of HIV-1 infection. These findings prompted reassessments of the in vitro activities of these agents to determine whether variables that can affect agent safety and efficacy had been overlooked during preclinical testing. One such variable is product retention and loss following topical application.

Results: In the present studies involving an HIV-1-susceptible cell line and primary human immune cells, product loss was mimicked by introducing and then removing polyanionic compounds prior to HIV-1 infection. In these in vitro "washout" experiments, LC and CS significantly enhanced HIV-1 infection, despite potent antiviral activity when introduced simultaneously with the virus. The presence and magnitude of this effect were dependent on compound identity and concentration; target cell; interval between compound removal and virus challenge; and coreceptor usage. Levels of enhancement (relative to controls) were considerable, exceeding a 200% increase (CS) in P4-R5 MAGI cells and a 300% increase (LC) in human peripheral blood mononuclear cells.

Conclusion: These studies, which demonstrate significant increases in HIV-1 infection subsequent to application and removal of LC and CS, support plausible explanations for the failures of microbicides formulated from these compounds. Detailed studies are now underway to determine the mechanism responsible for this enhancement effect and to assess the potential contribution of this effect to the clinical failures of these agents.

Abstract
Microbicides represent a potential intervention strategy for preventing HIV transmission. Vaginal microbicides would meet the need for a discreet method that women could use to protect themselves against HIV. Although early-generation microbicides failed to demonstrate efficacy, newer candidates are based on more potent antiretroviral (ARV) products. Positive data from the CAPRISA 004 trial of tenofovir gel support use in women and represent a turning point for the field. This article reviews current progress in development of ARV-based microbicides. We discuss the consensus on selection criteria, the potential for drug resistance, rationale for drug combinations, and the use of pharmacokinetic (PK)/pharmacodynamic (PD) assessment in product development. The urgent need for continued progress in development of formulations for sustained delivery is emphasized. Finally, as the boundaries between different prevention technologies become increasingly blurred, consideration is given to the potential synergy of diverse approaches across the prevention landscape.

Abstract
Adherence to microbicide gel use is critical to optimizing effectiveness in preventing human immunodeficiency virus transmission. The authors hypothesized that ester taggants added to vaginal gels would generate exhaled alcohol and ketone metabolites and provide a "breath test" for vaginal gel use. This 2-arm (vaginal and dermal), randomized, participant-blinded, pilot study tested this hypothesis. On 8 visits, healthy women (n = 8) received intravaginal taggant (2-butyl acetate, 2-pentyl acetate, isopropyl butyrate, or 2-pentyl butyrate; 30 mg) formulated in hydroxyethylcellulose or tenofovir placebo gel. A second group (n = 4) of women received the same formulations administered dermally on the forearm to determine if skin administration might confound the system. Breath samples were collected using bags before and after taggant administration for 1 hour. Samples were measured using a miniature gas chromatograph and/or gas chromatography-mass spectroscopy for ester taggant, alcohol, and ketone concentrations. After vaginal administration, 2-butyl acetate, 2-pentyl acetate, and metabolites were observed in breath, whereas isopropyl butyrate, 2-pentyl butyrate, and metabolites were not. Some women reported self-resolving, mild burning (24/64 visits) with vaginal administration or a "bubblegum" taste (7/64 visits). No taggants or metabolites were detected following dermal application. A "breath test" for adherence to antiretroviral vaginal gel application appears physiologically and technically feasible.

Abstract
HIV-exposed, uninfected (EUN) babies born from HIV-infected mothers are examples of natural resistance to HIV infection. In this study, we evaluated the titer and neutralizing potential of gp41 specific maternal antibodies and their correlation with HIV transmission in HIV-infected mother-child pairs. Specific gp41-binding and -neutralizing antibodies were determined in a cohort of 74 first-time mother-child pairs, of whom 40 mothers were HIV infected with subtype C. Within the infected mother cohort, sixteen babies were born infected and 24 were PCR negative and uninfected at birth (exposed seronegative, EUN). Thirty-four HIV uninfected and HIV unexposed mother-child pairs were included as controls. All HIV-positive mothers and their newborns showed high IgG titers to linear epitopes within the HR1 region and to the membrane-proximal (MPER) domain of gp41; most sera also recognized the disulphide loop, immunodominant epitope (IDE). Antibody titers to the gp41 epitopes were significantly lower in non-transmitting mothers (p<0.01) and in the EUN babies (p<0.005) as compared to HIV-positive mother-child pairs. Three domains of gp41, HR1, IDE and MPER, elicited antibodies that were effectively transmitted to EUN babies. Moreover, in EUN babies, epitopes overlapping the 2F5 (ELDKWAS), but not the 4E10 epitope, were neutralization targets in two out of four viruses tested. Our findings highlight important epitopes in gp41 that appear to be associated with exposure, but without infection, and would be important to consider for vaccine design.

During a study of 5567 South African women, looking at the effect of hormonal contraception on HIV acquisition, 270 women became HIV-infected. The researchers report that use of hormonal contraception did not increase the risk, overall, of becoming HIV positive, compared to non-hormonal contraception, in the advance online edition of AIDS. There was a modest but non-significant trend towards an increased risk of getting HIV in women who used an injectable hormonal contraceptive (DMPA). Hormonal contraception included combined oral contraceptives (COC) and injectable progestin (DMPA [Depo-Provera] or norethisterone enanthate [Net-En]). This analysis, of a subset of data from a randomised, double-blind, placebo controlled trial (Carraguard Phase 3 Efficacy) that looked at whether vaginal use of a microbicide prevented HIV transmission, did find a modest increased risk with the use of DMPA, notably, among younger women (16 to 24 years of age; aHR: 1.68 95% CI: 0.96-2.94)... The participants were HIV-negative, not pregnant and sexually active (defined as having had at least one sex act in the previous three months)... At enrolment 29% were using DPMA, 21% Net-En, and 9% COCs, with 41% in the non-hormonal group (comprising a combination of women who used male and female condoms, sterilisation, diaphragm, traditional methods or were not using any form of contraception)...Of the 270 women (3.7 per 100 woman-years) who became HIV infected, incidence was 2.8, 4.6, 3.5 and 3.4 per 100 woman-years, p=0.09 among those in the COC, DMPA, Net-En and non-hormonal groups, respectively...

The authors cite the recent publication of the secondary analyses of almost 3800 HIV sero-discordant couples from the two-year seven African country Partners in Prevention study data that showed double the risk of getting HIV and twice the risk of transmitting HIV, if infected, with the use of hormonal contraception (notably DMPA). The authors note that, while their findings of a moderate, but not significant, increased risk with the use of DPMA and getting HIV is in keeping with the HC-HIV study and other recent reports, it contrasts with the Partners in Prevention study findings... The difference may be attributable to a difference in exposure risk in the study populations. The Partners in Prevention study analysis evaluated the risk of infection according to contraceptive mode among women with HIV-positive partners (who could have been at risk of infection upon each occasion of sexual intercourse). In contrast, in this microbicide trial cohort, women may have been exposed to HIV on fewer occasions, if at all. The contraceptive analysis of the Carraguard trial cohort could not control for the HIV status of regular partners. If this explanation were correct, the greater exposure risk in the Partners in Prevention study would tend to amplify any trend towards an elevated risk of contracting HIV when using DMPA... The authors suggest that because the main agent (medroxyprogesterone) of DMPA binds to the glucocorticoid receptor of many cells of the immune system, it may have a greater immunosuppressive effect (compared to progesterone).

Journal Reference:
Morrison CS et al. Hormonal contraception and the risk of HIV acquisition among women in South Africa. AIDS 25, 2012.

As part of its larger effort to revamp its existing HIV/AIDS clinical trials networks, NIAID has issued five new requests for applications (RFAs) to establish leadership groups for clinical research networks focused on distinct areas of HIV/AIDS research. Applications for each RFA are due Sept. 28, 2012. Awards are expected to be made in 2013. The leadership groups will have overall responsibility for developing, implementing and adapting clinical research agendas to address NIAID's HIV/AIDS scientific priorities in the following areas:

-Therapeutics for HIV/AIDS and HIV-associated infections in adults
-HIV/AIDS and HIV-associated infections in pediatric and maternal populations
-Integrated strategies to prevent HIV infection
-Vaccines to prevent HIV infection
-Microbicides to prevent HIV infection

To view each of the RFAs, see the NIH Guide for Grants and Contracts. For the latest information on NIAID's clinical trials network restructuring process, see here.

Purpose: To develop and evaluate a clinic-based intervention that modifies the way reproductive health services are provided to high risk female teens aged 15-19, particularly those from racial and ethnic minority groups, to increase use of dual protection strategies that concurrently protect against unintended pregnancies and sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV). NCCDPHP intends to commit approximately $300,000 in FY2012; approximate total project period funded amount may not exceed $3,200,000.

Application Due Date: 03/26/2012
Project Start Date: 09/01/2012
Description: NCCDPHP intends to commit approximately $300,000 in FY2012; the approximate total project period funded amount may not exceed $3,200,000.
Fund Duration: Up to five years.
Eligible Locations: USA National

For further information, visit here.