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

via RH Reality Check, by Anna Forbes and Kate Ryan

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

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

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

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

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

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[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.]

NIH researchers show how anti-HIV drug acts to block herpes virus

via Infotech

"The findings explain the results of a recent clinical trial showing that the anti-HIV drug tenofovir, when it is formulated as a vaginal gel, could reduce the risk of herpes simplex virus (HSV) infections -- as well as HIV infections -- in women.

Tenofovir taken orally had been demonstrated to inhibit reproduction of HIV, but had not been known to block the genital herpes virus.

"HIV infection is closely associated with herpes viral infection. When people with genital herpes are exposed to HIV, they are more likely to become infected than are people who do not carry the herpes virus," said Leonid Margolis, Ph.D., head of the Section on Intercellular Interactions at NICHD and one of the authors of the study. "Human tissues convert tenofovir to a form that suppresses HIV. We found that this form of tenofovir also suppresses HSV. This discovery may help to identify drugs to treat the two viruses even more effectively." Discoveries leading to new uses for previously approved drugs have the potential to save millions of dollars, Dr. Margolis said. New drugs typically undergo years of testing for safety and effectiveness before they are approved for patients. Finding new uses for an approved drug increases the value of the initial investment in testing, because most of the testing has previously been completed."

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[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.]

Microbicide Trials Network Statement on Decision to Discontinue Use of Oral Tenofovir Tablets in VOICE, a Major HIV Prevention Study in Women

via Microbicide Trials Network

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women – daily use of one of two different ARV tablets or of a vaginal gel – will be dropping one of the oral tablets from the study. The decision to discontinue use of tenofovir tablets in VOICE comes after a routine review of study data concluded that the trial will not be able to demonstrate that tenofovir tablets are effective in preventing HIV in the women enrolled in the trial. VOICE will continue to test the safety and effectiveness of the other oral tablet, Truvada®, a combination of tenofovir and emtricitabine, and of the vaginal gel formulation of tenofovir.

Importantly, the review, which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID)’s independent Prevention Trials Data and Safety Monitoring Board (DSMB), identified no safety concerns with any of the products being studied in VOICE.

VOICE – Vaginal and Oral Interventions to Control the Epidemic – involves 5,029 women at 15 trial sites in Uganda, South Africa and Zimbabwe. The trial is being conducted by the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network funded by the National Institute for Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver Institute for Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.

The study was designed with five study groups: tenofovir gel, an inactive placebo gel, oral tenofovir, oral Truvada and an inactive placebo tablet. The women in each group (about 1,000) are asked to take their assigned study product daily. VOICE is the only trial evaluating the daily use of an ARV tablet – an approach called oral pre-exposure prophylaxis, or PrEP – and a vaginal gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women prefer.

On September 16, 2011, the NIAID Prevention Trials DSMB reviewed VOICE study data for the period between Sept. 9, 2009, when the study began, and July 1, 2011. Based on this interim review, the DSMB determined that it was not possible to show whether oral tenofovir tablets were any better than a placebo for preventing HIV in the women assigned to that study group. The DSMB therefore recommended that the women randomized to the oral tenofovir tablet group discontinue their use of the study product. This recommendation does not apply to the women in the groups using either the tenofovir gel or oral Truvada tablets, or the corresponding placebos; the DSMB recommended that these four study groups continue in VOICE.
 
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[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.]

Calling all Women and Spanish Speakers- Please Take our Survey!

Dear Women and Spanish Speakers,

We need your help with our Rectal Douching and Enema Survey! IRMA and researchers at the University of California, Los Angeles (UCLA) School of Public Health are conducting a brief survey to help us better understand the types of products people use rectally for anal sex including lubricants and enemas or douches. We are trying to gain a better understanding of rectal practices and behaviors that may affect the risk for sexually transmitted infections among people who practice anal intercourse. It is a brief survey (takes less than fifteen minutes) and is completely anonymous.

We have been running this survey for about a month now, and the participation level has been high. However, of the hundreds of responses we have received, less than 10% have been from women! We need more feedback on these anal products from women! We are asking you, ladies, to please take our survey or forward it to anyone you know who may be interested. Women’s opinions and experiences matter in all things anal, and we desperately want to take them into consideration so that women can be better protected from sexually transmitted infections.

Also, with many thanks to IRMA's chapter based in Lima, Peru, we now have a Spanish translation of the survey available! So IRMA blog followers, please forward the survey to anyone you may know who needs the Spanish translation. Thanks IRMA-ALC Lima!

You can click here for the survey or on the "Rectal Douching & Enenma Survey" logo at the top of the page. Thanks again for all of your help!

Sexual Pleasure is Key for Successful Microbicides

via WeNews, by Amy Littlefield

Participants in Kate Morrow's [IRMA Steering Committee Member] recent study may not have felt like they were fighting the global HIV epidemic.

In fact, what they were literally feeling were gels of various consistencies inside their vaginas.

The women in Morrow's Project LINK answered questions after handling the gels, inserting them vaginally, walking around and simulating intercourse with a fake phallus. Did the gel leak out? Did it inhibit the experience . . . or did they actually enjoy it?

Morrow has developed a set of scales to show the range of sensations and experiences women reported. Her goal now is to connect those sensations to data about which gels women would use to prevent HIV. Do they prefer gels that are smooth, thin or thick like hair gel? The answers to those questions could help lead to a microbicide that women will tolerate--and perhaps even enjoy.

For decades, women's health advocates have known that women need a way to protect themselves from HIV that is not dependent on a male partner. Vaginal microbicide gels are among an array of options--including pills, rectal microbicides and vaginal rings--that may one day help. Advocates hope microbicides could even be combined with birth control and help prevent other sexually-transmitted illnesses.

Read the rest.

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

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HPV Vaccine Protects Women Against Anal Infection

via Medpage Today

A vaccine against human papillomavirus (HPV) protects women against two strains of the virus that causes anal cancer, researchers reported.

The vaccine (Cervarix) against HPV strains 16 and 18 offered "strong protection" against anal infection in a study whose main goal was to assess the efficacy of vaccination against cervical infection and pre-cancerous lesions, according to Aimée Kreimer, PhD, of the National Cancer Institute, and colleagues.

The protection was higher in women who did not have HPV infection when they were first given the vaccine, Kreimer and colleagues reported online in The Lancet Oncology.

Anal cancer is rare in women, with an annual incidence of about 1.5 per 100,000, but rates are rising, the researchers noted. The rate is higher than for men in general, but markedly lower than for men who have sex with men or those with HIV.

Most anal cancers are caused by HPV, with strains 16 and 18 responsible for up to 80% of cases, Kreimer and colleagues noted.

They tested the vaccine against anal infection in a subgroup of young adult women, ages 18 through 25, who enrolled in a community-based randomized trial of cervical vaccine efficacy in Costa Rica.

The 6,352 participants who came for the final blinded study visit, four years after their first of three vaccine shots, were asked to give an anal sample, and 4,210 did so, with a median follow-up of 48.1 months.

The researchers analyzed anal infection in the whole cohort and also in a subgroup of women who had been negative for HPV DNA and antibodies at the start of the trial. Patient characteristics in both groups were well-balanced, the researchers reported, including the proportions who got the vaccine and those who were in the control group, given hepatitis A vaccine.

Kreimer and colleagues found...

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[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.]

Why So Anal about Pleasure?

Via EmpowHer, by Hannah Cutts.

Whether you are a committed fan, a non-subscriber, or have been considering engaging in anal play, I believe it is a subject that women should make an effort to include in their sexual awareness and conversations, even if only to expand their education on the female body and become resources for friends/family members who may have questions about the behavior.

According to the Center for Disease Control and Prevention’s National Survey of Family Growth, anal sex between heterosexual partners has been on the rise over the past decade. In 1992, 20.4 percent of women reported engaging in anal sex with a male partner, while in 2005, 32.6 percent indicated they include anal in part of their heterosexual repertoire (New York Magazine, 2006). While anal sex has historically been associated with gay couples, it is clear that people who enjoy sex with the opposite gender have adopted the practice, perhaps finally realizing what they have been missing out on. It is time for women—straight, gay and anywhere in between—to get the facts on anal play and what makes it worthwhile.

The bottom line is, like your vagina, your anus is packed with sensitive nerve endings that feel great when touched or stimulated. Although experimenting with this somewhat fragile opening is not necessarily a stand-alone endeavor (it requires some foreplay and careful lubrication), gentle exploration of the anus is a tremendous complement to other pleasure-giving (think cunnilingus). By slowly introducing the stimulation of this third hole into your sexual repertoire one step (or to be more accurate, one finger) at a time, you are opening yourself up to sensations that you won’t feel with vaginal-only penetration. Many sources suggest you begin simply with a massage of the anal opening, an action that carries almost no risk and allows both partners to get comfortable with the touch.

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.]

Laws fail to protect HIV patients, says advocate

Via The Fiji Times, by Frederica Elbourne.

PACIFIC political leaders have remained silent over the protection of the rights of people vulnerable to and affected with HIV, an organisation that champions AIDS awareness said.

The Pacific Islands AIDS Foundation said laws governing those infected with the virus failed to protect their privacy.

The existing legal frameworks condemned behaviour such as anal sex, sex between men, and sex work, the PIAF report launched by Minister for Women Doctor Jiko Luveni in Nadi last month said.

Such denunciation drives these practices underground, the PIAF said in a report that highlighted the plight of HIV positive women in Fiji and Papua New Guinea.

"Public Health Acts also reflect mentalities of the colonial periods and these acts usually provide wide powers to public health authorities, impose heavy duties on infected people and others who must notify and take precautionary measures," the report pointed out.

The acts rarely gave privacy to people who are subject to these provisions, PIAF said.

"These legal frameworks are outdated and are in many instances inappropriate for HIV. Most legal systems in the Pacific lack legislation that protects the rights of people living with HIV," PIAF said.

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

HIV Prevention in Women Requires a Full Toolbox

Via Medscape, by Emily Paulsen.

Women account for more than 50% of the worldwide AIDS epidemic, and a disproportionate number of those women are people of color. In the United States, black women make up a growing share of new AIDS cases; the rate for black women is nearly 20 times the rate for white women.

Although these statistics are dire, new research, presented here at the National Medical Association 2011 Annual Convention and Scientific Assembly, offers hope that the tide will turn on HIV transmission.

"This has been an amazing year for HIV research," Gina Brown, MD, told meeting attendees. Dr. Brown coordinates research on microbicides at the Office of AIDS Research, part of the National Institutes of Health in Bethesda, Maryland. She offered a "walk-through of some of the interesting things we've learned about what puts women at risk for HIV, and some of the interventions available."

The biggest news in HIV prevention, reported recently at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention, has been the use of antiretroviral therapy (ART) to reduce the risk for transmission, according to Dr. Brown. The HPTN 052 study showed a 96% reduction in transmission in serodiscordant couples in which the HIV-positive partner received early ART. In another study, once-daily tenofovir/emtricitabine (Truvada, Gilead Sciences) resulted in a 44% reduction in HIV transmission in men and transgender women who have sex with men. In that study, those who adhered to their medications at least 90% of the time achieved a 73% reduction in HIV transmission.

Dr. Brown pointed out that the couples in many of these studies were in steady relationships and volunteered to participate in the study. "Does this sound like the patients you see in your practice?" she asked the audience. She also said that costs and adverse effects might affect the practicality of this solution for many patients.

"When can we give up condoms?," she asked, answering that it would not likely be any time soon.

Dr. Brown said a full HIV prevention toolbox is still needed to reduce the risk for transmission. Education, partner reduction, treatment for sexually transmitted infections, condoms, circumcision, 1% tenofovir gel, and ART all offer varying amounts of protection. All interventions offer only harm reduction at this point, she said, not full protection.

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.]

WSJ: Trial Halted on HIV Pill for Women

[of interest: "There is research, as yet unpublished, showing that the concentration of tenofovir, when taken orally, is higher in rectal tissue than in vaginal tissue, said Timothy Mastro, an FHI vice president who spoke on behalf of the study. If so, the men might have had more of the drug than the women at the site where they were exposed to the virus."]

via Wall Street Journal, by Mark Schoofs

A highly anticipated trial to determine whether AIDS drugs taken by mouth can ward off HIV infection in women has been stopped early, a setback that surprised researchers after a string of successes in preventing transmission of the disease.

Researchers said Monday they had called off the trial among high-risk women in Africa because they wouldn't be able to determine whether use of antiretroviral medication produced any benefit. The study tested whether taking the medication once a day could prevent uninfected women from contracting the AIDS virus, estimated to infect more than 2.5 million people each year.

Several researchers lamented the result as "disappointing" and surprising. The same prevention method was proved successful just last year in a multicountry trial among gay and bisexual men. Moreover, an AIDS drug applied to the vagina in a topical gel—rather than swallowed as a pill—demonstrated a protective effect last year among women.

Researchers speculated that participants in the most recent trial might not have adhered to the regimen as closely as the participants in the other trials. Physiological differences between men and women might also account for the differences between this trial and the one among gay and bisexual men.

But a particularly intriguing hypothesis, supported by other research, is that swallowing a pill might not lead to high enough drug concentrations at the site where HIV enters a woman: in the tissues of the vagina.

In another surprise finding, women in the study taking the antiretroviral medication were more likely to get pregnant than women taking a placebo. This was true despite the fact that 96% of women in the study were on oral or injectable contraceptives when the study began.

There is no known interaction between the antiretroviral drugs and hormone contraceptives, said researchers. They said they would analyze their data to try to tease out if there might be such an interaction.

The randomized, placebo-controlled trial, called FEM-PrEP, was carried out among 1,951 women in South Africa, Kenya, and Tanzania by FHI, a non-profit health and development organization, with about $23 million in funding from the United States Agency for International Development and about $3 million from the Bill and Melinda Gates Foundation.

Approximately half the women were given Truvada, a pill that combines two antiretroviral medications, tenofovir and emtricitabine; the other half were given a placebo. Fifty-six infections occurred overall, with half among women taking a placebo and half among women taking the active drug.

Truvada is marketed world-wide by Gilead Sciences Inc., based in Foster City, Calif. In a statement Monday, the company said, "While this development is a disappointing one, Gilead believes that antiretroviral therapies remain a promising potential HIV prevention strategy."

Clinical trials are typically reviewed at regularly scheduled intervals by an independent committee. Such a committee decided that, statistically, the FEM-PrEP trial could not answer the fundamental question of whether Truvada reduces the risk of HIV infection. So the committee recommended closing the trial. Two other studies in Africa are continuing that could resolve the issue of whether AIDS drugs taken orally can prevent HIV infection in women.

Last year, a study of Truvada among gay and bisexual men showed it reduced the chance of infection by about 44%. There is research, as yet unpublished, showing that the concentration of tenofovir, when taken orally, is higher in rectal tissue than in vaginal tissue, said Timothy Mastro, an FHI vice president who spoke on behalf of the study. If so, the men might have had more of the drug than the women at the site where they were exposed to the virus.

Last year, another trial in South Africa showed that women could be protected against HIV by applying to their vaginas before and after sex a gel containing tenofovir, one of the two medications in the pill taken by the women in the latest study.

However, research presented earlier this year at the Conference on Retroviruses and Opportunistic Infections showed tenofovir concentrations in vaginal tissue were about 100 times higher when the drug was applied in the gel form compared with when it was taken orally.

One question researchers raised is whether women in the study took the pill faithfully. Dr. Mastro said his team would address this question by examining whether stored blood samples contain the medication.

[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.]

FHI to Initiate Orderly Closure of FEM-PrEP

via FHI website

Following a scheduled interim review of the FEM-PrEP study data, the Independent Data Monitoring Committee (IDMC) advised that the FEM-PrEP study will be highly unlikely to be able to demonstrate the effectiveness of Truvada [emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)] in preventing HIV infection in the study population, even if it continued to its originally planned conclusion. FHI subsequently concurred and has therefore decided to initiate an orderly closure of the study over the next few months. The final analyses have not yet been conducted. At this time, it cannot be determined whether or not Truvada works to prevent HIV infection in women.

The FEM-PrEP clinical trial—implemented by FHI in partnership with research centers in Africa—is designed to study whether HIV-negative women who are at higher risk of being exposed to HIV can safely use a daily dose of a pill called Truvada to prevent infection. This study was funded by the United States Agency for International Development (USAID), with early funding from the Bill & Melinda Gates Foundation.

The FEM-PrEP outcome is surprising and disappointing, given a number of earlier studies suggesting the promise of pre-exposure prophylaxis (PrEP) using antiretrovirals. Most recently, the iPrEX study showed that use of Truvada can prevent infection in men who have sex with men at risk of HIV.

There are a number of possible reasons for the study findings, including low adherence to study regimen, a true lack of effect of the product among women (versus men who have sex with men), or other factors still to be determined. FHI will be conducting further analyses and will share additional findings in the coming months. The IDMC commended the trial team on a study conducted to a high standard with good follow-up and careful attention to good clinical practice and ethical standards.

Only preliminary FEM-PrEP data are available at this time:

• As of February 18, 2011, the study had screened 3,752 women and enrolled 1,951: 739 in Bondo, Kenya; 764 in Pretoria, South Africa; 432 in Bloemfontein, South Africa; and 16 in Arusha, Tanzania. The most common reason for women not being enrolled was existing HIV infection. The overall HIV prevalence was 21 percent among women screened for enrollment across the sites.
• Preliminary data indicate about 90 percent of the participants were retained in the study.
• Adherence to study product was approximately 95 percent when the study product was available for use.
• Women reported an average of 3.7 vaginal sex acts in the 7 days prior to enrollment, consistent with the average of 3.6 acts reported during follow-up.
• As of February 18, the approximate rate of new HIV infections among trial participants was 5 percent per year. A total of 56 new HIV infections had occurred, with an equal number of infections in those participants assigned to Truvada and those assigned to a placebo pill.
• Women participating in FEM-PrEP used an effective method of contraception at the time of enrollment—66 percent were using injectables and 30 percent were using oral contraceptives. The overall pregnancy rate was 9 percent; the highest pregnancy rates were among women using oral contraceptives.
• The use of Truvada in FEM-PrEP was associated with some known side effects that were not serious.

Among study participants randomly assigned to the Truvada arm, observed pregnancy rates were higher than among women randomly assigned to the placebo arm. This is unexpected and inconsistent with known drug interactions involving tenofovir (TDF) and contraceptive hormones, and with known metabolic effects of emtricitabine (FTC). Possible explanations include differential pill adherence by group, previously undefined drug-drug interactions, chance, or a combination of factors (including yet unknown factors). FHI will conduct further analyses of these data.

FHI and its partners are especially grateful to the women whose willingness to participate and commitment to the study were essential. To the extent possible, all participants have been notified of the decision and are being asked to come to the study clinics for final visits. Study participants who became infected with HIV during the study are being followed by the study team for an additional year and are referred for appropriate medical care and treatment in their community.

When the follow-up of the HIV-uninfected women is complete in a few months' time, FHI will be conducting in-depth analyses of study data and blood specimens collected during the study to examine the factors contributing to the observed outcomes. FHI will also collaborate with scientists conducting other PrEP studies to compare findings and to better understand the results.

When available, the final results from FEM-PrEP will make a strong contribution to our understanding of the use of antiretrovirals for HIV prevention. FHI, USAID, and research partners in Africa are committed to finding new technologies and developing new strategies to protect women from HIV.

For more information, see the following fact sheets:

• Questions and Answers (PDF, 222 KB)
• About FEM-PrEP (PDF, 263 KB)
• Key Findings (PDF, 246 KB)
• Adherence (PDF, 230 KB)
• Community Engagement (PDF, 242 KB)
• Drug Resistance (PDF, 229 KB)
• Pregnancy and Contraceptive Effectiveness in the FEM-PrEP Trial (PDF, 217 KB)
• Safety (PDF, 220 KB)
• Socio-Behavioral Aspects of FEM-PrEP (PDF, 255 KB)

[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.]

Bringing Up The Rear

Via salon.com, by Tracy Clark-Flory

It's no secret that more Americans are having anal sex than ever before: A study published last year in the Journal of Sexual Medicine found that more than 45 percent of women in their late 20s had tried anal sex.

On the flip side, women rarely get the opportunity to be penetrators. Virginia Vitzthum exquisitely described the appeal of taking on the male role in a piece for Salon back in 1999 -- before we even called it "pegging"

"In a way I'd never understood those words before, he was mine. The knowledge I could really hurt this person by being less than careful made me feel responsible, protective. The vulnerability appalled me at the same time; it was vaguely disgusting that he would let someone do this to him. Mixed in with the disgust was possessiveness. The thought of anyone else penetrating him seemed revolting. These observations clicked into place in quick succession; I felt like a projector being loaded with slides of maleness, of male seeing."

But, taboos change, and so do the cultural meanings of particular sexual acts. Just as the gay community has long debated the politics of being a top or a bottom, the hetero world is slowly catching up -or, um, bringing up the rear. As Pulley puts it, "We only have so many orifices. You'd think we'd all be itching to take advantage of them all, right?"

Read the rest

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

HIV/AIDS: Five Ways to reduce women's vulnerability to HIV/AIDS



Via PlusNews

Women and girls across the globe continue to be disproportionately affected by the AIDS pandemic. HIV is the leading cause of death and disease among women of reproductive age worldwide.

IRIN/PlusNews presents five important ways to reduce women's vulnerability to HIV:

Education: According to UNAIDS, illiterate women are four times more likely to believe there is no way to prevent HIV infection, while in Africa and Latin America, girls with higher levels of education tend to delay first sexual experience and are more likely to insist their partner use a condom.

Access to reproductive health services: In many developing countries, women have very limited access to vital reproductive health services. A combination of biological and social factors means women are more vulnerable to sexually transmitted infections (STIs), which, if left untreated, increase their vulnerability to HIV.

Ending gender violence: One in three women has been beaten, experienced sexual violence or otherwise abused in their lifetime, according to the UN; one in five will be a victim of rape or attempted rape. More often than not, the perpetrators are known to the women.

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.]

Slate: Why are bisexual women more likely to have tried anal sex?

via Slate.com, by William Saletan

Have you heard the latest report on Americans' sex habits? The study, Sexual Behavior, Sexual Attraction, and Sexual Identity in the United States, comes from the National Survey of Family Growth, the country's most respected periodic sex survey. Media reports about the study have noted what seems to be a resurgence of virginity. But the data also show something more surprising: Compared with women who are totally straight, women who are slightly bisexual are more likely to have tried various sex acts with men. In fact, compared with totally straight women, women who are fully bisexual or lesbian are more likely to have tried anal sex.

Why?

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.]

Kenya: Anal sex - "the modern way" - lies, and HIV

via IRIN PlusNews

For 10 years Amina Hassan*, 37, trusted her husband and had a happy married life in Nakuru, in Rift Valley Province, western Kenya. Even if her religion allowed him to marry other wives, he had always assured her that she was enough, and he would have no reason to marry anyone else. But she told IRIN/PlusNews that life changed when her husband went to work in the port city of Mombasa and he returned a different man.

"I got married in 1994 at the age of 20 to a man who was five years older than me. Every time we talked, he assured me of his love for me and his commitment to making me happy all the time. He said he was faithful to me even though as a truck driver he travelled for long distances and many days.

"In return, I remained faithful to him, I would miss him when he travelled but kept off the temptations of having another partner. He had rented a house for us in Bondeni, Nakuru, and I made sure no man, even a relative, visited in his absence, lest speculations start spreading around.

"In January 2004 he told me he would be working around the costal town of Mombasa for three weeks but... he did not return as promised and told me on the phone that he would take a little longer, as he had been assigned more work.

"When he came back in July the same year, it was a joyous moment for me and our children. But unlike before, the joy did not last over the night.

"He had never before asked to have anal sex with me, but on that particular night he demanded that it had to be done 'the modern way'. When I resisted, he threatened to leave me, saying I and the children would soon die from starvation as he would no longer provide for us.

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.]

HPV and Anal Cancer in Older Women: Risk and Prevention

via Women's Voices for Change, by Patricia Yarberry Allen, M.D.

Excerpt:

Although it has not been documented rigorously, there is a reason to believe that anal cancer could develop very much the way cervical cancer does. The change in the cells begins with mild atypica, progresses to more serious abnormal change (mild, moderate and severe dysplasia), before developing into frank anal cancer. Doctors have known about the relationship of HPV and anal cancer from long experience with gay men, who have a high incidence of this cancer due to receptive anal sex practice. We need the expertise of these physicians, now that HPV has been recognized to be a growing concern for women and recognized as a cause of cervical, vaginal, and vulvar cancer and is now publicly discussed as a cause of anal and oral cancer.

It is important that colo-rectal surgeons develop expertise in high-resolution anoscopy and an interest in recognizing abnormal change at an early stage. Gynecologists are specially trained in colposcopy to view and recognized abnormal cellular patterns that can be biopsied, diagnosed, and treated.  It takes time and training to become very good at these procedures.

At the moment, there is no consensus among our specialities about how to monitor for and evaluate the presence of anal HPV. An HPV swab test can be done in the anal area. Pap smears can be done in this area. But there are no national guidelines for primary care doctors about when to do these tests, and no guidelines about what to do with the results. We don’t have a treatment protocol for anal dysplasia that is universally used.

The result is that women with high-risk HPV of the genital area are almost never tested for anal HPV, even if the woman expresses concern about her risk. That means that cells that could be treated earlier, before there is frank malignancy, are not found.

We don’t want women to wait for a diagnosis until they have rectal bleeding or a feeling that there is a constant fullness in the anal area. These are symptoms of many benign diseases but also the symptoms of anal cancer. We have to have a plan based on what is known and what evaluations are available.

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.]

Heterosexual Anal Sex Experiences Among Puerto Rican and Black Young Adults

Heterosexual Anal Sex Experiences Among Puerto Rican and Black Young Adults

Health providers should address it openly and, when appropriate, as a positive sexual and emotional experience.

Perspectives on Sexual & Reproductive Health Vol. 42; No. 4: doi:10.1363    (12..10):: Marion Carter; Dare Henry-Moss; Linda Hock-Long; Anna Bergdall; Karen Andes

Summary via U.S. Centers for Disease Control and Prevention

The authors introduced the study by noting that heterosexual anal sex, which poses risks for STDs, "is not uncommon in the United States." "However, who engages in it and why are not well understood, particularly among young adults."

In Hartford, Conn., and Philadelphia from 2006 to 2008, data on topics related to sexual health were collected via survey (483 respondents) and qualitative interviews (70 individuals) from black and Puerto Rican persons ages 18 to 25. Predictors of anal sex with the most recent serious heterosexual partner were assessed by bivariate and multivariate analyses. The team analyzed interview transcripts to assess experiences with anal sex and reasons for engaging or abstaining.

Anal sex was reported by 34 percent of survey respondents. It was more common with serious (22 percent) as opposed to casual (8 percent) partners. Black participants were less likely than Puerto Rican respondents to report anal sex (odds ratio, 0.3); women were more likely than men to report anal sex (2.9).

The qualitative cohort found perceptions of anal sex as painful and unappealing were the predominant reasons for abstaining. Sexual pleasure and, in serious relationships, intimacy were the main reasons cited for engaging in it. During anal sex, condom use "was rare and was motivated by STD or hygiene concerns."

"Heterosexual anal sex is not an infrequent behavior and should be considered in a broad sexual health context, not simply as an indicator of STD risk," the authors concluded. "Health providers should address it openly and, when appropriate, as a positive sexual and emotional experience."


[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.]

Heterosexual anal sex reported by women receiving HIV prevention services in Los Angeles County

Womens Health Issues. 2010 Nov-Dec;20(6):414-9.

Heterosexual anal sex reported by women receiving HIV prevention services in Los Angeles County.

Reynolds GL, Fisher DG, Napper LE, Fremming BW, Jansen MA.

California State University, Long Beach, Center for Behavioral Research and Services, Long Beach, California 90813, USA. greynol2@csulb.edu

Abstract

BACKGROUND: This study examined reported heterosexual receptive anal intercourse (HRAI) in a sample of women recruited from HIV prevention providers in Los Angeles County.

METHODS: The majority of women surveyed were Latina and the modal age was 19 years. Women reporting HRAI were more likely to use both injected and non injected drugs and to have sexual partners who injected drugs.

RESULTS: Factors associated with HRAI in a multivariate regression model included use of methamphetamine; use of alcohol before, during, or after sex; and use of dental services at the interview agency. Factors inversely associated with heterosexual anal sex were being African American (compared with Latina) and endorsing the use of condoms for episodes of vaginal sex from start to finish.

CONCLUSION: HIV prevention providers in Los Angeles County should be aware of the need for basic prevention messages concerning condom use and injection behavior in young Latina women.



[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.]

Hard Core Porn's Pervasiveness and Evolving Sexual Behaviors

via The Atlantic, by Natasha Vargas-Cooper

Excerpt:

Porn’s new pervasiveness and influence on the culture at large haven’t necessarily introduced anything new into our sexual repertoire: humans, after all, have been having sex—weird, debased, and otherwise—for quite a while. But pervasive hard-core porn has allowed many people to flirt openly with practices that may have always been desired, but had been deeply buried under social restraint. Take anal sex: in a 1992 study that surveyed sexual behaviors, published by the University of Chicago, 20 percent of women ages 25 to 29 reported having anal sex. In a study published in October 2010 by the Center for Sexual Health Promotion at Indiana University, the instances of anal sex reported by women in the same age cohort had more than doubled, to 46 percent. The practice has even made its way into the younger female demographic: the Indiana study shows 20 percent of 18- and 19-year-olds have had anal sex at least once.

One of the Indiana study’s co- authors, Debby Herbenick, believes that Internet porn now “plays a role in how many Americans perceive and become educated about sex.” How this influence actually works is speculative— no one can ever really know what other people do in their bedrooms or why. Some experts postulate a sort of monkey-see, monkey-do explanation, whereby both men and women are conforming to behaviors they witness on their browser media players. But in many ways this explanation doesn’t account for the subtle relationship between now-ubiquitous pornography and sexuality. To take anal sex again, porn doesn’t plant that idea in men’s minds; instead, porn puts the power of a mass medium behind ancient male desires. Anal sex as a run-of-the-mill practice, de rigueur pubic waxing for girls—and their mothers—and first-date doggy-style encounters (this is but a small sampling of rapidly shifting sexual mores) have been popularized and legitimized by porn. Which means that men now have a far easier time broaching subjects once considered off- putting—for instance, suburban dads can offhandedly suggest anal sex to their bethonged, waxed wives.

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.]

FDA approves Gardasil to prevent anal cancer [Dec 22]

Read the press release from the FDA.

The U.S. Food and Drug Administration today [December 22] approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Click here for the Gay Men's Health Crisis press release on Gardasil for men.
 

[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.]