Researchers Investigate Acceptability for PrEP in Chinese MSM

via PLoS ONE, by Feng Zhou

Introduction

In pre-exposure prophylaxis (PrEP), antiretroviral (ARV) drugs are given to HIV-negative people to decrease their chance of becoming infected. Several studies conducted among men who have sex with men (MSM) have shown that PrEP awareness was very low, and few participants reported having the experience of PrEP use, even in some countries where it is available. Although strategies including abstinence, being faithful, and condom use (ABC) have been proved to be effective for prevention of HIV transmission, the virus still prevails among MSM. It was estimated that 2.6 million individuals were newly infected in 2009 worldwide, which 19% fewer than the 3.1 million in 1999. China had about 740,000 people living with HIV and 105,000 with AIDS by the end of 2009. Homosexual intercourse has become a major mode of HIV transmission since 2009, and the prevalence of HIV in MSM has increased significantly from 2.5% in 2006 to 8.6% in 2009. A sociological study has estimated that there are 1.8–2.4 million homosexual or bisexual men in mainland China. In China, high-risk behavior, such as multiple partners and unprotected sex, have been reported to be common in this group. Also, recent studies have reported rapid transmission of HIV in this specific population from various geographic areas in China, despite the efforts made by the national and local governments and non-governmental organizations in the past few years. New effective approaches are urgently needed for this population.

In recent decades, researchers have made great efforts to explore alternative biomedical interventions, such as male circumcision (MC), HIV PrEP and post-exposure prophylaxis (PEP), HIV vaccines, and microbicides. Among these potential strategies, PrEP is considered to be one of the most promising strategies in MSM. Several animal and human studies have suggested that ARV drugs might reduce the risk of HIV infection either by PrEP or by non-occupational PEP. A 12-month PrEP clinical trial of daily oral tenofovir disoproxil fumarate (TDF) for HIV prevention was performed among 400 HIV-negative Ghanaian women, and achieved good acceptability and >82% adherence. In November 2010, the US National Institutes of Health (NIH) announced the results of the iPrEx trial of PrEP conducted among 2499 HIV-seronegative MSM in six countries, which showed that daily oral Truvada, a combination of emtricitabine (FTC) and TDF, reduced risk of HIV incidence by 44%, with a median 1.2 years follow-up, compared with the placebo group, and >75% adherence was reached. These findings represent a major advance in HIV prevention research, providing the first evidence that PrEP, when combined with other prevention strategies, can reduce HIV risk among MSM. A further study is ongoing in HIV Prevention Trials Network (HPTN) 067 to evaluate the feasibility of intermittent dosing of PrEP. Recent results from Partners PrEP and CDC TDF2 have shown that PrEP with daily oral TDF/FTC or TDF was effective at reducing HIV risk in heterosexual men and women. However, the Fem-Prep program on Truvada, a closed clinical trial implemented by Family Health International (FHI) in partnership with research centers in Africa, does not support the theory of PrEP having an effect on HIV prevention. Therefore, some factors that might influence the efficacy of PrEP, including adherence, sexual behavior, or other factors still need to be determined.

The awareness and acceptability of new strategies are very important when they are recommended for use. Therefore, the objective of our study was to investigate the awareness and acceptability of PrEP among MSM and potential impact factors, which will provide suggestions and guidelines for future clinical trials in China.

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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.]

PrEP: Attitudes and Acceptance Among Potential User Groups

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

Background

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

Methods and findings

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

Conclusions

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

Read the full study here.



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

Gay Men: PrEP Acceptable and Unlikely to Change Risk Behaviour

Via AIDSMap, by Michael Carter.

Approximately 50% of gay men said they were likely to use pre-exposure prophylaxis (PrEP), but few reported that it would lead to a change in their risk behaviour, according to data presented to the International AIDS Society conference in Rome.

Nevertheless, the investigators were concerned that even minor increases in rates of unprotected anal sex could offset the benefits of pre-exposure prophylaxis.

The IPrEX study showed that PrEP significantly reduced the risk of infection with HIV for gay and bisexual men. Overall, men who took PrEP had their risk of HIV reduced by 44%. If adherence was high, the risk was reduced by 73%.

“PrEP offers much promise as the first biomedical intervention to have success in at-risk men who have sex with men,” comment the researchers.

They therefore undertook further analysis to see how likely the men who participated in the study were to use PrEP and if its availability would change their HIV risk behaviour.

They undertook a survey in December 2010, immediately following the release of the IPrEX results, using Facebook and Black Gay Chat to recruit participants. A total of 1155 gay and other men who have sex with men were recruited to the study.

Participants completed a questionnaire about their knowledge and willingness to use PrEP; perceptions of the risk of HIV infection from unprotected anal sex with or without PrEP; perceptions of sexual pleasure; and perception of likelihood to experience sexual pleasure with or without a condom and with or without PrEP.

The men had an average age of 33 years, 75% were white, and 51% reported unprotected anal sex at least once in the last twelve months.

Only a third of men had heard of PrEP before the release of the study results. Just under half of individuals reported that they were “very” or “extremely” likely to use PrEP.

Unprotected anal sex without a condom was widely considered to involve a high risk of HIV.

The availability of PrEP did not alter the perception of the risk associated with HIV in the majority of men, regardless of whether they were the insertive (75%) or receptive (60%) partner in anal sex.

Three-quarters of men stated that the 44% efficacy of PrEP in the IPrEX study would not affect their use of condoms. However, 7% reported that they would use condoms less frequently.

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.]

Gay and lesbian parents: Teaching kids it’s OK to be different

via dallasvoice.com: Instant Tea, by Tammye Nash & Elizabeth Farr

As the child of a gay parent, I have decided to come out of the closet. I have finally “grown up” enough to realize that letting others know my dad is gay is a relief. I have never been ashamed of my father’s homosexuality but I have never openly acknowledged it either.

I was never brave enough to stand up and say, “Yeah my dad is gay. So what?” But I am now.        

                                                                              

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‘Queering the Census’ Seeks Inclusion of Sexual Orientation in Decennial Count

via Global Shift, by Ashley Michelle Papon

“Even in the absence of federal recognition of our relationships, we have an opportunity to say on an official form that, ‘Yes, we are married,’ ‘Yes, our relationships are every bit as equal to everyone else’s,’ ” Josh Friedes, executive director of Equal Rights Washington, a lesbian, gay, bisexual, transgender (LGBT) advocacy group in Seattle, tells the March 30 edition of The Seattle Times.

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Magee-Womens Research Institute Receives $17.5 million for Rectal Microbicide Research

Dr. Ian McGowan* (pictured), an investigator with the Magee-Womens Research Institute (MWRI), recently received a total of $17.5 million from the National Institutes of Health (NIH) to conduct two studies involving the development of rectal microbicides.

"This is exciting for the field of HIV prevention research, and especially important in terms of moving the research and development of rectal microbicides forward," said McGowan. "We applaud the leadership and vision of our sponsors at the NIH."

Microbicides are topical products that can be applied to the rectal or vaginal mucosa with the intent of preventing, or at least significantly reducing the risk of HIV acquisition in either compartment.

Recognizing the fact that women in the developed and developing world are at risk of HIV infection through anal and vaginal intercourse, the Microbicide Trials Network (MTN), based at MWRI, is currently evaluating the rectal safety of microbicides designed for vaginal use.

Dr. McGowan’s new studies focus the research towards developing microbicide products specifically designed for rectal use.

The first grant is entitled the Combination HIV Antiretroviral Rectal Microbicides or CHARM program. This is an $11 million, five year, multicenter U19 grant that brings together research groups from the University of Pittsburgh, University of North Carolina, Johns Hopkins Medical School, CONRAD, and the University of California at Los Angeles. The U19 grant is part of the NIH funded Integrated Preclinical Clinical Program and is intended to advance candidate microbicides from discovery into early clinical development.

The second grant is a $6.5 million, four year, R01 grant entitled Microbicide Safety and Acceptability in Young Men with Dr. Alex Carballo-Dieguez as the Co-Principal Investigator. The focus of this grant is to evaluate the safety and acceptability of rectal microbicides in young, ethnic minority men who have sex with men (MSM). Funding for this study comes from the National Institute of Child Health and Human Development as well as the National Institute of Mental Health and will generate critical data from a population of young African American and Latino men who are at the highest risk of HIV infection in the United States. Clinical trial sites will be in Pittsburgh, Boston, and Puerto Rico.

"We need to develop safe, effective, acceptable and accessible rectal microbicides for the millions of women and men worldwide who need options beyond condoms," said Jim Pickett, chair of the International Rectal Microbicide Advocates (IRMA) said. "Our global network of advocates, scientists, policy makers and funders is encouraged to see this work moving forward."

Together with ongoing MTN rectal safety studies and another collaborative grant with the University of Oxford, UK, these two new grants establish MWRI as a leading center for rectal microbicide translational research and will hopefully lead to the development of safe and effective products for individuals at risk of HIV infection through unprotected receptive anal sex.
 

* Dr. McGowan is also a Professor of Medicine in the Division of Gastroenterology, Hepatology, and Nutrition at the University of Pittsburgh Medical Center, with a secondary appointment in the Department of Obstetrics, Gynecology and Reproductive Science.

A condom specifically for anal intercourse?

IRMA chats up Dan Resnic of Strata Various Product Design about the ORIGAMI Condom - a new product in development designed specifically for anal intercourse.



IRMA - Tell us about this ORIGAMI condom you are working on. What is it? How is it different from other condoms?

DAN RESNIC - This is a radical new design concept, made of non-latex material and the first AI (anal intercourse) condom data ever presented to the FDA for review. The data will be used to help establish the first safety standards for a condom used exclusively for AI. ORIGAMI Condoms are designed foremost for the pleasure of both partners and simultaneously to improve safety. Its improved capacity for better sensation during AI is intended to increase consumer acceptability and to promote its consistent use among men and women currently at risk.

The non-latex material we developed is unique. It's been lab tested as a male condom against a leading brand of a male latex condoms. The ORIGAMI material had zero viral permability compared with the latex condom, which had 5% viral permeability. Viral permeability is tested by introducing virus smaller than HIV into sterile water inside the condom, suspended in sterile water for 72 hrs. The water outside the condom is then tested to detect virus that may permeate through the condom. The test is repeated in reverse, starting with virus outside the condom then testing for viral premeability in the opposite direction. The tests are repeated again with pinholes punctured into the condoms. Again, the ORIGAMI tested at zero viral permeability even with puncture holes while the latex condom failed. In addition, the new material will not degrade in sunlight as does a latex condom and, after accelerated aging tests, it is expected to offer an extended shelf life of 10-12 yrs.

Future condom studies currently under funding review include a new, reusable ORIGAMI elastomer material we developed that can be washed and dried in a washer/dryer at high temperatures and can even be sterilized in a microwave or boiling in water and air dried in sunlight without compromising its structural integrity. The latter could be especially significant in regions like Africa and India where cost and distribution can be issues that prevent consistent condom use.

Photos and further details will be made available following FDA pre-market approval.


I – Where is the research at the moment?

DR - Phase 1 research will begin next month, in July 2009, with the Behavioral Epidemiology Research Group at the UCLA Dept of Epidemiology, with co-Investigator Dr. Pamina Gorbach. R&D will be supported with the assistance of male and female consultants from design, medical and commercial sectors. The optimal design will undergo pre-clinical testing, with modified structural testing crietria appropriate for the higher stress in AI use. Clinical research will follow with study groups and data will be analized for final reports.


I – How are you collaborating with the NIH and UCLA? What is the timeline?

DR - As the PI for the project, I've awarded a sub-contract to UCLA, which will conduct the clinical research with volunteer couples who will test the condom in a unique study design developed by Dr. Gorbach, who heads the Behavioral Epidemiology Research Group at UCLA. The project has been funded by a substantial grant from the NIH. The study will run for 18-24 mos. starting July 1st. Subsequent Phase II research will take the project through to the end
of 2014, when the data can be reviewed by the FDA. Since there is no existing precedent the data cannot be reviewed under FDA's 510K application. Consequently, the process is much longer and much more expensive. The same is true of the ORIGAMI Female Condom we've developed. The FDA requires 3-4 similar products approved on the market before a similar device can be reviewed under a 510K application, which is typically a 90 day review process.


I – Why is it so important to have a condom specifically designed for anal intercourse?

DR- This is an excellent question. It would appear to many to be a frivolous and unnecessary product, however, the typical rolled condom design we are all familiar with, has not been tested for anal intercourse (AI), yet its the only means of protection available to men and women who engage in AI. The FDA states that condoms are the ". . . best available protection for anal sex..." although, to date, no data has been submitted to the FDA for review to support its use for AI.


I – Since unprotected anal intercourse is the most efficient means of sexual transmission of HIV, and since many people don’t use traditional condoms during anal intercourse each and every time, it seems odd that a condom like ORIGAMI hasn’t been thought of before. Why do you think that is?

DR- Inventive ideas for new condoms that address specific needs such as AI have been consistently inhibited by the high cost of R&D as well as the socio/political barriers that existed until 2008. It wasn't until the concept of a female condom emerged that it was even possible to consider an inseted anal condom. For many years people had tried using the female condom for AI but it's not strong enough and it's lacking the unique design features compatible with AI.

Essentially, condoms are tested and FDA approved for vaginal use only. The FDA is typically provided with testing documentation from condom manufacturers based exclusively on vaginal use, and consequently there are no established guidance documents available from the FDA for condoms used for AI. For many years, in the US and elsewhere, it was considered taboo to discuss AI. In recent years, the subject was discussed at a special summit conference conducted by the FDA, specifically intended to encourage manufacturers to produce condoms for AI, however, none of the manufacturers who attended the meeting followed through. No existing condom manufacturer would risk producing such testing data as the failure rate for breakage, leakage and viral permeability would be significantly higher than testing results for vaginal use.

The FDA relies on manufacturers to present data for their review. Unless a manufacturer submits data (of any medical device) for review, the FDA does not conduct independent testing. As a regulatory agency, they are authorized only to review data from manufacturers but the agency cannot conduct its own independent research to set guidelines. It would be cost prohibitive to cover all medical devices. FDA Guidance Documents are established over time based on existing products and related testing data provided by manufacturers. Regarding latex condoms, the most current guidance document for manufacturers was last updated with minor changes on November 14, 2005.


I – Next steps?

DR - We anticipate successful Phase I study data by June 2011, which we intend to follow with a larger, Phase II study. We will work closely with the FDA to help determine further testing criteria appropriate for condoms used for AI. For example, the breakage standards, not yet established for AI, will be significantly different from existing condoms designed and sold for vaginal intercourse. AI condoms must meet a higher safety standards than typical existing condoms that were originally designed in 1918 for vaginal sex.


Thank you Dan! We look forward to learning more about this important work.

Women's Anal Sex Practices: Implications for Formulation and Promotion of a Rectal Microbicide

Abstract - AIDS Education and Prevention, April 2008

To gain insight into practices that may inform formulation and use of rectal microbicides, in-depth interviews were conducted with an ethnically diverse sample of 28 women who engage in anal intercourse. Microbicides are compounds under development to decrease sexually transmitted infections. Most women practiced anal sex in conjunction with vaginal intercourse. Anal sex typically was not preplanned, and few women reported preparation. Condom use was rare. Most women relied on saliva, vaginal fluids, prelubricated condoms, or used no lubrication at last intercourse. Women were uncertain about the amount of lubricant used during sex, with typical estimates of 1 to 2 teaspoons. This may prove challenging to the formulation and promotion of rectal microbicides, as substantially higher amounts may be required. Additional challenges include infrequent use of packaged lubricants, and typical male lubricant application, which may make women's control of rectal microbicides more difficult. Women overwhelmingly expressed interest in rectal microbicides.

Click here for the full text, on IRMA's website.