$17 million grant to help Pitt researcher develop anti-HIV gel

via Pittsburgh Post-Gazette, by David Templeton

Highlight:

Dr. McGowan said the size of the NIH grants reflects a change in Washington, D.C., where the Obama administration has shown greater interest in funding HIV-prevention research.

"The Bush administration had a very high level of discomfort embracing HIV prevention research in men," he said. "But I think in the Obama administration that's a non-issue. They regard domestic HIV prevention in men who have sex with men as an important research priority."

It also reflects growing awareness that not only men have anal sex.

"There's increasing evidence that men and women have anal sex, too," he said. "If we are interested in HIV prevention, we have to look at options for both men and women."

 Read more.

Why Rectal Douches May Be Acceptable Rectal-Microbicide Delivery Vehicles for Men Who Have Sex With Men

Abstract via Sexually Transmitted Diseases

Carballo-Diéguez, Alex PHD; Bauermeister, José PHD; Ventuneac, Ana PHD; Dolezal, Curtis PHD; Mayer, Kenneth MD

Rationale: To explore age of onset of rectal douching among men who have sex with men (MSM) and reasons leading to and maintaining douching behavior; and to consider whether rectal douches containing microbicidal agents might be acceptable for men at HIV risk.

Methods: In stage 1, we used qualitative methods to explore douching behavior in a sample of 20 MSM. Subsequently, we developed a structured questionnaire that was administered in stage 2 to 105 MSM.

Results: More than half of participants who completed stage 1 douched during the trial despite having been advised not to do so. Of the 105 human immunodeficiency virus uninfected participants in stage 2, 51% reported using rectal douches in the prior 6 months; 47% douched before and 25% after anal intercourse. Most participants reported douching frequently or always. On average, men reported douching about 2 hours before or 1 hour following intercourse. Average age of onset was late 20s. Most men who douched wanted to be clean or were encouraged to douche by their partners. Some men thought douching after sex could prevent sexually transmitted infections.

Conclusion: Rectal douching appears to be a popular behavior among men who have receptive anal intercourse. It is necessary to identify harmless douches. If human immunodeficiency virus or sexually transmitted infections preventive douches can be developed, rectal douching before or following sexual intercourse could become an important additional prevention tool. To reshape an existing behavior to which some men strongly adhere, like douching, by suggesting use of 1 type of douche over another may be more successful than trying to convince MSM to engage in behaviors they never practiced before or those they resist (e.g., condom use).

(C) Copyright 2009 American Sexually Transmitted Diseases Association

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.

"Bareback Sex" motivations in HIV risk contexts

Assessing motivations to engage in intentional condomless anal intercourse in HIV risk contexts ("Bareback Sex") among men who have sex with men.
JA Bauermeister, A Carballo-Dieguez, A Ventuneac, and C Dolezal
AIDS Educ Prev, April 1, 2009; 21(2): 156-68.

Although condom use is an effective barrier against HIV transmission, some men who have sex with men (MSM) engage in bareback sex (unprotected anal sex in risky contexts) and increase their risk for HIV (re)infection. Understanding MSM's decision to bareback (vis-à-vis condom use) is essential to develop effective HIV/AIDS prevention programs for this population.

An ethnically diverse sample of men who bareback (n = 120) was recruited exclusively on the Internet and stratified to include two thirds who reported both unprotected receptive anal intercourse (URAI) and being HIV uninfected.

We used exploratory factor analysis to explore the domains within the Decisional Balance to Bareback (DBB) scale, and test the association between DBB and risky sexual behaviors. HIV-positive MSM (n = 31) reported higher costs/losses associated with condom use than HIV-negative men (n = 89).

We found two underlying factors in the DBB scale: a Coping with Social Vulnerabilities subscale (eight items; alpha = .89) and a Pleasure and Emotional Connection subscale (five items; alpha = .92). We found a positive association between DBB (i.e. greater gains associated with bareback sex) and URAI occasions, number of partners, and having one or more sero-discordant partners in the past 3 months.

We conclude that because MSM may avoid using condoms in order to cope with psychosocial vulnerabilities and create intimacy with other MSM, this population could benefit from alternatives to condoms such as pre/post exposure prophylaxis and rectal microbicides.

Next IRMA call: Habits and preferences of people having anal sex

Understanding the habits and preferences of people having anal sex: Implications for rectal microbicide development

Thursday, May 14, 2009

How often do people use saliva for anal sex? What about vaginal fluid? Would people prefer a rectal microbicide that comes in a gel or a suppository? What do the answers to these questions mean for rectal microbicide development?

Join the next IRMA call to find out, and to participate in discussions that help shape the rectal microbicide development landscape.

Dr. Alex Carballo-Dieguez (Columbia University) will present his study on whether users prefer a rectal microbicide that somes in a gel or a suppository. Dr. Lisa Butler and Dr. Jeff Martin (University of California, San Francisco) will present their study on the use of saliva during anal sex among MSM. IRMA's Marc-André LeBlanc will give an overview of the findings from IRMA's global web survey on the use of lubricants, saliva and vaginal fluid during anal sex.

Materials will be available here in advance of the call. Check back.

Send an email here to RSVP. You must RSVP so we reserve the proper amount of lines.

Everyone who RSVPs will receive the call-in information in advance. The call will be toll-free.

Times

Sydney – 12:30am Friday, May 15 (sorry Sydney!)

Kuala Lampur - 10:30pm

Delhi - 8:00pm

Lagos - 3:30pm

Cape Town - 4:30pm

London - 3:30pm

Washington DC - 10:30am

Lima - 9:30am

Chicago - 9:30am

Seattle - 7:30am

Send an email here to RSVP.

Special thanks to AVAC for hosting the call!

Count 'em - 4 Friendly Rectal Microbicide Advocates

Meet 4 of IRMA's new Steering Committee Members - Latifa Boyce, Dr. Jorge Sanchez, Cindra Feuer and Dr. Alex Carballo-Dieguez - Friendly Rectal Microbicide Advocates all. Click here to read their bios. They are part of IRMA's 23-member Steering Committee, many of whom just joined in February 2009.

Journal article: "Is ‘bareback’ a useful construct in primary HIV-prevention? Definitions, identity and research"

by A. Carballo-Diéguez, A. Ventuneac, J. Bauermeister, G. W. Dowsett, C. Dolezal, R. H. Remien I. and Balan M. Rowe, January 2009,Culture, Health & Sexuality.

The terms bareback and bareback identity are increasingly being used in academic discourse on HIV/AIDS without clear operationalisation. Using in depth,face-to-face interviews with an ethnically diverse sample of 120 HIVinfected and -uninfected men, mainly gay-identifying and recruited online in New York City, this study explored respondents’ definitions of bareback sex, the role that intentionality and risk played in those definitions, and whether respondents identified as ‘barebackers’. Results showed overall agreement with a basic definition of bareback sex as condomless anal intercourse, but considerable variation on other elements. Any identification as barebacker appeared too loose to be of use from a public health prevention perspective. To help focus HIV prevention efforts, we propose a re-conceptualisation that contextualises risky condomless anal intercourse and distinguishes between behaviours that are intentional and may result in HIV-primary transmission from those that are not.

Read the full article here (housed on the IRMA website.)

Preference for gel over suppository as delivery vehicle for a rectal microbicide

Preference for gel over suppository as delivery vehicle for a rectal microbicide: results of a randomised, crossover acceptability trial among men who have sex with men

Author(s): Carballo-Diéguez A, Dolezal C, Bauermeister JA, et al

Reference: Sex Transm Infect. 01 November 2008;84(6):483-87.

Published Abstract:

Objective: To assess whether men who have sex with men (MSM) prefer a gel or a suppository as a delivery vehicle for a rectal microbicide. Methods: 77 HIV-negative MSM with a recent history of inconsistent condom use during receptive anal intercourse (RAI) who acknowledged being at risk of contracting HIV were enrolled in a randomised, crossover acceptability trial. They compared 35 ml placebo gel with 8 g placebo rectal suppositories used on up to three RAI occasions each.

Results: Participants preferred the gel over the suppository (75% versus 25%, p<0.001) style="font-weight: bold;">Conclusions: In this sample taken from one of the populations most likely to benefit from rectal microbicide availability, gel had greater acceptability than a suppository as a potential microbicide vehicle.

Click here for the full article, on the IRMA website.