An Introduction to Rectal Microbicide Clinical Trials ........

Condoms out the window soon or complimentary as a safer sex method for anal sex, more choices?? 

HIV prevention organizations debut The Rectal Revolution Is Here: An Introduction to Rectal Microbicide Clinical Trials in advance of first-ever Phase II rectal microbicide trial

[Press Release]

International Rectal Microbicide Advocates (IRMA), the Population Council, and the Microbicide Trials Network (MTN) today released a collaborative video project called The Rectal Revolution Is Here: An Introduction to Rectal Microbicide Clinical Trials. The jointly produced video, the first of its kind, is designed to educate communities affected by HIV about rectal microbicide development and the importance of participating in clinical trials to help speed the search for new HIV prevention options.

"The Rectal Revolution will be an excellent tool for education and recruitment for MTN-017, the first-ever Phase II safety trial of a rectal microbicide planned to launch soon. The video will be particularly useful because it's not protocol-specific and can be used in future rectal microbicide trials as well," said Clare Collins, MTN associate director of communications and external relations and video co-producer.

"There is an engaging mixture of animation and live action with beautiful footage from Thailand, South Africa, Peru, and the United States," Collins continued, "and we showcase interviews with scientists, advocates, and an exceptional rectal microbicide trial participant, Rig Rush, who is both eloquent and entertaining as he shares his personal experience as a study volunteer."

Produced by Paw Print Productions of Cape Town, South Africa, the video is available for viewing now on YouTube in English, Spanish, and Thai.

"This educational video is a groundbreaking tool to recruit volunteers and educate public health leaders for what may be one of the most promising new methods to fight HIV," said co-producer Barbara Friedland, associate in the HIV and AIDS program at the Population Council. "It was developed through an intense consultative process to ensure accuracy and relevance to the communities where this video will be shown," she said.

"We wanted the video to be educational and engaging, and to encourage audiences to get involved in efforts to prevent HIV," Friedland continued."So we worked with an advisory committee comprising staff at rectal microbicide trial sites, scientists, advocates, and other community experts to develop the script. We screened 'rough cuts' of the video with 80 professionals in the field and pre-tested it in 13 focus group discussions with over 100 gay men and transgender women in Thailand, South Africa, Peru, and the United States," she said.

"The insights and wisdom these individuals shared with us were absolutely critical to shaping the final version of the video," said Friedland.

Major funding and support for the project was generously provided by the MAC AIDS Fund, the MTN, and the Population Council, through a grant from the Swedish Ministry of Foreign Affairs.

The video debut precedes the soon-to-be launched landmark study being conducted by MTN to test a reduced-glycerin formulation of tenofovir gel among gay men, other men who have sex with men, and transgender women for safety and acceptability. MTN-017 is not only the first-ever Phase II study of a rectal microbicide, it is also the first time rectal microbicide research is expanding outside the United States and going global, with sites in Thailand, South Africa, Peru, and Puerto Rico.

"IRMA and the Population Council enthusiastically support the start of MTN-017," said Jim Pickett, IRMA chair. "The 186 individuals who will volunteer for the trial will more than double the total number of people who have participated in rectal microbicide clinical trials to date. The study will mark a giant leap forward for the field of rectal microbicides and will set the stage for future large-scale efficacy trials," he said.

Pickett continued, "the day we have a safe, effective, and acceptable rectal microbicide as a much-needed HIV prevention option for people who engage in anal intercourse is within our sights—these are truly revolutionary times and we couldn't be more energized."

Learn more about the MTN-017 trial here.

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Currently in development, microbicides are products (gels, lubricants, films) that could be applied in the rectum or the vagina to reduce the risk of HIV infection.

Unprotected anal intercourse is 10 to 20 times more likely to result in HIV infection compared to unprotected vaginal intercourse. Unprotected anal intercourse—a common human behavior—is a significant driver in the global HIV epidemic among gay men and transgender women as well as among heterosexuals.

The Population Council confronts critical health and development issues—from stopping the spread of HIV to improving reproductive health and ensuring that young people lead full and productive lives. Through biomedical, social science, and public health research in 50 countries, we work with our partners to deliver solutions that lead to more effective policies, programs, and technologies that improve lives around the world. Established in 1952 and headquartered in New York, the Council is a nongovernmental, nonprofit organization governed by an international board of trustees.

The Microbicide Trials Network is a U.S. National Institutes of Health-funded worldwide collaborative clinical trials network focused on preventing the sexual transmission of HIV. Recognizing the importance of microbicides research to HIV/AIDS prevention, the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), established the Microbicide Trials Network (MTN) in 2006, with co-funding from the NIH’s National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The MTN brings together international investigators and community and industry partners devoted to reducing the sexual transmission of HIV through the development and evaluation of products used orally or applied topically.