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HIV/AIDS prevention news stories
VOICE study, a major HIV prevention trial for
Volume 1, Issue 29
women, is launched in Zimbabwe
September 22-28, 2009
from eurekalert.org
Testing ARVs as prevention instead of treatment—
PITTSBURGH, SEPT. 16, 2009 – Hopeful that some of the
same antiretroviral (ARV) drugs used to treat HIV infection can
also prevent it, researchers from the Microbicide Trials
Network have enrolled the first participants into a new,
large-scale clinical trial testing two approaches of the strategy
in women.
The VOICE Study – Vagina and Oral Interventions to Control the Epidemic – will help determine whether applying a vaginal microbicide gel containing an ARV every day or taking an oral ARV tablet once a day can reduce a woman's risk of While the study's primary aim is to evaluate the safety and effectiveness of the two regimens, an important question VOICE will also address is which of the two – the tablet or the gel – women will actually be more inclined to use. It is the first HIV prevention trial testing these two different approaches in the same study and the first effectiveness trial of a microbicide in which women use the gel every day instead of only at the time of sex. Up to 5,000 women will be enrolled in VOICE at clinical trial sites in Uganda, South Africa, Zambia and Zimbabwe. Pending government approval, the study may also be conducted in Malawi. The Spilhaus Clinical Research Site at the University of Zimbabwe-University of California-San Francisco (UZ-UCSF) Clinical Trials Unit in Harare, began enrolling trial participants this week.
VOICE is being conducted under the leadership of the U.S. National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), which is based at the University of Pittsburgh and Magee-Womens "The HIV prevention field has not been without its share of disappointments. So, naturally we are excited that in VOICE we have not just one, but two promising approaches to evaluate. Hopefully, we'll find that ARVs, which helped turn the tide in the treatment of HIV, can be a prevention powerhouse, too," said Mike Chirenje, M.D., FRCOG, associate professor and consultant gynecologist in the department of obstetrics and gynecology at the University of Zimbabwe in Harare and co-chair of the VOICE Study. Women represent nearly 60 percent of adults living with HIV in sub-Saharan Africa, and in several southern African countries young women are at least three times more likely to be HIV-positive than young men. In most cases, women acquire HIV through sexual intercourse with an infected male partner. Although correct and consistent use of male condoms has been shown to prevent HIV infection, women often cannot control if or when condoms are used by their male partners. Moreover, women are twice as likely as their male partners to acquire HIV during unprotected sex, due in part to biological factors that make them more susceptible to infection. "Women need safe and effective methods for preventing HIV that they can control themselves. Importantly, women need methods that they are willing and able to use, because no approach can be truly effective if she leaves it in her purse or hidden in a drawer," added Jeanne Marrazzo, M.D., M.P.H., associate professor of medicine in the division of allergy and infectious diseases at the University of Washington in Seattle, U.S.A., and VOICE Study co-chair with Dr. Chirenje. Two ARV tablets are being tested in VOICE: tenofovir and Truvada®. Tenofovir, short for tenofovir disoproxil fumarate (TDF), is also known by the brand name Viread®, while Truvada is the brand name for a combination drug that contains tenofovir and another active ingredient called emtricitabine (FTC). Both are approved for treating HIV as part of antiretroviral therapy (ART). While at least three ARVs are typically used for ART, a single ARV tablet taken once a day is the regimen being tested for HIV prevention in current trials, including VOICE, an approach called The vaginal microbicide being evaluated in VOICE, tenofovir topical gel, contains the activated form of the same ingredient in the tenofovir oral tablet. It is among a newer class of candidate microbicides – substances intended to reduce or prevent the sexual transmission of HIV and other sexually transmitted infections when applied topically inside the vagina or rectum – with specific activity against HIV. This article continues on page 2 . . . REACH is a collaborative program of Northwestern University and the University of Ibadan with the support of the Bill & Melinda Gates Foundation. REACH aims to improve HIV/AIDS prevention strategies in Nigeria through social science and community-based research.
HIV/AIDS prevention news stories Page 2 “VOICE study, a major HIV prevention trial for women, is launched in Zimbabwe” continued, from page 1 Women in VOICE are randomly assigned to one of five study groups. Two groups will apply gel every day – either tenofovir gel or a placebo gel with no active ingredient. Three groups will be assigned to daily tablet regimens, taking either tenofovir, Truvada or a placebo tablet. Because the study is blinded, neither the participants nor the researchers will know who is in which gel or tablet group. Women will use the same product every day the entire time they are in the study, which is expected to be an average of 22.5 months. All participants will receive regular HIV testing and risk-reduction counseling, condoms, and testing for sexually transmitted infections (STIs). Staff will refer any participant who acquires HIV or an STI during the study to appropriate treatment and care in her community. Researchers at the Uganda and Zimbabwe sites are also conducting a companion study called VOICE B, or the Bone Mineral Density Sub-study. VOICE B will involve about 300 women who have been randomized to the oral tablet groups to determine the potential effects, if any, that the oral ARVs may have on bone health in HIV-negative women. Both studies were designed according to the most rigorous international medical practice and ethical standards and include numerous measures, beginning at the site level, intended to protect the safety and well-being of participants. All women participating in VOICE and VOICE B will provide written informed consent through a process that ensures they understand the procedures, as well as possible risks and benefits of the study. Safety will be monitored closely throughout their participation. To access the article online, go to http://www.eurekalert.org/pub_releases/2009-09/mtn-vsa091609.php Uganda: Children Fight HIV/Aids Stigma Through Sports
from allafrica.com
Children have upheld the fight against HIV/Aids stigma through sports, drama and dance. And last Saturday at Kyambogo University playground, children living with HIV/Aids from three NGOs turned up in large numbers to celebrate their success and share experiences by participating in a sports gala. The organisations included; Reach Out Mbuya which had 250 children participate with 87 HIV positive children and Makerere University in collaboration with John Hopkins University and Naguru Teenage Information Centre presenting 50 and 30 children respectively. The gala organised by Reach Out Mbuya, an NGO that assists vulnerable and HIV positive living children, saw over 167 HIV of them participate in various games ranging from athletics, volleyball, netball and football among others. The participants were awarded certificates and trophies. The games were intended to bring together children living positively from various organisations to share their experiences as well as create new friends, according to Reach Out Mbuya, Human Resource and Communications Manager, Ms Lydia Tamale. "Children are expected to make friends and share experiences on their HIV status," Ms Tamale said. In schools where they study, they might be discriminated against, so this gives them that opportunity." The organisations care for over 1100 vulnerable and HIV positive children countrywide. The children were however encouraged to abstain from sex and fight against the stigma to remain healthy. "Both negative and positive living children should abstain from sex to remain healthy," Josephine Nabukenya, a teenager from Caltec Academy said. She said people should fight the HIV/Aids stigma and discrimination against children living with the disease. The Assistant Commissioner for children in the Ministry of Gender, Labour and Social Development, Mr James Kabogoza said HIV positive children participation in sports activities creates discipline, sharing and good relationship among them. "Through such activities (sports), we can solve problems of stigma," Mr Kabogoza said. To access the article online, go to http://allafrica.com/stories/200909180481.html Newsletter continues on page 3 . . . REACH is a collaborative program of Northwestern University and the University of Ibadan with the support of the Bill & Melinda Gates Foundation. REACH aims to improve HIV/AIDS prevention strategies in Nigeria through social science and community-based research.
HIV/AIDS prevention news stories Page 3 KENYA: Country Tests Gels That Block Spread of HIV
from allafrica.com
Nairobi — Kenya has become a global centre for the testing of new medical compounds that block HIV transmission in women. More than five studies are either being planned or going on in the country. Human trials of various products - microbicides - are going on in Kisumu, Nairobi and Mombasa. Some of the candidates have been found to be safe for use in studies done in other countries. A microbicide is a substance that can be incorporated in a lubricant, gel or barrier such as a diaphragm that will stop HIV transmission According to the International Partnership for Microbicides chief executive officer, Dr Zeda Rosenberg, there is a new impetus to find new weapons in the fight against HIV following recent disappointments in the search for either a vaccine or a microbicide. In an interview in Nairobi at the weekend, Dr Rosenberg said the new urgency is because of the development of a new generation of very effective antiretroviral drugs that can also be used as microbicide gels. The new drugs, already in use by infected people or to prevent mother-to-child transmission, include Tenofovir Truvada and Dapivirine. Studies on Tenofovir, which is used before having sex to curb HIV transmission, are also going on in Kenya. HIV-negative people take anti-HIV drugs before sex to prevent transmission. Several strategies are being studied on microbicide delivery, including a daily dose of the gel. A more innovative way is a vaginal ring that releases the microbicide slowly for as long as a month. "This would be a powerful protection tool for women who may not be able to discuss and reach a decision on safe sex with their partners," said Dr Rosenberg. To access the article online, go to http://allafrica.com/stories/200909141659.html If you wish to leave the listserv, please send an email to REACH@northwestern.edu stating that you would like to be removed or send a “SIGNOFF REACH” command to LISTSERV@LISTSERV.IT.NORTHWESTERN.EDU. If you have any comments or questions about this newsletter, please feel free to email REACH@northwestern.edu. REACH is a collaborative program of Northwestern University and the University of Ibadan with the support of the Bill & Melinda Gates Foundation. REACH aims to improve HIV/AIDS prevention strategies in Nigeria through social science and community-based research.

Source: http://www.bcics.northwestern.edu/documents/reach/REACH_newsletter_v1_i29.pdf